Drug · FAERS side-effect profile with label screen
Fluvastatin side effects: what 4,017 FDA adverse event reports show
Drug class
Not stated in label
Who reports
4,017 reports · 88% serious · 589 with death outcome · 48% 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) 3Likely indication confounding 2Lab value / disease marker 6Not in label — unassessed 23
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. 208 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 | 231 | 113.5 100.0–128.8ROR 120.3 · χ² 25,101 / p <1e-300 | 110.1 EB05 98.7 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=230 · 92% clinician | no trial data cached |
| Generalised oedema | 233 | 100.7 88.8–114.2ROR 106.8 · χ² 22,473 / p <1e-300 | 98.0 EB05 87.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 71.6 · ♀ 7% (drug 48%) · 95% clinician | no trial data cached |
| Head discomfort | 230 | 69.1 60.9–78.4ROR 73.2 · χ² 15,171 / p <1e-300 | 67.8 EB05 60.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 79.6 · 93% clinician | no trial data cached |
| Altered state of consciousness | 231 | 56.6 49.9–64.2ROR 60.0 · χ² 12,430 / p <1e-300 | 55.7 EB05 49.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 37.1 · 93% clinician | no trial data cached |
| Presyncope (near-fainting) | 238 | 51.9 45.8–58.7ROR 55.1 · χ² 11,716 / p <1e-300 | 51.2 EB05 45.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 43.2 · ♀ 10% (drug 48%) · 91% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 238 | 49.3 43.6–55.8ROR 52.4 · χ² 11,130 / p <1e-300 | 48.7 EB05 43.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 32.8 · 94% clinician | no trial data cached |
| Photophobia (light sensitivity) | 174 | 49.1 42.4–56.8ROR 51.3 · χ² 8,083 / p <1e-300 | 48.4 EB05 42.7 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 51.8 · 95% clinician | no trial data cached |
| Diplopia (double vision) | 202 | 40.9 35.8–46.8ROR 43.0 · χ² 7,774 / p <1e-300 | 40.5 EB05 36.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 36.3 · 94% clinician | no trial data cached |
| Ascites | 228 | 40.8 35.9–46.3ROR 43.2 · χ² 8,751 / p <1e-300 | 40.3 EB05 36.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 26.9 · 93% clinician | no trial data cached |
| Haematuria (blood in urine) | 219 | 33.5 29.5–38.2ROR 35.4 · χ² 6,849 / p <1e-300 | 33.2 EB05 29.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 24.0 · 94% clinician | no trial data cached |
| Blindness | 235 | 30.3 26.8–34.3ROR 32.1 · χ² 6,605 / p <1e-300 | 30.1 EB05 27.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 · 92% clinician | no trial data cached |
| Cardio-respiratory arrest | 235 | 29.3 25.9–33.2ROR 31.1 · χ² 6,375 / p <1e-300 | 29.1 EB05 26.1 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 19.2 · 92% clinician | no trial data cached |
| Coma | 238 | 26.2 23.1–29.6ROR 27.8 · χ² 5,726 / p <1e-300 | 26.0 EB05 23.4 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.1 · 93% clinician | no trial data cached |
| Blood creatine phosphokinase increased | 144 | 25.8 22.0–30.3ROR 26.8 · χ² 3,400 / p <1e-300 | 25.6 EB05 22.3 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 15.5 | no trial data cached |
| Tinnitus (ringing in the ears) | 211 | 24.0 21.1–27.4ROR 25.3 · χ² 4,626 / p <1e-300 | 23.9 EB05 21.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 24.0 · 93% clinician | no trial data cached |
| Eye pain | 237 | 22.5 19.9–25.5ROR 23.8 · χ² 4,839 / p <1e-300 | 22.4 EB05 20.1 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.7 · 93% clinician | no trial data cached |
| Myalgia (muscle pain) | 684 | 21.1 19.7–22.6ROR 25.2 · χ² 13,125 / p <1e-300 | 21.0 EB05 19.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.1 | no trial data cached |
| Arteriosclerosis | 35 | 19.5 14.0–27.1ROR 19.6 · χ² 592 / p 4e-131 | 19.2 EB05 14.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 · ♀ 6% (drug 48%) | no trial data cached |
| Gamma-glutamyltransferase increased | 65 | 15.3 12.1–19.5ROR 15.6 · χ² 856 / p 2e-188 | 15.2 EB05 12.3 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 10.1 · 90% clinician | no trial data cached |
| Blood potassium increased | 47 | 15.2 11.4–20.2ROR 15.3 · χ² 606 / p 3e-134 | 15.0 EB05 11.6 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 12.6 · ♀ 17% (drug 48%) | no trial data cached |
| Tachycardia (fast heart rate) | 253 | 14.9 13.2–16.8ROR 15.8 · χ² 3,273 / p <1e-300 | 14.8 EB05 13.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · 91% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 26 | 13.6 9.3–20.0ROR 13.7 · χ² 291 / p 2e-65 | 13.1 EB05 9.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 92% (drug 48%) · 100% clinician | no trial data cached |
| Basal cell carcinoma | 39 | 13.1 9.6–17.9ROR 13.2 · χ² 422 / p 5e-94 | 12.7 EB05 9.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 6% (drug 48%) | no trial data cached |
| Syncope (fainting) | 246 | 12.9 11.4–14.5ROR 13.6 · χ² 2,685 / p <1e-300 | 12.8 EB05 11.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 · 95% clinician | no trial data cached |
| Pancreatitis acute | 54 | 12.7 9.7–16.5ROR 12.8 · χ² 568 / p 9e-126 | 12.4 EB05 9.8 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 · 90% clinician | no trial data cached |
| Sepsis (blood infection) | 267 | 12.5 11.1–14.1ROR 13.3 · χ² 2,827 / p <1e-300 | 12.5 EB05 11.2 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · 93% clinician | no trial data cached |
| Hepatic steatosis | 44 | 12.4 9.2–16.6ROR 12.5 · χ² 448 / p 1e-99 | 12.0 EB05 9.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · ♀ 13% (drug 48%) | no trial data cached |
| Restless legs syndrome | 43 | 12.4 9.2–16.6ROR 12.5 · χ² 437 / p 3e-97 | 12.0 EB05 9.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 · ♀ 5% (drug 48%) | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 97 | 12.2 10.0–14.8ROR 12.5 · χ² 985 / p 1e-216 | 12.0 EB05 10.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · 91% clinician | no trial data cached |
| Hyperlipidaemia | 27 | 11.8 8.1–17.2ROR 11.9 · χ² 255 / p 9e-58 | 11.1 EB05 7.7 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.5 · ♀ 69% (drug 48%) · 100% clinician | no trial data cached |
| Blood urea increased | 37 | 11.5 8.3–15.9ROR 11.6 · χ² 344 / p 5e-77 | 11.0 EB05 8.2 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 8.1 · 94% clinician | no trial data cached |
| Chills | 254 | 11.3 10.0–12.7ROR 12.0 · χ² 2,387 / p <1e-300 | 11.2 EB05 10.1 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 · 92% clinician | no trial data cached |
| Haemorrhoids | 38 | 10.2 7.4–14.0ROR 10.3 · χ² 305 / p 2e-68 | 9.6 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 9% (drug 48%) | no trial data cached |
| Glycosylated haemoglobin increased | 44 | 9.1 6.8–12.3ROR 9.2 · χ² 310 / p 9e-70 | 8.6 EB05 6.6 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 13.0 · ♀ 10% (drug 48%) | no trial data cached |
| Metabolic acidosis | 53 | 8.8 6.7–11.4ROR 8.9 · χ² 356 / p 9e-80 | 8.3 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Tendon rupture (torn tendon) | 20 | 8.4 5.5–13.1ROR 8.5 · χ² 124 / p 5e-29 | 7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Face oedema | 27 | 8.3 5.7–12.1ROR 8.4 · χ² 167 / p 2e-38 | 7.6 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · ♀ 19% (drug 48%) · 96% clinician | no trial data cached |
| Blood pressure increased | 243 | 8.3 7.3–9.4ROR 8.8 · χ² 1,560 / p <1e-300 | 8.2 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 · ♀ 28% (drug 48%) · 93% clinician | no trial data cached |
| Hemiparesis | 27 | 8.3 5.7–12.1ROR 8.3 · χ² 166 / p 4e-38 | 7.5 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Blood pressure fluctuation | 38 | 8.3 6.0–11.3ROR 8.3 · χ² 235 / p 2e-53 | 7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 6.5 · ♀ 12% (drug 48%) | 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) | 684 | 21.1 19.7–22.6ROR 25.2 · χ² 13,125 / p <1e-300 | 21.0 EB05 19.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.1 | no trial data cached |
| Diarrhoea (diarrhea) | 376 | 3.1 2.8–3.4ROR 3.3 · χ² 533 / p 3e-118 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Dizziness | 374 | 3.9 3.6–4.3ROR 4.2 · χ² 831 / p 4e-183 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Dyspnoea (shortness of breath) | 353 | 3.3 3.0–3.6ROR 3.5 · χ² 566 / p 2e-125 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Headache | 328 | 2.7 2.5–3.0ROR 2.9 · χ² 370 / p 7e-83 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Arthralgia (joint pain) | 327 | 4.1 3.7–4.6ROR 4.4 · χ² 785 / p 4e-173 | 4.1 EB05 3.7 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Fall | 324 | 5.1 4.6–5.7ROR 5.5 · χ² 1,078 / p 1e-236 | 5.1 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 92% clinician | no trial data cached |
| Pruritus (itching) | 314 | 4.3 3.9–4.8ROR 4.6 · χ² 818 / p 3e-180 | 4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · ♀ 26% (drug 48%) · 91% clinician | no trial data cached |
| Pyrexia (fever) | 307 | 4.6 4.2–5.2ROR 4.9 · χ² 885 / p 1e-194 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 · 94% clinician | no trial data cached |
| Vomiting | 286 | 3.2 2.8–3.6ROR 3.4 · χ² 436 / p 3e-97 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · ♀ 72% (drug 48%) | no trial data cached |
| Asthenia (weakness) | 283 | 3.9 3.5–4.4ROR 4.2 · χ² 627 / p 1e-138 | 3.9 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Malaise (feeling unwell) | 280 | 3.3 3.0–3.7ROR 3.5 · χ² 463 / p 5e-103 | 3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Abdominal pain | 275 | 6.2 5.5–6.9ROR 6.6 · χ² 1,201 / p 2e-263 | 6.1 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 91% clinician | no trial data cached |
| Decreased appetite (loss of appetite) | 273 | 6.2 5.5–6.9ROR 6.5 · χ² 1,187 / p 2e-260 | 6.1 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 91% clinician | no trial data cached |
| Insomnia (trouble sleeping) | 267 | 5.2 4.7–5.9ROR 5.5 · χ² 920 / p 2e-202 | 5.2 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | 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=231, PRR 113.5
- Generalised oedema — n=233, PRR 100.7
- Head discomfort — n=230, PRR 69.1
- Altered state of consciousness — n=231, PRR 56.6
- Presyncope — n=238, PRR 51.9
- Haematemesis — n=238, PRR 49.3
- Photophobia — n=174, PRR 49.1
- Diplopia — n=202, PRR 40.9
- Ascites — n=228, PRR 40.8
- Haematuria — n=219, PRR 33.5
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, diarrhoea, dizziness, dyspnoea, headache, 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, 248 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.