Candesartan side effects: what 35,463 FDA adverse event reports show

Candesartan · 1,246 reaction terms · 289,029 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

35,463 reports · 96% serious · 4,872 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Candesartan cilexetil tablets are 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 ).

FDA label, Indications and Usage

What it is

Candesartan cilexetil, USP a prodrug, is hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan is a selective AT 1 subtype angiotensin II receptor antagonist.

FDA label, Description section

Boxed warning

FETAL TOXICITY When pregnancy is detected, discontinue candesartan cilexetil tablets as soon as possible. [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] Drugs that act directly on the .

FDA 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

Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 6Not in label — unassessed 32

What the badges mean

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, 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). 1,206 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hepatic enzyme	79	779.9 556.8–1,092.6ROR 781.7 · calibrated p 2e-15 ✓	309.0 EB05 255.9 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=79 · ♀ 100% (drug 57%) · 100% clinician	not reported in cached trials
Cardiospasm	275	580.4 491.3–685.6ROR 584.9 · calibrated p 2e-14 ✓	285.4 EB05 258.2 · IC025 +7.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=275	not reported in cached trials
Hypocholesterolaemia	131	441.1 351.6–553.3ROR 442.7 · calibrated p 4e-13 ✓	242.6 EB05 209.6 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious n=131 · ♀ 100% (drug 57%) · 100% clinician	not reported in cached trials
Immunisation	176	406.8 335.7–493.1ROR 408.8 · calibrated p 7e-13 ✓	233.9 EB05 206.3 · IC025 +6.9 3/3 methods agree	Not in label — unassessed	serious n=176	not reported in cached trials
Palmoplantar keratoderma	267	350.3 301.1–407.5ROR 352.9 · calibrated p 3e-12 ✓	215.7 EB05 194.9 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious n=267	not reported in cached trials
Pulmonary vasculitis	181	309.2 258.3–370.1ROR 310.8 · calibrated p 1e-11 ✓	198.1 EB05 175.0 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=181 · ♀ 0% (drug 57%)	not reported in cached trials
Total lung capacity abnormal	118	266.4 214.3–331.2ROR 267.3 · calibrated p 5e-11 ✓	177.9 EB05 152.5 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=118 · ♀ 0% (drug 57%)	not reported in cached trials
Facet joint syndrome	869	225.7 208.8–243.9ROR 231.3 · calibrated p 1e-10 ✓	162.4 EB05 153.5 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious n=869 · ♀ 100% (drug 57%) · 93% clinician	not reported in cached trials
Capillaritis	65	189.3 143.1–250.4ROR 189.7 · calibrated p 1e-9 ✓	137.4 EB05 111.6 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=65 · ♀ 0% (drug 57%)	not reported in cached trials
Neovascularisation	59	177.1 132.4–237.0ROR 177.4 · calibrated p 2e-9 ✓	130.4 EB05 104.8 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=59 · ♀ 100% (drug 57%) · 100% clinician	not reported in cached trials
Neurologic neglect syndrome	118	158.0 129.0–193.6ROR 158.5 · calibrated p 4e-9 ✓	122.1 EB05 104.7 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=118 · ♀ 100% (drug 57%) · 100% clinician	not reported in cached trials
Spirometry abnormal	120	152.0 124.3–185.7ROR 152.5 · calibrated p 6e-9 ✓	118.5 EB05 101.7 · IC025 +6.0 3/3 methods agree	Lab value / disease marker	serious n=120 · ♀ 0% (drug 57%)	not reported in cached trials
Peripheral venous disease	782	144.1 133.4–155.8ROR 147.4 · calibrated p 5e-9 ✓	115.4 EB05 108.8 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=782 · ♀ 98% (drug 57%) · 92% clinician	not reported in cached trials
Cardiac output increased	33	141.3 96.6–206.7ROR 141.5 · calibrated p 2e-8 ✓	107.0 EB05 79.7 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious n=33 · ♀ 100% (drug 57%) · 100% clinician	not reported in cached trials
Blood lactic acid decreased	33	139.3 95.3–203.6ROR 139.4 · calibrated p 3e-8 ✓	105.9 EB05 78.9 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious n=33 · ♀ 100% (drug 57%) · 100% clinician	not reported in cached trials
Malignant melanoma stage 0	32	126.8 86.5–185.8ROR 126.9 · calibrated p 5e-8 ✓	98.3 EB05 72.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=32 · ♀ 0% (drug 57%) · 100% clinician	not reported in cached trials
Congenital hiatus hernia	39	126.2 89.3–178.4ROR 126.3 · calibrated p 5e-8 ✓	99.0 EB05 75.6 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=39 · ♀ 0% (drug 57%) · 100% clinician	not reported in cached trials
Mite allergy	108	120.5 98.0–148.2ROR 120.9 · calibrated p 4e-8 ✓	98.3 EB05 83.7 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=108 · ♀ 0% (drug 57%)	not reported in cached trials
Steroid dependence	139	115.7 96.4–138.7ROR 116.1 · calibrated p 5e-8 ✓	95.4 EB05 82.8 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=139 · ♀ 21% (drug 57%) · 92% clinician	not reported in cached trials
Onychomadesis	666	112.9 104.0–122.6ROR 115.1 · calibrated p 4e-8 ✓	94.5 EB05 88.6 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=666 · ♀ 100% (drug 57%) · 93% clinician	not reported in cached trials
Catarrh	132	103.1 85.7–124.0ROR 103.4 · calibrated p 1e-7 ✓	86.7 EB05 74.9 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=132 · ♀ 24% (drug 57%) · 91% clinician	not reported in cached trials
Blepharospasm	907	101.2 94.4–108.6ROR 103.9 · calibrated p 9e-8 ✓	86.3 EB05 81.6 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=907 · ♀ 100% (drug 57%) · 93% clinician	not reported in cached trials
Breast cancer stage iii	922	98.9 92.3–106.0ROR 101.5 · calibrated p 1e-7 ✓	84.6 EB05 80.1 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=922 · ♀ 100% (drug 57%) · 94% clinician	not reported in cached trials
Bronchopulmonary aspergillosis allergic	129	96.8 80.4–116.6ROR 97.2 · calibrated p 2e-7 ✓	82.2 EB05 71.0 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=129	not reported in cached trials
Antineutrophil cytoplasmic antibody positive	102	96.3 78.1–118.7ROR 96.6 · calibrated p 2e-7 ✓	81.6 EB05 69.1 · IC025 +5.6 3/3 methods agree	Lab value / disease marker	serious n=102 · ♀ 0% (drug 57%)	not reported in cached trials
Vitamin b1 decreased	35	96.2 67.3–137.5ROR 96.3 · calibrated p 3e-7 ✓	79.2 EB05 59.6 · IC025 +4.7 3/3 methods agree	Lab value / disease marker	serious n=34 · ♀ 100% (drug 57%) · 100% clinician	not reported in cached trials
Rheumatic fever	580	90.5 83.0–98.7ROR 92.0 · calibrated p 2e-7 ✓	78.3 EB05 73.1 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=580 · ♀ 100% (drug 57%) · 92% clinician	not reported in cached trials
Carotid artery thrombosis	113	90.2 74.0–109.9ROR 90.5 · calibrated p 3e-7 ✓	77.2 EB05 66.0 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=113 · ♀ 100% (drug 57%) · 100% clinician	not reported in cached trials
Atrial tachycardia	279	90.1 79.5–102.2ROR 90.8 · calibrated p 3e-7 ✓	77.8 EB05 70.4 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=279	not reported in cached trials
Mycotic allergy	111	89.7 73.5–109.5ROR 90.0 · calibrated p 3e-7 ✓	76.9 EB05 65.6 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=111 · ♀ 0% (drug 57%)	not reported in cached trials
Product monitoring error	188	89.2 76.5–103.9ROR 89.6 · calibrated p 3e-7 ✓	76.9 EB05 68.1 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious n=188 · 90% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	897	85.4 79.7–91.5ROR 87.6 · calibrated p 3e-7 ✓	74.5 EB05 70.5 · IC025 +6.1 3/3 methods agree	Lab value / disease marker	serious PRR 44.7 · ♀ 100% (drug 57%) · 92% clinician	not reported in cached trials
Overlap syndrome	85	83.1 66.2–104.2ROR 83.3 · calibrated p 6e-7 ✓	71.7 EB05 59.8 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=85 · ♀ 100% (drug 57%)	not reported in cached trials
Duodenal ulcer perforation	891	81.7 76.2–87.5ROR 83.7 · calibrated p 4e-7 ✓	71.6 EB05 67.8 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 42.8 · ♀ 100% (drug 57%) · 93% clinician	not reported in cached trials
Therapeutic drug monitoring analysis not performed	36	81.3 57.4–115.2ROR 81.4 · calibrated p 1e-6 ✓	68.9 EB05 52.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=36 · ♀ 100% (drug 57%) · 100% clinician	not reported in cached trials
Pruritus genital	276	79.5 70.1–90.1ROR 80.1 · calibrated p 6e-7 ✓	69.7 EB05 63.1 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=276	not reported in cached trials
Lupus vulgaris	141	79.4 66.6–94.7ROR 79.7 · calibrated p 7e-7 ✓	69.4 EB05 60.3 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=141 · ♀ 100% (drug 57%) · 93% clinician	not reported in cached trials
Dust allergy	109	75.3 61.7–91.9ROR 75.5 · calibrated p 1e-6 ✓	66.1 EB05 56.3 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=109 · ♀ 0% (drug 57%)	not reported in cached trials
Neuritis	170	73.4 62.6–86.1ROR 73.8 · calibrated p 1e-6 ✓	64.8 EB05 57.1 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=170 · ♀ 0% (drug 57%)	not reported in cached trials
Onychomycosis	452	68.0 61.7–74.9ROR 68.9 · calibrated p 2e-6 ✓	60.9 EB05 56.3 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=452 · ♀ 100% (drug 57%) · 94% clinician	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Hyponatraemia	770	5.75.3–6.1	signal
Interstitial lung disease	852	5.34.9–5.7	signal
Liver injury	2,213	4.44.2–4.5	signal
Arrhythmia / qt	1,357	4.24.0–4.4	signal
Kidney injury	3,020	3.93.8–4.1	signal
Hyperglycaemia / diabetes	2,084	3.63.4–3.7	signal
Depression	1,573	3.33.2–3.5	signal
Rhabdomyolysis / myopathy	446	3.33.0–3.6	signal
Gi bleeding	962	3.12.9–3.3	signal
Fall / fracture	1,946	3.02.9–3.2	signal
Anaemia	1,501	3.02.8–3.1	signal
Anaphylaxis / angioedema	617	2.92.7–3.2	signal
Tendon disorder	185	2.92.5–3.3	signal
Serious infection	3,200	2.52.4–2.5	signal
Heart failure	723	2.42.2–2.6	signal
Myocardial infarction	808	2.32.2–2.5	signal

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Candesartan 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).

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
Off label use (used outside approved label)	3,770	2.6 2.5–2.7ROR 2.8 · calibrated p 0.708	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.3 · serious PRR 2.8	not reported in cached trials
Fatigue (tiredness)	3,401	2.6 2.5–2.7ROR 2.8 · calibrated p 0.708	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.4 · serious PRR 2.9	not reported in cached trials
Dyspnoea (shortness of breath)	3,359	3.5 3.4–3.6ROR 3.8 · calibrated p 0.419	3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.9 · serious PRR 2.9	NCT02166697: 1/13,804 (0.0%) on Candesartan
Nausea	3,189	2.4 2.3–2.5ROR 2.5 · calibrated p 0.799	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.2 · serious PRR 2.7	NCT02166697: 1/13,804 (0.0%) on Candesartan (serious AE)
Diarrhoea (diarrhea)	3,028	2.8 2.7–2.9ROR 3.0 · calibrated p 0.640	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled — boxed warning exact term	age-adj. PRR 2.3 · serious PRR 2.9	NCT02166697: 1/13,804 (0.0%) on Candesartan
Dizziness	2,929	3.5 3.4–3.6ROR 3.7 · calibrated p 0.434	3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.0 · serious PRR 3.6	NCT02211638: 41/17,130 (0.2%) on Candesartan
Headache	2,759	2.6 2.5–2.7ROR 2.7 · calibrated p 0.714	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.6 · serious PRR 3.2	NCT02166697: 9/13,804 (0.1%) on Candesartan
Pain	2,674	2.6 2.5–2.7ROR 2.7 · calibrated p 0.730	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.8 · serious PRR 2.4	NCT02211638: 1/17,130 (0.0%) on Candesartan (serious AE)
Drug ineffective (drug did not work)	2,572	1.2 1.1–1.2ROR 1.2 · calibrated p 0.418	1.2 EB05 1.1 · IC025 +0.1	Reporting / coding artifact	age-adj. PRR 1.5 · serious PRR 1.9	not reported in cached trials
Vomiting	2,485	3.1 3.0–3.3ROR 3.3 · calibrated p 0.535	3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree	Labeled — boxed warning exact term	age-adj. PRR 2.9 · serious PRR 2.8 · ♀ 79% (drug 57%)	NCT02211638: 1/17,130 (0.0%) on Candesartan (serious AE)
Arthralgia (joint pain)	2,389	3.4 3.3–3.6ROR 3.6 · calibrated p 0.461	3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	age-adj. PRR 3.1 · serious PRR 3.7	not reported in cached trials
General physical health deterioration	2,389	12.5 12.1–13.0ROR 13.4 · calibrated p 0.011 ✓	12.3 EB05 11.9 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 10.6 · serious PRR 8.6 · 91% clinician	not reported in cached trials
Asthenia (weakness)	2,211	3.5 3.4–3.6ROR 3.7 · calibrated p 0.448	3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.7 · serious PRR 2.9	NCT02166697: 1/13,804 (0.0%) on Candesartan
Hypertension (high blood pressure)	2,153	6.1 5.8–6.3ROR 6.4 · calibrated p 0.127	6.0 EB05 5.8 · IC025 +2.5 3/3 methods agree	Labeled — boxed warning exact term	age-adj. PRR 5.0 · serious PRR 4.4	NCT02166697: 1/13,804 (0.0%) on Candesartan (serious AE)
Malaise (feeling unwell)	2,137	2.9 2.8–3.0ROR 3.0 · calibrated p 0.625	2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	age-adj. PRR 2.7 · serious PRR 2.9 · ♀ 78% (drug 57%)	NCT02166697: 1/13,804 (0.0%) on Candesartan

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.

Hepatic enzyme — n=79, PRR 779.9
Hypocholesterolaemia — n=131, PRR 441.1
Immunisation — n=176, PRR 406.8
Palmoplantar keratoderma — n=267, PRR 350.3
Pulmonary vasculitis — n=181, PRR 309.2
Total lung capacity abnormal — n=118, PRR 266.4
Facet joint syndrome — n=869, PRR 225.7
Capillaritis — n=65, PRR 189.3
Neovascularisation — n=59, PRR 177.1
Neurologic neglect syndrome — n=118, PRR 158.0

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?

In FDA FAERS, the most frequently co-reported reaction terms for Candesartan are fatigue, dyspnoea, nausea, diarrhoea, dizziness, headache. 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 have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue candesartan cilexetil tablets as soon as possible. [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] Drugs that act directly on the .

Do FAERS signals prove that Candesartan 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 7eb297cb-ef1b-44e0-a49d-03727100579e, effective 20260205; matched on openfda.generic_name.exact:"CANDESARTAN")
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, field patient.drug.openfda.generic_name.exact, 1,246 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, 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.