🇺🇸 Sulfate, Magnesium in United States

FDA authorised Sulfate, Magnesium on 23 February 2017 · 185 US adverse-event reports

Marketing authorisation

FDA — authorised 23 February 2017

  • Application: ANDA202511
  • Marketing authorisation holder: NOVEL LABS INC
  • 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. Vomiting — 51 reports (27.57%)
  2. Nausea — 39 reports (21.08%)
  3. Abdominal Pain — 16 reports (8.65%)
  4. Dizziness — 14 reports (7.57%)
  5. Headache — 14 reports (7.57%)
  6. Drug Ineffective — 12 reports (6.49%)
  7. Diarrhoea — 11 reports (5.95%)
  8. Abdominal Pain Upper — 10 reports (5.41%)
  9. Abdominal Distension — 9 reports (4.86%)
  10. Chills — 9 reports (4.86%)

Source database →

Frequently asked questions

Is Sulfate, Magnesium approved in United States?

Yes. FDA authorised it on 23 February 2017.

Who is the marketing authorisation holder for Sulfate, Magnesium in United States?

NOVEL LABS INC holds the US marketing authorisation.