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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 11 | 3 | 3 |
| 2014 | 21 | 0 | 5 |
What Is MAKENA Used For?
| Indication | Reports |
|---|---|
| Premature delivery | 7 |
Official FDA Label for MAKENA
Official prescribing information from the FDA-approved drug label.