Simvastatin side effects: what 248,690 FDA adverse event reports show

Simvastatin · 1,176 reaction terms · 933,126 drug–reaction co-reports · data 2026-09-14

Drug class

HMG-CoA Reductase Inhibitor

FDA label (Established Pharmacologic Class)

Who reports

248,690 reports · 73% serious · 22,213 with death outcome · 51% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Simvastatin tablets USP are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.

FDA label, Indications and Usage

What it is

Simvastatin is a member of the class of hexahydronaphthalenes that is lovastatin in which the 2-methylbutyrate ester moiety has been replaced by a 2,2-dimethylbutyrate ester group.

PubChem CID 54454 (ChEBI)

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 3Labeled (related wording) 4Likely indication confounding 4Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 26

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,136 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Appendicolith	299	323.4 251.4–415.9ROR 323.8 · calibrated p 9e-12 ✓	66.1 EB05 60.0 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=299 · ♀ 0% (drug 51%) · 100% clinician	not reported in cached trials
Cardiospasm	401	219.7 182.2–265.1ROR 220.1 · calibrated p 2e-10 ✓	60.4 EB05 55.6 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=401	not reported in cached trials
Immunisation	260	127.2 104.8–154.4ROR 127.3 · calibrated p 2e-8 ✓	50.4 EB05 45.4 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=260	not reported in cached trials
Palmoplantar keratoderma	388	98.7 85.2–114.4ROR 98.9 · calibrated p 1e-7 ✓	45.3 EB05 41.6 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=388	NCT00202878: 1/9,077 (0.0%) on Simvastatin (serious AE)
Amaurosis fugax	265	27.5 24.0–31.6ROR 27.6 · calibrated p 4e-4 ✓	20.9 EB05 18.8 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=265 · 100% clinician	not reported in cached trials
Atrial tachycardia	460	23.3 21.0–25.9ROR 23.4 · calibrated p 1e-3 ✓	18.4 EB05 17.0 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=457	NCT00202878: 5/9,077 (0.1%) on Simvastatin (serious AE)
Chronic kidney disease-mineral and bone disorder	219	21.4 18.4–24.8ROR 21.4 · calibrated p 0.002 ✓	17.1 EB05 15.3 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=219	not reported in cached trials
Pruritus genital	425	18.6 16.8–20.7ROR 18.7 · calibrated p 0.003 ✓	15.4 EB05 14.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=409	not reported in cached trials
Hyperparathyroidism secondary	439	17.5 15.8–19.4ROR 17.5 · calibrated p 0.004 ✓	14.6 EB05 13.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=438	NCT00202878: 1/9,077 (0.0%) on Simvastatin (serious AE)
Nephrogenic anaemia	771	16.5 15.3–17.8ROR 16.5 · calibrated p 0.005 ✓	13.9 EB05 13.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=771	not reported in cached trials
Carotid artery occlusion	574	15.5 14.2–17.0ROR 15.6 · calibrated p 0.006 ✓	13.2 EB05 12.3 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=570	NCT00202878: 1/9,067 (0.0%) on Simvastatin (serious AE)
Myopathy	1,268	14.3 13.5–15.2ROR 14.4 · calibrated p 0.008 ✓	12.3 EB05 11.8 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.6	NCT00202878: 2/9,077 (0.0%) on Simvastatin (serious AE)
Product monitoring error	209	14.2 12.3–16.5ROR 14.2 · calibrated p 0.009 ✓	12.2 EB05 10.9 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious n=209 · 100% clinician	not reported in cached trials
Rebound acid hypersecretion	399	12.5 11.2–13.9ROR 12.5 · calibrated p 0.015 ✓	10.9 EB05 10.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=399	not reported in cached trials
Rhabdomyolysis (muscle breakdown)	5,389	12.4 12.1–12.8ROR 12.7 · calibrated p 0.014 ✓	10.9 EB05 10.7 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 10.3 · serious PRR 8.6 · 94% clinician	NCT00202878: 18/9,077 (0.2%) on Simvastatin (serious AE)
Tension headache	463	10.1 9.1–11.1ROR 10.1 · calibrated p 0.032 ✓	9.0 EB05 8.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=444	NCT00202878: 1/9,067 (0.0%) on Simvastatin (serious AE)
Sleep terror	435	9.6 8.7–10.6ROR 9.6 · calibrated p 0.037 ✓	8.7 EB05 8.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=426	not reported in cached trials
Blood phosphorus increased	257	8.7 7.6–9.9ROR 8.7 · calibrated p 0.052	7.9 EB05 7.1 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious n=253 · ♀ 0% (drug 51%) · 100% clinician	not reported in cached trials
Female genital tract fistula	158	8.4 7.2–9.9ROR 8.4 · calibrated p 0.058	7.6 EB05 6.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=158 · ♀ 100% (drug 51%) · 100% clinician	NCT00202878: 2/9,067 (0.0%) on Simvastatin (serious AE)
Hyperphosphataemia	192	8.3 7.2–9.6ROR 8.3 · calibrated p 0.060	7.5 EB05 6.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=190 · ♀ 0% (drug 51%) · 100% clinician	not reported in cached trials
Radiculopathy	231	8.0 7.0–9.2ROR 8.0 · calibrated p 0.067	7.3 EB05 6.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=231 · ♀ 100% (drug 51%) · 100% clinician	NCT00202878: 2/9,077 (0.0%) on Simvastatin (serious AE)
Haemorrhagic anaemia	382	7.8 7.0–8.7ROR 7.8 · calibrated p 0.072	7.2 EB05 6.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=382	NCT00202878: 3/9,077 (0.0%) on Simvastatin (serious AE)
End stage renal disease	1,517	7.5 7.1–7.9ROR 7.5 · calibrated p 0.080	6.9 EB05 6.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	not reported in cached trials
Ischaemic cardiomyopathy	254	7.4 6.6–8.5ROR 7.5 · calibrated p 0.083	6.8 EB05 6.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=253 · ♀ 0% (drug 51%)	NCT00202878: 6/9,077 (0.1%) on Simvastatin (serious AE)
Blood creatine phosphokinase increased	2,398	7.4 7.1–7.8ROR 7.5 · calibrated p 0.081	6.9 EB05 6.7 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	age-adj. PRR 7.0 · serious PRR 5.6	NCT00202878: 4/9,077 (0.0%) on Simvastatin (serious AE)
Myositis	731	7.4 6.9–8.0ROR 7.4 · calibrated p 0.084	6.8 EB05 6.4 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 6.7 · serious PRR 5.6	NCT00202878: 1/9,067 (0.0%) on Simvastatin (serious AE)
Aortic arteriosclerosis	205	7.2 6.2–8.3ROR 7.2 · calibrated p 0.093	6.6 EB05 5.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious n=202	not reported in cached trials
Renal failure acute	3,263	6.8 6.6–7.1ROR 6.9 · calibrated p 0.102	6.4 EB05 6.2 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 5.2 · serious PRR 5.1	NCT00202878: 29/9,077 (0.3%) on Simvastatin (serious AE)
Coronary artery stenosis	380	6.8 6.1–7.5ROR 6.8 · calibrated p 0.108	6.3 EB05 5.8 · IC025 +2.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=378	not reported in cached trials
Self esteem decreased	181	6.7 5.7–7.8ROR 6.7 · calibrated p 0.114	6.2 EB05 5.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=168 · ♀ 0% (drug 51%) · 100% consumer	not reported in cached trials
Hyperlipidaemia	874	6.6 6.1–7.0ROR 6.6 · calibrated p 0.118	6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications	serious PRR 5.0	not reported in cached trials
Diabetic neuropathy	362	6.5 5.9–7.3ROR 6.5 · calibrated p 0.120	6.1 EB05 5.6 · IC025 +2.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=338	NCT00202878: 2/9,077 (0.0%) on Simvastatin (serious AE)
Aortic stenosis	252	6.5 5.7–7.4ROR 6.5 · calibrated p 0.122	6.0 EB05 5.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=247 · 100% clinician	NCT00202878: 4/9,077 (0.0%) on Simvastatin (serious AE)
Chronic sinusitis	263	6.3 5.6–7.1ROR 6.3 · calibrated p 0.133	5.9 EB05 5.3 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious n=251 · ♀ 100% (drug 51%)	NCT00202878: 1/9,077 (0.0%) on Simvastatin (serious AE)
Immune-mediated myositis	183	6.2 5.3–7.2ROR 6.2 · calibrated p 0.139	5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious n=183 · 100% clinician	not reported in cached trials
Subarachnoid haemorrhage	694	6.1 5.6–6.6ROR 6.1 · calibrated p 0.145	5.7 EB05 5.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	not reported in cached trials
Carotid artery stenosis	238	6.1 5.3–6.9ROR 6.1 · calibrated p 0.147	5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=238 · 100% clinician	NCT00202878: 4/9,077 (0.0%) on Simvastatin (serious AE)
Coronary artery disease	2,061	6.0 5.8–6.3ROR 6.1 · calibrated p 0.145	5.7 EB05 5.5 · IC025 +2.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 4.5	not reported in cached trials
Renal failure chronic	525	6.0 5.5–6.6ROR 6.0 · calibrated p 0.149	5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.5	NCT00202878: 29/9,077 (0.3%) on Simvastatin (serious AE)
Actinic keratosis	175	6.0 5.1–7.0ROR 6.0 · calibrated p 0.153	5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=164 · ♀ 0% (drug 51%) · 100% clinician	NCT00202878: 18/9,077 (0.2%) on Simvastatin (serious AE)

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Rhabdomyolysis / myopathy	8,517	9.89.6–10.0	signal
Hyponatraemia	3,219	3.53.3–3.6	signal
Kidney injury	17,443	3.33.3–3.4	signal
Gi bleeding	6,700	3.23.1–3.2	signal
Myocardial infarction	6,586	2.82.7–2.8	signal
Tendon disorder	1,223	2.82.6–2.9	signal
Arrhythmia / qt	6,122	2.72.7–2.8	signal
Hypoglycaemia	2,683	2.42.3–2.5	signal
Heart failure	4,940	2.42.3–2.4	signal
Fall / fracture	9,910	2.22.2–2.3	signal
Anaemia	7,694	2.22.1–2.2	signal
Pancreatitis	2,066	2.22.1–2.3	signal
Stroke	6,352	2.22.1–2.2	signal
Hyperglycaemia / diabetes	8,806	2.22.1–2.2	signal
Interstitial lung disease	1,798	1.61.5–1.7	raised
Serious infection	14,208	1.61.5–1.6	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Simvastatin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (20 of 40 signal terms matched).

NCT00202878 — IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Si (N=18144, PHASE3; 1831 AE terms posted; arms: Ezetimide/Simvastatin; Simvastatin)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Fatigue (tiredness)	13,810	1.5 1.5–1.5ROR 1.5 · calibrated p 0.666	1.5 EB05 1.5 · IC025 +0.6	Labeled (related wording) related wording	age-adj. PRR 1.3 · serious PRR 1.6	NCT00202878: 2/9,077 (0.0%) on Simvastatin (serious AE)
Nausea	13,173	1.4 1.4–1.4ROR 1.4 · calibrated p 0.600	1.4 EB05 1.4 · IC025 +0.5	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.5	NCT00202878: 11/9,077 (0.1%) on Simvastatin (serious AE)
Dyspnoea (shortness of breath)	12,637	1.9 1.9–1.9ROR 2.0 · calibrated p 0.918	1.9 EB05 1.9 · IC025 +0.9	Labeled adverse reaction exact term	age-adj. PRR 1.6 · serious PRR 1.7	NCT00202878: 56/9,077 (0.6%) on Simvastatin (serious AE)
Diarrhoea (diarrhea)	12,024	1.6 1.6–1.6ROR 1.6 · calibrated p 0.717	1.6 EB05 1.6 · IC025 +0.6	Not in label — unassessed	age-adj. PRR 1.3 · serious PRR 1.5	NCT00202878: 15/9,077 (0.2%) on Simvastatin (serious AE)
Drug ineffective (drug did not work)	11,545	0.7 0.7–0.8ROR 0.7 · calibrated p 0.142	0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 0.9 · serious PRR 0.8	not reported in cached trials
Dizziness	11,144	1.9 1.9–1.9ROR 2.0 · calibrated p 0.917	1.9 EB05 1.9 · IC025 +0.9	Labeled adverse reaction exact term	age-adj. PRR 1.6 · serious PRR 2.0	NCT00202878: 30/9,077 (0.3%) on Simvastatin (serious AE)
Fall	9,310	2.4 2.4–2.4ROR 2.5 · calibrated p 0.832	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 1.6 · serious PRR 2.0	NCT00202878: 12/9,077 (0.1%) on Simvastatin (serious AE)
Pain	9,258	1.3 1.2–1.3ROR 1.3 · calibrated p 0.496	1.3 EB05 1.2 · IC025 +0.3	Labeled adverse reaction exact term	age-adj. PRR 1.4 · serious PRR 1.2	NCT00202878: 43/9,077 (0.5%) on Simvastatin (serious AE)
Asthenia (weakness)	9,242	2.1 2.1–2.1ROR 2.1 · calibrated p 0.981	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 1.6 · serious PRR 1.9	NCT00202878: 18/9,077 (0.2%) on Simvastatin (serious AE)
Headache	9,000	1.2 1.2–1.2ROR 1.2 · calibrated p 0.456	1.2 EB05 1.2 · IC025 +0.2	Labeled adverse reaction exact term	age-adj. PRR 1.2 · serious PRR 1.3	NCT00202878: 13/9,077 (0.1%) on Simvastatin (serious AE)
Myalgia (muscle pain)	8,444	4.4 4.3–4.5ROR 4.5 · calibrated p 0.300	4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.8 · serious PRR 4.2	NCT00202878: 1/9,067 (0.0%) on Simvastatin (serious AE)
Vomiting	8,254	1.5 1.5–1.5ROR 1.5 · calibrated p 0.648	1.5 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	age-adj. PRR 1.5 · serious PRR 1.5	NCT00202878: 1/9,067 (0.0%) on Simvastatin (serious AE)
Malaise (feeling unwell)	7,723	1.5 1.5–1.5ROR 1.5 · calibrated p 0.645	1.5 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.6	NCT00202878: 8/9,077 (0.1%) on Simvastatin (serious AE)
Arthralgia (joint pain)	7,701	1.6 1.5–1.6ROR 1.6 · calibrated p 0.704	1.6 EB05 1.5 · IC025 +0.6	Labeled adverse reaction exact term	age-adj. PRR 1.4 · serious PRR 1.7	NCT00202878: 23/9,077 (0.3%) on Simvastatin (serious AE)
Drug interaction	7,369	4.1 4.0–4.2ROR 4.2 · calibrated p 0.350	3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 3.4 · serious PRR 3.3	not reported in cached trials

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Appendicolith — n=299, PRR 323.4
Cardiospasm — n=401, PRR 219.7
Immunisation — n=260, PRR 127.2
Palmoplantar keratoderma — n=388, PRR 98.7 (also seen in trial arm)
Amaurosis fugax — n=265, PRR 27.5
Atrial tachycardia — n=460, PRR 23.3 (also seen in trial arm)
Chronic kidney disease-mineral and bone disorder — n=219, PRR 21.4
Pruritus genital — n=425, PRR 18.6
Hyperparathyroidism secondary — n=439, PRR 17.5 (also seen in trial arm)
Nephrogenic anaemia — n=771, PRR 16.5

✓ A hand-written Bradford Hill causality assessment exists for this drug: Simvastatin (statins) ↔ Rhabdomyolysis.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Simvastatin?

In FDA FAERS, the most frequently co-reported reaction terms for Simvastatin are fatigue, nausea, dyspnoea, diarrhoea, dizziness, fall. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Simvastatin have an FDA boxed warning?

No. The FDA label retrieved for Simvastatin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Simvastatin causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 00896fff-081d-4553-be8c-1999a8a73dda, effective 20260226; matched on openfda.generic_name.exact:"SIMVASTATIN" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 54454 description (ChEBI)
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,176 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query SIMVASTATIN, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.