FDA — authorised 1 December 2010
- Application: NDA020919
- Marketing authorisation holder: VIATRIS
- Indication: Labeling
- Status: approved
🇺🇸 ZIPRASIDONE MESYLATE in United States
FDA authorised ZIPRASIDONE MESYLATE on 1 December 2010 · 948 US adverse-event reports
Marketing authorisations
FDA — authorised 26 December 2019
- Application: ANDA211908
- Marketing authorisation holder: GLAND
- Local brand name: ZIPRASIDONE MESYLATE
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
FDA — authorised 15 September 2022
- Application: ANDA216091
- Marketing authorisation holder: MSN
- Local brand name: ZIPRASIDONE MESYLATE
- Indication: POWDER — INTRAMUSCULAR
- Status: approved
FDA — authorised 3 September 2025
- Application: ANDA217595
- Marketing authorisation holder: STERISCIENCE
- Local brand name: ZIPRASIDONE MESYLATE
- Indication: POWDER — INTRAMUSCULAR
- 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: 948
Most-reported reactions
- Suicide Attempt — 114 reports (12.03%)
- Drug Ineffective — 113 reports (11.92%)
- Anosognosia — 91 reports (9.6%)
- Blood Glucose Increased — 90 reports (9.49%)
- Blood Prolactin Abnormal — 90 reports (9.49%)
- Disturbance In Social Behaviour — 90 reports (9.49%)
- Dyskinesia — 90 reports (9.49%)
- Metabolic Disorder — 90 reports (9.49%)
- Sedation — 90 reports (9.49%)
- Sexual Dysfunction — 90 reports (9.49%)
ZIPRASIDONE MESYLATE 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 ZIPRASIDONE MESYLATE approved in United States?
Yes. FDA authorised it on 1 December 2010; FDA authorised it on 26 December 2019; FDA authorised it on 15 September 2022.
Who is the marketing authorisation holder for ZIPRASIDONE MESYLATE in United States?
VIATRIS holds the US marketing authorisation.