Drug · FAERS side-effect profile with label screen
Budesonide and Formoterol side effects: what 96,445 FDA adverse event reports show
Drug class
Corticosteroid
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Budesonide (Pulmicort Flexhaler)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
96,445 reports · 61% serious · 6,674 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
PULMICORT FLEXHALER is a corticosteroid indicated for: • Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Treatment of Asthma PULMICORT FLEXHALER is indicated for the maintenance treatment of asthma as prophylactic therapy in patients six years of age or older.
FDA label, Indications and Usage
What it is
Budesonide is a glucocorticoid steroid having a highly oxygenated pregna-1,4-diene structure. It is used mainly in the treatment of asthma and non-infectious rhinitis and for treatment and prevention of nasal polyposis.
PubChem CID 5281004 (ChEBI)
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 1Labeled (related wording) 3Likely indication confounding 5Reporting / coding artifact 3Lab value / disease marker 5Not in label — unassessed 23
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. 1,174 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 |
|---|---|---|---|---|---|---|
| Congenital hiatus hernia | 89 | 146.1 111.6–191.3ROR 146.2 · χ² 7,528 / p <1e-300 | 85.6 EB05 71.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=89 · ♀ 0% (drug 64%) · 100% clinician | not reported in cached trials |
| Reversible airways obstruction | 200 | 138.6 116.0–165.6ROR 138.9 · χ² 16,480 / p <1e-300 | 83.8 EB05 74.5 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=200 | not reported in cached trials |
| Intentional device misuse | 1,305 | 89.9 84.3–95.9ROR 91.1 · χ² 80,696 / p <1e-300 | 63.5 EB05 60.7 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious n=304 · 93% consumer | not reported in cached trials |
| Total lung capacity increased | 73 | 79.1 60.5–103.4ROR 79.1 · χ² 4,049 / p <1e-300 | 57.2 EB05 47.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=73 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 116 | 62.2 50.6–76.5ROR 62.3 · χ² 5,362 / p <1e-300 | 48.0 EB05 41.1 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=111 | not reported in cached trials |
| Vital capacity decreased | 99 | 61.1 48.8–76.3ROR 61.1 · χ² 4,501 / p <1e-300 | 47.3 EB05 40.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=99 | not reported in cached trials |
| Forced expiratory volume decreased | 575 | 55.2 50.3–60.4ROR 55.5 · χ² 24,255 / p <1e-300 | 44.0 EB05 41.0 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=566 | not reported in cached trials |
| Respiratory gas exchange disorder | 70 | 50.5 38.9–65.5ROR 50.5 · χ² 2,705 / p <1e-300 | 40.6 EB05 33.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=70 | not reported in cached trials |
| Forced vital capacity decreased | 120 | 49.3 40.4–60.1ROR 49.3 · χ² 4,570 / p <1e-300 | 40.0 EB05 34.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=119 | not reported in cached trials |
| Obstructive airways disorder | 1,967 | 46.4 44.2–48.7ROR 47.3 · χ² 71,763 / p <1e-300 | 38.3 EB05 36.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 37.0 | not reported in cached trials |
| Eosinophil count abnormal | 124 | 43.2 35.7–52.4ROR 43.3 · χ² 4,220 / p <1e-300 | 35.9 EB05 30.9 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=121 | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 148 | 41.7 35.0–49.8ROR 41.8 · χ² 4,887 / p <1e-300 | 34.9 EB05 30.4 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=147 | not reported in cached trials |
| Laryngeal stenosis | 89 | 39.5 31.5–49.5ROR 39.5 · χ² 2,785 / p <1e-300 | 33.3 EB05 27.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=89 · ♀ 100% (drug 64%) · 100% consumer | not reported in cached trials |
| Vocal cord dysfunction | 75 | 38.3 30.0–49.0ROR 38.3 · χ² 2,278 / p <1e-300 | 32.4 EB05 26.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=73 · ♀ 100% (drug 64%) · 100% consumer | not reported in cached trials |
| Blood immunoglobulin e increased | 362 | 37.8 33.8–42.3ROR 38.0 · χ² 10,992 / p <1e-300 | 32.2 EB05 29.5 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=350 | not reported in cached trials |
| Respiratory tract inflammation | 69 | 37.5 29.0–48.4ROR 37.5 · χ² 2,053 / p <1e-300 | 31.8 EB05 26.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 100% (drug 64%) | not reported in cached trials |
| Peak expiratory flow rate decreased | 65 | 37.4 28.7–48.7ROR 37.4 · χ² 1,928 / p <1e-300 | 31.7 EB05 25.7 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=51 · ♀ 100% (drug 64%) | not reported in cached trials |
| Bronchial wall thickening | 94 | 32.3 26.0–40.1ROR 32.3 · χ² 2,446 / p <1e-300 | 28.0 EB05 23.6 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=94 | not reported in cached trials |
| Device misuse | 168 | 31.1 26.4–36.5ROR 31.1 · χ² 4,242 / p <1e-300 | 27.2 EB05 23.9 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Lung hyperinflation | 106 | 30.3 24.7–37.1ROR 30.3 · χ² 2,603 / p <1e-300 | 26.5 EB05 22.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=103 | not reported in cached trials |
| Asthmatic crisis | 442 | 29.8 27.0–32.9ROR 29.9 · χ² 10,767 / p <1e-300 | 26.2 EB05 24.2 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=441 | not reported in cached trials |
| Drug delivery system issue | 226 | 29.6 25.7–34.0ROR 29.6 · χ² 5,455 / p <1e-300 | 26.0 EB05 23.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=63 · 100% consumer | not reported in cached trials |
| Full blood count abnormal | 1,193 | 27.6 26.0–29.3ROR 28.0 · χ² 27,106 / p <1e-300 | 24.6 EB05 23.4 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 30.9 | not reported in cached trials |
| Asthma | 12,105 | 26.2 25.8–26.7ROR 29.8 · χ² 262,933 / p <1e-300 | 23.5 EB05 23.1 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 25.1 | NCT01444430: 36/5,847 (0.6%) on Budesonide and Formoterol (serious AE) |
| Allergy to animal | 110 | 25.4 20.8–30.9ROR 25.4 · χ² 2,278 / p <1e-300 | 22.7 EB05 19.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=101 | not reported in cached trials |
| Off label use of device | 135 | 25.3 21.2–30.3ROR 25.4 · χ² 2,797 / p <1e-300 | 22.7 EB05 19.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Sleep disorder due to a general medical condition | 1,679 | 25.1 23.9–26.4ROR 25.5 · χ² 34,757 / p <1e-300 | 22.6 EB05 21.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 39.9 | not reported in cached trials |
| Perfume sensitivity | 58 | 25.1 19.1–32.9ROR 25.1 · χ² 1,177 / p 3e-258 | 22.4 EB05 18.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=56 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Sputum discoloured | 963 | 24.6 23.0–26.3ROR 24.8 · χ² 19,511 / p <1e-300 | 22.1 EB05 21.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 25.7 | not reported in cached trials |
| Dust allergy | 97 | 24.2 19.6–29.9ROR 24.2 · χ² 1,918 / p <1e-300 | 21.8 EB05 18.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=89 | not reported in cached trials |
| Total lung capacity decreased | 156 | 23.4 19.8–27.6ROR 23.4 · χ² 2,990 / p <1e-300 | 21.1 EB05 18.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=135 | not reported in cached trials |
| Sinus polyp | 56 | 23.3 17.7–30.7ROR 23.3 · χ² 1,057 / p 3e-232 | 21.0 EB05 16.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=53 · ♀ 0% (drug 64%) · 100% consumer | not reported in cached trials |
| Wheezing | 5,738 | 23.3 22.7–23.9ROR 24.7 · χ² 110,523 / p <1e-300 | 21.1 EB05 20.6 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.3 | not reported in cached trials |
| Breath sounds abnormal | 478 | 23.2 21.1–25.5ROR 23.3 · χ² 9,153 / p <1e-300 | 21.0 EB05 19.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=438 | not reported in cached trials |
| Ejection fraction | 55 | 22.5 17.0–29.7ROR 22.5 · χ² 1,002 / p 3e-220 | 20.3 EB05 16.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 100% (drug 64%) · 100% clinician | not reported in cached trials |
| Pulmonary function test abnormal | 145 | 22.2 18.7–26.3ROR 22.2 · χ² 2,634 / p <1e-300 | 20.1 EB05 17.5 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=119 | not reported in cached trials |
| Sensitisation | 69 | 21.4 16.7–27.5ROR 21.4 · χ² 1,203 / p 7e-264 | 19.5 EB05 15.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=68 · ♀ 100% (drug 64%) | not reported in cached trials |
| Pulmonary function test decreased | 392 | 21.2 19.1–23.5ROR 21.3 · χ² 6,838 / p <1e-300 | 19.3 EB05 17.8 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=325 | not reported in cached trials |
| Bronchial secretion retention | 108 | 20.2 16.6–24.6ROR 20.2 · χ² 1,785 / p <1e-300 | 18.5 EB05 15.7 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=93 | not reported in cached trials |
| Bronchiectasis | 550 | 19.5 17.9–21.3ROR 19.6 · χ² 8,824 / p <1e-300 | 17.9 EB05 16.7 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=533 | 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 Budesonide and Formoterol 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 (1 of 40 signal terms matched).
- NCT01444430 — A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescent (N=12460, PHASE3; 170 AE terms posted; arms: Symbicort; Budesonide)
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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 17,739 | 7.0 6.9–7.1ROR 8.4 · χ² 90,873 / p <1e-300 | 6.8 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | NCT01444430: 2/5,847 (0.0%) on Budesonide and Formoterol (serious AE) |
| Asthma | 12,105 | 26.2 25.8–26.7ROR 29.8 · χ² 262,933 / p <1e-300 | 23.5 EB05 23.1 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 25.1 | NCT01444430: 36/5,847 (0.6%) on Budesonide and Formoterol (serious AE) |
| Cough | 7,935 | 6.3 6.2–6.5ROR 6.8 · χ² 34,937 / p <1e-300 | 6.2 EB05 6.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | NCT01444430: 1/5,846 (0.0%) on Budesonide and Formoterol (serious AE) |
| Drug ineffective (drug did not work) | 6,816 | 1.1 1.1–1.2ROR 1.1 · χ² 101 / p 4e-24 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.6 | not reported in cached trials |
| Off label use (used outside approved label) | 5,910 | 1.5 1.4–1.5ROR 1.5 · χ² 963 / p 1e-211 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Pneumonia (lung infection) | 5,857 | 4.0 3.9–4.1ROR 4.2 · χ² 13,093 / p <1e-300 | 3.9 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | NCT01444430: 6/5,847 (0.1%) on Budesonide and Formoterol (serious AE) |
| Wheezing | 5,738 | 23.3 22.7–23.9ROR 24.7 · χ² 110,523 / p <1e-300 | 21.1 EB05 20.6 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.3 | not reported in cached trials |
| Fatigue (tiredness) | 5,410 | 1.5 1.5–1.6ROR 1.5 · χ² 982 / p 8e-216 | 1.5 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.9 | not reported in cached trials |
| Malaise (feeling unwell) | 4,611 | 2.3 2.2–2.4ROR 2.4 · χ² 3,396 / p <1e-300 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | not reported in cached trials |
| Headache | 4,580 | 1.6 1.5–1.6ROR 1.6 · χ² 1,036 / p 1e-227 | 1.6 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.0 | not reported in cached trials |
| Chronic obstructive pulmonary disease | 4,050 | 18.2 17.7–18.8ROR 19.0 · χ² 60,915 / p <1e-300 | 16.9 EB05 16.4 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.9 | not reported in cached trials |
| Nausea | 4,006 | 1.1 1.1–1.1ROR 1.1 · χ² 40 / p 1e-10 | 1.1 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.4 | not reported in cached trials |
| Death | 3,809 | 1.0 0.9–1.0ROR 1.0 · χ² 6 / p 0.006 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.9 | NCT01444430: 1/5,847 (0.0%) on Budesonide and Formoterol (serious AE) |
| Drug dose omission | 3,643 | 4.8 4.7–5.0ROR 5.0 · χ² 10,816 / p <1e-300 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 · 88% consumer | not reported in cached trials |
| Intentional product misuse | 3,554 | 9.2 8.9–9.5ROR 9.5 · χ² 25,101 / p <1e-300 | 8.9 EB05 8.6 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 · 90% consumer | 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.
- Congenital hiatus hernia — n=89, PRR 146.1
- Reversible airways obstruction — n=200, PRR 138.6
- Total lung capacity increased — n=73, PRR 79.1
- Vital capacity decreased — n=99, PRR 61.1
- Respiratory gas exchange disorder — n=70, PRR 50.5
- Forced vital capacity decreased — n=120, PRR 49.3
- Obstructive airways disorder — n=1,967, PRR 46.4
- Laryngeal stenosis — n=89, PRR 39.5
- Vocal cord dysfunction — n=75, PRR 38.3
- Respiratory tract inflammation — n=69, PRR 37.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Tenofovir disoproxil fumarate ↔ Bone loss.
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 Budesonide and Formoterol?
In FDA FAERS, the most frequently co-reported reaction terms for Budesonide and Formoterol are dyspnoea, asthma, cough, pneumonia, wheezing, fatigue. 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 Budesonide and Formoterol have an FDA boxed warning?
No. The FDA label retrieved for Budesonide and Formoterol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Budesonide and Formoterol 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 10ea5d87-6ed0-4fa5-a37b-2043c8560bc0, effective 20231107; matched on
openfda.generic_name.exact:"BUDESONIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 5281004 description (ChEBI)
- 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, 1,214 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
BUDESONIDE, 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.