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Cerivastatin

  • Withdrawn substance
  • Withdrawn
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Cerivastatin does in the body

Statins block the enzyme the liver uses to build cholesterol, so the liver pulls more cholesterol out of the blood to compensate.

They also reach muscle, where the same blocked pathway can make muscle cells fail. Cerivastatin was unusually potent per milligram and, critically, cleared by two liver enzyme routes that gemfibrozil interferes with. Combine the two and blood levels of the statin climb far above what the dose implies, which is how a rare complication became a common one.

Why people take it. Formerly used to lower cholesterol.

What happened in people

Hospital-treated muscle breakdown occurred about twelve times as often as with three competing cholesterol medicines.

Reviewed first-read answer

Where this came from

A person wrote this and a reviewer approved it against this exact record. It carries no effect size.

A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.

No source is stored against this line.

The limit that matters most

It was never shown to prevent heart attacks before leaving the market.

Where it acts
Hepatocyte cytoplasm; the toxicity site is skeletal muscle
Kind of result
A step measured inside a person
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 · AM91H2KS67 · read 2026-08-29

  • Its recorded molecular formula is C26H34FNO5, weighing 459.5.

    PubChem record · 446156 · read 2026-08-29

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

A reviewer approved this sentence against this exact record and its sources.

The limit a reviewer approved as the one that matters most here.

The four opening statements run to 100 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.

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 peopleRead 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.

Incidence of hospitalised rhabdomyolysis per 10,000 person-years by lipid-lowering drug and combination

The study showed what it set out to show

Who was studied
FDA / HMO Research Network rhabdomyolysis cohort (Graham et al.)
How many people
252460
Study design
Retrospective inception-cohort study across 11 managed care plans
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Cerivastatin monotherapy 5.34 per 10,000 person-years (95% CI 1.46 to 13.68) versus 0.44 (0.20 to 0.84) for atorvastatin, pravastatin or simvastatin; cerivastatin plus fibrate 1,035 (389 to 2,117)
Repeated elsewhere
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. The cohort ends 30 June 2001, five weeks before withdrawal, so it captures the drug at its peak use and cannot include events after market removal.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, once daily in the evening (0.2 to 0.8 mg)

Interval reported. 95% CI 1

Written into the record, not signed off as a reviewed claim.

Timing and content of the evidence available to the sponsor versus to prescribers on cerivastatin-associated rhabdomyolysis

The study showed what it set out to show

Who was studied
Postmarketing surveillance review (Psaty et al., including litigation documents)
How many people
0
Study design
Systematic review of published and unpublished postmarketing data
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Not a hypothesis test; the finding is documentary — interaction case reports within ~100 days of launch, contraindication added after more than 18 months
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. Company analyses of FDA adverse event reporting data from late 1999 and early 2000, showing increased rhabdomyolysis risk versus atorvastatin, were to the authors' knowledge never published.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, once daily in the evening (0.2 to 0.8 mg)

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 2 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 bodyRead 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.

  1. Start

    Cerivastatin

    What a person takes: Oral tablet, once daily in the evening (0.2 to 0.8 mg).

    The measurement behind this step

    Sub-milligram once-daily tablet. Dual clearance by CYP2C8 and CYP3A4 with OATP1B1-mediated hepatic uptake, which is an unusually interaction-exposed disposition for a drug given to patients who are frequently on several other agents.

  2. Getting in

    A sub-milligram tablet, taken once daily

    Doses were a fraction of a milligram, where other statins are given in tens of milligrams. It was the most potent statin per milligram ever sold.

    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
  3. Reaching the cell

    Carried into liver cells by a transporter

    A pump on the surface of liver cells drags the drug inside, which is where it is supposed to act.

    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

    Hepatic uptake is mediated principally by OATP1B1 (SLCO1B1). This transporter step concentrates statins in the liver and is also the first point at which the gemfibrozil interaction bites.

  4. What it acts on

    Blocks HMG-CoA reductase

    It occupies the site where the enzyme normally grips its substrate, so the liver cannot make cholesterol from scratch.

    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

    The 3,5-dihydroxyheptenoic acid side chain mimics the tetrahedral intermediate of HMG-CoA reduction and binds the catalytic site of HMG-CoA reductase with high affinity, blocking mevalonate synthesis.

  5. The change it makes

    LDL receptors go up; muscle mevalonate goes down

    The liver compensates by pulling more cholesterol out of the blood. Muscle cells, which also need the blocked pathway, run short of the products that keep them intact.

    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

    Depleted hepatic sterol triggers SREBP-2 activation and LDL receptor upregulation, lowering plasma LDL. In skeletal muscle the same mevalonate blockade depletes ubiquinone and the prenylated small GTPases needed for membrane maintenance, which is the accepted route to statin myopathy.

  6. What that does for a person

    LDL falls; in some patients the muscle dissolves

    Cholesterol came down as designed. In a fraction of patients — far larger than for other statins — muscle broke down enough to injure the kidneys.

    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

    Measured endpoints: LDL reduction, versus 5.34 hospitalised rhabdomyolysis cases per 10,000 person-years on monotherapy and 1,035 per 10,000 person-years with a fibrate. Myoglobin released from ruptured myocytes precipitates in renal tubules and causes acute kidney injury, which is the mechanism of the 52 reported deaths.

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 unclearRead 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.

  • Nobody now. It was prescribed from 1997 to 2001 as a cheaper, more potent-per-milligram alternative to the established statins.

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.

Where the result stopped carrying

  • Voluntary worldwide withdrawal by Bayer on 8 August 2001, less than four years after United States approval
  • The gemfibrozil contraindication was added more than 18 months after case reports first pointed to the interaction
  • 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 takeRead 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.

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 (11)
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.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. 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 takeRead 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

Withdrawn

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 tablet, once daily in the evening (0.2 to 0.8 mg)

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: S8.

No source is stored against this line.

What is in the pack

Sub-milligram once-daily tablet. Dual clearance by CYP2C8 and CYP3A4 with OATP1B1-mediated hepatic uptake, which is an unusually interaction-exposed disposition for a drug given to patients who are frequently on several other agents.

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 and what that means for what is in the pack.

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 takeRead 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

Withdrawn worldwide on 8 August 2001 for rhabdomyolysis. The measured harms are 5.34 hospitalised cases per 10,000 person-years on monotherapy, 1,035 per 10,000 person-years with a fibrate, and 52 deaths from rhabdomyolysis with renal failure reported at withdrawal. Risk concentrated at the 0.8 mg dose and in concomitant gemfibrozil use.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

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 unclearNothing found in the sources checked

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 tablet, once daily in the evening (0.2 to 0.8 mg)

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

Dual clearance by CYP2C8 and CYP3A4 with OATP1B1-mediated hepatic uptake, which is an unusually interaction-exposed disposition for a drug given to patients who are frequently on several other agents.

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 which forms are sold and how they compare.

No source is stored against this line.

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 takeRead 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, withdrawn medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Cerivastatin 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 unclearRead 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 LDL reduction by this particular statin implied the outcome benefit demonstrated for others in the class — cerivastatin never completed a cardiovascular outcome trial

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 statins are interchangeable within the class, when clearance route, potency per milligram and interaction profile differ enough to change the safety profile by an order of magnitude

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 unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records 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 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 Cerivastatin 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 peopleRead 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.

FDA cohort: 5.34 hospitalised rhabdomyolysis cases per 10,000 person-years
In plain words
Across a quarter of a million patients in eleven health plans, cerivastatin caused hospitalised muscle breakdown at about twelve times the rate of the three statins it competed with.
What was measured
Hospitalised rhabdomyolysis per 10,000 person-years by drug
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Drug-specific inception cohorts built from claims data across 11 US managed care plans, patients entered between 1 January 1998 and 30 June 2001. Among 252,460 patients treated with lipid-lowering agents there were 24 hospitalised rhabdomyolysis cases during treatment. Incidence per 10,000 person-years of monotherapy: atorvastatin, pravastatin or simvastatin pooled 0.44 (95% CI 0.20 to 0.84); cerivastatin 5.34 (95% CI 1.46 to 13.68); fibrate 2.82 (95% CI 0.58 to 8.24). Incidence during unexposed person-time was 0 (95% CI 0 to 0.48, p=0.056). The number needed to treat for one year to produce one case was 22,727 for statin monotherapy.
Source
Graham DJ et al., JAMA 2004;292:2585-2590
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
With a fibrate the rate was 1,035 per 10,000 person-years — about 1 in 10 per year
In plain words
Taken together with a fibrate, roughly one in ten patients per year was hospitalised with muscle breakdown. That is not a rare adverse event; that is what the drug did in that combination.
What was measured
Hospitalised rhabdomyolysis per 10,000 person-years, cerivastatin plus fibrate
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In the same cohort, combined cerivastatin-fibrate use gave an incidence of 1,035 per 10,000 person-years (95% CI 389 to 2,117), against 5.98 (95% CI 0.72 to 216.0) for atorvastatin, pravastatin or simvastatin combined with a fibrate. The number needed to treat for one year to observe one case ranged from 9.7 to 12.7 for cerivastatin plus fibrate, against 484 for older diabetic patients on any other statin plus fibrate. The authors' stated conclusion: "Cerivastatin combined with fibrate conferred a risk of approximately 1 in 10 treated patients per year."
Source
Graham DJ et al., JAMA 2004;292:2585-2590
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
Fifty-two deaths, and rhabdomyolysis ten times more common than with other statins
In plain words
The withdrawal followed 52 deaths from muscle breakdown leading to kidney failure. The rate was about ten times that of the five other statins then approved.
What was measured
Deaths from drug-related rhabdomyolysis reported at withdrawal
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Furberg and Pitt, writing immediately after the August 2001 withdrawal, recorded 52 deaths attributed to drug-related rhabdomyolysis progressing to renal failure. Risk was concentrated at the full 0.8 mg daily dose and in patients taking gemfibrozil concomitantly. Rhabdomyolysis was approximately ten times more common with cerivastatin than with the other five approved statins. The FDA also received and analysed fatal-rhabdomyolysis reports for cerivastatin specifically, published as a research letter in the New England Journal of Medicine in February 2002.
Source
Furberg CD, Pitt B. Curr Control Trials Cardiovasc Med 2001;2:205-207; Staffa JA, Chang J, Green L. N Engl J Med 2002;346:539-540
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 interaction was visible in company files about 100 days after launch
In plain words
Internal documents released in litigation showed the manufacturer had case reports pointing to the gemfibrozil interaction within roughly a hundred days of launch. The contraindication was added more than eighteen months later.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Psaty and colleagues reviewed internal company documents that entered the public record during litigation in Nueces County, Texas, alongside the published literature. Their findings: multiple case reports suggested a drug-drug interaction within approximately 100 days of the 1998 launch, but a contraindication for concomitant gemfibrozil was not added to the package insert for more than 18 months. Unpublished data available in July 1999 also indicated increased rhabdomyolysis risk with high-dose cerivastatin monotherapy. In late 1999 and early 2000 company scientists ran high-quality analyses of FDA adverse event reporting system data showing cerivastatin monotherapy substantially increased rhabdomyolysis risk compared with atorvastatin; to the authors' knowledge those analyses were never disseminated or published.
Source
Psaty BM, Furberg CD, Ray WA, Weiss NS. JAMA 2004;292:2622-2631
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
Approved on LDL cholesterol, withdrawn before any outcome trial reported
In plain words
The drug was licensed because it lowered a cholesterol number. Whether it prevented a single heart attack was never established, because it left the market before the trial that would have shown it finished.
What was measured
That LDL cholesterol reduction by cerivastatin implied the cardiovascular outcome benefit demonstrated for other statins, so the risk was worth accepting
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Cerivastatin was approved on the surrogate endpoint of LDL cholesterol reduction. Furberg and Pitt used the withdrawal to pose the question directly — "Should we continue to approve drugs on surrogate efficacy?" — and answered that decisions about drug use should rest on direct evidence from long-term clinical outcome trials. Their second question, "Are all statins interchangeable?", is answered by the same episode: the class shares a mechanism but not a safety profile, and the drug with the highest potency per milligram and the most interaction-prone clearance route was the one that failed. The benefit side of cerivastatin's risk-benefit calculation was, and remains, an inference from other statins' trials.
Source
Furberg CD, Pitt B. Curr Control Trials Cardiovasc Med 2001;2:205-207
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
The interaction is pharmacokinetic and was demonstrated in a three-day study
In plain words
A short pharmacokinetic study confirmed that gemfibrozil raises cerivastatin blood levels sharply. The problem was mechanical and predictable, not mysterious.
What was measured
Proportion of published rhabdomyolysis case reports occurring on cerivastatin plus gemfibrozil
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Psaty et al. record that although only a small percentage of cerivastatin users also took gemfibrozil, approximately half of the published rhabdomyolysis case reports came from that combination, and that a cerivastatin-gemfibrozil interaction was supported by the results of a three-day pharmacokinetic study. Mechanistically, cerivastatin is cleared by both CYP2C8 and CYP3A4 and taken up into hepatocytes by OATP1B1; gemfibrozil and particularly its 1-O-beta-glucuronide inhibit CYP2C8 and OATP1B1, so systemic exposure rises well beyond what the milligram dose predicts and muscle sees a concentration the label never contemplated.
Source
Psaty BM, Furberg CD, Ray WA, Weiss NS. JAMA 2004;292:2622-2631
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

Where else this substance is registered

FDA substance identifier (UNII)
AM91H2KS67
CAS registry number
145599-86-6
PubChem compound
446156
ChEMBL
CHEMBL1477
ChEBI
3558
WHO international nonproprietary name list entry
7083
RxNorm concept
596723
EMA substance identifier
100000082046
DrugBank
DB00439

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S8.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead 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.

  1. Withdrawn in Worldwide, 2001, for "musculoskeletal toxicity" (ChEMBL; Open Targets)

  2. Withdrawn in Worldwide, 2001, for "nephrotoxicity" (ChEMBL; Open Targets)

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was NDA020740, approved 19970626 to BAYER PHARMS.

    Drugs@FDA application register · NDA020740 · read 2026-08-29

  • Marketing status on the register: discontinued.

    Drugs@FDA application register · NDA020740 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

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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 statin approved on cholesterol numbers alone that produced hospitalised rhabdomyolysis at roughly twelve times the rate of atorvastatin, pravastatin or simvastatin, and about one case per ten patients per year when combined with a fibrate.

Recorded evidence blocks (3)

Approved in 1997, withdrawn in 2001: what happened to Cerivastatin in Worldwide?


Approved 1997, withdrawn 2001 in Worldwide; the register's words: "musculoskeletal toxicity". Open Targets drug warning · CHEMBL1200563 · 2026-06-24

4 recorded reasons; Worldwide

Show the evidence

Reason

  • "musculoskeletal toxicity"
  • "nephrotoxicity"
  • "musculoskeletal toxicity"
  • "nephrotoxicity"

recorded 2026-06-24 · last checked 2026-09-04

What do 26 spontaneous reports say about Cerivastatin — 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.

Cerivastatin appears in spontaneous reports to regulators. Across the 6 most-reported reaction terms, 26 reaction mentions were counted: drug hypersensitivity 7; myalgia 6; rhabdomyolysis 4; muscle spasms 4. FAERS via Open Targets · CHEMBL1200563 · 2026-06-24

Show the evidence
  • drug hypersensitivity
    7
  • myalgia
    6
  • rhabdomyolysis
    4
  • muscle spasms
    4
  • laboratory test abnormal
    3
  • congenital anomaly
    2

recorded 2026-06-24 · last checked 2026-09-04

Where do the label and the trials disagree about Cerivastatin?


"musculoskeletal toxicity" against "approved": withdrawal status vs register status for Cerivastatin.

OPEN_TARGETS_DRUG_WARNING, Drugs@FDA; 1 recorded pair

Show the evidence
  • OPEN_TARGETS_DRUG_WARNING CHEMBL1200563
    musculoskeletal toxicity; 2026-06-24
  • Drugs@FDA NDA020740
    approved; 2026-08-28
Where it is registered

Where it’s registered

Withdrawn in Worldwide, 2001, for "musculoskeletal toxicity" (ChEMBL; Open Targets)

Withdrawn in Worldwide, 2001, for "nephrotoxicity" (ChEMBL; Open Targets)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1200563
PubChem CID
23663992
CAS number
143201-11-0
RxCUI
221072
InChIKey
SEERZIQQUAZTOL-ANMDKAQQSA-N
Also called
CERIVASTATIN SODIUM, Cerivastatina, Cerivastatine, (+)-SODIUM (3R,5S,6E)-7-(4-(P-FLUOROPHENYL)-2,6-DIISOPROPYL-5-(METHOXYMETHYL)-3-PYRIDYL)-3,5-DIHYDROXY-6-HEPTENOATE, 6-HEPTANOIC ACID, 7-(4-(4-FLUOROPHENYL)-5-(METHOXYMETHYL)-2,6-BIS(1-METHYLETHYL)-3-PYRIDINYL)-3,5-DIHYDROXY-(S-(R*,S*-(E)))-, SODIUM SALT, CERIVASTATIN SODIUM SALT [MI], CERIVASTATIN SODIUM [JAN], CERIVASTATIN SODIUM [MART.], CERIVASTATIN SODIUM [ORANGE BOOK], CERIVASTATIN SODIUM [USAN]
Trade name
Baycol, Lipobay, Baycol / Lipobay
Development code
BAY W 6228
Salt form
Cerivastatin sodium salt
Sources (5)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · Open Targets 26.06 — CC0 · PubMed — US Government work · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 5 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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.