Drug Landscape ›
Atomoxetine 80 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: 11
Most-reported reactions
Insomnia — 2 reports (18.18%) Adverse Drug Reaction — 1 report (9.09%) Aggression — 1 report (9.09%) Agitation — 1 report (9.09%) Condition Aggravated — 1 report (9.09%) Decreased Appetite — 1 report (9.09%) Decreased Interest — 1 report (9.09%) Depressed Mood — 1 report (9.09%) Diplopia — 1 report (9.09%) Dissociation — 1 report (9.09%)
Source database →
Atomoxetine 80 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 Atomoxetine 80 MG approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Atomoxetine 80 MG in United States?
Brigham and Women's Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.