Lisinopril and Hydrochlorothiazide Tablets side effects: what 7,813 FDA adverse event reports show
Drug class
Angiotensin converting enzyme (ace) inhibitor
Label matched
Lisinopril (Lisinopril)
Who reports
7,813 reports · 56% serious · 411 with death outcome · 56% female
Used for
Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1 ) Adjunct therapy for heart failure ( 1.2 ) Treatment of Acute Myocardial.
What it is
Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate.
Boxed warning
FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue lisinopril as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
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. 987 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 |
|---|---|---|---|---|---|---|
| Angioedema (deep swelling of face/throat) | 262 | 16.0 14.2–18.1ROR 16.5 · χ² 3,660 / p <1e-300 | 15.9 EB05 14.4 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.1 · ♀ 25% (drug 56%) · 96% clinician | no trial data cached |
| Pancreatitis necrotising | 10 | 11.9 6.4–22.1ROR 11.9 · χ² 89 / p 3e-21 | 9.7 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Therapeutic agent toxicity | 13 | 10.4 6.0–17.8ROR 10.4 · χ² 100 / p 6e-24 | 8.7 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Nephrogenic anaemia | 16 | 9.2 5.6–15.0ROR 9.2 · χ² 109 / p 9e-26 | 7.9 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Diabetic neuropathy | 17 | 9.2 5.7–14.8ROR 9.2 · χ² 116 / p 3e-27 | 7.9 EB05 5.0 · IC025 +2.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Recalled product administered | 29 | 8.9 6.2–12.8ROR 8.9 · χ² 194 / p 2e-44 | 8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | 76% consumer | no trial data cached |
| Hypovolaemia | 19 | 8.7 5.6–13.7ROR 8.8 · χ² 122 / p 1e-28 | 7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Pre-existing condition improved | 16 | 6.8 4.2–11.1ROR 6.8 · χ² 74 / p 5e-18 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Atrioventricular block first degree | 11 | 6.8 3.8–12.3ROR 6.8 · χ² 49 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Renal failure acute | 103 | 6.4 5.3–7.8ROR 6.5 · χ² 467 / p 6e-104 | 6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 | no trial data cached |
| Lung neoplasm | 10 | 6.3 3.4–11.6ROR 6.3 · χ² 39 / p 2e-10 | 5.0 EB05 2.9 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Sarcoidosis | 11 | 6.2 3.4–11.2ROR 6.2 · χ² 43 / p 3e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Rhinitis allergic | 10 | 6.1 3.3–11.3ROR 6.1 · χ² 37 / p 5e-10 | 4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Swollen tongue | 69 | 5.9 4.7–7.5ROR 6.0 · χ² 278 / p 1e-62 | 5.7 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Blood pressure inadequately controlled | 13 | 5.8 3.3–9.9ROR 5.8 · χ² 46 / p 5e-12 | 4.9 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious n=9 | no trial data cached |
| Dizziness postural | 20 | 5.6 3.6–8.7ROR 5.6 · χ² 71 / p 2e-17 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Seasonal allergy | 27 | 5.1 3.5–7.5ROR 5.2 · χ² 86 / p 1e-20 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Overweight | 10 | 5.0 2.7–9.3ROR 5.0 · χ² 28 / p 5e-8 | 4.2 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Blood sodium decreased | 33 | 4.7 3.4–6.6ROR 4.7 · χ² 93 / p 3e-22 | 4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.0 | no trial data cached |
| Coeliac disease | 17 | 4.7 2.9–7.5ROR 4.7 · χ² 45 / p 9e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Flushing | 173 | 4.6 3.9–5.3ROR 4.6 · χ² 478 / p 4e-106 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 · 87% consumer | no trial data cached |
| Economic problem | 26 | 4.5 3.1–6.7ROR 4.5 · χ² 68 / p 8e-17 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 | no trial data cached |
| Breast mass | 11 | 4.4 2.4–7.9ROR 4.4 · χ² 25 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Blood urea increased | 26 | 4.1 2.8–6.1ROR 4.2 · χ² 59 / p 8e-15 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Lab value / disease marker | serious PRR 4.2 | no trial data cached |
| Pharyngeal oedema | 24 | 4.1 2.8–6.2ROR 4.1 · χ² 54 / p 1e-13 | 3.9 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Vitamin d deficiency | 15 | 4.1 2.5–6.9ROR 4.1 · χ² 33 / p 6e-9 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Hypoaesthesia oral | 23 | 4.1 2.7–6.2ROR 4.1 · χ² 51 / p 5e-13 | 3.8 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Lip swelling | 50 | 4.0 3.1–5.3ROR 4.1 · χ² 111 / p 2e-26 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Restless legs syndrome | 27 | 4.0 2.7–5.8ROR 4.0 · χ² 57 / p 2e-14 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Type 2 diabetes mellitus | 50 | 4.0 3.0–5.2ROR 4.0 · χ² 108 / p 1e-25 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 | no trial data cached |
| Laceration | 14 | 3.9 2.3–6.7ROR 3.9 · χ² 28 / p 7e-8 | 3.5 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Blood potassium decreased | 43 | 3.8 2.8–5.2ROR 3.9 · χ² 87 / p 4e-21 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 3.9 | no trial data cached |
| Hyponatraemia (low sodium) | 80 | 3.8 3.1–4.8ROR 3.9 · χ² 164 / p 7e-38 | 3.7 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Hot flush (hot flashes) | 107 | 3.8 3.2–4.6ROR 3.9 · χ² 220 / p 5e-50 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.7 · 79% consumer | no trial data cached |
| Hyperlipidaemia | 17 | 3.8 2.4–6.1ROR 3.8 · χ² 32 / p 6e-9 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.8 | no trial data cached |
| Abnormal dreams | 39 | 3.8 2.8–5.2ROR 3.8 · χ² 77 / p 1e-18 | 3.6 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 74% consumer | no trial data cached |
| Gout | 25 | 3.7 2.5–5.5ROR 3.7 · χ² 47 / p 3e-12 | 3.5 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Arthropod bite | 10 | 3.7 2.0–6.8ROR 3.7 · χ² 17 / p 2e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious n=8 | no trial data cached |
| Sleep apnoea syndrome | 26 | 3.7 2.5–5.4ROR 3.7 · χ² 47 / p 3e-12 | 3.5 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Sinus bradycardia | 13 | 3.6 2.1–6.2ROR 3.6 · χ² 22 / p 1e-6 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | 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 |
|---|---|---|---|---|---|---|
| Nausea | 547 | 1.9 1.7–2.0ROR 1.9 · χ² 226 / p 3e-51 | 1.9 EB05 1.7 · IC025 +0.8 | Labeled — boxed warning exact term | serious PRR 2.0 | no trial data cached |
| Fatigue (tiredness) | 538 | 1.9 1.7–2.0ROR 1.9 · χ² 221 / p 3e-50 | 1.9 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Diarrhoea (diarrhea) | 487 | 2.0 1.9–2.2ROR 2.1 · χ² 262 / p 3e-59 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Drug ineffective (drug did not work) | 479 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.303 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.1 | no trial data cached |
| Dizziness | 392 | 2.1 1.9–2.3ROR 2.2 · χ² 234 / p 3e-53 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Pain | 384 | 1.7 1.5–1.8ROR 1.7 · χ² 107 / p 2e-25 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled — boxed warning exact term | serious PRR 1.7 | no trial data cached |
| Headache | 335 | 1.4 1.3–1.6ROR 1.5 · χ² 45 / p 9e-12 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Dyspnoea (shortness of breath) | 319 | 1.5 1.4–1.7ROR 1.5 · χ² 57 / p 3e-14 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Cough | 291 | 2.8 2.5–3.1ROR 2.9 · χ² 337 / p 1e-75 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Vomiting | 282 | 1.6 1.4–1.8ROR 1.6 · χ² 67 / p 1e-16 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled — boxed warning exact term | serious PRR 1.7 | no trial data cached |
| Asthenia (weakness) | 277 | 2.0 1.8–2.2ROR 2.0 · χ² 135 / p 1e-31 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Arthralgia (joint pain) | 270 | 1.7 1.6–2.0ROR 1.8 · χ² 88 / p 4e-21 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 262 | 16.0 14.2–18.1ROR 16.5 · χ² 3,660 / p <1e-300 | 15.9 EB05 14.4 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.1 · ♀ 25% (drug 56%) · 96% clinician | no trial data cached |
| Pruritus (itching) | 250 | 1.8 1.6–2.0ROR 1.8 · χ² 85 / p 1e-20 | 1.8 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Malaise (feeling unwell) | 239 | 1.5 1.3–1.7ROR 1.5 · χ² 35 / p 2e-9 | 1.5 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.6 | 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.
- Recalled product administered — n=29, PRR 8.9
- Swollen tongue — n=69, PRR 5.9
- Dizziness postural — n=20, PRR 5.6
- Seasonal allergy — n=27, PRR 5.1
- Pharyngeal oedema — n=24, PRR 4.1
- Hypoaesthesia oral — n=23, PRR 4.1
- Lip swelling — n=50, PRR 4.0
- Restless legs syndrome — n=27, PRR 4.0
- Abnormal dreams — n=39, PRR 3.8
- Sleep apnoea syndrome — n=26, PRR 3.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Lisinopril (ACE inhibitors) ↔ Angioedema.
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 Lisinopril and Hydrochlorothiazide?
In FDA FAERS, the most frequently co-reported reaction terms for Lisinopril and Hydrochlorothiazide are nausea, fatigue, diarrhoea, dizziness, pain, 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 Lisinopril and Hydrochlorothiazide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue lisinopril as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Do FAERS signals prove that Lisinopril 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 021831ab-dfeb-40fc-aede-4aa1fbb8d918, effective 20230818; matched on
openfda.generic_name.exact:"LISINOPRIL") - 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, 1,027 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.