🇺🇸 Mirtazapine Tablets in United States
174 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: 174
Most-reported reactions
- Drug Ineffective — 31 reports (17.82%)
- Insomnia — 21 reports (12.07%)
- Somnolence — 19 reports (10.92%)
- Completed Suicide — 18 reports (10.34%)
- Dizziness — 16 reports (9.2%)
- Headache — 15 reports (8.62%)
- Off Label Use — 15 reports (8.62%)
- Diarrhoea — 14 reports (8.05%)
- Product Substitution Issue — 13 reports (7.47%)
- Anxiety — 12 reports (6.9%)
Other Psychiatry / Mental Health approved in United States
Frequently asked questions
Is Mirtazapine Tablets approved in United States?
Mirtazapine Tablets does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for Mirtazapine Tablets in United States?
National Institute of Mental Health, Dhaka is the originator. The local marketing authorisation holder may differ — check the official source linked above.