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What the label lists and what reports show

Hydrochlorothiazide and quinapril side effects

Hydrochlorothiazide and quinapril's FDA label: “The most common reasons for discontinuation of therapy with quinapril and hydrochlorothiazide tablets were cough (1.0%; see PRECAUTIONS ) and headache (0.7%).” FAERS holds 115 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 hypertensive emergency (32 reports).

  • Generic listed
  • In shortage
  • Boxed warning

Check it at the source: the hydrochlorothiazide and quinapril FDA label on DailyMed (effective December 11, 2023, Chartwell RX, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common reasons for discontinuation of therapy with quinapril and hydrochlorothiazide tablets were cough (1.0%; see PRECAUTIONS ) and headache (0.7%).

From the label: adverse reactions, continued

Quinapril and hydrochlorothiazide tablets has been evaluated for safety in 1571 patients in controlled and uncontrolled studies. Of these, 498 were given quinapril plus hydrochlorothiazide for at least 1 year, with 153 patients extending combination therapy for over 2 years. In clinical trials with quinapril and hydrochlorothiazide tablets, no adverse experience specific to the combination has been observed. Adverse experiences that have occurred have been limited to those that have been previously reported with quinapril or hydrochlorothiazide. Adverse experiences were usually mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy because of adverse effects was required in 2.1% in patients in controlled studies. The most common reasons for discontinuation of therapy with quinapril and hydrochlorothiazide tablets were cough (1.0%; see PRECAUTIONS ) and headache (0.7%). Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 943 patients treated with quinapril plus hydrochlorothiazide in controlled trials are shown below.

Source: FDA drug label, Chartwell RX, LLC, effective December 11, 2023 (SPL set 2eae533f-d0af-47e8-a1f2-94bc8cc89b5a), via openFDA; the full label on DailyMed

What do FAERS reports show?

115 reports list hydrochlorothiazide and quinapril among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 25 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, 10 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.

The 25 most reported reactions

  • Hypertensive Emergency32
  • Dyspnoea (named in the label)17
  • Chest Pain (named in the label)11
  • Headache (named in the label)8
  • Pain In Extremity8
  • Death (an outcome recorded in the report)7
  • Cough (named in the label)6
  • Nausea (named in the label)6
  • Acute Myocardial Infarction5
  • Asthenia (named in the label)5
  • Atrial Fibrillation5
  • Confusional State5
  • Drug Ineffective (a use or a product term, not a reaction)5
  • Haematuria (named in the label)5
  • Oedema Peripheral5
  • Blood Pressure Increased4
  • Cardiac Failure4
  • Diarrhoea (named in the label)4
  • Dysphagia4
  • Fall4
  • Fatigue (named in the label)4
  • Hypertension (a use or a product term, not a reaction)4
  • Obesity4
  • Renal Failure Chronic4
  • Angina Pectoris (named in the label)3

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

What next?

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