HYDROXYPROGESTERONE: 201 Adverse Event Reports & Safety Profile
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201
Total FAERS Reports
4 (2.0%)
Deaths Reported
29
Hospitalizations
201
As Primary/Secondary Suspect
3
Life-Threatening
3
Disabilities
First Report: 20131220 · Latest Report: 20200409
What Are the Most Common HYDROXYPROGESTERONE Side Effects?
#1 Most Reported
Foetal exposure during pregnancy
27 reports (13.4%)
#2 Most Reported
Premature baby
26 reports (12.9%)
#3 Most Reported
Off label use
22 reports (10.9%)
All HYDROXYPROGESTERONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Foetal exposure during pregnancy | 27 | 13.4% | 3 | 4 |
| Premature baby | 26 | 12.9% | 3 | 5 |
| Off label use | 22 | 11.0% | 0 | 1 |
| Product use issue | 20 | 10.0% | 0 | 0 |
| Exposure during pregnancy | 19 | 9.5% | 0 | 2 |
| Intentional overdose | 15 | 7.5% | 0 | 15 |
| Maternal exposure during pregnancy | 15 | 7.5% | 0 | 3 |
| Premature delivery | 15 | 7.5% | 0 | 2 |
| Haemodynamic instability | 13 | 6.5% | 0 | 13 |
| Low birth weight baby | 13 | 6.5% | 3 | 3 |
| Hypotension | 12 | 6.0% | 0 | 12 |
| Injection site swelling | 12 | 6.0% | 0 | 1 |
| Injection site pain | 11 | 5.5% | 0 | 0 |
| Product prescribing issue | 11 | 5.5% | 0 | 0 |
| Injection site pruritus | 10 | 5.0% | 0 | 0 |
| Product dispensing error | 7 | 3.5% | 0 | 0 |
| Injection site erythema | 6 | 3.0% | 0 | 0 |
| Pruritus | 6 | 3.0% | 0 | 1 |
| Headache | 5 | 2.5% | 0 | 1 |
| Rash | 5 | 2.5% | 0 | 0 |
Who Reports HYDROXYPROGESTERONE Side Effects? Age & Gender Data
Gender: 89.2% female, 10.8% male. Average age: 31.7 years. Most reports from: US. View detailed demographics →
Is HYDROXYPROGESTERONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 2 | 0 | 0 |
| 2015 | 2 | 0 | 0 |
| 2016 | 1 | 0 | 1 |
| 2017 | 1 | 0 | 1 |
| 2018 | 29 | 0 | 2 |
| 2019 | 81 | 0 | 0 |
| 2020 | 12 | 0 | 1 |
What Is HYDROXYPROGESTERONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 35 |
| Premature labour | 22 |
| Prophylaxis | 7 |
| Pregnancy | 5 |
HYDROXYPROGESTERONE vs Alternatives: Which Is Safer?
HYDROXYPROGESTERONE vs HYDROXYPROGESTERONE CAPROATE
HYDROXYPROGESTERONE vs HYDROXYPROPYL CELLULOSE
HYDROXYPROGESTERONE vs HYDROXYUREA
HYDROXYPROGESTERONE vs HYDROXYZINE
HYDROXYPROGESTERONE vs HYDROXYZINE\HYDROXYZINE
HYDROXYPROGESTERONE vs HYOSCYAMINE
HYDROXYPROGESTERONE vs HYPROMELLOSE 2910
HYDROXYPROGESTERONE vs IBALIZUMAB-UIYK
HYDROXYPROGESTERONE vs IBANDRONATE
HYDROXYPROGESTERONE vs IBANDRONIC ACID
Official FDA Label for HYDROXYPROGESTERONE
Official prescribing information from the FDA-approved drug label.