OpenClaim

Hydroxyprogesterone Side Effects

The most commonly reported side effects of hydroxyprogesterone include premature baby, premature delivery, and exposure during pregnancy, based on 232 FDA adverse event reports from 2004 to 2025. 2.6% of reports found the drug to be ineffective.

Hydroxyprogesterone side effects

Percentages show how often each reaction appears relative to total reports for hydroxyprogesterone.

1
Premature Baby8.2%19
2
Premature Delivery7.8%18
3
Exposure During Pregnancy6.0%14
4
Foetal Exposure During Pregnancy5.6%13
5
Maternal Exposure During Pregnancy5.6%13
6
Off Label Use5.6%13
7
Fatigue5.2%12
8
Drug Exposure During Pregnancy4.3%10
9
Low Birth Weight Baby3.0%7
10
Headache2.6%6
11
Drug Ineffective2.6%6
12
Nausea2.6%6
13
Pruritus2.6%6
14
Product Quality Issue2.6%6
15
Injection Site Mass2.6%6

These are voluntary reports and do not establish that hydroxyprogesterone caused these reactions.

Report severity

60.3%Serious140 reports
26.3%Hospitalizations61 reports
3.4%Fatal8 reports

Seriousness is determined by the reporter, not by OpenClaim.

Hydroxyprogesterone drug interactions

Other drugs that appear in adverse event reports alongside hydroxyprogesterone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Acetaminophen3.0%7
2
Betamethasone3.0%7
3
Progesterone3.0%7
4
Adalimumab2.6%6
5
Aspirin2.2%5
6
Denosumab1.3%3
7
Ruxolitinib1.3%3
8
Hydrocortisone1.3%3
9
Fludrocortisone-acetate1.3%3
10
Caffeine0.9%2
11
Niacin0.9%2
12
Gonadotropin-chorionic0.9%2
13
Enoxaparin-sodium0.9%2
14
Lenalidomide0.9%2
15
Teriparatide0.9%2

Taken alongside

1
Ergocalciferol15.9%37
2
Aspirin12.1%28
3
Calcium9.9%23
4
Fish7.8%18
5
Ascorbic-acid6.9%16
6
Folic-acid6.5%15
7
Cyanocobalamin6.5%15
8
Acetaminophen5.6%13
9
Gabapentin5.2%12
10
Magnesium-acetate-tetrahydrate5.2%12
11
Metoprolol4.7%11
12
Atorvastatin-calcium4.3%10
13
Levothyroxine-sodium4.3%10
14
Furosemide4.3%10
15
Amlodipine3.9%9

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports hydroxyprogesterone side effects

72.4% of hydroxyprogesterone adverse event reports involve female patients and 14.7% involve male patients. The largest age group is adult at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female72.4%
Male14.7%
Unknown12.9%

Age group

< 214.4%
2–110.7%
12–170.7%
18–6460.1%
65+24.2%

What is hydroxyprogesterone used for

Conditions and purposes for which patients were taking hydroxyprogesterone when the adverse event was reported.

Assisted FertilisationCervix Cerclage ProcedureCongenital Uterine AnomalyCervical IncompetenceComplication Of PregnancyDeliveryDrug Exposure During PregnancyDrug Use For Unknown IndicationExposure During PregnancyEye DisorderEye DisorderFoetal Exposure During PregnancyFoetal Exposure During PregnancyHigh Risk PregnancyHigh Risk Pregnancy

Showing 15 of 45 indications

Hydroxyprogesterone brand names and reporting trend

Hydroxyprogesterone is sold under the brand name Hydroxyprogesterone Caproate.

Brand names

Hydroxyprogesterone Caproate202

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking hydroxyprogesterone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.