Drug · FAERS side-effect profile with label screen
Fluvastatin Sodium side effects: what 4,461 FDA adverse event reports show
Drug class
Not stated in label
Who reports
4,461 reports · 81% serious · 459 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.
FDA label, Indications and Usage
What it is
Fluvastatin sodium, USP is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. Fluvastatin sodium, USP is.
FDA label, Description section
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 6Labeled (related wording) 4Likely indication confounding 4Lab value / disease marker 7Not in label — unassessed 19
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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 366 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Ocular discomfort | 66 | 28.7 22.6–36.5ROR 29.1 · χ² 1,729 / p <1e-300 | 28.4 EB05 23.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=65 | no trial data cached |
| Blood creatine phosphokinase increased | 127 | 20.5 17.3–24.3ROR 21.1 · χ² 2,328 / p <1e-300 | 20.3 EB05 17.5 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 15.6 · ♀ 32% (drug 55%) | no trial data cached |
| Generalised oedema | 51 | 19.5 14.9–25.7ROR 19.8 · χ² 875 / p 1e-192 | 19.3 EB05 15.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · 92% clinician | no trial data cached |
| Head discomfort | 70 | 18.7 14.9–23.7ROR 19.0 · χ² 1,155 / p 2e-253 | 18.6 EB05 15.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.8 | no trial data cached |
| Altered state of consciousness | 73 | 16.0 12.7–20.1ROR 16.2 · χ² 1,007 / p 3e-221 | 15.8 EB05 13.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Blood urea increased | 52 | 14.6 11.1–19.1ROR 14.7 · χ² 642 / p 8e-142 | 14.4 EB05 11.3 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 11.2 · 94% clinician | no trial data cached |
| Gamma-glutamyltransferase increased | 65 | 13.8 10.8–17.6ROR 14.0 · χ² 758 / p 4e-167 | 13.6 EB05 11.0 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 10.2 · 91% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 72 | 13.3 10.6–16.8ROR 13.5 · χ² 809 / p 4e-178 | 13.2 EB05 10.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 92% clinician | no trial data cached |
| Hyperlipidaemia | 33 | 13.0 9.2–18.2ROR 13.1 · χ² 352 / p 8e-79 | 12.6 EB05 9.1 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.8 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 114 | 12.9 10.8–15.5ROR 13.2 · χ² 1,239 / p 1e-271 | 12.8 EB05 10.9 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 · 94% clinician | no trial data cached |
| Arteriosclerosis | 25 | 12.5 8.4–18.5ROR 12.6 · χ² 252 / p 4e-57 | 11.9 EB05 8.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · ♀ 14% (drug 55%) | no trial data cached |
| Presyncope (near-fainting) | 63 | 12.3 9.6–15.7ROR 12.4 · χ² 640 / p 2e-141 | 12.0 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · 90% clinician | no trial data cached |
| Blood alkaline phosphatase increased | 64 | 12.1 9.5–15.5ROR 12.3 · χ² 641 / p 1e-141 | 11.9 EB05 9.5 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.7 | no trial data cached |
| Mitral valve incompetence | 29 | 12.1 8.4–17.4ROR 12.1 · χ² 283 / p 9e-64 | 11.5 EB05 8.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Ascites | 75 | 12.0 9.6–15.0ROR 12.2 · χ² 745 / p 2e-164 | 11.8 EB05 9.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Photophobia (light sensitivity) | 46 | 11.6 8.7–15.5ROR 11.7 · χ² 435 / p 9e-97 | 11.2 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · 96% clinician | no trial data cached |
| Sinus bradycardia | 23 | 11.2 7.4–16.8ROR 11.2 · χ² 203 / p 3e-46 | 10.4 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 90% clinician | no trial data cached |
| Aspartate aminotransferase increased | 124 | 11.0 9.2–13.1ROR 11.3 · χ² 1,117 / p 3e-245 | 10.8 EB05 9.3 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.4 · 92% clinician | no trial data cached |
| Coronary artery disease | 71 | 11.0 8.7–13.8ROR 11.1 · χ² 632 / p 9e-140 | 10.7 EB05 8.7 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 | no trial data cached |
| Anorexia | 29 | 10.4 7.3–15.0ROR 10.5 · χ² 238 / p 5e-54 | 9.8 EB05 6.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 | no trial data cached |
| Renal failure acute | 90 | 9.8 8.0–12.1ROR 10.0 · χ² 706 / p 6e-156 | 9.6 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.0 | no trial data cached |
| Diplopia (double vision) | 54 | 9.8 7.5–12.8ROR 9.9 · χ² 417 / p 6e-93 | 9.4 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Haematuria (blood in urine) | 71 | 9.7 7.7–12.3ROR 9.9 · χ² 548 / p 2e-121 | 9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Cardio-respiratory arrest | 87 | 9.7 7.9–12.0ROR 9.9 · χ² 673 / p 1e-148 | 9.5 EB05 7.9 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.9 | no trial data cached |
| Alanine aminotransferase increased | 125 | 9.6 8.1–11.4ROR 9.8 · χ² 953 / p 2e-209 | 9.4 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.4 | no trial data cached |
| Blindness | 80 | 9.3 7.4–11.5ROR 9.4 · χ² 580 / p 2e-128 | 9.0 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Tendon rupture (torn tendon) | 24 | 9.1 6.1–13.6ROR 9.2 · χ² 165 / p 4e-38 | 8.2 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 33% (drug 55%) | no trial data cached |
| Hiatus hernia | 25 | 9.1 6.1–13.4ROR 9.1 · χ² 171 / p 2e-39 | 8.2 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · ♀ 83% (drug 55%) | no trial data cached |
| Blood potassium increased | 31 | 9.0 6.3–12.8ROR 9.0 · χ² 212 / p 2e-48 | 8.3 EB05 6.0 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.5 · ♀ 34% (drug 55%) | no trial data cached |
| Haemorrhoids | 37 | 8.9 6.5–12.3ROR 9.0 · χ² 252 / p 5e-57 | 8.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 29% (drug 55%) | no trial data cached |
| Myalgia (muscle pain) | 318 | 8.8 7.9–9.8ROR 9.4 · χ² 2,207 / p <1e-300 | 8.7 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Erythema multiforme | 17 | 8.6 5.3–13.8ROR 8.6 · χ² 106 / p 3e-25 | 7.4 EB05 4.7 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Hypercholesterolaemia | 17 | 8.4 5.2–13.4ROR 8.4 · χ² 103 / p 2e-24 | 7.2 EB05 4.6 · IC025 +2.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.5 | no trial data cached |
| Hyperkalaemia (high potassium) | 62 | 8.4 6.5–10.7ROR 8.5 · χ² 394 / p 5e-88 | 8.0 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 28% (drug 55%) | no trial data cached |
| Coma | 84 | 8.3 6.7–10.3ROR 8.4 · χ² 532 / p 6e-118 | 8.0 EB05 6.7 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Cardiomegaly | 21 | 8.0 5.2–12.2ROR 8.0 · χ² 121 / p 2e-28 | 7.0 EB05 4.8 · IC025 +2.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.8 | no trial data cached |
| Myocardial ischaemia | 19 | 7.8 5.0–12.2ROR 7.8 · χ² 106 / p 4e-25 | 6.8 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| International normalised ratio increased | 47 | 7.7 5.8–10.2ROR 7.8 · χ² 266 / p 3e-60 | 7.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 44 | 7.7 5.7–10.3ROR 7.7 · χ² 249 / p 3e-56 | 7.2 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Blood lactate dehydrogenase increased | 26 | 7.7 5.2–11.3ROR 7.7 · χ² 144 / p 2e-33 | 6.9 EB05 4.9 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 · 95% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Myalgia (muscle pain) | 318 | 8.8 7.9–9.8ROR 9.4 · χ² 2,207 / p <1e-300 | 8.7 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Dizziness | 296 | 2.8 2.5–3.1ROR 2.9 · χ² 348 / p 7e-78 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Asthenia (weakness) | 243 | 3.0 2.7–3.4ROR 3.2 · χ² 336 / p 2e-75 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Myocardial infarction (heart attack) | 221 | 5.9 5.2–6.7ROR 6.2 · χ² 904 / p 8e-199 | 5.8 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · ♀ 30% (drug 55%) | no trial data cached |
| Fall | 207 | 2.9 2.6–3.3ROR 3.0 · χ² 265 / p 8e-60 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Arthralgia (joint pain) | 198 | 2.2 2.0–2.6ROR 2.3 · χ² 138 / p 3e-32 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Cerebrovascular accident (stroke) | 180 | 5.0 4.3–5.7ROR 5.1 · χ² 572 / p 8e-127 | 4.9 EB05 4.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Abdominal pain | 173 | 3.5 3.0–4.0ROR 3.6 · χ² 309 / p 1e-69 | 3.5 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Pruritus (itching) | 169 | 2.1 1.8–2.4ROR 2.1 · χ² 98 / p 2e-23 | 2.1 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Insomnia (trouble sleeping) | 164 | 2.9 2.5–3.4ROR 3.0 · χ² 203 / p 2e-46 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Chest pain | 148 | 3.7 3.2–4.4ROR 3.8 · χ² 298 / p 4e-67 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Cough | 141 | 2.4 2.0–2.8ROR 2.4 · χ² 112 / p 2e-26 | 2.4 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Drug interaction | 138 | 4.1 3.5–4.8ROR 4.2 · χ² 321 / p 4e-72 | 4.0 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 · 92% clinician | no trial data cached |
| Renal failure (kidney failure) | 137 | 4.8 4.1–5.7ROR 4.9 · χ² 413 / p 5e-92 | 4.7 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Pain in extremity | 136 | 2.2 1.8–2.6ROR 2.2 · χ² 85 / p 1e-20 | 2.2 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
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.
- Ocular discomfort — n=66, PRR 28.7
- Generalised oedema — n=51, PRR 19.5
- Head discomfort — n=70, PRR 18.7
- Altered state of consciousness — n=73, PRR 16.0
- Haematemesis — n=72, PRR 13.3
- Arteriosclerosis — n=25, PRR 12.5
- Presyncope — n=63, PRR 12.3
- Mitral valve incompetence — n=29, PRR 12.1
- Ascites — n=75, PRR 12.0
- Photophobia — n=46, PRR 11.6
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 Fluvastatin?
In FDA FAERS, the most frequently co-reported reaction terms for Fluvastatin are myalgia, dizziness, asthenia, myocardial infarction, fall, arthralgia. 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 Fluvastatin have an FDA boxed warning?
No. The FDA label retrieved for Fluvastatin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fluvastatin 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 48801d7c-99ac-4a78-b714-299e2a5562ea, effective 20250626; matched on
openfda.generic_name.exact:"FLUVASTATIN") - 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, fieldpatient.drug.openfda.generic_name.exact, 406 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
Page generated 2026-10-08. 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.