Candesartan Cilexetil side effects: what 26,144 FDA adverse event reports show
Drug class
Angiotensin ii receptor blocker (arb)
Who reports
26,144 reports · 88% serious · 2,426 with death outcome · 57% female
Used for
Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions (1.1) .
What it is
Candesartan cilexetil, a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Ca.
Boxed warning
FETAL TOXICITY • When pregnancy is detected, discontinue candesartan cilexetil as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. • Drugs that act directly on the reni.
Causality screen of the 40 strongest signals
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.
- 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, 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). 1,172 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 |
|---|---|---|---|---|---|---|
| Vascular anastomotic haemorrhage | 23 | 6,060.9 1,819.9–20,185.0ROR 6,066.2 · calibrated p 6e-17 ✓ | 441.8 EB05 310.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 57%) | not reported in cached trials |
| Neurologic neglect syndrome | 159 | 319.0 265.5–383.4ROR 321.0 · calibrated p 7e-12 ✓ | 221.5 EB05 194.1 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=159 · ♀ 100% (drug 57%) · 92% clinician | not reported in cached trials |
| Cardiospasm | 155 | 309.4 257.1–372.4ROR 311.3 · calibrated p 1e-11 ✓ | 216.7 EB05 189.6 · IC025 +6.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=155 | not reported in cached trials |
| Vena cava injury | 23 | 279.7 173.9–450.0ROR 280.0 · calibrated p 2e-10 ✓ | 176.7 EB05 124.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 57%) | not reported in cached trials |
| Immunisation | 101 | 244.2 195.4–305.1ROR 245.1 · calibrated p 1e-10 ✓ | 180.5 EB05 152.8 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=101 | not reported in cached trials |
| Pulmonary vasculitis | 122 | 241.1 196.9–295.2ROR 242.2 · calibrated p 1e-10 ✓ | 179.8 EB05 154.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=122 · ♀ 0% (drug 57%) | not reported in cached trials |
| Palmoplantar keratoderma | 152 | 215.0 179.8–257.1ROR 216.2 · calibrated p 3e-10 ✓ | 165.7 EB05 144.8 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=152 | not reported in cached trials |
| Carotid artery thrombosis | 160 | 185.2 156.0–219.9ROR 186.3 · calibrated p 9e-10 ✓ | 147.6 EB05 129.4 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=160 · ♀ 100% (drug 57%) · 92% clinician | not reported in cached trials |
| Total lung capacity abnormal | 70 | 180.8 139.5–234.4ROR 181.3 · calibrated p 2e-9 ✓ | 141.7 EB05 116.0 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=70 · ♀ 0% (drug 57%) | not reported in cached trials |
| Renal cyst haemorrhage | 35 | 152.0 105.9–218.2ROR 152.2 · calibrated p 1e-8 ✓ | 119.5 EB05 89.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 0% (drug 57%) | not reported in cached trials |
| Capillaritis | 40 | 140.5 100.4–196.7ROR 140.8 · calibrated p 2e-8 ✓ | 113.2 EB05 86.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 0% (drug 57%) | not reported in cached trials |
| Adjustment disorder | 159 | 111.3 94.3–131.4ROR 112.0 · calibrated p 6e-8 ✓ | 96.6 EB05 84.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=158 · ♀ 100% (drug 57%) · 91% clinician | not reported in cached trials |
| Spirometry abnormal | 68 | 105.0 81.6–135.2ROR 105.3 · calibrated p 1e-7 ✓ | 90.5 EB05 73.8 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=68 · ♀ 0% (drug 57%) | not reported in cached trials |
| Mite allergy | 65 | 90.9 70.4–117.5ROR 91.2 · calibrated p 3e-7 ✓ | 79.8 EB05 64.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=65 · ♀ 0% (drug 57%) | not reported in cached trials |
| Antineutrophil cytoplasmic antibody positive | 57 | 68.1 51.9–89.2ROR 68.2 · calibrated p 3e-6 ✓ | 61.5 EB05 49.2 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=57 · ♀ 0% (drug 57%) | not reported in cached trials |
| Neuritis | 119 | 67.2 55.7–81.0ROR 67.5 · calibrated p 2e-6 ✓ | 61.4 EB05 52.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=119 · ♀ 0% (drug 57%) | not reported in cached trials |
| Blood growth hormone increased | 43 | 66.0 48.4–90.1ROR 66.1 · calibrated p 4e-6 ✓ | 59.5 EB05 46.0 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=43 · ♀ 0% (drug 57%) | not reported in cached trials |
| Mycotic allergy | 64 | 65.9 51.1–85.0ROR 66.0 · calibrated p 3e-6 ✓ | 59.9 EB05 48.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=64 · ♀ 0% (drug 57%) | not reported in cached trials |
| Atrial tachycardia | 156 | 64.0 54.4–75.3ROR 64.4 · calibrated p 3e-6 ✓ | 58.9 EB05 51.5 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=156 | not reported in cached trials |
| Intraductal papillary mucinous neoplasm | 21 | 62.2 39.9–96.9ROR 62.2 · calibrated p 9e-6 ✓ | 55.0 EB05 37.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Vascular compression | 22 | 61.0 39.6–94.1ROR 61.1 · calibrated p 9e-6 ✓ | 54.2 EB05 37.7 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=22 · ♀ 0% (drug 57%) | not reported in cached trials |
| Dust allergy | 68 | 60.8 47.5–77.8ROR 61.0 · calibrated p 5e-6 ✓ | 55.7 EB05 45.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=68 · ♀ 0% (drug 57%) | not reported in cached trials |
| Pruritus genital | 161 | 59.5 50.7–69.8ROR 59.9 · calibrated p 5e-6 ✓ | 55.1 EB05 48.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=159 | not reported in cached trials |
| Personality disorder | 164 | 53.2 45.4–62.3ROR 53.5 · calibrated p 1e-5 ✓ | 49.6 EB05 43.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=164 · ♀ 100% (drug 57%) · 91% clinician | not reported in cached trials |
| Overlap syndrome | 37 | 45.4 32.6–63.2ROR 45.5 · calibrated p 4e-5 ✓ | 42.1 EB05 31.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 100% (drug 57%) · 100% clinician | not reported in cached trials |
| Eosinophilic granulomatosis with polyangiitis | 100 | 41.8 34.2–51.0ROR 41.9 · calibrated p 5e-5 ✓ | 39.4 EB05 33.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=100 · ♀ 0% (drug 57%) | not reported in cached trials |
| Carotid artery occlusion | 179 | 41.2 35.5–47.9ROR 41.5 · calibrated p 5e-5 ✓ | 39.1 EB05 34.5 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=179 | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 44 | 40.4 29.8–54.7ROR 40.5 · calibrated p 7e-5 ✓ | 37.9 EB05 29.4 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 100% (drug 57%) | not reported in cached trials |
| Conjunctivitis allergic | 70 | 40.3 31.7–51.2ROR 40.4 · calibrated p 6e-5 ✓ | 38.0 EB05 31.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=70 · ♀ 0% (drug 57%) | not reported in cached trials |
| Respiratory symptom | 119 | 35.6 29.6–42.7ROR 35.7 · calibrated p 1e-4 ✓ | 33.9 EB05 29.1 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=119 · ♀ 0% (drug 57%) | not reported in cached trials |
| Delayed graft function | 30 | 35.5 24.6–51.2ROR 35.5 · calibrated p 2e-4 ✓ | 33.4 EB05 24.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 0% (drug 57%) | not reported in cached trials |
| Catarrh | 37 | 34.8 25.0–48.3ROR 34.8 · calibrated p 2e-4 ✓ | 32.8 EB05 24.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=37 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Forced expiratory volume decreased | 117 | 34.5 28.7–41.5ROR 34.6 · calibrated p 1e-4 ✓ | 32.9 EB05 28.2 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=117 | not reported in cached trials |
| Renal artery stenosis | 57 | 34.4 26.4–44.8ROR 34.4 · calibrated p 2e-4 ✓ | 32.7 EB05 26.1 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=57 | NCT02166697: 1/13,804 (0.0%) on Candesartan Cilexetil (serious AE) |
| Steroid dependence | 33 | 32.4 22.9–45.8ROR 32.4 · calibrated p 3e-4 ✓ | 30.6 EB05 22.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 0% (drug 57%) · 100% clinician | not reported in cached trials |
| Carotid arteriosclerosis | 38 | 30.9 22.3–42.7ROR 30.9 · calibrated p 3e-4 ✓ | 29.4 EB05 22.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 0% (drug 57%) | not reported in cached trials |
| Tension headache | 158 | 30.6 26.1–35.8ROR 30.8 · calibrated p 2e-4 ✓ | 29.4 EB05 25.7 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=153 | not reported in cached trials |
| Sleep terror | 153 | 30.2 25.7–35.5ROR 30.4 · calibrated p 3e-4 ✓ | 29.1 EB05 25.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=153 | not reported in cached trials |
| Arterial occlusive disease | 280 | 29.4 26.2–33.2ROR 29.8 · calibrated p 3e-4 ✓ | 28.4 EB05 25.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 19.4 · ♀ 81% (drug 57%) | not reported in cached trials |
| Gangrene | 202 | 27.6 24.0–31.7ROR 27.8 · calibrated p 4e-4 ✓ | 26.6 EB05 23.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=202 · ♀ 100% (drug 57%) · 91% clinician | 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 Candesartan Cilexetil 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).
- NCT02211638 — Candesartan Cilexetil Special Drug Use Surveillance 「Challenge - Quality Control」 (N=18113, phase n/a; 40 AE terms posted; arms: Candesartan Cilexetil 4 mg to 8 mg)
- NCT02166697 — Blopress Tablets Specified Drug-use Survey "Hypertension: Survey on Patients With Metabolic Syndrome" (N=14151, phase n/a; 222 AE terms posted; arms: Candesartan Cilexetil)
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) | 1,724 | 2.4 2.3–2.6ROR 2.6 · calibrated p 0.791 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | NCT02166697: 1/13,804 (0.0%) on Candesartan Cilexetil |
| Fatigue (tiredness) | 1,711 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.843 | 1.8 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.0 | not reported in cached trials |
| Nausea | 1,649 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.784 | 1.7 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.9 | NCT02166697: 1/13,804 (0.0%) on Candesartan Cilexetil (serious AE) |
| Headache | 1,590 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.999 | 2.0 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.4 | NCT02166697: 9/13,804 (0.1%) on Candesartan Cilexetil |
| Drug ineffective (drug did not work) | 1,574 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.278 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Dizziness | 1,491 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.817 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | NCT02211638: 41/17,130 (0.2%) on Candesartan Cilexetil |
| Diarrhoea (diarrhea) | 1,361 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.792 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled — boxed warning exact term | serious PRR 1.8 | NCT02166697: 1/13,804 (0.0%) on Candesartan Cilexetil |
| Malaise (feeling unwell) | 1,356 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.788 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | NCT02166697: 1/13,804 (0.0%) on Candesartan Cilexetil |
| Off label use (used outside approved label) | 1,283 | 1.2 1.1–1.3ROR 1.2 · calibrated p 0.437 | 1.2 EB05 1.1 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.3 | not reported in cached trials |
| Fall | 1,278 | 3.1 2.9–3.3ROR 3.2 · calibrated p 0.565 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | NCT02166697: 2/13,804 (0.0%) on Candesartan Cilexetil (serious AE) |
| Pain | 1,204 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.705 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT02211638: 1/17,130 (0.0%) on Candesartan Cilexetil (serious AE) |
| Vomiting | 1,146 | 2.0 1.9–2.1ROR 2.0 · calibrated p 0.948 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled — boxed warning exact term | serious PRR 1.8 | NCT02211638: 1/17,130 (0.0%) on Candesartan Cilexetil (serious AE) |
| Blood pressure increased | 1,146 | 6.0 5.7–6.4ROR 6.3 · calibrated p 0.134 | 6.0 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.0 | NCT02166697: 1/13,804 (0.0%) on Candesartan Cilexetil (serious AE) |
| Hypertension (high blood pressure) | 1,129 | 4.3 4.1–4.5ROR 4.4 · calibrated p 0.306 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.0 | NCT02166697: 1/13,804 (0.0%) on Candesartan Cilexetil (serious AE) |
| Asthenia (weakness) | 1,075 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.879 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | NCT02166697: 1/13,804 (0.0%) on Candesartan Cilexetil |
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.
- Vascular anastomotic haemorrhage — n=23, PRR 6,060.9
- Neurologic neglect syndrome — n=159, PRR 319.0
- Vena cava injury — n=23, PRR 279.7
- Immunisation — n=101, PRR 244.2
- Pulmonary vasculitis — n=122, PRR 241.1
- Palmoplantar keratoderma — n=152, PRR 215.0
- Carotid artery thrombosis — n=160, PRR 185.2
- Total lung capacity abnormal — n=70, PRR 180.8
- Renal cyst haemorrhage — n=35, PRR 152.0
- Capillaritis — n=40, PRR 140.5
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 Candesartan Cilexetil?
In FDA FAERS, the most frequently co-reported reaction terms for Candesartan Cilexetil are dyspnoea, fatigue, nausea, headache, dizziness, diarrhoea. 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 Candesartan Cilexetil have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY • When pregnancy is detected, discontinue candesartan cilexetil as soon as possible [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )]. • Drugs that act directly on the reni.
Do FAERS signals prove that Candesartan Cilexetil 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 4621249c-1f44-4d95-8513-a1a2b1859e41, effective 20251222; matched on
openfda.generic_name.exact:"CANDESARTAN CILEXETIL") - 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, 1,212 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
CANDESARTAN CILEXETIL, 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.