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What the label lists and what reports show

Hydrochlorothiazide and irbesartan side effects

Hydrochlorothiazide and irbesartan's FDA label: “Most common adverse events (≥5% on AVALIDE and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain.” FAERS holds 5,302 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 (351 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the hydrochlorothiazide and irbesartan FDA label on DailyMed (effective October 7, 2025, Sanofi-Aventis U.S. LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse events (≥5% on AVALIDE and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain.

A table the label prints in its adverse reactions section without a title; its column headings name the groups compared

ReactionIrbesartan/HCTZ (n=898) (%)Placebo (n=236) (%)Irbesartan (n=400) (%)HCTZ (n=380) (%)
Chest Pain2122
Fatigue6343
Influenza3122
Edema3322
Tachycardia1011
Abdominal Pain2122
Dyspepsia/heartburn2102
Nausea/vomiting3022
Allergy1011
Musculoskeletal Pain65610
Dizziness8465
Dizziness Orthostatic1011
Abnormality Urination2112

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.

From the label: adverse reactions, continued

Most common adverse events (≥5% on AVALIDE and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Irbesartan and Hydrochlorothiazide AVALIDE tablets have been evaluated for safety in 1694 patients treated for essential hypertension in 6 clinical trials. In Studies I through IV with AVALIDE, no adverse events peculiar to this combination drug product have been observed. Adverse events have been limited to those that were reported previously with irbesartan or hydrochlorothiazide (HCTZ). The overall incidence of adverse events was similar with the combination and placebo. In general, treatment with AVALIDE was well tolerated. …

Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective October 7, 2025 (SPL set 0d91895e-c869-4b33-9b83-d55c1ad6317e), via openFDA; the full label on DailyMed

What do FAERS reports show?

5,302 reports list hydrochlorothiazide and irbesartan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 277 are coded as a death and 1,518 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 23 reactions below, 12 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 irbesartan: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions