FDA
- Status: approved
🇺🇸 Nitrates in United States
149 US adverse-event reports
Marketing authorisation
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: 27 March 2025 – 27 March 2026
- Total reports: 149
Most-reported reactions
- Dyspnoea — 25 reports (16.78%)
- Myocardial Infarction — 17 reports (11.41%)
- Cardiac Failure — 16 reports (10.74%)
- Angina Pectoris — 15 reports (10.07%)
- Hypotension — 15 reports (10.07%)
- Chest Pain — 13 reports (8.72%)
- Drug Interaction — 13 reports (8.72%)
- Renal Failure — 12 reports (8.05%)
- Renal Failure Acute — 12 reports (8.05%)
- Dizziness — 11 reports (7.38%)
Other Other approved in United States
Frequently asked questions
Is Nitrates approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Nitrates in United States?
Gladwin, Mark, MD is the originator. The local marketing authorisation holder may differ — check the official source linked above.