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What the label lists and what reports show

Hydroxyprogesterone caproate side effects

Hydroxyprogesterone caproate's FDA label lists its adverse reactions in its own words. FAERS holds 133 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is premature baby (20 reports).

  • Generic listed

Check it at the source: the hydroxyprogesterone caproate FDA label on DailyMed (effective June 12, 2026, Eugia US LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

A. Serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, have been reported in women using progestins. B. neuroocular lesions (e.g., retinal thrombosis and optic neuritis); nausea; vomiting; gastrointestinal symptoms (such as abdominal cramps or bloating); edema; breakthrough bleeding, spotting, or withdrawal bleeding; breast tenderness; changes in body weight (increase or decrease); headache; increase in cervical mucus; allergic rash; abscess; pain at the injection site; migraine headaches. C. chloasma or melasma, cholestatic jaundice, rise in blood pressure, mental depression, and amenorrhea during or after treatment. D. …

Source: FDA drug label, Eugia US LLC, effective June 12, 2026 (SPL set 687bcf42-f437-42c7-8909-a91f621f55df), via openFDA; the full label on DailyMed

What do FAERS reports show?

133 reports list hydroxyprogesterone caproate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 38 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Premature Baby20
  • Premature Delivery18
  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)12
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)11
  • Exposure During Pregnancy (a use or a product term, not a reaction)9
  • Drug Exposure During Pregnancy (a use or a product term, not a reaction)8
  • Premature Labour8
  • Low Birth Weight Baby6
  • Abortion Spontaneous5
  • Off Label Use (a use or a product term, not a reaction)5
  • Injection Site Pain4
  • Therapy Cessation4
  • Breech Presentation3
  • Drug Ineffective (a use or a product term, not a reaction)3
  • Gestational Diabetes3
  • Ovarian Hyperstimulation Syndrome3
  • Product Administration Error3
  • Product Dose Omission (a use or a product term, not a reaction)3
  • Recalled Product Administered3
  • Swelling (named in the label)3
  • Vaginal Haemorrhage3
  • Abdominal Pain2
  • Anxiety2
  • Caesarean Section2
  • Cough2

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Hydroxyprogesterone caproate: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions