This page shows what was measured, who it was measured in, and what that does not settle.
What Cariprazine does in the body
Schizophrenia, both phases of bipolar I disorder, and depression that has not responded to an antidepressant alone
Dopamine acts on a family of related receptors. Almost every antipsychotic aims at the one called D2. Cariprazine binds a close relative called D3 several times more tightly than it binds D2, and it turns both of them partly on rather than switching them off, in the way aripiprazole does. D3 receptors are concentrated in the parts of the brain that handle motivation and reward, which is the reasoning behind testing it against the symptoms of schizophrenia that look like an absence of drive. It also produces a metabolite that is active in the same way and clears from the body over weeks, so both the benefits and the side effects build up and fade slowly.
What happened in people
A 1.46-point advantage over risperidone on the PANSS negative-symptom factor at 26 weeks (95% CI -2.39 to -0.53, p=0.0022, effect size 0.31) in 461 patients
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
The limit that matters most
The only drug in this class with randomised evidence of superiority over another antipsychotic on negative symptoms
Where it acts
Mesolimbic and mesocortical dopamine synapses, with the D3 receptor — densest in the ventral striatum and the islands of Calleja — as the distinguishing target
Kind of result
Symptoms and quality of life
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · F6RJL8B278 · read 2026-08-29
Its recorded molecular formula is C21H3, weighing 463.9 g/mol.
US prescribing information · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 166 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Change from baseline to week 26 in the PANSS factor score for negative symptoms, in adults with stable schizophrenia of over two years and predominant negative symptoms for over six months
✓ The study showed what it set out to show
Who was studied
EudraCT 2012-005485-36 (cariprazine versus risperidone in predominant negative symptoms)
Least-squares mean change -8.90 on cariprazine against -7.44 on risperidone; difference -1.46 (95% CI -2.39 to -0.53), p=0.0022, effect size 0.31
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. There was no placebo arm, so the trial establishes superiority over risperidone rather than efficacy against negative symptoms as such. Funding was from Gedeon Richter, the originator. 77% of each group completed the 26 weeks.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule taken once daily, with or without food
Interval reported. 95% CI -2
Written into the record, not signed off as a reviewed claim.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
NCT01469377 — phase 2 study of cariprazine as adjunctive therapy in major depressive disorder, posted results (NCT01469377) · a recorded source, not a stored snapshot
Change from baseline in MADRS total score, cariprazine added to an antidepressant in major depressive disorder
Least-squares mean change -7.7 against -7.5 on placebo; difference -0.2 (95% CI -1.6 to 1.2), p=0.7948
Repeated elsewhere
Failed to Replicate
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. The largest of the three adjunctive depression trials and unambiguously null, on the Sheehan Disability Scale as well as the MADRS. The indication was granted on the two positive dose arms in the other two trials.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule taken once daily, with or without food
Interval reported. 95% CI -1
Written into the record, not signed off as a reviewed claim.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
NCT01469377 — phase 2 study of cariprazine as adjunctive therapy in major depressive disorder, posted results (NCT01469377) · a recorded source, not a stored snapshot
Change from baseline to week 6 in MADRS total score, cariprazine added to an antidepressant after inadequate response
1.5 mg arm difference -2.5 (95% CI -4.17 to -0.89), p=0.0050; 3 mg arm difference -1.5 (95% CI -3.16 to 0.12), p=0.0727
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Only one of the two arms separated, and it was the lower one, which reverses the direction seen in the phase 2 trial where the higher range succeeded and the lower failed.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule taken once daily, with or without food
Interval reported. 95% CI -4
Written into the record, not signed off as a reviewed claim.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
NCT01469377 — phase 2 study of cariprazine as adjunctive therapy in major depressive disorder, posted results (NCT01469377) · a recorded source, not a stored snapshot
Change from baseline in MADRS total score at week 8, cariprazine added to an antidepressant in major depressive disorder
Lower dose range difference -0.9 (95% CI -2.4 to 0.6), p=0.2404; higher dose range difference -2.2 (95% CI -3.7 to -0.6), p=0.0114
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. One of two arms separated. Taken with the two phase 3 trials, two of five active arms across roughly 2,600 patients beat placebo, and the successful amounts are not consistent between trials.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule taken once daily, with or without food
Interval reported. 95% CI -2
Written into the record, not signed off as a reviewed claim.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
NCT01469377 — phase 2 study of cariprazine as adjunctive therapy in major depressive disorder, posted results (NCT01469377) · a recorded source, not a stored snapshot
Time to first relapse of any mood episode during the double-blind treatment period in bipolar I disorder
✗ The study did not show it
Who was studied
NCT03573297
How many people
901
Study design
Double-blind placebo-controlled randomised-withdrawal trial in a dose-reduction paradigm
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Hazard ratio 0.83 (95% CI 0.48 to 1.43), p=0.5745 for the lower arm and 0.89 (95% CI 0.52 to 1.51), p=0.6308 for the higher arm
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Median time to relapse was not reached in any group. Cariprazine has acute bipolar I indications for both mania and depression and no maintenance indication.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral capsule taken once daily, with or without food
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
NCT01469377 — phase 2 study of cariprazine as adjunctive therapy in major depressive disorder, posted results (NCT01469377) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Cariprazine
What a person takes: Oral capsule taken once daily, with or without food.
The measurement behind this step
There is no injectable and no long-acting form, and none is needed in the usual sense: the drug behaves like a slow-release product because of its own metabolite. Cariprazine and desmethylcariprazine reach steady state within one to two weeks, while didesmethylcariprazine approaches steady state only at week four to eight and reaches about four times the parent's concentration by twelve weeks. Clearance is primarily by CYP3A4, with a minor CYP2D6 contribution, so strong inhibitors and inducers of CYP3A4 materially change exposure.
Getting in
A once-daily capsule that takes weeks to reach full effect
Cariprazine is a capsule taken once a day. Unlike most tablets it keeps accumulating for a month or two, because one of the molecules the body makes from it clears very slowly.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Cariprazine and desmethylcariprazine reach steady state at around week 1 to 2. Didesmethylcariprazine, which is pharmacologically equipotent to the parent, only approaches steady state at week 4 to 8, and some patients had not reached it at 12 weeks. By 12 weeks its concentration is about 400% of the parent's.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
Reaching the cell
The liver makes two more active molecules from it
The liver strips methyl groups off cariprazine in two steps, and both products are active in the same way as the original. The second one is the one that lingers.
╌╌Measured in animals. A result in animals says what to test next. It does not say what happens in people.
The measurement behind this step
Demethylation is primarily CYP3A4-mediated, with a minor CYP2D6 contribution. Both desmethylcariprazine and didesmethylcariprazine have in vitro receptor binding profiles similar to the parent and are described in the label as pharmacologically equipotent to it. Half-lives estimated from time to steady state are 2 to 4 days, 1 to 2 days and approximately 1 to 3 weeks respectively.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
What it acts on
It binds D3 several times more tightly than D2, and turns both partly on
Almost every drug in this class aims at the D2 dopamine receptor. Cariprazine holds on to its close relative D3 six to eight times more tightly, and rather than switching either off it turns them partly on.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Partial agonism at D3 with Ki 0.085 nM and at D2 with Ki 0.49 nM (D2L) and 0.69 nM (D2S), plus partial agonism at 5-HT1A (2.6 nM) and antagonism at 5-HT2B (0.58 nM) and 5-HT2A (18.8 nM). D3 receptors are concentrated in the ventral striatum and islands of Calleja, regions associated with motivation and reward, which is the anatomical basis of the negative-symptom hypothesis.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
The change it makes
The proposed effect is on drive rather than on hallucinations
Blocking D2 dampens hallucinations and delusions. The argument for D3 is different: that partly activating it in the circuits that handle motivation might lift the flatness and withdrawal that antipsychotics normally leave untouched or worsen.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
The one randomised test of that proposition gave a least-squares mean difference of -1.46 PANSS-FSNS points against risperidone at 26 weeks (95% CI -2.39 to -0.53, p=0.0022, effect size 0.31), in patients with predominant negative symptoms for over six months. The label's own mechanism sentence attributes efficacy to D2 and 5-HT1A partial agonism and 5-HT2A antagonism, and states the mechanism is unknown.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
What that does for a person
Symptoms improve, akathisia appears, and everything moves slowly
Effects on symptoms are real and modest. The characteristic complaint is restlessness. Because of the slow-clearing metabolite, both the benefit and the side effects arrive and leave over weeks rather than days.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Akathisia, extrapyramidal symptoms, insomnia and nausea are the characteristic adverse reactions, consistent with a dopamine partial agonist. The label states that at three times the maximum recommended amount cariprazine does not prolong the QTc interval to a clinically relevant extent. Section 5.6 directs monitoring for adverse reactions for several weeks after starting and with each change, because of the long half-life.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Adults and adolescents with schizophrenia, adults and children with bipolar mania, adults with bipolar depression, and adults whose depression has not responded to an antidepressant alone. The last of those is the largest population by far.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of VRAYLAR for the treatment of schizophrenia have not been established in pediatric patients less than 13 years of age.”
US prescribing information · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · read 2026-08-30
On older people, the label states: “Clinical trials of VRAYLAR did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients.”
US prescribing information · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VRAYLAR during pregnancy.”
US prescribing information · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Lactation studies have not been conducted to assess the presence of cariprazine in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · read 2026-08-30
On people with reduced liver function, the label states: “No dosage adjustment for VRAYLAR is required in patients with mild to moderate hepatic impairment (Child-Pugh score between 5 and 9) [ see C linical Pharmacology ( 12.3 ) ] .”
US prescribing information · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · read 2026-08-30
On people with reduced kidney function, the label states: “No dosage adjustment for VRAYLAR is required in patients with mild to moderate (CrCL ≥ 30 mL/minute) renal impairment [ see Clinical Pharmacology ( 12.3 ) ] .”
US prescribing information · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · read 2026-08-30
Where the result stopped carrying
NCT01715805, the largest adjunctive depression trial at 1,022 patients, missed by 0.2 MADRS points at p=0.7948
NCT03573297, the 901-patient bipolar relapse-prevention trial, missed on both arms
The dose that worked in the phase 2 depression trial was the higher one; the dose that worked in the later phase 3 was the lower one, and the higher arm failed there
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
There was nothing to correct
Where a level is already normal, topping it up may change nothing.
On this record: A pharmacokinetic profile in which starting, changing and stopping all take weeks to register, with a dedicated label section about it
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral capsule taken once daily, with or without food
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S6.
No source is stored against this line.
What is in the pack
There is no injectable and no long-acting form, and none is needed in the usual sense: the drug behaves like a slow-release product because of its own metabolite.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold. The rest of the recorded wording: Cariprazine and desmethylcariprazine reach steady state within one to two weeks, while didesmethylcariprazine approaches steady state only at week four to eight and reaches about four times the parent's concentration by twelve weeks. Clearance is primarily by CYP3A4, with a minor CYP2D6 contribution, so strong inhibitors and inducers of CYP3A4 materially change exposure.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
The United States label carries boxed warnings for increased mortality in elderly patients with dementia-related psychosis and for suicidal thoughts and behaviours in children, adolescents and young adults. Section 5.6, Late-Occurring Adverse Reactions, directs monitoring for several weeks after starting and after every change in amount because of the long half-life. Akathisia and extrapyramidal symptoms are the characteristic adverse reactions. Metabolic changes, leukopenia, neutropenia and agranulocytosis, orthostatic hypotension and syncope, seizures, neuroleptic malignant syndrome, tardive dyskinesia and cognitive and motor impairment are all in the label. At three times the maximum recommended amount the label states cariprazine does not prolong the QTc interval to a clinically relevant extent.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results showing p=0.7948 on the primary endpoint (NCT01… · a recorded source, not a stored snapshot
NCT03738215 — cariprazine as an adjunct to antidepressants after inadequate response, posted results (NCT03738215) · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral capsule taken once daily, with or without food
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
A recorded note compares this form with the others that are sold. It is kept below, word for word.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
The recorded note, unchanged: Cariprazine and desmethylcariprazine reach steady state within one to two weeks, while didesmethylcariprazine approaches steady state only at week four to eight and reaches about four times the parent's concentration by twelve weeks. Clearance is primarily by CYP3A4, with a minor CYP2D6 contribution, so strong inhibitors and inducers of CYP3A4 materially change exposure.
No source is stored against this line.
What is recorded as being sold
22 products list this as an active ingredient in the United States drug directory. 22 of them contain it and nothing else.
FDA National Drug Code directory · 61874-115 · read 2026-08-29
They are sold as capsule, gelatin coated and powder, taken oral.
FDA National Drug Code directory · 61874-115 · read 2026-08-29
The regulator's established pharmacologic class for it is atypical antipsychotic [epc].
FDA National Drug Code directory · 61874-115 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · read 2026-08-29
Vraylar is oral at 3 ., recorded as fda label in effect 2025-12-18 in the United States.
US prescribing information · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Cariprazine studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That cariprazine's effects follow from its D3 preference — the label states the mechanism is unknown and its own proposed mechanism names D2, 5-HT1A and 5-HT2A
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That it treats negative symptoms — the one trial had no placebo arm and shows superiority over risperidone by 1.46 points
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the adjunctive depression evidence is solid — two of five active arms separated, the largest trial was null, and the effective amounts disagree between trials
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That its clinical advantage over generic aripiprazole justifies a 380-fold price difference — the two have never been compared
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Cariprazine are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
The first antipsychotic to beat another one on negative symptoms — by 1.46 points
In plain words
Over 26 weeks, 461 patients with long-standing schizophrenia and predominantly negative symptoms took either cariprazine or risperidone. Cariprazine did better on the negative-symptom score, by about one and a half points on a scale where both groups improved by seven to nine.
What was measured
Least-squares mean difference in PANSS-FSNS change at week 26: -1.46 (95% CI -2.39 to -0.53), p=0.0022, effect size 0.31
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
This phase 3b trial, registered as EudraCT 2012-005485-36 and funded by Gedeon Richter, enrolled adults aged 18 to 65 with stable schizophrenia of more than two years and predominant negative symptoms for more than six months, at 66 centres in 11 European countries. 461 were randomised 1:1 to fixed-dose cariprazine or risperidone for 26 weeks after a two-week discontinuation of previous medication, with 77% of each group completing. Least-squares mean change in the PANSS negative-symptom factor score was -8.90 on cariprazine against -7.44 on risperidone, least-squares mean difference -1.46 (95% CI -2.39 to -0.53), p=0.0022, effect size 0.31. Treatment-emergent adverse events occurred in 54% on cariprazine and 57% on risperidone. Two things are true at once: this is the first randomised demonstration that one antipsychotic outperforms another on the symptom domain that most determines whether a person works or lives independently, and the difference is 1.46 points at an effect size of 0.31 in a trial with no placebo arm, so it establishes superiority over risperidone rather than efficacy against the symptoms themselves.
Written into the record, not signed off as a reviewed claim
A 1,022-patient depression trial missed by two tenths of a point
In plain words
The largest trial of cariprazine added to an antidepressant enrolled 1,022 people. The depression score improved by 7.7 points on the drug and 7.5 on placebo. The difference was 0.2 points, with a p-value of 0.79.
What was measured
Least-squares mean difference in MADRS change: -0.2 (95% CI -1.6 to 1.2), p=0.7948
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
NCT01715805, a phase 3 double-blind placebo-controlled study of cariprazine as adjunctive therapy in major depressive disorder run by Forest Laboratories, enrolled 1,022 patients. Least-squares mean change from baseline in MADRS total score in the double-blind period was -7.7 on cariprazine plus antidepressant against -7.5 on placebo plus antidepressant, a difference of -0.2 with a 95% confidence interval from -1.6 to 1.2 and p=0.7948. The secondary endpoint, change in Sheehan Disability Scale score, was -3.7 against -3.1, difference -0.7 (95% CI -1.9 to 0.5), p=0.2784. This trial is larger than the two that produced the positive dose arms and it is unambiguously null on both endpoints. Its results are posted on ClinicalTrials.gov and it is rarely mentioned alongside the indication it did not support.
Source
NCT01715805 — Phase 3 study of cariprazine as adjunctive therapy in major depressive disorder, posted results, Forest Laboratories
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Two positive dose arms out of five across 2,600 patients, and the doses disagree
In plain words
Three trials tested cariprazine added to an antidepressant. Across five drug arms and about 2,600 patients, two arms beat placebo. In one trial the higher amount worked and the lower did not; in the other the lower worked and the higher did not.
What was measured
MADRS differences against placebo across five active arms: -0.9 (p=0.2404), -2.2 (p=0.0114), -0.2 (p=0.7948), -2.5 (p=0.0050), -1.5 (p=0.0727)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
NCT01469377, a phase 2 trial in 819 patients, tested two dose ranges: the lower gave a MADRS difference of -0.9 (95% CI -2.4 to 0.6), p=0.2404, and the higher gave -2.2 (95% CI -3.7 to -0.6), p=0.0114. NCT01715805, a phase 3 trial in 1,022 patients, tested a single arm and gave -0.2 (95% CI -1.6 to 1.2), p=0.7948. NCT03738215, a phase 3 trial in 759 patients, tested two fixed amounts: the 1.5 mg arm gave -2.5 (95% CI -4.17 to -0.89), p=0.0050, and the 3 mg arm gave -1.5 (95% CI -3.16 to 0.12), p=0.0727. So of five active arms, two separated from placebo. More striking is the direction: the amount that worked in the phase 2 trial sat above the one that failed there, while in the later phase 3 the smaller amount worked and the larger one did not. That is not a dose-response relationship in either direction, and it is the pattern that appears when a real but small effect is being sampled repeatedly. The adjunctive major depressive disorder indication was granted on this evidence base.
Source
NCT01469377, NCT01715805 and NCT03738215 — posted results for cariprazine as adjunctive therapy in major depressive disorder
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
A 901-patient bipolar relapse-prevention trial missed on both arms
In plain words
A trial randomised 901 people to two amounts of cariprazine or placebo and measured how long until the next mood episode. Neither amount separated from placebo, and there is no bipolar maintenance indication.
What was measured
Hazard ratios for time to first relapse of any mood episode: 0.83 (95% CI 0.48 to 1.43) and 0.89 (95% CI 0.52 to 1.51)
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
NCT03573297, an AbbVie double-blind placebo-controlled randomised-withdrawal trial in a dose-reduction paradigm, enrolled 901 patients and measured time to first relapse of any mood episode during the double-blind period. The lower arm gave a hazard ratio of 0.83 (95% CI 0.48 to 1.43), p=0.5745; the higher arm gave 0.89 (95% CI 0.52 to 1.51), p=0.6308. Median time to relapse was not reached in any of the three groups. Both confidence intervals span 1.00 comfortably. Cariprazine holds acute indications in bipolar I disorder for both mania and depression, and no maintenance indication, which is consistent with this result.
Source
NCT03573297 — randomised-withdrawal trial of cariprazine in a dose-reduction paradigm for prevention of relapse in bipolar I disorder, posted results, AbbVie
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
An active metabolite with a half-life of up to three weeks, four times the parent
In plain words
Cariprazine turns into a second active molecule that clears from the body over weeks rather than days and builds up to about four times the concentration of the drug itself. The label tells prescribers to keep watching for side effects for weeks after any change.
What was measured
Half-life of didesmethylcariprazine approximately 1 to 3 weeks, reaching about 400% of parent concentration by 12 weeks
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 12.3 of the label records that activity is mediated by cariprazine and by two major metabolites, desmethylcariprazine and didesmethylcariprazine, which are pharmacologically equipotent to the parent. Half-lives estimated from time to steady state are 2 to 4 days for cariprazine, 1 to 2 days for desmethylcariprazine and approximately 1 to 3 weeks for didesmethylcariprazine. Cariprazine and desmethylcariprazine reach steady state at around week 1 to week 2; didesmethylcariprazine only approaches it at around week 4 to week 8, and the label states the time to steady state for it was variable across patients, with some not achieving it by the end of a 12-week study. By 12 weeks its mean concentration is approximately 400% of the parent's. Section 5.6, headed Late-Occurring Adverse Reactions, instructs monitoring for adverse reactions and patient response for several weeks after starting and with each change in amount. The practical consequence is that a six-week trial of this drug measures a partially loaded system, and that stopping it does not end exposure for some weeks.
Source
United States prescribing information for cariprazine, sections 5.6 and 12.3, via the openFDA drug label endpoint
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The D3 story is a proposal, and the label says the mechanism is unknown
In plain words
Cariprazine is marketed on binding the D3 dopamine receptor more tightly than the D2 receptor. The binding numbers are real. The label still states that the mechanism of action is unknown.
What was measured
That cariprazine's clinical effects follow from its D3 preference — the affinity ratio is measured, and the label's own mechanism sentence names D2, 5-HT1A and 5-HT2A rather than D3
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 12.2 gives the affinities: D3 Ki 0.085 nM against D2L 0.49 nM and D2S 0.69 nM, a six-to-eight-fold preference that is genuine and unmatched in this class. Section 12.1 nonetheless reads: "The mechanism of action of cariprazine is unknown. However, the efficacy of cariprazine could be mediated through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors." Note which receptors that sentence names — D2, 5-HT1A and 5-HT2A — and which it does not. The label's own proposed mechanism does not rest on D3. The chain from a binding constant to a clinical effect requires that the receptor be occupied at clinical exposures, that occupancy produce the intended functional change, and that the change explain the outcome; for D3 the first link is measured and the rest are argued.
Source
United States prescribing information for cariprazine, sections 12.1 and 12.2, via the openFDA drug label endpoint
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Three hundred and eighty times the price of the drug with the same mechanism
In plain words
Cariprazine costs about fifty dollars a capsule at what pharmacies pay. Aripiprazole, the first dopamine partial agonist and a generic, costs about thirteen cents.
What was measured
That cariprazine's clinical advantage over generic aripiprazole justifies its price — the two have never been compared in a trial
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The CMS National Average Drug Acquisition Cost survey effective 19 August 2026 lists cariprazine at US$50.85 per capsule as a brand product across 10 listed products, and generic aripiprazole at about thirteen cents per tablet. No head-to-head randomised trial of cariprazine against aripiprazole exists. What distinguishes cariprazine on measured evidence is one 26-week trial showing superiority over risperidone on negative symptoms by 1.46 points, and the D3 affinity ratio. What it shares with aripiprazole is the partial-agonist mechanism, the adjunctive depression indication, and the schizophrenia and bipolar indications. A price ratio of roughly 380 to 1 is a fact about markets rather than a fact about pharmacology, and no verifiable cost-of-production figure exists for either molecule to place beside it.
Source
CMS National Average Drug Acquisition Cost survey, effective 19 August 2026; Németh G et al., Lancet 2017;389:1103-1113
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
Where else this substance is registered
FDA substance identifier (UNII)
F6RJL8B278
RxNorm concept
1667660
Checks this page had to pass
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Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
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Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
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Suppression classes recorded: S6.
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Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
4 approved applications cover products containing this substance. The earliest was NDA204370, approved 20150917 to ABBVIE.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A dopamine partial agonist with six-to-eight-fold preference for the D3 receptor over D2, the only antipsychotic to have beaten an active comparator on negative symptoms in a randomised trial (1.46 PANSS-FSNS points against risperidone over 26 weeks, effect size 0.31), whose add-on depression indication rests on two positive dose arms out of five across 2,600 patients including one entire 1,022-patient trial that missed by 0.2 points, and whose active metabolite has a half-life of one to three weeks.
Recorded evidence blocks (10)
Q2
On the Cariprazine label: indicated for what?
"1 . INDICATIONS AND USAGE VRAYLAR ® is indicated for: • Treatment of schizophrenia in adult and pediatric patients 13 years of age and older [see Clinical Studies ( 14.1 )] • Acute treatment of manic or mixed episodes associated with bipolar I disorder in adult and pediatric patients 10 years of age and older [see…": indications and usage on Cariprazine's label. DailyMed label · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · 2025-12-18
Q3
50 registered trials of Cariprazine — at which phases?
"FDA Released Allergan from this post marketing requirement"; 5 of 50 registered studies
Show the evidence
Trial
NCT03593213
terminated; "FDA Released Allergan from this post marketing requirement"
NCT04771299
terminated; "Research support no longer available."
NCT04965272
withdrawn; "Strategic Decision"
NCT05060549
withdrawn; "Funding decision"
NCT05368558
terminated; "Strategic considerations"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Cariprazine used Cariprazine 3 mg — over how long?
studies of Cariprazine used the recorded amount. ClinicalTrials.gov · 2026-09-01
14 recorded entries; human; also "Cariprazine 3 mg", "Cariprazine 6 mg", "Cariprazine 12.5 mg"
Show the evidence
human
NCT00862992
Cariprazine 3 mg
NCT00862992
Cariprazine 6 mg
NCT00862992
Cariprazine 12.5 mg
NCT01625000
MP-214 3mg
NCT01625000
MP-214 6mg
NCT01625000
MP-214 9mg
8 more recorded rows
humanNCT04965272
Cariprazine 0.75 mg/day
humanNCT04965272
Cariprazine 1.5 mg/day
humanNCT04965272
Cariprazine 3.0 mg/day
humanNCT05063201
Cariprazine 1.5 MG
humanNCT07722728
Vraylar® 1.5 mg
humanNCT07722728
Vraylar® 3.0 mg
humanNCT07722728
Vraylar® 4.5 mg
humanNCT07722728
Vraylar® 6.0 mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Cariprazine's half-life is 2 to 4 days — which schedules were studied?
2 to 4 days, the half-life Cariprazine's label states: "The half-lives based on time to reach steady state, estimated from the mean concentration-time curves, are 2 to 4 days for cariprazine, about 1 to 2 days for DCAR, and approximately 1 to 3 weeks for DDCAR." DailyMed label · 4b5f7c65-aa2d-452a-b3db-bc85c06ff12f · 2025-12-18
Show the evidence
half lifepharmacokinetics
2 to 4 days; The half-lives based on time to reach steady state, estimated from the mean concentration-time curves, are 2 to 4 days for cariprazine, about 1 to 2 days for DCAR, and approximately 1 to 3 weeks for DDCAR.
metabolismpharmacokinetics
Elimination Metabolism Cariprazine is extensively metabolized by CYP3A4 and, to a lesser extent, by CYP2D6 to DCAR and DDCAR.
recorded 2025-12-18 · last checked 2026-09-04
Q7
Which 4 trials of Cariprazine posted no result?
Posted no result
4 of 4 completed trials
Registrations
NCT01376076, NCT02165098, NCT04382885 and NCT05384483
Completion dates
oldest 2012-02; newest 2024-04-15
Show the evidence
Trial
NCT01376076
2012-02
NCT02165098
2016-02
NCT04382885
2021-12-10
NCT05384483
2024-04-15
Q8
At the median, Cariprazine's trials enrolled 236 people — anything larger?
Median enrolment
236
Largest enrolment
2726
Registered trials counted
50
Q9
What do 193 spontaneous reports say about Cariprazine — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Cariprazine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 193 reaction mentions were counted: weight increased 34; akathisia 28; anxiety 21; tardive dyskinesia 19. FAERS via Open Targets · CHEMBL2024517 · 2026-06-24
Show the evidence
weight increased
34
akathisia
28
anxiety
21
tardive dyskinesia
19
tremor
19
suicide attempt
16
4 more recorded rows
agitation
16
mania
14
restlessness
13
extrapyramidal disorder
13
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Cariprazine's label not list?
Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ].
drug_interactions
Intervention: If VRAYLAR is used with a strong or moderate CYP3A4 inhibitor, reduce VRAYLAR dosage [see D osage and A dministration ( 2.6 ) ] .
drug_interactions
CYP3A4 Inducers Clinical Impact: CYP3A4 is responsible for the formation and elimination of the active metabolites of cariprazine.
drug_interactions
The effect of CYP3A4 inducers on the exposure of VRAYLAR has not been evaluated, and the net effect is unclear [see Clinical Pharmacology ( 12.3 ) ].
drug_interactions
Intervention: Concomitant use of VRAYLAR with a CYP3A4 inducer is not recommended [see Dosage and Administration ( 2.1 , 2.6 ) ] .
drug_interactions
Strong and Moderate CYP3A4 inhibitors: Reduce VRAYLAR dosage ( 2.6 , 7 ) CYP3A4 inducers: Concomitant use is not recommended ( 2.6 , 7 )
2 more recorded rows
Interaction statementpharmacokinetics
Elimination Metabolism Cariprazine is extensively metabolized by CYP3A4 and, to a lesser extent, by CYP2D6 to DCAR and DDCAR.
Interaction statementpharmacokinetics
DCAR is further metabolized into DDCAR by CYP3A4 and CYP2D6.
ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
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This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.