🇺🇸 Cyclobenzaprine HCl in United States

FDA authorised Cyclobenzaprine HCl on 1 February 2007 · 2,526 US adverse-event reports

Marketing authorisations

FDA — authorised 1 February 2007

  • Application: NDA021777
  • Marketing authorisation holder: TEVA PHARMS INTL
  • Local brand name: AMRIX
  • Indication: CAPSULE, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA

  • Status: approved

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.

Most-reported reactions

  1. Fatigue — 340 reports (13.46%)
  2. Pain — 308 reports (12.19%)
  3. Completed Suicide — 296 reports (11.72%)
  4. Nausea — 281 reports (11.12%)
  5. Diarrhoea — 258 reports (10.21%)
  6. Drug Ineffective — 237 reports (9.38%)
  7. Headache — 227 reports (8.99%)
  8. Fall — 201 reports (7.96%)
  9. Death — 190 reports (7.52%)
  10. Dizziness — 188 reports (7.44%)

Source database →

Cyclobenzaprine HCl 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 Cyclobenzaprine HCl approved in United States?

Yes. FDA authorised it on 1 February 2007; FDA has authorised it.

Who is the marketing authorisation holder for Cyclobenzaprine HCl in United States?

TEVA PHARMS INTL holds the US marketing authorisation.