🇺🇸 Histoacryl in United States

98 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: 98

Most-reported reactions

1. Product Use In Unapproved Indication — 44 reports (44.9%)
2. Off Label Use — 21 reports (21.43%)
3. Splenic Infarction — 7 reports (7.14%)
4. Product Use Issue — 6 reports (6.12%)
5. Gastrointestinal Necrosis — 4 reports (4.08%)
6. Vascular Procedure Complication — 4 reports (4.08%)
7. Ascites — 3 reports (3.06%)
8. Cerebral Infarction — 3 reports (3.06%)
9. Disseminated Intravascular Coagulation — 3 reports (3.06%)
10. Embolism Arterial — 3 reports (3.06%)

Source database →

Frequently asked questions

Is Histoacryl approved in United States?

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

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

National Science and Technology Council, Taiwan is the originator. The local marketing authorisation holder may differ — check the official source linked above.