🇺🇸 Spiramycine in United States

77 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: 28 March 2025 – 28 March 2026
• Total reports: 77

Most-reported reactions

1. Tooth Abscess — 10 reports (12.99%)
2. Acute Generalised Exanthematous Pustulosis — 8 reports (10.39%)
3. Cholestasis — 8 reports (10.39%)
4. Hepatocellular Injury — 8 reports (10.39%)
5. Pyrexia — 8 reports (10.39%)
6. Acute Kidney Injury — 7 reports (9.09%)
7. Condition Aggravated — 7 reports (9.09%)
8. Lung Disorder — 7 reports (9.09%)
9. Off Label Use — 7 reports (9.09%)
10. Urticaria — 7 reports (9.09%)

Source database →

Frequently asked questions

Is Spiramycine approved in United States?

Spiramycine does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Spiramycine in United States?

Assistance Publique - Hôpitaux de Paris is the originator. The local marketing authorisation holder may differ — check the official source linked above.