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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 Off label use? 632 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 632 reports of Off label use have been filed in association with MISOPROSTOL (Misoprostol). This represents 17.9% of all adverse event reports for MISOPROSTOL.

632
Reports of Off label use with MISOPROSTOL
17.9%
of all MISOPROSTOL reports
18
Deaths
141
Hospitalizations

How Dangerous Is Off label use From MISOPROSTOL?

Of the 632 reports, 18 (2.8%) resulted in death, 141 (22.3%) required hospitalization, and 63 (10.0%) were considered life-threatening.

Is Off label use Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for MISOPROSTOL. However, 632 reports have been filed with the FAERS database.

What Other Side Effects Does MISOPROSTOL Cause?

Haemorrhage (588) Abortion incomplete (535) Product use in unapproved indication (296) 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 Off label use?

RITUXIMAB (39,751) INFLIXIMAB (34,801) DENOSUMAB (34,612) METHOTREXATE (24,020) VEDOLIZUMAB (21,017) ETANERCEPT (20,178) TOCILIZUMAB (18,256) PREDNISONE (17,867) LENALIDOMIDE (17,017) ADALIMUMAB (16,417)

Which MISOPROSTOL Alternatives Have Lower Off label use Risk?

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

Related Pages

MISOPROSTOL Full Profile All Off label use Reports All Drugs Causing Off label use MISOPROSTOL Demographics