Irbesartan and Hydrochlorothiazide side effects: what 5,302 FDA adverse event reports show
Drug class
Angiotensin 2 Receptor Blocker
Label matched
Irbesartan (Irbesartan)
Who reports
5,302 reports · 57% serious · 277 with death outcome · 63% female
Used for
Irbesartan tablets are angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria.
What it is
Irbesartan, USP is an angiotensin II receptor (AT 1 subtype) antagonist. Irbesartan, USP is a non-peptide compound, chemically described as a 2-butyl-3-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one.
Boxed warning
FETAL TOXICITY • When pregnancy is detected, discontinue irbesartan tablets as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ].
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.
- 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. 399 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 |
|---|---|---|---|---|---|---|
| Mitral valve incompetence | 26 | 9.1 6.2–13.4ROR 9.1 · χ² 179 / p 4e-41 | 8.3 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Coronary artery disease | 61 | 7.9 6.2–10.2ROR 8.0 · χ² 362 / p 6e-81 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| End stage renal disease | 36 | 7.7 5.6–10.7ROR 7.8 · χ² 204 / p 1e-46 | 7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.8 | no trial data cached |
| Arteriosclerosis | 18 | 7.6 4.8–12.0ROR 7.6 · χ² 96 / p 6e-23 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Intervertebral disc degeneration | 17 | 7.2 4.5–11.6ROR 7.3 · χ² 85 / p 1e-20 | 6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Anorexia | 23 | 7.0 4.6–10.5ROR 7.0 · χ² 112 / p 2e-26 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Hyperlipidaemia | 21 | 6.9 4.5–10.6ROR 7.0 · χ² 101 / p 5e-24 | 6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 7.7 | no trial data cached |
| Renal failure acute | 75 | 6.9 5.5–8.6ROR 7.0 · χ² 373 / p 2e-83 | 6.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.0 | no trial data cached |
| Nocturia (night-time urination) | 21 | 6.9 4.5–10.5ROR 6.9 · χ² 99 / p 1e-23 | 6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 80% consumer | no trial data cached |
| Blood pressure fluctuation | 38 | 6.3 4.6–8.6ROR 6.3 · χ² 162 / p 2e-37 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 3.8 · 70% consumer | no trial data cached |
| Hypercholesterolaemia | 15 | 6.2 3.7–10.3ROR 6.2 · χ² 60 / p 4e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Cyst | 19 | 6.1 3.9–9.5ROR 6.1 · χ² 75 / p 2e-18 | 5.3 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Hypertensive crisis | 17 | 6.0 3.7–9.7ROR 6.0 · χ² 66 / p 2e-16 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.1 | no trial data cached |
| Cardiomegaly | 18 | 5.7 3.6–9.1ROR 5.8 · χ² 66 / p 2e-16 | 5.1 EB05 3.4 · IC025 +1.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.0 | no trial data cached |
| Blood potassium increased | 23 | 5.6 3.7–8.4ROR 5.6 · χ² 83 / p 5e-20 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 5.5 | no trial data cached |
| Blood pressure increased | 217 | 5.6 4.9–6.4ROR 5.8 · χ² 822 / p 5e-181 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.3 · 71% consumer | no trial data cached |
| Bursitis | 17 | 5.6 3.5–9.0ROR 5.6 · χ² 59 / p 7e-15 | 4.9 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Blood glucose fluctuation | 15 | 5.4 3.3–9.0ROR 5.4 · χ² 49 / p 1e-12 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious n=8 | no trial data cached |
| Metabolic acidosis | 42 | 5.3 3.9–7.1ROR 5.3 · χ² 140 / p 1e-32 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 28% (drug 63%) | no trial data cached |
| Hyponatraemia (low sodium) | 74 | 5.2 4.2–6.5ROR 5.3 · χ² 248 / p 3e-56 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Myocardial ischaemia | 15 | 5.2 3.1–8.6ROR 5.2 · χ² 46 / p 5e-12 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.2 | no trial data cached |
| Gout | 23 | 5.1 3.4–7.6ROR 5.1 · χ² 71 / p 2e-17 | 4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · ♀ 36% (drug 63%) | no trial data cached |
| Blood pressure systolic increased | 25 | 5.1 3.4–7.5ROR 5.1 · χ² 77 / p 8e-19 | 4.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.1 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 155 | 5.0 4.3–5.9ROR 5.1 · χ² 497 / p 2e-110 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 | no trial data cached |
| Sinus bradycardia | 12 | 4.9 2.8–8.6ROR 4.9 · χ² 33 / p 4e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Hepatic steatosis | 23 | 4.9 3.3–7.4ROR 4.9 · χ² 67 / p 1e-16 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Osteoarthritis | 52 | 4.8 3.7–6.4ROR 4.9 · χ² 155 / p 7e-36 | 4.7 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Carpal tunnel syndrome | 17 | 4.8 3.0–7.7ROR 4.8 · χ² 47 / p 3e-12 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Osteopenia | 18 | 4.7 2.9–7.4ROR 4.7 · χ² 48 / p 2e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Tooth abscess | 12 | 4.6 2.6–8.2ROR 4.7 · χ² 31 / p 1e-8 | 4.0 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Rotator cuff syndrome | 15 | 4.6 2.8–7.6ROR 4.6 · χ² 39 / p 2e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Coronary artery occlusion | 16 | 4.6 2.8–7.5ROR 4.6 · χ² 41 / p 6e-11 | 4.1 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Hiatus hernia | 15 | 4.6 2.8–7.6ROR 4.6 · χ² 38 / p 3e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Sleep apnoea syndrome | 22 | 4.6 3.0–6.9ROR 4.6 · χ² 57 / p 2e-14 | 4.2 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Chronic kidney disease | 87 | 4.5 3.6–5.5ROR 4.6 · χ² 233 / p 6e-53 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.6 | no trial data cached |
| Atelectasis | 11 | 4.5 2.5–8.1ROR 4.5 · χ² 26 / p 1e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 55 | 4.5 3.4–5.8ROR 4.5 · χ² 146 / p 8e-34 | 4.3 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · ♀ 40% (drug 63%) | no trial data cached |
| Vitamin d deficiency | 11 | 4.5 2.5–8.1ROR 4.5 · χ² 26 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 38 | 4.4 3.2–6.1ROR 4.5 · χ² 98 / p 2e-23 | 4.2 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Blood sodium decreased | 21 | 4.4 2.9–6.8ROR 4.4 · χ² 52 / p 3e-13 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.1 | 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 |
|---|---|---|---|---|---|---|
| Dizziness | 337 | 2.7 2.4–3.0ROR 2.8 · χ² 361 / p 8e-81 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.4 | no trial data cached |
| Blood pressure increased | 217 | 5.6 4.9–6.4ROR 5.8 · χ² 822 / p 5e-181 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.3 · 71% consumer | no trial data cached |
| Hypertension (high blood pressure) | 202 | 3.8 3.3–4.3ROR 3.9 · χ² 412 / p 6e-92 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.2 | no trial data cached |
| Fall | 173 | 2.1 1.8–2.4ROR 2.1 · χ² 95 / p 1e-22 | 2.1 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Pain in extremity | 170 | 2.3 2.0–2.6ROR 2.3 · χ² 122 / p 1e-28 | 2.3 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Arthralgia (joint pain) | 161 | 1.5 1.3–1.8ROR 1.6 · χ² 30 / p 2e-8 | 1.5 EB05 1.3 · IC025 +0.4 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 155 | 5.0 4.3–5.9ROR 5.1 · χ² 497 / p 2e-110 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 | no trial data cached |
| Chest pain | 142 | 3.0 2.6–3.6ROR 3.1 · χ² 192 / p 5e-44 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Insomnia (trouble sleeping) | 139 | 2.1 1.7–2.4ROR 2.1 · χ² 76 / p 2e-18 | 2.1 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Renal failure (kidney failure) | 128 | 3.8 3.2–4.5ROR 3.9 · χ² 261 / p 5e-59 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.8 | no trial data cached |
| Blood glucose increased | 123 | 2.6 2.2–3.1ROR 2.6 · χ² 118 / p 1e-27 | 2.6 EB05 2.2 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 2.8 · 71% consumer | no trial data cached |
| Myocardial infarction (heart attack) | 121 | 2.7 2.3–3.2ROR 2.8 · χ² 131 / p 1e-30 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 2.8 · ♀ 42% (drug 63%) | no trial data cached |
| Back pain | 118 | 2.0 1.7–2.4ROR 2.0 · χ² 59 / p 7e-15 | 2.0 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Depression | 115 | 2.0 1.7–2.4ROR 2.0 · χ² 56 / p 3e-14 | 2.0 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Feeling abnormal | 114 | 1.9 1.6–2.2ROR 1.9 · χ² 46 / p 5e-12 | 1.9 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.0 | 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.
- Mitral valve incompetence — n=26, PRR 9.1
- Coronary artery disease — n=61, PRR 7.9
- Anorexia — n=23, PRR 7.0
- Nocturia — n=21, PRR 6.9
- Metabolic acidosis — n=42, PRR 5.3
- Hyponatraemia — n=74, PRR 5.2
- Gout — n=23, PRR 5.1
- Hepatic steatosis — n=23, PRR 4.9
- Osteoarthritis — n=52, PRR 4.8
- Sleep apnoea syndrome — n=22, PRR 4.6
✓ 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 Irbesartan and Hydrochlorothiazide?
In FDA FAERS, the most frequently co-reported reaction terms for Irbesartan and Hydrochlorothiazide are dizziness, blood pressure increased, hypertension, fall, pain in extremity, arthralgia. 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 Irbesartan and Hydrochlorothiazide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY • When pregnancy is detected, discontinue irbesartan tablets as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ].
Do FAERS signals prove that Irbesartan and Hydrochlorothiazide 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 068224c4-a34d-32d7-bb2a-7eed44ccf7d3, effective 20260421; matched on
openfda.generic_name.exact:"IRBESARTAN") - 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, 439 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.