🇺🇸 MYOBLOC in United States

FDA authorised MYOBLOC on 8 December 2000 · 266 US adverse-event reports

Marketing authorisation

FDA — authorised 8 December 2000

  • Application: BLA103846
  • Marketing authorisation holder: ELAN PHARM
  • Status: supplemented

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. Dry Mouth — 48 reports (18.05%)
  2. Dysphagia — 41 reports (15.41%)
  3. Death — 40 reports (15.04%)
  4. Drug Ineffective — 27 reports (10.15%)
  5. Vision Blurred — 24 reports (9.02%)
  6. Headache — 22 reports (8.27%)
  7. Off Label Use — 20 reports (7.52%)
  8. Constipation — 15 reports (5.64%)
  9. Dyspnoea — 15 reports (5.64%)
  10. Asthenia — 14 reports (5.26%)

Source database →

Other Neurology approved in United States

Frequently asked questions

Is MYOBLOC approved in United States?

Yes. FDA authorised it on 8 December 2000.

Who is the marketing authorisation holder for MYOBLOC in United States?

ELAN PHARM holds the US marketing authorisation.