Drug · FAERS side-effect profile with label screen
Pitavastatin side effects: what 3,404 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Pitavastatin Calcium
openFDA label
Who reports
3,404 reports · 93% serious · 584 with death outcome · 49% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Pitavastatin tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: • Adults with primary hyperlipidemia. • Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
FDA label, Indications and Usage
What it is
Pitavastatin tablets for oral use are an HMG-CoA reductase inhibitor.
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 4Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 25
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 111 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 | 228 | 132.1 116.3–149.9ROR 141.5 · χ² 28,912 / p <1e-300 | 127.9 EB05 114.6 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=227 · 92% clinician | no trial data cached |
| Generalised oedema | 206 | 104.8 91.7–119.7ROR 111.5 · χ² 20,724 / p <1e-300 | 102.1 EB05 90.9 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 70.7 · 95% clinician | no trial data cached |
| Head discomfort | 227 | 80.4 70.8–91.2ROR 86.1 · χ² 17,502 / p <1e-300 | 78.8 EB05 70.6 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 87.2 · 93% clinician | no trial data cached |
| Altered state of consciousness | 259 | 74.9 66.6–84.3ROR 81.0 · χ² 18,603 / p <1e-300 | 73.6 EB05 66.4 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 46.2 · 92% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 234 | 57.2 50.5–64.8ROR 61.4 · χ² 12,761 / p <1e-300 | 56.4 EB05 50.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 35.9 · 94% clinician | no trial data cached |
| Photophobia (light sensitivity) | 168 | 55.9 48.2–64.8ROR 58.8 · χ² 8,931 / p <1e-300 | 55.1 EB05 48.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 55.5 · 95% clinician | no trial data cached |
| Presyncope (near-fainting) | 194 | 49.8 43.4–57.1ROR 52.7 · χ² 9,157 / p <1e-300 | 49.1 EB05 43.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 39.1 · 95% clinician | no trial data cached |
| Ascites | 227 | 47.9 42.2–54.3ROR 51.2 · χ² 10,308 / p <1e-300 | 47.3 EB05 42.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 29.8 · 93% clinician | no trial data cached |
| Diplopia (double vision) | 198 | 47.3 41.3–54.2ROR 50.2 · χ² 8,869 / p <1e-300 | 46.7 EB05 41.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 39.7 · 95% clinician | no trial data cached |
| Haematuria (blood in urine) | 222 | 40.1 35.3–45.6ROR 42.8 · χ² 8,386 / p <1e-300 | 39.7 EB05 35.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 27.2 · 94% clinician | no trial data cached |
| Cardio-respiratory arrest | 240 | 35.3 31.2–39.9ROR 37.9 · χ² 7,937 / p <1e-300 | 35.0 EB05 31.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.8 · 92% clinician | no trial data cached |
| Blindness | 228 | 34.7 30.6–39.3ROR 37.1 · χ² 7,395 / p <1e-300 | 34.4 EB05 30.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.9 · 93% clinician | no trial data cached |
| Coma | 225 | 29.2 25.7–33.1ROR 31.2 · χ² 6,084 / p <1e-300 | 29.0 EB05 26.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 · 93% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 216 | 29.0 25.5–33.1ROR 30.9 · χ² 5,805 / p <1e-300 | 28.8 EB05 25.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.5 · 93% clinician | no trial data cached |
| Eye pain | 232 | 26.0 22.9–29.4ROR 27.8 · χ² 5,537 / p <1e-300 | 25.8 EB05 23.2 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 36.5 · 92% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 246 | 17.1 15.2–19.3ROR 18.3 · χ² 3,717 / p <1e-300 | 17.0 EB05 15.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · 91% clinician | no trial data cached |
| Myalgia (muscle pain) | 445 | 16.2 14.8–17.6ROR 18.4 · χ² 6,349 / p <1e-300 | 16.1 EB05 14.9 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.6 · 91% clinician | no trial data cached |
| Hepatic function abnormal | 90 | 15.0 12.2–18.4ROR 15.4 · χ² 1,160 / p 1e-254 | 14.9 EB05 12.4 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.4 · 92% clinician | no trial data cached |
| Hypercholesterolaemia | 23 | 14.8 9.9–22.3ROR 14.9 · χ² 283 / p 1e-63 | 14.3 EB05 9.7 · IC025 +2.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.9 · ♀ 9% (drug 49%) | no trial data cached |
| Syncope (fainting) | 221 | 13.6 12.0–15.5ROR 14.5 · χ² 2,579 / p <1e-300 | 13.6 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · 94% clinician | no trial data cached |
| Sepsis (blood infection) | 244 | 13.5 12.0–15.2ROR 14.5 · χ² 2,818 / p <1e-300 | 13.4 EB05 12.1 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 · 93% clinician | no trial data cached |
| Chills | 242 | 12.7 11.3–14.4ROR 13.6 · χ² 2,610 / p <1e-300 | 12.7 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · 93% clinician | no trial data cached |
| Cerebral infarction | 50 | 12.6 9.6–16.6ROR 12.8 · χ² 523 / p 6e-116 | 12.3 EB05 9.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Blood creatine phosphokinase increased | 52 | 11.0 8.4–14.4ROR 11.1 · χ² 461 / p 2e-102 | 10.6 EB05 8.3 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 7.4 · 96% clinician | no trial data cached |
| Interstitial lung disease | 78 | 10.0 8.0–12.4ROR 10.2 · χ² 620 / p 4e-137 | 9.7 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · ♀ 28% (drug 49%) | no trial data cached |
| Blood pressure increased | 241 | 9.7 8.6–11.0ROR 10.4 · χ² 1,883 / p <1e-300 | 9.6 EB05 8.6 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 8.7 · 91% clinician | no trial data cached |
| Vision blurred (blurred vision) | 188 | 8.5 7.4–9.8ROR 8.9 · χ² 1,240 / p 5e-272 | 8.4 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Drug eruption | 24 | 8.4 5.6–12.5ROR 8.4 · χ² 149 / p 1e-34 | 7.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Pneumonia aspiration | 32 | 7.9 5.6–11.2ROR 8.0 · χ² 186 / p 9e-43 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 20% (drug 49%) | no trial data cached |
| Decreased appetite (loss of appetite) | 293 | 7.8 7.0–8.7ROR 8.4 · χ² 1,747 / p <1e-300 | 7.7 EB05 7.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 91% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 20 | 7.7 5.0–12.0ROR 7.8 · χ² 111 / p 4e-26 | 6.8 EB05 4.6 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 51 | 7.6 5.8–9.9ROR 7.7 · χ² 284 / p 6e-64 | 7.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 · 95% clinician | no trial data cached |
| Subdural haematoma | 17 | 7.3 4.5–11.7ROR 7.3 · χ² 86 / p 9e-21 | 6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Arteriosclerosis | 11 | 7.2 4.0–13.0ROR 7.2 · χ² 53 / p 2e-13 | 5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Gamma-glutamyltransferase increased | 25 | 6.9 4.7–10.3ROR 7.0 · χ² 121 / p 2e-28 | 6.3 EB05 4.4 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 | no trial data cached |
| Aspartate aminotransferase increased | 59 | 6.8 5.3–8.8ROR 7.0 · χ² 289 / p 4e-65 | 6.5 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · 94% clinician | no trial data cached |
| Somnolence (drowsiness) | 221 | 6.8 6.0–7.7ROR 7.2 · χ² 1,092 / p 1e-239 | 6.7 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 91% clinician | no trial data cached |
| Drug interaction | 171 | 6.6 5.7–7.7ROR 6.9 · χ² 819 / p 2e-180 | 6.5 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · 96% clinician | no trial data cached |
| Erythema multiforme | 10 | 6.6 3.6–12.3ROR 6.6 · χ² 42 / p 4e-11 | 5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Drug-induced liver injury | 33 | 6.6 4.7–9.3ROR 6.6 · χ² 151 / p 5e-35 | 6.1 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · ♀ 28% (drug 49%) · 97% 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) | 445 | 16.2 14.8–17.6ROR 18.4 · χ² 6,349 / p <1e-300 | 16.1 EB05 14.9 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.6 · 91% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 350 | 3.4 3.0–3.7ROR 3.6 · χ² 593 / p 2e-131 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Dizziness | 305 | 3.8 3.4–4.2ROR 4.0 · χ² 634 / p 3e-140 | 3.8 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Dyspnoea (shortness of breath) | 298 | 3.2 2.9–3.6ROR 3.5 · χ² 473 / p 3e-105 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Headache | 295 | 2.9 2.6–3.2ROR 3.1 · χ² 377 / p 3e-84 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · ♀ 75% (drug 49%) · 91% clinician | no trial data cached |
| Decreased appetite (loss of appetite) | 293 | 7.8 7.0–8.7ROR 8.4 · χ² 1,747 / p <1e-300 | 7.7 EB05 7.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 91% clinician | no trial data cached |
| Malaise (feeling unwell) | 285 | 4.0 3.6–4.5ROR 4.3 · χ² 650 / p 1e-143 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 91% clinician | no trial data cached |
| Pruritus (itching) | 285 | 4.6 4.2–5.2ROR 5.0 · χ² 826 / p 5e-182 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 92% clinician | no trial data cached |
| Pyrexia (fever) | 282 | 5.0 4.5–5.6ROR 5.4 · χ² 918 / p 6e-202 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · 92% clinician | no trial data cached |
| Arthralgia (joint pain) | 277 | 4.1 3.7–4.6ROR 4.4 · χ² 664 / p 1e-146 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 · 91% clinician | no trial data cached |
| Fall | 277 | 5.1 4.6–5.7ROR 5.5 · χ² 932 / p 5e-205 | 5.1 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 91% clinician | no trial data cached |
| Asthenia (weakness) | 260 | 4.3 3.8–4.8ROR 4.5 · χ² 657 / p 4e-145 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 91% clinician | no trial data cached |
| Altered state of consciousness | 259 | 74.9 66.6–84.3ROR 81.0 · χ² 18,603 / p <1e-300 | 73.6 EB05 66.4 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 46.2 · 92% clinician | no trial data cached |
| Insomnia (trouble sleeping) | 249 | 5.8 5.1–6.5ROR 6.1 · χ² 985 / p 2e-216 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 91% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 246 | 17.1 15.2–19.3ROR 18.3 · χ² 3,717 / p <1e-300 | 17.0 EB05 15.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · 91% clinician | 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.
- Generalised oedema — n=206, PRR 104.8
- Altered state of consciousness — n=259, PRR 74.9
- Haematemesis — n=234, PRR 57.2
- Photophobia — n=168, PRR 55.9
- Presyncope — n=194, PRR 49.8
- Ascites — n=227, PRR 47.9
- Diplopia — n=198, PRR 47.3
- Haematuria — n=222, PRR 40.1
- Cardio-respiratory arrest — n=240, PRR 35.3
- Blindness — n=228, PRR 34.7
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 Pitavastatin?
In FDA FAERS, the most frequently co-reported reaction terms for Pitavastatin are myalgia, diarrhoea, dizziness, dyspnoea, headache, decreased appetite. 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 Pitavastatin have an FDA boxed warning?
No. The FDA label retrieved for Pitavastatin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pitavastatin 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 26b5e5e8-45cd-4a98-9af4-2d04c1130881, effective 20240815; matched on
openfda.generic_name.exact:"PITAVASTATIN") - 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, 151 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.