Paliperidone Palmitate side effects: what 31,866 FDA adverse event reports show
Drug class
Atypical antipsychotic
Brand names
Erzofri Extended-Release
Who reports
31,866 reports · 43% serious · 1,184 with death outcome · 40% female
Used for
ERZOFRI is indicated for the treatment of: Schizophrenia in adults . Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants . ERZOFRI is an atypical antipsychotic indicated for: Treatment of schizophrenia in adults. ( 1 ) Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. ( 1 )
What it is
ERZOFRI (paliperidone palmitate) extended-release injectable suspension contains a racemic mixture of (+)- and (-)- paliperidone palmitate. Paliperidone palmitate, is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives.
Boxed warning
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. ERZOFRI is not approved for use in patients with dementia-related psychosis. [see Warnings and Precautions (5.1) ] .
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. 987 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 |
|---|---|---|---|---|---|---|
| Blood prolactin abnormal | 292 | 331.4 287.9–381.4ROR 334.4 · χ² 63,347 / p <1e-300 | 216.2 EB05 196.2 · IC025 +7.1 3/3 methods agree | Lab value / disease marker | serious n=210 · ♀ 71% (drug 40%) | not reported in cached trials |
| Anosognosia | 214 | 252.2 215.4–295.2ROR 253.9 · χ² 38,323 / p <1e-300 | 178.8 EB05 159.5 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=207 · ♀ 70% (drug 40%) | not reported in cached trials |
| Blood prolactin increased | 938 | 162.6 151.5–174.5ROR 167.4 · χ² 120,221 / p <1e-300 | 129.7 EB05 122.9 · IC025 +6.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=259 · ♀ 64% (drug 40%) | not reported in cached trials |
| Psychosexual disorder | 42 | 109.8 79.2–152.3ROR 109.9 · χ² 3,778 / p <1e-300 | 90.2 EB05 69.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=6 · ♀ 0% (drug 40%) | not reported in cached trials |
| Personality change due to a general medical condition | 17 | 102.6 61.5–171.1ROR 102.6 · χ² 1,389 / p <1e-300 | 80.9 EB05 53.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Disturbance in social behaviour | 258 | 80.1 70.4–91.2ROR 80.8 · χ² 17,868 / p <1e-300 | 71.0 EB05 64.1 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=234 · ♀ 67% (drug 40%) | not reported in cached trials |
| Galactorrhoea | 697 | 78.9 73.0–85.3ROR 80.7 · χ² 47,743 / p <1e-300 | 70.3 EB05 66.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=118 · ♀ 75% (drug 40%) | not reported in cached trials |
| Psychotic symptom | 215 | 77.2 67.1–88.9ROR 77.7 · χ² 14,380 / p <1e-300 | 68.7 EB05 61.3 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=211 · 92% clinician | not reported in cached trials |
| Schizoaffective disorder | 169 | 68.2 58.2–79.8ROR 68.5 · χ² 10,057 / p <1e-300 | 61.3 EB05 54.0 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=165 | NCT01662648: 1/587 (0.2%) on Paliperidone Palmitate (serious AE) |
| Schizophrenia | 1,127 | 66.9 63.0–71.1ROR 69.3 · χ² 66,283 / p <1e-300 | 60.7 EB05 57.8 · IC025 +5.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 83.0 | NCT00589914: 15/606 (2.5%) on Paliperidone Palmitate (serious AE) |
| Saccadic eye movement | 15 | 63.7 37.5–108.3ROR 63.8 · χ² 787 / p 2e-173 | 54.3 EB05 34.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Schizoaffective disorder bipolar type | 18 | 55.3 34.2–89.6ROR 55.4 · χ² 835 / p 6e-184 | 48.6 EB05 32.5 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=18 | not reported in cached trials |
| Boredom | 22 | 45.1 29.3–69.5ROR 45.1 · χ² 846 / p 3e-186 | 40.8 EB05 28.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 · ♀ 10% (drug 40%) · 86% consumer | not reported in cached trials |
| Breast discharge | 108 | 43.0 35.4–52.3ROR 43.2 · χ² 4,117 / p <1e-300 | 40.1 EB05 34.2 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=19 · ♀ 84% (drug 40%) | not reported in cached trials |
| Prolactin-producing pituitary tumour | 11 | 38.4 20.9–70.5ROR 38.4 · χ² 344 / p 5e-77 | 34.3 EB05 20.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Blunted affect | 40 | 38.3 27.8–52.6ROR 38.3 · χ² 1,336 / p 1e-292 | 35.6 EB05 27.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Hyperprolactinaemia (high prolactin hormone) | 355 | 37.8 34.0–42.1ROR 38.2 · χ² 11,989 / p <1e-300 | 35.7 EB05 32.7 · IC025 +4.9 3/3 methods agree | Labeled — boxed warning exact term | serious n=200 | not reported in cached trials |
| Poor personal hygiene | 28 | 37.5 25.6–54.9ROR 37.5 · χ² 906 / p 2e-199 | 34.7 EB05 25.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Myelocyte count increased | 10 | 36.7 19.4–69.4ROR 36.7 · χ² 296 / p 2e-66 | 32.8 EB05 19.0 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=10 | not reported in cached trials |
| Refusal of treatment by patient | 347 | 36.7 32.9–40.8ROR 37.1 · χ² 11,364 / p <1e-300 | 34.7 EB05 31.7 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=85 | not reported in cached trials |
| Soliloquy | 43 | 34.5 25.4–46.9ROR 34.5 · χ² 1,296 / p 4e-284 | 32.4 EB05 25.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Injection site nodule | 521 | 32.6 29.9–35.6ROR 33.1 · χ² 15,170 / p <1e-300 | 31.1 EB05 28.9 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=30 · ♀ 65% (drug 40%) · 93% clinician | not reported in cached trials |
| Lactation disorder | 23 | 32.4 21.3–49.2ROR 32.4 · χ² 636 / p 1e-140 | 30.2 EB05 21.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=8 · ♀ 100% (drug 40%) | not reported in cached trials |
| Retrograde ejaculation | 36 | 32.1 23.0–44.9ROR 32.1 · χ² 1,004 / p 1e-220 | 30.2 EB05 22.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 · ♀ 0% (drug 40%) | not reported in cached trials |
| Exposure to contaminated device | 12 | 30.9 17.3–55.1ROR 30.9 · χ² 303 / p 3e-68 | 28.3 EB05 17.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Injection site cyst | 13 | 30.3 17.4–52.8ROR 30.3 · χ² 324 / p 8e-73 | 27.9 EB05 17.3 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Hallucination, auditory | 677 | 29.1 27.0–31.4ROR 29.7 · χ² 17,556 / p <1e-300 | 27.9 EB05 26.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 30.2 | NCT00589914: 1/606 (0.2%) on Paliperidone Palmitate (serious AE) |
| Imprisonment | 75 | 28.6 22.7–36.0ROR 28.7 · χ² 1,886 / p <1e-300 | 27.3 EB05 22.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=28 | not reported in cached trials |
| Schizophreniform disorder | 10 | 27.8 14.8–52.4ROR 27.8 · χ² 223 / p 1e-50 | 25.4 EB05 14.5 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=8 | not reported in cached trials |
| Breast engorgement | 12 | 27.7 15.5–49.3ROR 27.7 · χ² 271 / p 4e-61 | 25.5 EB05 15.4 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | – | not reported in cached trials |
| Metabolic disorder | 233 | 27.4 24.0–31.2ROR 27.6 · χ² 5,657 / p <1e-300 | 26.3 EB05 23.5 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=213 · ♀ 70% (drug 40%) | not reported in cached trials |
| Akathisia (inner restlessness) | 520 | 25.9 23.8–28.3ROR 26.3 · χ² 11,966 / p <1e-300 | 24.9 EB05 23.2 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.5 | NCT01662648: 1/587 (0.2%) on Paliperidone Palmitate (serious AE) |
| Gynaecomastia (male breast enlargement) | 1,085 | 23.5 22.1–24.9ROR 24.3 · χ² 22,568 / p <1e-300 | 22.7 EB05 21.6 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.5 · ♀ 1% (drug 40%) · 73% consumer | not reported in cached trials |
| Extraocular muscle paresis | 16 | 23.3 14.2–38.4ROR 23.3 · χ² 309 / p 2e-69 | 22.0 EB05 14.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Sexual dysfunction | 384 | 22.3 20.1–24.6ROR 22.5 · χ² 7,521 / p <1e-300 | 21.5 EB05 19.8 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.7 | not reported in cached trials |
| Drooling | 220 | 21.7 18.9–24.8ROR 21.8 · χ² 4,175 / p <1e-300 | 21.0 EB05 18.7 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=94 | not reported in cached trials |
| Emotional poverty | 55 | 21.2 16.2–27.7ROR 21.2 · χ² 1,005 / p 7e-221 | 20.4 EB05 16.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=32 · 82% consumer | not reported in cached trials |
| Flat affect | 71 | 21.1 16.6–26.7ROR 21.1 · χ² 1,296 / p 5e-284 | 20.3 EB05 16.7 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=24 | not reported in cached trials |
| Breast enlargement | 102 | 21.0 17.2–25.5ROR 21.0 · χ² 1,861 / p <1e-300 | 20.3 EB05 17.2 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=30 | not reported in cached trials |
| Psychotic disorder | 899 | 20.5 19.2–21.9ROR 21.1 · χ² 16,207 / p <1e-300 | 19.9 EB05 18.9 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.6 | NCT00589914: 13/606 (2.1%) on Paliperidone Palmitate (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Paliperidone Palmitate 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 (5 of 40 signal terms matched).
- NCT00589914 — Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia (N=1221, PHASE3; 29 AE terms posted; arms: R092670; RISPERDAL CONSTA)
- NCT01662648 — Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophren (N=1117, PHASE3; 74 AE terms posted; arms: Paliperidone ER: Lack of Efficacy; Paliperidone ER: Lack of Tolerability, C)
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) | 3,278 | 2.5 2.4–2.6ROR 2.7 · χ² 3,011 / p <1e-300 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,205 | 1.1 1.1–1.1ROR 1.1 · χ² 20 / p 3e-6 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.9 | not reported in cached trials |
| Hospitalisation | 1,803 | 7.8 7.5–8.2ROR 8.2 · χ² 10,696 / p <1e-300 | 7.7 EB05 7.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.8 | not reported in cached trials |
| Weight increased (weight gain) | 1,655 | 4.9 4.7–5.1ROR 5.1 · χ² 5,146 / p <1e-300 | 4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.1 | NCT01662648: 1/512 (0.2%) on Paliperidone Palmitate (serious AE) |
| Drug dose omission | 1,417 | 5.6 5.3–5.9ROR 5.8 · χ² 5,316 / p <1e-300 | 5.5 EB05 5.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | not reported in cached trials |
| Product dose omission issue | 1,404 | 3.2 3.1–3.4ROR 3.3 · χ² 2,195 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | not reported in cached trials |
| Schizophrenia | 1,127 | 66.9 63.0–71.1ROR 69.3 · χ² 66,283 / p <1e-300 | 60.7 EB05 57.8 · IC025 +5.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 83.0 | NCT00589914: 15/606 (2.5%) on Paliperidone Palmitate (serious AE) |
| Gynaecomastia (male breast enlargement) | 1,085 | 23.5 22.1–24.9ROR 24.3 · χ² 22,568 / p <1e-300 | 22.7 EB05 21.6 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.5 · ♀ 1% (drug 40%) · 73% consumer | not reported in cached trials |
| Condition aggravated | 987 | 2.1 2.0–2.3ROR 2.2 · χ² 610 / p 7e-135 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | not reported in cached trials |
| Treatment noncompliance | 948 | 11.6 10.9–12.4ROR 11.9 · χ² 9,054 / p <1e-300 | 11.4 EB05 10.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 13.3 | not reported in cached trials |
| Blood prolactin increased | 938 | 162.6 151.5–174.5ROR 167.4 · χ² 120,221 / p <1e-300 | 129.7 EB05 122.9 · IC025 +6.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=259 · ♀ 64% (drug 40%) | not reported in cached trials |
| Psychotic disorder | 899 | 20.5 19.2–21.9ROR 21.1 · χ² 16,207 / p <1e-300 | 19.9 EB05 18.9 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.6 | NCT00589914: 13/606 (2.1%) on Paliperidone Palmitate (serious AE) |
| Incorrect dose administered | 876 | 2.6 2.4–2.7ROR 2.6 · χ² 836 / p 4e-184 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | not reported in cached trials |
| Inappropriate schedule of drug administration | 785 | 7.2 6.7–7.7ROR 7.4 · χ² 4,151 / p <1e-300 | 7.1 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 | not reported in cached trials |
| Therapeutic response decreased | 759 | 8.3 7.8–9.0ROR 8.5 · χ² 4,849 / p <1e-300 | 8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 | not reported in cached trials |
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=214, PRR 252.2
- Psychosexual disorder — n=42, PRR 109.8
- Galactorrhoea — n=697, PRR 78.9
- Boredom — n=22, PRR 45.1
- Blunted affect — n=40, PRR 38.3
- Poor personal hygiene — n=28, PRR 37.5
- Soliloquy — n=43, PRR 34.5
- Lactation disorder — n=23, PRR 32.4
- Retrograde ejaculation — n=36, PRR 32.1
- Hallucination, auditory — n=677, PRR 29.1 (also seen in trial arm)
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 Paliperidone Palmitate?
In FDA FAERS, the most frequently co-reported reaction terms for Paliperidone Palmitate are weight increased, schizophrenia, gynaecomastia, blood prolactin increased, psychotic disorder. 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 Paliperidone Palmitate have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: 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. ERZOFRI is not approved for use in patients with dementia-related psychosis. [see Warnings and Precautions (5.1) ] .
Do FAERS signals prove that Paliperidone Palmitate 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 492bf9dd-868e-421a-92db-8cca8973aac1, effective 20260309; matched on
openfda.generic_name.exact:"PALIPERIDONE PALMITATE") - 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, 1,027 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
PALIPERIDONE PALMITATE, 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.