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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does MISOPROSTOL Cause Product use in unapproved indication? 296 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 296 reports of Product use in unapproved indication have been filed in association with MISOPROSTOL (Misoprostol). This represents 8.4% of all adverse event reports for MISOPROSTOL.

296
Reports of Product use in unapproved indication with MISOPROSTOL
8.4%
of all MISOPROSTOL reports
25
Deaths
79
Hospitalizations

How Dangerous Is Product use in unapproved indication From MISOPROSTOL?

Of the 296 reports, 25 (8.4%) resulted in death, 79 (26.7%) required hospitalization, and 31 (10.5%) were considered life-threatening.

Is Product use in unapproved indication Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for MISOPROSTOL. However, 296 reports have been filed with the FAERS database.

What Other Side Effects Does MISOPROSTOL Cause?

Off label use (632) Haemorrhage (588) Abortion incomplete (535) Maternal exposure during pregnancy (261) Pain (231) Foetal exposure during pregnancy (221) Foetal exposure during delivery (204) Drug ineffective (190) Anaemia (185) Vomiting (185)

What Other Drugs Cause Product use in unapproved indication?

DUPILUMAB (33,452) DICLOFENAC (12,197) METHOTREXATE (8,930) PREDNISONE (7,625) RITUXIMAB (7,519) MYCOPHENOLATE MOFETIL (5,910) ACETAMINOPHEN (5,819) CYCLOPHOSPHAMIDE (5,750) RISPERIDONE (5,551) TACROLIMUS (5,057)

Which MISOPROSTOL Alternatives Have Lower Product use in unapproved indication Risk?

MISOPROSTOL vs MITAPIVAT MISOPROSTOL vs MITOMYCIN MISOPROSTOL vs MITOTANE MISOPROSTOL vs MITOXANTRONE MISOPROSTOL vs MITRAGYNINE\HERBALS

Related Pages

MISOPROSTOL Full Profile All Product use in unapproved indication Reports All Drugs Causing Product use in unapproved indication MISOPROSTOL Demographics