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What the label lists and what reports show

Candesartan and hydrochlorothiazide side effects

Candesartan and hydrochlorothiazide's FDA label lists its adverse reactions in its own words. FAERS holds 2,599 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 blood pressure increased (239 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the candesartan and hydrochlorothiazide FDA label on DailyMed (effective December 22, 2025, ANI Pharmaceuticals, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Candesartan Cilexetil and Hydrochlorothiazide Candesartan cilexetil and hydrochlorothiazide tablets have been evaluated for safety in more than 2800 patients treated for hypertension. More than 750 of these patients were studied for at least six months and more than 500 patients were treated for at least one year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse events reported with candesartan cilexetil and hydrochlorothiazide tablets was comparable to placebo. The overall frequency of adverse experiences was not related to dose, age, gender, or race. …

Source: FDA drug label, NDA021093 (Ani Pharms), as published by ANI Pharmaceuticals, Inc., effective December 22, 2025 (SPL set bd8d318d-167a-4b26-935d-265dde3193de), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,599 reports list candesartan and hydrochlorothiazide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 165 are coded as a death and 1,240 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 20 reactions below, 5 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

  • Drug Ineffective (a use or a product term, not a reaction)310
  • Blood Pressure Increased239
  • Hypertension (a use or a product term, not a reaction)223
  • Dizziness (named in the label)196
  • Dyspnoea130
  • Fatigue124
  • Nausea124
  • Headache118
  • Drug Dose Omission (a use or a product term, not a reaction)107
  • Fall105
  • Malaise104
  • Off Label Use (a use or a product term, not a reaction)99
  • Vomiting (named in the label)98
  • Hypotension (named in the label)97
  • Asthenia89
  • Hyponatraemia (named in the label)86
  • Diarrhoea (named in the label)84
  • Anxiety80
  • Diabetes Mellitus79
  • Myocardial Infarction (a use or a product term, not a reaction)79
  • Weight Decreased78
  • Pain In Extremity72
  • Blood Pressure Inadequately Controlled71
  • Syncope70
  • Chest Pain69

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Candesartan and hydrochlorothiazide: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions