🇺🇸 loperamide-simethicone in United States

43 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: 22 April 2025 – 22 April 2026
• Total reports: 43

Most-reported reactions

1. Drug Ineffective — 12 reports (27.91%)
2. Intentional Product Use Issue — 11 reports (25.58%)
3. Off Label Use — 4 reports (9.3%)
4. Wrong Technique In Product Usage Process — 4 reports (9.3%)
5. Cerebrovascular Accident — 2 reports (4.65%)
6. Choking — 2 reports (4.65%)
7. Constipation — 2 reports (4.65%)
8. Dizziness — 2 reports (4.65%)
9. Drug Ineffective For Unapproved Indication — 2 reports (4.65%)
10. Drug Interaction — 2 reports (4.65%)

Source database →

Frequently asked questions

Is loperamide-simethicone approved in United States?

loperamide-simethicone does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for loperamide-simethicone in United States?

Johnson & Johnson Consumer and Personal Products Worldwide is the originator. The local marketing authorisation holder may differ — check the official source linked above.