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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.

MAKENA: 33 Adverse Event Reports & Safety Profile

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33
Total FAERS Reports
3 (9.1%)
Deaths Reported
9
Hospitalizations
33
As Primary/Secondary Suspect

First Report: 2013 · Latest Report: 201406

What Are the Most Common MAKENA Side Effects?

#1 Most Reported
Premature baby
6 reports (18.2%)
#2 Most Reported
Injection site pain
5 reports (15.2%)
#3 Most Reported
Off label use
3 reports (9.1%)

All MAKENA Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Premature baby 6 18.2% 2 1
Injection site pain 5 15.2% 0 1

Who Reports MAKENA Side Effects? Age & Gender Data

Average age: 28.0 years. Most reports from: US. View detailed demographics →

Is MAKENA Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 11 3 3
2014 21 0 5

View full timeline →

What Is MAKENA Used For?

IndicationReports
Premature delivery 7

Official FDA Label for MAKENA

Official prescribing information from the FDA-approved drug label.