What the label lists and what reports show
Hydrochlorothiazide and lisinopril side effects
Hydrochlorothiazide and lisinopril's FDA label lists its adverse reactions in its own words. FAERS holds 10,178 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (685 reports).
- Generic listed
- Boxed warning
Check it at the source: the hydrochlorothiazide and lisinopril FDA label on DailyMed (effective March 31, 2025, Almatica Pharma Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsZESTORETIC has been evaluated for safety in 930 patients including 100 patients treated for 50 weeks or more. In clinical trials with ZESTORETIC no adverse experiences peculiar to this combination drug have been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with lisinopril or hydrochlorothiazide. The most frequent clinical adverse experiences in controlled trials (including open label extensions) with any combination of lisinopril and hydrochlorothiazide were: dizziness (7.5%), headache (5.2%), cough (3.9%), fatigue (3.7%) and orthostatic effects (3.2%) all of which were more common than in placebo-treated patients. Generally, adverse experiences were mild and transient in nature, but see WARNINGS regarding angioedema and excessive hypotension or syncope. …
Percent of Patients in Controlled Studies
This table is printed in the Lisinopril and Hydrochlorothiazide label published by Lupin Pharmaceuticals, Inc. of November 24, 2025; the label quoted above does not print one.
| Reaction | Lisinopril - Hydrochlorothiazide ( n = 930 ) | Incidence ( discontinuation ) | Placebo ( n = 207 ) Incidence |
|---|---|---|---|
| Dizziness | 7.5 | (0.8) | 1.9 |
| Headache | 5.2 | (0.3) | 1.9 |
| Cough | 3.9 | (0.6) | 1.0 |
| Fatigue | 3.7 | (0.4) | 1.0 |
| Orthostatic Effects | 3.2 | (0.1) | 1.0 |
| Diarrhea | 2.5 | (0.2) | 2.4 |
| Nausea | 2.2 | (0.1) | 2.4 |
| Upper Respiratory Infection | 2.2 | (0.0) | 0.0 |
| Muscle Cramps | 2.0 | (0.4) | 0.5 |
| Asthenia | 1.8 | (0.2) | 1.0 |
| Paresthesia | 1.5 | (0.1) | 0.0 |
| Hypotension | 1.4 | (0.3) | 0.5 |
| Vomiting | 1.4 | (0.1) | 0.5 |
| Dyspepsia | 1.3 | (0.0) | 0.0 |
| Rash | 1.2 | (0.1) | 0.5 |
| Impotence | 1.2 | (0.3) | 0.0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Almatica Pharma Inc., effective March 31, 2025 (SPL set 0d3a966f-f937-05a8-a90f-5aa52ebbd613), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,178 reports list hydrochlorothiazide and lisinopril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 595 are coded as a death and 3,301 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 17 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Hydrochlorothiazide and lisinopril: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions