Drug Landscape ›
Dexamethasone 12 mg ›
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: 22
Most-reported reactions
Infusion Related Reaction — 5 reports (22.73%) Chest Discomfort — 3 reports (13.64%) Dyspnoea — 3 reports (13.64%) Erythema — 3 reports (13.64%) Back Pain — 2 reports (9.09%) Pruritus — 2 reports (9.09%) Abdominal Discomfort — 1 report (4.55%) Anaphylactic Reaction — 1 report (4.55%) Angioedema — 1 report (4.55%) Atrial Fibrillation — 1 report (4.55%)
Source database →
Dexamethasone 12 mg 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 Dexamethasone 12 mg approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Dexamethasone 12 mg in United States?
Zealand University Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.