🇺🇸 amlodipine/hydrochlorothiazide in United States

195 US adverse-event reports

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: 22 April 2025 – 22 April 2026
• Total reports: 195

Most-reported reactions

1. Drug Ineffective — 28 reports (14.36%)
2. Fatigue — 26 reports (13.33%)
3. Hyponatraemia — 22 reports (11.28%)
4. Dyspnoea — 20 reports (10.26%)
5. Dizziness — 19 reports (9.74%)
6. Syncope — 18 reports (9.23%)
7. Acute Kidney Injury — 16 reports (8.21%)
8. Headache — 16 reports (8.21%)
9. Drug Interaction — 15 reports (7.69%)
10. Nausea — 15 reports (7.69%)

Source database →

Frequently asked questions

Is amlodipine/hydrochlorothiazide approved in United States?

amlodipine/hydrochlorothiazide does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for amlodipine/hydrochlorothiazide in United States?

Shanghai Jiao Tong University School of Medicine is the originator. The local marketing authorisation holder may differ — check the official source linked above.