Drug · FAERS side-effect profile with label screen
Pitavastatin Calcium side effects: what 10,168 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Pitavastatin Calcium
openFDA label
Who reports
10,168 reports · 74% serious · 1,063 with death outcome · 53% 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 3Labeled (related wording) 3Lab value / disease marker 3Not in label — unassessed 31
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.
- 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. 1,015 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 |
|---|---|---|---|---|---|---|
| Amaurosis fugax | 227 | 556.8 481.4–644.0ROR 569.4 · χ² 98,430 / p <1e-300 | 421.7 EB05 377.6 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=227 · 93% clinician | no trial data cached |
| Urinary tract disorder | 197 | 94.4 81.9–108.8ROR 96.2 · χ² 17,312 / p <1e-300 | 89.5 EB05 79.5 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=196 · 95% clinician | no trial data cached |
| Haemorrhagic stroke | 249 | 67.4 59.5–76.4ROR 69.1 · χ² 15,713 / p <1e-300 | 65.0 EB05 58.5 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 51.1 · 92% clinician | no trial data cached |
| Ocular discomfort | 235 | 45.6 40.1–51.8ROR 46.6 · χ² 9,984 / p <1e-300 | 44.5 EB05 39.9 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=230 · 91% clinician | no trial data cached |
| Generalised oedema | 214 | 36.4 31.9–41.7ROR 37.2 · χ² 7,217 / p <1e-300 | 35.7 EB05 31.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 30.9 · 95% clinician | no trial data cached |
| Lymphocyte stimulation test positive | 13 | 33.5 19.4–58.0ROR 33.6 · χ² 372 / p 3e-83 | 31.6 EB05 19.6 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Embolic cerebral infarction | 10 | 31.4 16.8–58.6ROR 31.4 · χ² 260 / p 7e-59 | 29.3 EB05 16.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Upper respiratory tract inflammation | 17 | 29.5 18.3–47.5ROR 29.5 · χ² 433 / p 2e-96 | 28.2 EB05 18.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Altered state of consciousness | 297 | 28.8 25.7–32.2ROR 29.6 · χ² 7,838 / p <1e-300 | 28.4 EB05 25.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 · 91% clinician | no trial data cached |
| Head discomfort | 235 | 27.9 24.5–31.6ROR 28.5 · χ² 5,982 / p <1e-300 | 27.4 EB05 24.6 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 37.3 · 91% clinician | no trial data cached |
| Hyperuricaemia | 48 | 24.4 18.4–32.4ROR 24.5 · χ² 1,042 / p 8e-229 | 23.9 EB05 18.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=46 | no trial data cached |
| Haematemesis (vomiting blood) | 244 | 20.0 17.6–22.6ROR 20.4 · χ² 4,340 / p <1e-300 | 19.8 EB05 17.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 · 92% clinician | no trial data cached |
| Immune-mediated myositis | 25 | 19.7 13.3–29.2ROR 19.8 · χ² 422 / p 5e-94 | 19.2 EB05 13.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 14% (drug 53%) · 100% clinician | no trial data cached |
| Photophobia (light sensitivity) | 171 | 19.0 16.4–22.1ROR 19.4 · χ² 2,881 / p <1e-300 | 18.8 EB05 16.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.8 · 94% clinician | no trial data cached |
| Presyncope (near-fainting) | 202 | 17.3 15.1–19.9ROR 17.7 · χ² 3,072 / p <1e-300 | 17.2 EB05 15.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.1 · 92% clinician | no trial data cached |
| Diplopia (double vision) | 207 | 16.6 14.5–19.0ROR 16.9 · χ² 2,989 / p <1e-300 | 16.4 EB05 14.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 · 93% clinician | no trial data cached |
| Ascites | 233 | 16.5 14.5–18.7ROR 16.8 · χ² 3,344 / p <1e-300 | 16.3 EB05 14.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · 92% clinician | no trial data cached |
| Pulmonary sepsis | 11 | 15.8 8.7–28.6ROR 15.8 · χ² 137 / p 7e-32 | 14.3 EB05 7.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Urine ketone body present | 12 | 15.8 8.9–27.8ROR 15.8 · χ² 150 / p 7e-35 | 14.5 EB05 7.9 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Haemorrhage subcutaneous | 27 | 15.7 10.8–23.0ROR 15.8 · χ² 355 / p 1e-79 | 15.3 EB05 10.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=26 · 93% clinician | no trial data cached |
| Haematuria (blood in urine) | 244 | 14.8 13.0–16.7ROR 15.1 · χ² 3,099 / p <1e-300 | 14.6 EB05 13.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 · ♀ 19% (drug 53%) · 93% clinician | no trial data cached |
| Embolic stroke | 23 | 13.6 9.0–20.5ROR 13.6 · χ² 254 / p 2e-57 | 12.9 EB05 8.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=23 · 91% clinician | no trial data cached |
| Diabetic nephropathy | 14 | 13.1 7.8–22.2ROR 13.1 · χ² 144 / p 2e-33 | 11.8 EB05 6.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Hyperparathyroidism secondary | 16 | 13.1 8.0–21.4ROR 13.1 · χ² 166 / p 3e-38 | 12.0 EB05 7.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Cerebral infarction | 154 | 13.1 11.2–15.3ROR 13.2 · χ² 1,694 / p <1e-300 | 12.9 EB05 11.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Cardio-respiratory arrest | 260 | 12.8 11.4–14.4ROR 13.1 · χ² 2,807 / p <1e-300 | 12.7 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · ♀ 23% (drug 53%) · 91% clinician | no trial data cached |
| Bronchitis chronic | 15 | 12.7 7.6–21.0ROR 12.7 · χ² 149 / p 2e-34 | 11.4 EB05 6.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Blindness | 235 | 12.0 10.5–13.6ROR 12.2 · χ² 2,341 / p <1e-300 | 11.8 EB05 10.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 91% clinician | no trial data cached |
| Enterocolitis | 31 | 11.2 7.9–16.0ROR 11.3 · χ² 278 / p 1e-62 | 10.6 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial data cached |
| Pemphigoid | 40 | 11.2 8.2–15.2ROR 11.2 · χ² 359 / p 2e-80 | 10.7 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 100% clinician | no trial data cached |
| Hepatic function abnormal | 199 | 11.1 9.7–12.8ROR 11.3 · χ² 1,816 / p <1e-300 | 11.0 EB05 9.7 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 · 92% clinician | no trial data cached |
| Akinesia | 11 | 11.0 6.1–19.9ROR 11.0 · χ² 90 / p 1e-21 | 9.1 EB05 4.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Toxic encephalopathy | 26 | 10.9 7.4–16.0ROR 10.9 · χ² 223 / p 1e-50 | 10.1 EB05 7.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Pyelonephritis acute | 10 | 10.6 5.7–19.7ROR 10.6 · χ² 77 / p 7e-19 | 8.5 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Dyslipidaemia | 26 | 10.6 7.2–15.6ROR 10.6 · χ² 215 / p 5e-49 | 9.8 EB05 6.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=26 · ♀ 20% (drug 53%) · 100% clinician | no trial data cached |
| Myopathy | 44 | 10.5 7.8–14.1ROR 10.6 · χ² 368 / p 3e-82 | 10.0 EB05 7.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 | no trial data cached |
| Tinnitus (ringing in the ears) | 232 | 10.4 9.2–11.9ROR 10.7 · χ² 1,965 / p <1e-300 | 10.3 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Small intestinal haemorrhage | 10 | 10.3 5.5–19.2ROR 10.3 · χ² 75 / p 3e-18 | 8.2 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Myalgia (muscle pain) | 845 | 10.3 9.6–11.0ROR 11.1 · χ² 7,104 / p <1e-300 | 10.2 EB05 9.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Blood creatine phosphokinase increased | 145 | 10.3 8.7–12.1ROR 10.4 · χ² 1,199 / p 5e-263 | 10.1 EB05 8.8 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 7.5 · 91% 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) | 845 | 10.3 9.6–11.0ROR 11.1 · χ² 7,104 / p <1e-300 | 10.2 EB05 9.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Diarrhoea (diarrhea) | 633 | 2.0 1.9–2.2ROR 2.1 · χ² 340 / p 4e-76 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Fatigue (tiredness) | 575 | 1.5 1.4–1.7ROR 1.6 · χ² 108 / p 2e-25 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Nausea | 570 | 1.5 1.4–1.6ROR 1.5 · χ² 95 / p 1e-22 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Headache | 549 | 1.8 1.7–2.0ROR 1.9 · χ² 203 / p 2e-46 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Arthralgia (joint pain) | 521 | 2.6 2.4–2.8ROR 2.7 · χ² 518 / p 5e-115 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Dizziness | 515 | 2.1 2.0–2.3ROR 2.2 · χ² 316 / p 5e-71 | 2.1 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Dyspnoea (shortness of breath) | 476 | 1.7 1.6–1.9ROR 1.8 · χ² 152 / p 4e-35 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Malaise (feeling unwell) | 458 | 2.1 2.0–2.4ROR 2.2 · χ² 286 / p 2e-64 | 2.1 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Fall | 443 | 2.7 2.5–3.0ROR 2.8 · χ² 499 / p 1e-110 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Decreased appetite (loss of appetite) | 440 | 3.9 3.6–4.3ROR 4.1 · χ² 964 / p 7e-212 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Pruritus (itching) | 436 | 2.4 2.2–2.6ROR 2.4 · χ² 353 / p 4e-79 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Asthenia (weakness) | 432 | 2.4 2.2–2.6ROR 2.4 · χ² 347 / p 1e-77 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Pyrexia (fever) | 429 | 2.6 2.3–2.8ROR 2.6 · χ² 411 / p 1e-91 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 | no trial data cached |
| Insomnia (trouble sleeping) | 381 | 2.9 2.7–3.3ROR 3.0 · χ² 494 / p 1e-109 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | 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.
- Amaurosis fugax — n=227, PRR 556.8
- Urinary tract disorder — n=197, PRR 94.4
- Haemorrhagic stroke — n=249, PRR 67.4
- Generalised oedema — n=214, PRR 36.4
- Altered state of consciousness — n=297, PRR 28.8
- Hyperuricaemia — n=48, PRR 24.4
- Haematemesis — n=244, PRR 20.0
- Immune-mediated myositis — n=25, PRR 19.7
- Photophobia — n=171, PRR 19.0
- Presyncope — n=202, PRR 17.3
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, fatigue, nausea, 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 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, 1,055 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.