Candesartan Cilexetil and Hydrochlorothiazide side effects: what 2,599 FDA adverse event reports show
Drug class
Angiotensin ii receptor blocker (arb)
Who reports
2,599 reports · 83% serious · 165 with death outcome · 61% 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 — 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. 100 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 |
|---|---|---|---|---|---|---|
| Coronary artery occlusion | 62 | 36.5 28.5–46.7ROR 37.3 · χ² 2,095 / p <1e-300 | 35.9 EB05 29.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · ♀ 35% (drug 61%) · 91% consumer | no trial data cached |
| Arteriosclerosis | 26 | 22.3 15.2–32.7ROR 22.5 · χ² 507 / p 1e-112 | 21.9 EB05 15.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 · ♀ 9% (drug 61%) | no trial data cached |
| Obstructive airways disorder | 29 | 21.0 14.6–30.2ROR 21.2 · χ² 532 / p 5e-118 | 20.7 EB05 15.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · ♀ 8% (drug 61%) · 93% clinician | no trial data cached |
| Vasculitis | 28 | 19.4 13.4–28.1ROR 19.6 · χ² 470 / p 1e-104 | 19.1 EB05 13.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 · ♀ 0% (drug 61%) · 93% clinician | no trial data cached |
| Full blood count abnormal | 24 | 18.4 12.4–27.4ROR 18.6 · χ² 377 / p 2e-84 | 18.1 EB05 12.6 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 16.9 · ♀ 0% (drug 61%) · 92% clinician | no trial data cached |
| Hypercholesterolaemia | 20 | 16.9 10.9–26.2ROR 17.0 · χ² 283 / p 8e-64 | 16.4 EB05 10.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Pulmonary fibrosis | 34 | 14.4 10.3–20.1ROR 14.6 · χ² 410 / p 2e-91 | 14.1 EB05 10.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 7% (drug 61%) · 94% clinician | no trial data cached |
| Sleep disorder due to a general medical condition | 28 | 14.0 9.7–20.2ROR 14.1 · χ² 325 / p 7e-73 | 13.6 EB05 9.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.5 · ♀ 0% (drug 61%) · 93% clinician | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 17 | 13.5 8.4–21.7ROR 13.6 · χ² 184 / p 3e-42 | 12.6 EB05 7.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Nodule | 21 | 13.0 8.5–19.9ROR 13.1 · χ² 221 / p 3e-50 | 12.3 EB05 8.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 · 90% clinician | no trial data cached |
| Renal failure acute | 69 | 13.0 10.3–16.4ROR 13.3 · χ² 750 / p 2e-165 | 12.8 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 · 92% clinician | no trial data cached |
| Blood pressure increased | 238 | 12.6 11.1–14.2ROR 13.7 · χ² 2,534 / p <1e-300 | 12.5 EB05 11.2 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.3 · 82% consumer | no trial data cached |
| Hyponatraemia (low sodium) | 86 | 12.4 10.0–15.2ROR 12.8 · χ² 888 / p 2e-195 | 12.2 EB05 10.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Blood pressure fluctuation | 36 | 12.1 8.7–16.7ROR 12.2 · χ² 355 / p 2e-79 | 11.7 EB05 8.6 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 9.1 · 100% consumer | no trial data cached |
| Hypertensive crisis | 16 | 11.6 7.1–18.9ROR 11.6 · χ² 144 / p 2e-33 | 10.4 EB05 6.3 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.1 | no trial data cached |
| Intentional drug misuse | 28 | 10.7 7.4–15.4ROR 10.8 · χ² 236 / p 2e-53 | 10.0 EB05 7.0 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 · 100% consumer | no trial data cached |
| Hyperlipidaemia | 15 | 10.1 6.1–16.8ROR 10.2 · χ² 114 / p 6e-27 | 8.7 EB05 5.3 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.7 | no trial data cached |
| Hypothyroidism | 39 | 9.9 7.2–13.5ROR 10.0 · χ² 303 / p 3e-68 | 9.4 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · ♀ 34% (drug 61%) | no trial data cached |
| Blood cholesterol increased | 53 | 9.2 7.0–12.0ROR 9.4 · χ² 379 / p 1e-84 | 8.8 EB05 6.9 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 8.9 · 90% consumer | no trial data cached |
| Hypertension (high blood pressure) | 222 | 8.5 7.5–9.6ROR 9.2 · χ² 1,466 / p <1e-300 | 8.4 EB05 7.5 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.7 · 72% consumer | no trial data cached |
| Angina pectoris | 30 | 8.4 5.9–12.0ROR 8.5 · χ² 188 / p 4e-43 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Diabetes mellitus | 79 | 8.3 6.7–10.4ROR 8.6 · χ² 504 / p 7e-112 | 8.1 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · 90% consumer | no trial data cached |
| Haemoptysis | 27 | 7.8 5.4–11.4ROR 7.9 · χ² 153 / p 2e-35 | 7.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · ♀ 0% (drug 61%) · 93% clinician | no trial data cached |
| Blood pressure abnormal | 19 | 7.7 4.9–12.1ROR 7.8 · χ² 105 / p 6e-25 | 6.7 EB05 4.5 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.9 | no trial data cached |
| Gout | 17 | 7.6 4.8–12.3ROR 7.7 · χ² 92 / p 5e-22 | 6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Drug dispensing error | 14 | 7.3 4.3–12.3ROR 7.3 · χ² 70 / p 3e-17 | 6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Pharyngitis | 11 | 7.1 4.0–12.9ROR 7.2 · χ² 52 / p 3e-13 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Gastritis | 23 | 7.1 4.7–10.6ROR 7.1 · χ² 114 / p 7e-27 | 6.3 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 83% (drug 61%) | no trial data cached |
| Electrolyte imbalance | 10 | 7.0 3.8–13.0ROR 7.0 · χ² 46 / p 7e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Gamma-glutamyltransferase increased | 19 | 6.9 4.4–10.8ROR 7.0 · χ² 90 / p 1e-21 | 6.0 EB05 4.1 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 4.7 | no trial data cached |
| Hypokinesia | 12 | 6.7 3.8–11.7ROR 6.7 · χ² 52 / p 2e-13 | 5.5 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Productive cough (cough with phlegm) | 39 | 6.7 4.9–9.1ROR 6.7 · χ² 182 / p 9e-42 | 6.2 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Drug prescribing error | 16 | 6.6 4.1–10.8ROR 6.7 · χ² 71 / p 2e-17 | 5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=15 | no trial data cached |
| Blood triglycerides increased | 14 | 6.4 3.8–10.8ROR 6.4 · χ² 58 / p 1e-14 | 5.4 EB05 3.4 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 6.5 | no trial data cached |
| Arrhythmia | 37 | 6.3 4.6–8.7ROR 6.4 · χ² 159 / p 8e-37 | 5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 94% consumer | no trial data cached |
| Hyperglycaemia (high blood sugar) | 28 | 6.2 4.3–9.0ROR 6.3 · χ² 118 / p 1e-27 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Urinary incontinence | 22 | 6.0 4.0–9.1ROR 6.0 · χ² 87 / p 6e-21 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Basal cell carcinoma | 11 | 5.7 3.2–10.3ROR 5.7 · χ² 38 / p 4e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Syncope (fainting) | 70 | 5.6 4.5–7.1ROR 5.8 · χ² 264 / p 1e-59 | 5.5 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 12 | 5.6 3.2–9.8ROR 5.6 · χ² 40 / p 1e-10 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Blood pressure increased | 238 | 12.6 11.1–14.2ROR 13.7 · χ² 2,534 / p <1e-300 | 12.5 EB05 11.2 · IC025 +3.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.3 · 82% consumer | no trial data cached |
| Hypertension (high blood pressure) | 222 | 8.5 7.5–9.6ROR 9.2 · χ² 1,466 / p <1e-300 | 8.4 EB05 7.5 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.7 · 72% consumer | no trial data cached |
| Drug dose omission | 107 | 5.2 4.3–6.2ROR 5.3 · χ² 357 / p 8e-80 | 5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 · ♀ 81% (drug 61%) · 92% consumer | no trial data cached |
| Hyponatraemia (low sodium) | 86 | 12.4 10.0–15.2ROR 12.8 · χ² 888 / p 2e-195 | 12.2 EB05 10.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Myocardial infarction (heart attack) | 79 | 3.6 2.9–4.5ROR 3.7 · χ² 149 / p 2e-34 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 2.5 · 77% consumer | no trial data cached |
| Diabetes mellitus | 79 | 8.3 6.7–10.4ROR 8.6 · χ² 504 / p 7e-112 | 8.1 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · 90% consumer | no trial data cached |
| Syncope (fainting) | 70 | 5.6 4.5–7.1ROR 5.8 · χ² 264 / p 1e-59 | 5.5 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Renal failure acute | 69 | 13.0 10.3–16.4ROR 13.3 · χ² 750 / p 2e-165 | 12.8 EB05 10.4 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 · 92% clinician | no trial data cached |
| General physical health deterioration | 67 | 4.7 3.7–6.0ROR 4.8 · χ² 193 / p 4e-44 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · ♀ 38% (drug 61%) · 95% clinician | no trial data cached |
| Coronary artery occlusion | 62 | 36.5 28.5–46.7ROR 37.3 · χ² 2,095 / p <1e-300 | 35.9 EB05 29.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · ♀ 35% (drug 61%) · 91% consumer | no trial data cached |
| Cerebrovascular accident (stroke) | 56 | 2.7 2.1–3.4ROR 2.7 · χ² 57 / p 2e-14 | 2.6 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 · 81% consumer | no trial data cached |
| Asthma | 56 | 4.0 3.1–5.2ROR 4.1 · χ² 125 / p 2e-29 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Blood cholesterol increased | 53 | 9.2 7.0–12.0ROR 9.4 · χ² 379 / p 1e-84 | 8.8 EB05 6.9 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 8.9 · 90% consumer | no trial data cached |
| Thrombosis | 39 | 3.9 2.9–5.3ROR 3.9 · χ² 82 / p 8e-20 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · ♀ 34% (drug 61%) | no trial data cached |
| Productive cough (cough with phlegm) | 39 | 6.7 4.9–9.1ROR 6.7 · χ² 182 / p 9e-42 | 6.2 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
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.
- Coronary artery occlusion — n=62, PRR 36.5
- Arteriosclerosis — n=26, PRR 22.3
- Obstructive airways disorder — n=29, PRR 21.0
- Vasculitis — n=28, PRR 19.4
- Hypercholesterolaemia — n=20, PRR 16.9
- Pulmonary fibrosis — n=34, PRR 14.4
- Sleep disorder due to a general medical condition — n=28, PRR 14.0
- Nodule — n=21, PRR 13.0
- Hypothyroidism — n=39, PRR 9.9
- Angina pectoris — n=30, PRR 8.4
✓ A hand-written Bradford Hill causality assessment exists for this drug: Hydrochlorothiazide (thiazides) ↔ Hyponatraemia.
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 blood pressure increased, hypertension, hyponatraemia, myocardial infarction, diabetes mellitus, syncope. 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, 140 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
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.