Drug · FAERS side-effect profile with label screen
Triamcinolone Acetonide Ointment and 0.05% side effects: what 23,260 FDA adverse event reports show
Drug class
Corticosteroid
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Triamcinolone Acetonide Ointment Usp, 0.05% (Triamcinolone Acetonide)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
23,260 reports · 54% serious · 3,019 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Triamcinolone Acetonide Ointment 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
FDA label, Indications and Usage
What it is
DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide.
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
Reporting / coding artifact 2Lab value / disease marker 7No label text to screen 31
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,150 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 |
|---|---|---|---|---|---|---|
| Human anti-human antibody test | 15 | 1,110.0 519.6–2,371.0ROR 1,110.7 · calibrated p 3e-14 ✓ | 303.0 EB05 194.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=15 | not reported in cached trials |
| Vaginal flatulence | 154 | 924.0 737.6–1,157.4ROR 930.1 · calibrated p 1e-16 ✓ | 429.1 EB05 375.1 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=154 · ♀ 100% (drug 66%) | not reported in cached trials |
| Hepatic enzyme | 64 | 768.0 549.7–1,072.9ROR 770.1 · calibrated p 3e-15 ✓ | 366.9 EB05 297.5 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=64 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Human antichimeric antibody positive | 139 | 629.7 506.9–782.3ROR 633.5 · calibrated p 9e-15 ✓ | 351.0 EB05 304.7 · IC025 +7.0 3/3 methods agree | Lab value / disease marker | serious n=139 · ♀ 100% (drug 66%) | not reported in cached trials |
| Mastitis bacterial | 26 | 607.6 369.0–1,000.4ROR 608.2 · calibrated p 2e-13 ✓ | 285.4 EB05 204.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Hypocholesterolaemia | 96 | 409.8 321.9–521.8ROR 411.5 · calibrated p 9e-13 ✓ | 265.9 EB05 224.2 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=95 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 202 | 392.5 332.8–463.0ROR 395.9 · calibrated p 9e-13 ✓ | 265.6 EB05 236.3 · IC025 +7.1 3/3 methods agree | Lab value / disease marker | serious n=202 · ♀ 100% (drug 66%) · 98% clinician | not reported in cached trials |
| Swollen joint count | 65 | 324.3 244.2–430.7ROR 325.2 · calibrated p 1e-11 ✓ | 222.3 EB05 180.5 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=65 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, hypersomnia type | 26 | 316.3 202.2–494.7ROR 316.6 · calibrated p 5e-11 ✓ | 199.4 EB05 143.0 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=26 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 229 | 304.9 262.5–354.1ROR 307.9 · calibrated p 9e-12 ✓ | 223.0 EB05 199.8 · IC025 +7.0 3/3 methods agree | Lab value / disease marker | serious n=229 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Infective scleritis | 23 | 304.8 189.9–489.4ROR 305.1 · calibrated p 8e-11 ✓ | 191.3 EB05 134.3 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 734 | 274.1 252.6–297.4ROR 283.0 · calibrated p 2e-11 ✓ | 208.5 EB05 196.2 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=734 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Tender joint count | 19 | 259.6 155.7–432.7ROR 259.8 · calibrated p 5e-10 ✓ | 167.5 EB05 113.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | not reported in cached trials |
| Lupus vulgaris | 260 | 252.3 220.0–289.4ROR 255.2 · calibrated p 5e-11 ✓ | 193.9 EB05 174.9 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=260 · ♀ 100% (drug 66%) · 94% clinician | not reported in cached trials |
| Body height below normal | 136 | 238.7 197.6–288.3ROR 240.1 · calibrated p 1e-10 ✓ | 183.5 EB05 159.0 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=136 · ♀ 100% (drug 66%) | not reported in cached trials |
| Pseudomeningocele | 31 | 218.5 147.5–323.6ROR 218.8 · calibrated p 8e-10 ✓ | 158.6 EB05 117.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=31 · 100% clinician | not reported in cached trials |
| Orbital infection | 17 | 215.7 127.0–366.3ROR 215.8 · calibrated p 2e-9 ✓ | 145.6 EB05 96.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | not reported in cached trials |
| Deep vein thrombosis postoperative | 365 | 206.3 184.2–231.0ROR 209.6 · calibrated p 3e-10 ✓ | 166.2 EB05 152.3 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=365 · ♀ 100% (drug 66%) · 94% clinician | not reported in cached trials |
| Rheumatic fever | 776 | 194.9 180.5–210.4ROR 201.6 · calibrated p 4e-10 ✓ | 159.4 EB05 150.2 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=776 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Swollen joint count increased | 539 | 188.4 171.9–206.6ROR 192.9 · calibrated p 6e-10 ✓ | 154.8 EB05 144.1 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=539 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Necrotising scleritis | 25 | 188.1 122.2–289.6ROR 188.3 · calibrated p 3e-9 ✓ | 139.1 EB05 99.1 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · 100% clinician | not reported in cached trials |
| Pseudoendophthalmitis | 17 | 184.1 109.2–310.3ROR 184.2 · calibrated p 8e-9 ✓ | 130.6 EB05 86.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | not reported in cached trials |
| Retinitis | 277 | 179.4 157.8–204.0ROR 181.6 · calibrated p 1e-9 ✓ | 147.9 EB05 133.9 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=277 · ♀ 100% (drug 66%) · 95% clinician | not reported in cached trials |
| Short stature | 38 | 153.4 108.7–216.4ROR 153.6 · calibrated p 1e-8 ✓ | 123.0 EB05 93.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=38 · ♀ 100% (drug 66%) | not reported in cached trials |
| Bone density increased | 58 | 152.8 115.7–201.9ROR 153.2 · calibrated p 7e-9 ✓ | 125.2 EB05 100.4 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=58 · ♀ 100% (drug 66%) | not reported in cached trials |
| Non-infectious endophthalmitis | 121 | 149.4 123.3–181.1ROR 150.2 · calibrated p 6e-9 ✓ | 125.6 EB05 107.9 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=59 · ♀ 43% (drug 66%) · 100% clinician | not reported in cached trials |
| Cerebrospinal fistula | 13 | 146.1 81.3–262.7ROR 146.2 · calibrated p 7e-8 ✓ | 106.4 EB05 66.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | not reported in cached trials |
| Ankle arthroplasty | 49 | 142.7 105.5–192.8ROR 143.0 · calibrated p 1e-8 ✓ | 117.5 EB05 92.4 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=49 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 274 | 141.8 124.9–161.0ROR 143.5 · calibrated p 7e-9 ✓ | 121.4 EB05 109.8 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=274 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 74 | 141.6 110.8–180.9ROR 142.1 · calibrated p 1e-8 ✓ | 118.6 EB05 97.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=74 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Peripheral venous disease | 539 | 140.6 128.5–153.9ROR 144.0 · calibrated p 7e-9 ✓ | 121.0 EB05 112.7 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=539 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Joint destruction | 203 | 134.4 116.0–155.7ROR 135.6 · calibrated p 1e-8 ✓ | 115.6 EB05 102.9 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=203 · ♀ 100% (drug 66%) · 94% clinician | not reported in cached trials |
| Seronegative arthritis | 145 | 133.7 112.3–159.1ROR 134.5 · calibrated p 1e-8 ✓ | 114.6 EB05 99.8 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=145 · ♀ 100% (drug 66%) · 93% clinician | not reported in cached trials |
| Dislocation of vertebra | 285 | 132.4 117.0–149.9ROR 134.1 · calibrated p 1e-8 ✓ | 114.5 EB05 103.8 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=285 · ♀ 100% (drug 66%) · 93% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 927 | 130.3 121.7–139.4ROR 135.6 · calibrated p 1e-8 ✓ | 113.5 EB05 107.5 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 120.4 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Rheumatoid factor positive | 707 | 125.9 116.5–136.0ROR 129.8 · calibrated p 2e-8 ✓ | 110.0 EB05 103.4 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=707 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Hypothalamic pituitary adrenal axis suppression | 43 | 124.4 90.4–171.1ROR 124.6 · calibrated p 4e-8 ✓ | 104.3 EB05 80.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 · 100% clinician | not reported in cached trials |
| X-ray abnormal | 212 | 121.5 105.3–140.1ROR 122.6 · calibrated p 3e-8 ✓ | 106.0 EB05 94.5 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=212 · ♀ 100% (drug 66%) · 95% clinician | not reported in cached trials |
| Eye infection toxoplasmal | 47 | 119.9 88.5–162.6ROR 120.2 · calibrated p 5e-8 ✓ | 101.5 EB05 79.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=47 · 100% clinician | not reported in cached trials |
| Conjunctival ulcer | 16 | 119.4 70.9–201.2ROR 119.5 · calibrated p 2e-7 ✓ | 93.9 EB05 61.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | 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 Triamcinolone Acetonide Ointment and 0.05% 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 (0 of 40 signal terms matched).
- NCT00682539 — Intraocular Anti-VEGF Compared With Intraocular Triamcinolone in Patients With Diabetic Macular Edema (N=71, PHASE4; 1 AE terms posted; arms: Avastin; Triamciolone; Lucentis)
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 3,693 | 2.5 2.5–2.6ROR 2.8 · calibrated p 0.688 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | not reported in cached trials |
| Off label use (used outside approved label) | 2,750 | 2.9 2.8–3.0ROR 3.1 · calibrated p 0.592 | 2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 | not reported in cached trials |
| Pruritus (itching) | 2,514 | 6.0 5.8–6.3ROR 6.6 · calibrated p 0.115 | 6.0 EB05 5.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | not reported in cached trials |
| Rash | 2,415 | 5.0 4.9–5.2ROR 5.5 · calibrated p 0.186 | 5.0 EB05 4.8 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 | not reported in cached trials |
| Pain | 2,037 | 3.0 2.9–3.1ROR 3.2 · calibrated p 0.571 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 · ♀ 86% (drug 66%) | not reported in cached trials |
| Fatigue (tiredness) | 1,940 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.872 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | not reported in cached trials |
| Nausea | 1,851 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.945 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 | not reported in cached trials |
| Product use in unapproved indication | 1,663 | 6.2 5.9–6.5ROR 6.6 · calibrated p 0.118 | 6.1 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 | not reported in cached trials |
| Vomiting | 1,625 | 3.1 3.0–3.3ROR 3.3 · calibrated p 0.540 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 · ♀ 93% (drug 66%) | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,604 | 2.2 2.1–2.4ROR 2.3 · calibrated p 0.883 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | not reported in cached trials |
| Condition aggravated | 1,595 | 4.8 4.6–5.0ROR 5.1 · calibrated p 0.229 | 4.8 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | not reported in cached trials |
| Headache | 1,526 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.911 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 · ♀ 88% (drug 66%) | not reported in cached trials |
| Arthralgia (joint pain) | 1,458 | 3.2 3.0–3.3ROR 3.3 · calibrated p 0.530 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 | not reported in cached trials |
| Infusion related reaction (reaction during infusion) | 1,356 | 18.9 17.9–19.9ROR 20.0 · calibrated p 0.002 ✓ | 18.5 EB05 17.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.5 · ♀ 99% (drug 66%) · 93% clinician | not reported in cached trials |
| Dizziness | 1,353 | 2.5 2.3–2.6ROR 2.5 · calibrated p 0.795 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 · ♀ 88% (drug 66%) | not reported in cached trials |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Triamcinolone Acetonide Ointment and 0.05%?
In FDA FAERS, the most frequently co-reported reaction terms for Triamcinolone Acetonide Ointment and 0.05% are pruritus, rash, pain, fatigue, nausea, vomiting. 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 Triamcinolone Acetonide Ointment and 0.05% have an FDA boxed warning?
No. The FDA label retrieved for Triamcinolone Acetonide Ointment and 0.05% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Triamcinolone Acetonide Ointment and 0.05% 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 a20baaac-002d-40ac-9c7b-f92e8ee987ea, effective 20250925; matched on
openfda.generic_name.exact:"TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%") - 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, 1,190 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
TRIAMCINOLONE ACETONIDE OINTMENT, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.