🇺🇸 spirolactone in United States

157 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: 28 March 2025 – 28 March 2026
• Total reports: 157

Most-reported reactions

1. Dyspnoea — 27 reports (17.2%)
2. Fatigue — 22 reports (14.01%)
3. Drug Ineffective — 17 reports (10.83%)
4. Diarrhoea — 15 reports (9.55%)
5. Condition Aggravated — 14 reports (8.92%)
6. Dizziness — 13 reports (8.28%)
7. Nausea — 13 reports (8.28%)
8. Pain In Extremity — 13 reports (8.28%)
9. Headache — 12 reports (7.64%)
10. Off Label Use — 11 reports (7.01%)

Source database →

Frequently asked questions

Is spirolactone approved in United States?

spirolactone does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for spirolactone in United States?

Second Xiangya Hospital of Central South University is the originator. The local marketing authorisation holder may differ — check the official source linked above.