🇺🇸 SM-13496 in United States

42 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: 23 April 2025 – 23 April 2026
• Total reports: 42

Most-reported reactions

1. Psychotic Disorder — 10 reports (23.81%)
2. Schizophrenia — 10 reports (23.81%)
3. Aggression — 4 reports (9.52%)
4. Depression — 4 reports (9.52%)
5. Suicide Attempt — 4 reports (9.52%)
6. Mania — 3 reports (7.14%)
7. Asthma — 2 reports (4.76%)
8. Overdose — 2 reports (4.76%)
9. Seizure — 2 reports (4.76%)
10. Acute Psychosis — 1 report (2.38%)

Source database →

Frequently asked questions

Is SM-13496 approved in United States?

SM-13496 does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for SM-13496 in United States?

Sumitomo Pharma Co., Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.