🇺🇸 Myo-inositol in United States

44 US adverse-event reports

Marketing authorisation

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. Exposure During Pregnancy — 9 reports (20.45%)
  2. Gestational Diabetes — 8 reports (18.18%)
  3. Maternal Exposure During Pregnancy — 5 reports (11.36%)
  4. Normal Newborn — 4 reports (9.09%)
  5. Product Use In Unapproved Indication — 4 reports (9.09%)
  6. Product Use Issue — 4 reports (9.09%)
  7. Hypoglycaemia — 3 reports (6.82%)
  8. Premature Rupture Of Membranes — 3 reports (6.82%)
  9. Abortion Induced — 2 reports (4.55%)
  10. Off Label Use — 2 reports (4.55%)

Source database →

Myo-inositol 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 Myo-inositol approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Myo-inositol in United States?

American University of Beirut Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.