What the label lists and what reports show

Hydrochlorothiazide and spironolactone side effects

Hydrochlorothiazide and spironolactone's FDA label lists its adverse reactions in its own words. FAERS holds 751 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 dyspnoea (97 reports).

Generic listed

Check it at the source: the hydrochlorothiazide and spironolactone FDA label on DailyMed (effective March 11, 2026, Mylan Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
The following adverse reactions have been reported and, within each category (body system), are listed in order of decreasing severity. Hydrochlorothiazide Body as a whole: Weakness. Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics, or antihypertensive drugs). Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialoadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Eye Disorders: Acute myopia and acute angle-closure glaucoma (see Warnings ). Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity: Anaphylactic reactions, necrotizing angitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura. …

Source: FDA drug label, Mylan Pharmaceuticals Inc., effective March 11, 2026 (SPL set 0c8c973f-13a2-4883-8316-4006398e2931), via openFDA; the full label on DailyMed

What do FAERS reports show?

751 reports list hydrochlorothiazide and spironolactone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 45 are coded as a death and 264 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 21 reactions below, 6 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

Dyspnoea97
Fatigue73
Nausea (named in the label)70
Headache (named in the label)69
Diarrhoea (named in the label)68
Dizziness (named in the label)51
Cough48
Pain42
Infusion Site Pain41
Off Label Use (a use or a product term, not a reaction)39
Malaise37
Pneumonia34
Fall33
Oedema Peripheral33
Pain In Extremity32
Death (an outcome recorded in the report)31
Hypotension (named in the label)31
Vomiting (named in the label)31
Nasopharyngitis30
Cardiac Failure Congestive28
Drug Ineffective (a use or a product term, not a reaction)28
Product Dose Omission Issue (a use or a product term, not a reaction)28
Weight Decreased26
Arthralgia25
Asthenia24

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

What next?

Hydrochlorothiazide and spironolactone: 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