FDA
- Status: approved
🇺🇸 VORTIOXETINE in United States
3,799 US adverse-event reports
Marketing authorisations
FDA
- Application: ANDA211024
- Marketing authorisation holder: PRINSTON PHARMA INC
- Local brand name: VORTIOXETINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA211085
- Marketing authorisation holder: CIPLA LTD
- Local brand name: VORTIOXETINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA211089
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: VORTIOXETINE
- Indication: TABLET — ORAL
- Status: approved
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: 3,799
Most-reported reactions
- Nausea — 503 reports (13.24%)
- Drug Ineffective — 470 reports (12.37%)
- Suicidal Ideation — 403 reports (10.61%)
- Dizziness — 392 reports (10.32%)
- Headache — 374 reports (9.84%)
- Fall — 352 reports (9.27%)
- Off Label Use — 334 reports (8.79%)
- Drug Interaction — 326 reports (8.58%)
- Fatigue — 325 reports (8.55%)
- Diarrhoea — 320 reports (8.42%)
VORTIOXETINE 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 VORTIOXETINE approved in United States?
Yes. FDA has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for VORTIOXETINE in United States?
Marketing authorisation holder not available in our data.