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alverine citrate, simeticone ›
Regulatory · United States
Marketing authorisation
FDA
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: 42
Most-reported reactions
Loss Of Consciousness — 7 reports (16.67%) Beta Haemolytic Streptococcal Infection — 6 reports (14.29%) Necrosis Ischaemic — 6 reports (14.29%) Pneumonia Streptococcal — 6 reports (14.29%) Septic Shock — 6 reports (14.29%) Confusional State — 3 reports (7.14%) Aggression — 2 reports (4.76%) Agitation — 2 reports (4.76%) Headache — 2 reports (4.76%) Hypotension — 2 reports (4.76%)
Source database →
alverine citrate, simeticone 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 alverine citrate, simeticone approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for alverine citrate, simeticone in United States?
Laboratoires Mayoly Spindler is the originator. The local marketing authorisation holder may differ — check the official source linked above.