Lurasidone side effects: what 20,799 FDA adverse event reports show
Drug class
Atypical antipsychotic
Label matched
Lurasidone Hydrochloride (Lurasidone Hydrochloride)
Who reports
20,799 reports · 45% serious · 576 with death outcome · 70% female
Used for
Lurasidone hydrochloride tablet is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia . Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) .
What it is
Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives.
Boxed warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA‐RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 1,031 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Anosognosia | 433 | 1,307.8 1,133.9–1,508.4ROR 1,335.6 · χ² 243,569 / p <1e-300 | 551.4 EB05 509.1 · IC025 +8.3 3/3 methods agree | Not in label — unassessed | serious n=428 | not reported in cached trials |
| Blood prolactin abnormal | 431 | 996.0 872.1–1,137.6ROR 1,017.1 · χ² 213,472 / p <1e-300 | 487.1 EB05 449.7 · IC025 +8.1 3/3 methods agree | Lab value / disease marker | serious n=427 | not reported in cached trials |
| Personality change due to a general medical condition | 25 | 250.9 161.9–389.0ROR 251.2 · χ² 4,771 / p <1e-300 | 174.1 EB05 124.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 70%) · 100% clinician | not reported in cached trials |
| Disturbance in social behaviour | 418 | 216.4 194.9–240.4ROR 220.9 · χ² 73,439 / p <1e-300 | 176.5 EB05 162.7 · IC025 +7.0 3/3 methods agree | Reporting / coding artifact | serious n=414 | not reported in cached trials |
| Activation syndrome | 33 | 105.1 73.4–150.4ROR 105.3 · χ² 2,984 / p <1e-300 | 90.3 EB05 67.3 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
| Metabolic disorder | 444 | 83.5 75.8–91.9ROR 85.3 · χ² 33,312 / p <1e-300 | 76.8 EB05 71.0 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=430 | not reported in cached trials |
| Tongue movement disturbance | 49 | 61.0 45.7–81.4ROR 61.2 · χ² 2,669 / p <1e-300 | 56.3 EB05 44.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=18 · 94% consumer | not reported in cached trials |
| Personality change | 419 | 47.3 42.9–52.1ROR 48.2 · χ² 18,077 / p <1e-300 | 45.1 EB05 41.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 75.4 | not reported in cached trials |
| Akathisia (inner restlessness) | 571 | 44.0 40.5–47.8ROR 45.2 · χ² 22,945 / p <1e-300 | 42.1 EB05 39.3 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 31.1 · 72% consumer | NCT01358357: 9/246 (3.7%) on Lurasidone; 8/250 (3.2%) control |
| Sexual dysfunction | 488 | 43.9 40.2–48.1ROR 45.0 · χ² 19,581 / p <1e-300 | 42.1 EB05 39.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 76.5 | not reported in cached trials |
| Time perception altered | 15 | 43.7 26.1–73.3ROR 43.7 · χ² 559 / p 6e-124 | 40.0 EB05 25.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Schizophrenia | 474 | 40.9 37.3–44.7ROR 41.8 · χ² 17,673 / p <1e-300 | 39.2 EB05 36.3 · IC025 +5.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 49.9 | not reported in cached trials |
| Bipolar ii disorder | 13 | 37.8 21.7–65.7ROR 37.8 · χ² 414 / p 3e-92 | 34.7 EB05 21.6 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=9 | NCT01358357: 1/246 (0.4%) on Lurasidone; 2/250 (0.8%) control (serious AE) |
| Aversion | 10 | 36.4 19.4–68.4ROR 36.4 · χ² 299 / p 3e-67 | 33.1 EB05 19.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Mania | 571 | 36.3 33.4–39.4ROR 37.3 · χ² 18,871 / p <1e-300 | 35.0 EB05 32.6 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.2 · 79% consumer | NCT01358357: 2/246 (0.8%) on Lurasidone; 3/250 (1.2%) control (serious AE) |
| Emotional poverty | 59 | 35.1 27.1–45.4ROR 35.2 · χ² 1,853 / p <1e-300 | 33.6 EB05 27.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 50% (drug 70%) · 92% consumer | not reported in cached trials |
| Bipolar disorder | 337 | 32.0 28.7–35.6ROR 32.5 · χ² 9,776 / p <1e-300 | 31.0 EB05 28.3 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 36.6 · 75% consumer | NCT01358357: 1/246 (0.4%) on Lurasidone; 2/250 (0.8%) control (serious AE) |
| Dystonia | 573 | 30.6 28.1–33.2ROR 31.4 · χ² 15,877 / p <1e-300 | 29.6 EB05 27.7 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 38.3 | not reported in cached trials |
| Oromandibular dystonia | 21 | 30.2 19.6–46.6ROR 30.2 · χ² 547 / p 2e-121 | 28.7 EB05 19.8 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=8 | not reported in cached trials |
| Bipolar i disorder | 63 | 29.8 23.2–38.3ROR 29.9 · χ² 1,677 / p <1e-300 | 28.8 EB05 23.3 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=42 · 73% consumer | NCT01358357: 1/246 (0.4%) on Lurasidone; 2/250 (0.8%) control (serious AE) |
| Blood prolactin increased | 131 | 28.7 24.2–34.1ROR 28.9 · χ² 3,380 / p <1e-300 | 27.8 EB05 24.1 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=54 | not reported in cached trials |
| Grandiosity | 10 | 28.5 15.2–53.4ROR 28.5 · χ² 232 / p 1e-52 | 26.3 EB05 15.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Soliloquy | 23 | 27.7 18.3–41.9ROR 27.7 · χ² 550 / p 6e-122 | 26.5 EB05 18.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 · 87% consumer | not reported in cached trials |
| Tachyphrenia | 92 | 27.5 22.3–33.8ROR 27.6 · χ² 2,259 / p <1e-300 | 26.6 EB05 22.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=35 · 83% consumer | not reported in cached trials |
| Therapeutic product effect increased | 30 | 27.2 18.9–39.1ROR 27.2 · χ² 712 / p 4e-157 | 26.1 EB05 19.2 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | 80% consumer | not reported in cached trials |
| Hypometabolism | 10 | 27.2 14.5–50.9ROR 27.2 · χ² 220 / p 4e-50 | 25.2 EB05 14.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Oculogyric crisis | 55 | 27.0 20.7–35.3ROR 27.1 · χ² 1,316 / p 2e-288 | 26.1 EB05 20.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=54 | not reported in cached trials |
| Psychotic symptom | 49 | 24.8 18.7–32.9ROR 24.8 · χ² 1,069 / p 1e-234 | 24.0 EB05 18.9 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=49 | not reported in cached trials |
| Sedation | 624 | 24.7 22.8–26.7ROR 25.4 · χ² 13,840 / p <1e-300 | 24.1 EB05 22.6 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 34.8 | NCT01358357: 34/962 (3.5%) on Lurasidone |
| Hypomania | 87 | 24.3 19.7–30.1ROR 24.4 · χ² 1,878 / p <1e-300 | 23.7 EB05 19.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=32 | not reported in cached trials |
| Schizoaffective disorder | 42 | 24.2 17.8–32.8ROR 24.2 · χ² 888 / p 2e-195 | 23.4 EB05 18.0 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=36 | not reported in cached trials |
| Belligerence | 10 | 23.8 12.7–44.6ROR 23.8 · χ² 192 / p 6e-44 | 22.1 EB05 12.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Nail bed bleeding | 13 | 23.7 13.7–41.0ROR 23.7 · χ² 254 / p 2e-57 | 22.3 EB05 13.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Flat affect | 48 | 21.7 16.3–28.9ROR 21.7 · χ² 908 / p 1e-199 | 21.1 EB05 16.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=24 · 70% consumer | not reported in cached trials |
| Protrusion tongue | 12 | 21.3 12.0–37.8ROR 21.3 · χ² 208 / p 2e-47 | 20.0 EB05 11.7 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | not reported in cached trials |
| Dyskinesia (involuntary movements) | 829 | 21.0 19.6–22.5ROR 21.8 · χ² 15,487 / p <1e-300 | 20.6 EB05 19.4 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 26.6 | not reported in cached trials |
| Bruxism | 108 | 20.6 17.0–24.9ROR 20.7 · χ² 1,951 / p <1e-300 | 20.1 EB05 17.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=43 · 73% consumer | not reported in cached trials |
| Borderline personality disorder | 14 | 20.3 11.9–34.4ROR 20.3 · χ² 233 / p 7e-53 | 19.2 EB05 11.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Tardive dyskinesia (persistent involuntary movements) | 562 | 20.3 18.7–22.0ROR 20.8 · χ² 10,084 / p <1e-300 | 19.9 EB05 18.5 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 17.5 · 72% consumer | not reported in cached trials |
| Cogwheel rigidity | 20 | 19.5 12.5–30.3ROR 19.5 · χ² 326 / p 3e-73 | 18.7 EB05 12.6 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=17 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Lurasidone 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 (6 of 40 signal terms matched).
- NCT01358357 — Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex (N=965, PHASE3; 62 AE terms posted; arms: Lurasidone 20-80 mg Flexible Dose; Placebo; All Subjects)
- NCT00868959 — Lurasidone - A 24-week Extension Study of Patients With Bipolar I Depression (N=817, PHASE3; 23 AE terms posted; arms: Lurasidone)
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 2,078 | 2.4 2.3–2.5ROR 2.6 · χ² 1,795 / p <1e-300 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 · 76% consumer | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,864 | 1.4 1.4–1.5ROR 1.5 · χ² 254 / p 2e-57 | 1.4 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | serious PRR 2.7 | not reported in cached trials |
| Anxiety | 1,236 | 4.4 4.2–4.6ROR 4.6 · χ² 3,253 / p <1e-300 | 4.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 83% consumer | NCT01358357: 1/962 (0.1%) on Lurasidone (serious AE) |
| Feeling abnormal | 1,170 | 4.9 4.7–5.2ROR 5.2 · χ² 3,677 / p <1e-300 | 4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 91% consumer | not reported in cached trials |
| Depression | 1,142 | 5.1 4.8–5.4ROR 5.3 · χ² 3,736 / p <1e-300 | 5.0 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.7 · 80% consumer | NCT01358357: 2/246 (0.8%) on Lurasidone; 1/250 (0.4%) control (serious AE) |
| Weight increased (weight gain) | 1,095 | 5.0 4.7–5.3ROR 5.2 · χ² 3,493 / p <1e-300 | 4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.3 · 81% consumer | NCT01358357: 24/246 (9.8%) on Lurasidone; 13/250 (5.2%) control |
| Somnolence (drowsiness) | 1,076 | 5.4 5.1–5.7ROR 5.7 · χ² 3,889 / p <1e-300 | 5.4 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 87% consumer | NCT01358357: 69/962 (7.2%) on Lurasidone; 4/250 (1.6%) control |
| Nausea | 1,051 | 1.3 1.3–1.4ROR 1.4 · χ² 95 / p 8e-23 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.2 · 78% consumer | NCT01358357: 111/962 (11.5%) on Lurasidone |
| Insomnia (trouble sleeping) | 1,014 | 3.8 3.6–4.1ROR 4.0 · χ² 2,148 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 87% consumer | NCT01358357: 1/962 (0.1%) on Lurasidone (serious AE) |
| Suicidal ideation (thoughts of suicide) | 979 | 10.9 10.2–11.6ROR 11.4 · χ² 8,710 / p <1e-300 | 10.8 EB05 10.2 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 14.2 · 72% consumer | NCT01358357: 2/246 (0.8%) on Lurasidone (serious AE) |
| Fatigue (tiredness) | 951 | 1.2 1.2–1.3ROR 1.2 · χ² 44 / p 2e-11 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.1 · 80% consumer | NCT01358357: 29/962 (3.0%) on Lurasidone |
| Dyskinesia (involuntary movements) | 829 | 21.0 19.6–22.5ROR 21.8 · χ² 15,487 / p <1e-300 | 20.6 EB05 19.4 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 26.6 | not reported in cached trials |
| Suicide attempt | 772 | 13.0 12.1–13.9ROR 13.4 · χ² 8,423 / p <1e-300 | 12.8 EB05 12.1 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 16.6 | NCT01358357: 1/246 (0.4%) on Lurasidone (serious AE) |
| Tremor (shaking) | 713 | 4.3 4.0–4.7ROR 4.5 · χ² 1,834 / p <1e-300 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 77% consumer | NCT01358357: 15/246 (6.1%) on Lurasidone; 11/250 (4.4%) control |
| Vomiting | 677 | 1.5 1.4–1.6ROR 1.5 · χ² 98 / p 2e-23 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.1 · 78% consumer | NCT01358357: 59/962 (6.1%) on Lurasidone |
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.
- Anosognosia — n=433, PRR 1,307.8
- Personality change due to a general medical condition — n=25, PRR 250.9
- Tongue movement disturbance — n=49, PRR 61.0
- Personality change — n=419, PRR 47.3
- Sexual dysfunction — n=488, PRR 43.9
- Emotional poverty — n=59, PRR 35.1
- Soliloquy — n=23, PRR 27.7
- Tachyphrenia — n=92, PRR 27.5
- Flat affect — n=48, PRR 21.7
- Bruxism — n=108, PRR 20.6
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 Lurasidone?
In FDA FAERS, the most frequently co-reported reaction terms for Lurasidone are anxiety, feeling abnormal, depression, weight increased, somnolence, nausea. 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 Lurasidone have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA‐RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
Do FAERS signals prove that Lurasidone 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 083a1a52-5a13-4e28-8ef2-127ac4ce5b2d, effective 20260714; matched on
openfda.generic_name.exact:"LURASIDONE HYDROCHLORIDE") - 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, 1,071 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
LURASIDONE, results-bearing studies sorted by enrollment)
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.