Drug Landscape ›
Hydrochlorothiazide 12.5mg ›
Regulatory · United States
Marketing authorisation
FDA
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Window: 20 April 2025 – 20 April 2026
Total reports: 60
Most-reported reactions
Angioedema — 19 reports (31.67%) Cough — 7 reports (11.67%) Acute Kidney Injury — 6 reports (10%) Dyspnoea — 6 reports (10%) Hyponatraemia — 5 reports (8.33%) Disease Progression — 4 reports (6.67%) Nausea — 4 reports (6.67%) Death — 3 reports (5%) Decreased Appetite — 3 reports (5%) Diarrhoea — 3 reports (5%)
Source database →
Hydrochlorothiazide 12.5mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Hydrochlorothiazide 12.5mg approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Hydrochlorothiazide 12.5mg in United States?
University of Kansas Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.