Statins in FAERS: 911,539 adverse-event reports by the numbers

The FDA Adverse Event Reporting System (FAERS) holds 911,539 individual safety reports that name at least one of the seven statins still marketed in the United States — atorvastatin (Lipitor), simvastatin (Zocor), rosuvastatin (Crestor), pravastatin (Pravachol), lovastatin (Mevacor), pitavastatin (Livalo), and fluvastatin (Lescol) — in any role, filed between 2004, when the modern openFDA FAERS record begins, and early 2026. Atorvastatin dominates the class with 435,513 reports, 47.8 percent of the class total and a multiple of its next-largest peer, reflecting two decades as the highest-volume prescription statin; simvastatin contributes 223,292 (24.5 percent) and rosuvastatin 191,597 (21.0 percent), and the remaining four statins together account for less than 10 percent. Of the class-level reports, 630,075 — 69.1 percent — carry an FDA seriousness flag, and 66,665 (7.3 percent) record a fatal outcome. The musculoskeletal footprint is the class signature: 34,990 reports in the rhabdomyolysis and myopathy family and a further 31,619 myalgia reports, with creatine phosphokinase elevation coded on 7,573 reports. The label-relevant signals the FDA added in the 2011–2012 safety communications are visible too — 25,430 reports in the diabetes and hyperglycaemia family and 12,862 in the hepatic and transaminase-elevation family.

This article is a class-level descriptive read of statin reporting in FAERS, written for pharmacovigilance, medical-affairs, cardiometabolic market-access, and formulary teams who encounter statin safety numbers in labeling reviews, drug-interaction policy, step-therapy design, and generic-substitution analysis. Every figure here is computed from the public openFDA FAERS extract (20,328,575 total reports, export dated 2026-06-08). It is not a disproportionality signal analysis, it is not a safety claim, and it is not incidence data. FAERS is a spontaneous-reporting system: it captures what was reported, never what was caused, it has no exposure denominator, and statin reporting is dominated by a polypharmacy, older, cardiometabolic population in which muscle symptoms, renal events, and death are common regardless of attribution. Those caveats shape every number below. For the class-wide FAERS methodology and the database aggregate picture, see the companion analysis of 20 million FAERS reports; for the other class cuts, see GLP-1 receptor agonists, SGLT2 inhibitors, JAK inhibitors, DOACs, and checkpoint inhibitors in FAERS. This article stays on the seven marketed statins.

Methodology, in one paragraph

A report is counted for a statin when the statin's generic or brand name appears as an exact drug-field token in that report — as a suspect, concomitant, or interacting drug — using an exact-token match across the drug_substances, drug_generics, and drug_brands fields (a |-delimited token match, so that the same number is not double-attributed across the class). Because a single report can name several statins (simvastatin co-formulated with niacin, or a patient documented on more than one lipid agent), the per-substance totals sum to more than the 911,539 class-level (union, deduplicated) reports. Cerivastatin (Baycol), withdrawn from the market on August 8, 2001 for drug-related fatal rhabdomyolysis, is excluded because it has essentially no reporting footprint in the post-2004 extract. A "serious" report is any report the FDA coded as serious. A report counts toward death when either the seriousness field carries a death flag or the outcome field carries a Fatal outcome. Reactions are coded to MedDRA Preferred Terms; reaction counts are case-normalized. The adverse-event families aggregate related Preferred Terms (for example, "rhabdomyolysis and myopathy" combines rhabdomyolysis, myopathy, myositis, and muscular weakness; "hepatic / transaminase elevation" combines hepatic enzyme increased, transaminases increased, gamma-glutamyltransferase increased, hepatic function abnormal, and drug-induced liver injury), and a report contributes once to a family if any term in the family appears. The "any role" counts reported here are intentionally inclusive, so they will exceed suspect-only or differently normalized counts cited elsewhere for the same agent.

The reporting-volume picture, by drug

Three patterns matter for access and medical-affairs teams. First, volume tracks market penetration and time on market, not intrinsic risk: atorvastatin alone carries nearly half of class reporting because Lipitor was, for most of the 2000s, the highest-selling prescription drug in the world and remains the highest-volume generic statin, and simvastatin's share reflects its decade as the preferred generic until the 2011 dose restriction pushed prescribing toward atorvastatin. Second, the serious-share band runs from the mid-50s to the low-80s percent — high, because this is an older, multi-morbid cardiometabolic population in which hospitalization and death are common regardless of attribution; fluvastatin's 83.0 percent serious share is a small-denominator artifact (7,332 reports, a residual branded niche), not a safety differential. Third, the per-drug death-flag percentages cluster tightly between 5.6 and 8.1 percent and move with indication and population mix (rosuvastatin's lower 5.6 percent reflects a relatively newer, somewhat younger prescribing base than simvastatin's), not with a clean drug-safety ranking. Quoting any single statin's death-flag rate without that caveat is quoting a population-confounded number.

The class-level outcome profile

A report can carry more than one outcome, so these shares sum to more than 100 percent. The dominant "unknown outcome" share is typical of FAERS follow-up gaps; the Fatal outcome count (47,003) sits below the death-flag measure (66,665) because not every death-flagged report carries a resolved Fatal outcome field. As with every FAERS outcome table, none of these percentages are incidence — the denominator is reports, not exposed patients. Tens of millions of patients take statins; the reporting volume here is a small, skewed slice of real-world exposure.

The muscle, metabolic, and hepatic footprint

Stripping out the non-specific terms (fatigue, drug ineffective, dyspnoea, dizziness, diarrhoea) that dominate the raw reaction list for any high-volume outpatient class, the label-relevant adverse-event families that define the statin safety profile leave a clear footprint:

The muscle signal is exactly what the labels and the published disproportionality literature describe. A 2025 FAERS disproportionality analysis of lipid-lowering drugs and rhabdomyolysis reported reporting odds ratios of roughly 2.5 for simvastatin, 2.3 for pravastatin, 2.2 for lovastatin, 2.1 for rosuvastatin, and 1.8 for atorvastatin and fluvastatin against the database reference — every marketed statin signals, none to the degree that cerivastatin did — and a separate 2025 transcriptomic FAERS study found that, against a simvastatin reference, reporting of rhabdomyolysis was lower for atorvastatin (OR 0.31), rosuvastatin (OR 0.38), pravastatin (OR 0.22), and lovastatin (OR 0.18); the same study found simvastatin carried a more than two-fold rhabdomyolysis reporting likelihood versus other statins and that men reported rhabdomyolysis at roughly twice the rate of women regardless of agent, with the highest sex-stratified risk for pravastatin (ROR 2.30) and atorvastatin (ROR 2.03). A 2025 seven-statin comparative FAERS analysis likewise found no single statin dominated across all adverse-event categories, the signal profile varying by organ system. The descriptive counts here are the reporting backdrop to that risk-ranking; the disproportionality literature, not the raw volumes, established the ordering.

Rhabdomyolysis — the cerivastatin shadow and the simvastatin dose cap

Muscle toxicity is the safety issue that has shaped the class more than any other, and the historical anchor is cerivastatin. Approved in 1997 and withdrawn worldwide on August 8, 2001, cerivastatin carried a fatal-rhabdomyolysis reporting rate of roughly 1.9 per million prescriptions — on the order of ten to fifty times the rate of other statins — with 31 deaths reported in the United States and roughly 385 non-fatal rhabdomyolysis cases among an estimated 700,000 users, frequently in combination with gemfibrozil, which raised cerivastatin exposure more than five-fold. The withdrawal is the reason "statin" and "rhabdomyolysis" are permanently linked in pharmacovigilance, and it set the template for the dose and interaction restrictions that followed.

The durable regulatory consequence for the still-marketed class was the 2011 simvastatin action. On June 8, 2011, the FDA restricted the 80 mg dose of simvastatin after the SEARCH trial (12,064 patients; 6,031 on 80 mg, 6,033 on 20 mg) showed myopathy in 53 of 6,031 patients on 80 mg versus 2 on 20 mg, and rhabdomyolysis in 7 versus 0 — risk concentrated in the first year of treatment, amplified by older age, female sex, renal impairment, the SLCO1B1 transporter variant, and interacting drugs (calcium-channel blockers, amiodarone, diltiazem, dronedarone, and strong CYP3A4 inhibitors). Simvastatin 80 mg was not to be started in new patients, and the same restriction cascaded onto the simvastatin-containing fixed-dose combinations (Vytorin, Simcor). In the FAERS trajectory, simvastatin's reporting share declined as prescribing shifted toward atorvastatin, a transition the generic-entry economics accelerated.

The 2012 label changes — diabetes, liver monitoring, and interactions

The second shaping event was the February 28, 2012 FDA safety communication that revised the entire class label in four ways: it added a warning for increases in glycosylated haemoglobin and fasting serum glucose (the diabetes signal), removed the requirement for routine periodic liver-enzyme monitoring in asymptomatic patients (concluding that serious liver injury is rare and unpredictable and that routine monitoring does not prevent it), added lovastatin dose limits and contraindications with protease inhibitors and a contraindication with gemfibrozil, and added a note on generally reversible cognitive effects. The diabetes family in the FAERS data — 25,430 reports, dominated by atorvastatin (17,175) — is the descriptive echo of that label addition, and the hepatic family (12,862) is the echo of the liver-injury language that, paradoxically, was being relaxed at the same time the spontaneous reports continued to accumulate. Neither count is incidence; both are reporting artifacts shaped by the fact that atorvastatin has by far the largest exposed denominator.

The reporting trajectory, by year

The trajectory tracks the class's reporting ecosystem, not a safety trend. The 2010–2012 step-up (from ~24,000 in 2009 to ~38,000–44,000) coincides with the simvastatin 80 mg restriction and the 2012 label changes, which generated both prescriber attention and consumer-reporting volume; the 2014–2019 climb to a ~62,000-report plateau tracks the broadening of statin prescribing under the 2013 ACC/AHA cholesterol guideline and rising generic atorvastatin volume; and the post-2019 decline to a ~45,000-report steady state reflects both reporting normalization and a cohort effect as the reporting infrastructure matured. The 2026 figure (11,324) is a partial year through the extract cut-off. The pre-2004 counts are negligible because the modern openFDA FAERS record begins in late 2003.

What this means for pharmacovigilance, medical-affairs, and access teams

• For pharmacovigilance teams, the class's 69.1 percent serious share and 7.3 percent death-flag rate are population effects, not signal. Read serious and death proportions against an older, polypharmacy, cardiometabolic baseline; the signals that matter are the disproportionality-documented muscle, renal, and metabolic families, not the headline death counts.
• For medical-affairs and label teams, rhabdomyolysis and myopathy (34,990 reports) and the 2012 diabetes addition (25,430) are the durable pressure points. Any label or risk-management review of the class will continue to center muscle toxicity, the simvastatin dose-interaction framework, and the glycaemic warning.
• For cardiometabolic market-access and formulary teams, the simvastatin 80 mg restriction and the CYP3A4/SLCO1B1 interaction profile are embedded in step-therapy and quantity-limit design. Preferred-generic positioning (atorvastatin and rosuvastatin) is defensible against this reporting picture; simvastatin 80 mg remains non-preferred across Medicaid and commercial formularies for the same reason the FDA restricted it.
• For dossier and evidence teams, per-agent FAERS figures must be anchored with exposure context. An atorvastatin number in a multi-billion-prescription-per-year population is not comparable to a pitavastatin or fluvastatin number in a fraction of that denominator; quoting raw volumes without exposure invites a misread.
• For generic and lifecycle teams, the cerivastatin withdrawal remains the regulatory precedent for any new lipid-lowering agent with a myopathy signal. The reporting-rates-per-million-prescriptions framework, not raw FAERS counts, is the metric regulators reach for when a muscle signal emerges in a new product.

Sources

• US FDA, openFDA FAERS (Adverse Event Reporting System) extract, export dated 2026-06-08 (20,328,575 total reports). Per-drug, class-union, outcome, AE-family, and trajectory aggregates computed by PharmaDossier from the public FAERS extract. https://open.fda.gov/data/faers/
• US FDA. "FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury." June 8, 2011 — 80 mg dose restriction and drug-interaction framework following the SEARCH trial (myopathy 53 vs 2; rhabdomyolysis 7 vs 0 at 80 mg vs 20 mg). https://www.fda.gov/Drugs/DrugSafety/ucm256581.htm
• US FDA. "FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs." February 28, 2012 — class-wide label revision adding diabetes/glycosylated haemoglobin warning, removing routine liver-enzyme monitoring, adding lovastatin interaction dose limits, and noting cognitive effects. https://www.fda.gov/Drugs/DrugSafety/ucm293101.htm
• Search Trial; FDA simvastatin prescribing information (NDA 019766/S-083, revised October 2011) — dose-dependent myopathy and rhabdomyolysis risk and predisposing factors (age, female sex, renal impairment, SLCO1B1 variant, interacting drugs). https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019766Orig1s083.pdf
• World Health Organization, Information Exchange System Alert No. 102. "Voluntary withdrawal of Cerivastatin — Reports of Rhabdomyolysis." August 9, 2001 — cerivastatin (Baycol) withdrawal; fatal rhabdomyolysis reporting rate ~1.9 per million prescriptions, ~10–50× other statins; 31 US deaths and ~385 non-fatal cases among ~700,000 users. https://cdn.who.int/media/docs/default-source/pvg/drug-alerts/da102---drugalert102.pdf
• Federal Register. "Bayer Healthcare Pharmaceuticals; Withdrawal of Approval of a New Drug Application for BAYCOL (cerivastatin sodium) Tablets." August 18, 2017 — formal NDA withdrawal following the 2001 market withdrawal. https://www.federalregister.gov/documents/2017/08/18/2017-17510
• Endo A, et al. "Data Mining of the FDA Adverse Event Reporting System and Animal Experiments for Assessment of Rhabdomyolysis Risk Associated with Lipid-lowering Drugs." International Journal of Medical Sciences 2025;22:1485 — statin rhabdomyolysis reporting odds ratios by agent (cerivastatin 8.07; simvastatin 2.48; pravastatin 2.34; lovastatin 2.18; rosuvastatin 2.05; atorvastatin 1.80; fluvastatin 1.80; pitavastatin 1.43). https://www.medsci.org/v22p1485.htm
• Lucas C, et al. "The Association Between Statin Drugs and Rhabdomyolysis: An Analysis of FDA Adverse Event Reporting System (FAERS) Data and Transcriptomic Profiles." Genes 2025;16(3):248 — rhabdomyolysis reporting odds for atorvastatin (OR 0.31), rosuvastatin (0.38), pravastatin (0.22), and lovastatin (0.18) against a simvastatin reference; simvastatin >2-fold versus other statins; men ~2x women. https://www.mdpi.com/2073-4425/16/3/248
• "Comparative Analysis of Adverse Event Profiles Among Seven Statins for Hypercholesterolemia Management Using the United States FDA Adverse Event Reporting System." 2025 — per-organ-system ROR and aROR comparison across seven statins against an atorvastatin reference. https://pmc.ncbi.nlm.nih.gov/articles/PMC12032439
• US FDA, Drugs@FDA approval records — lovastatin (Mevacor, 1987), simvastatin (Zocor, 1991), pravastatin (Pravachol, 1991), fluvastatin (Lescol, 1993), atorvastatin (Lipitor, 1996), cerivastatin (Baycol, 1997; withdrawn 2001), rosuvastatin (Crestor, 2003), pitavastatin (Livalo, 2009). https://www.accessdata.fda.gov/scripts/cder/daf/