What the label lists and what reports show
Choriogonadotropin alfa side effects
Choriogonadotropin alfa's FDA label lists its adverse reactions in its own words. FAERS holds 2,355 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 ovarian hyperstimulation syndrome (624 reports).
- No generic listed
Check it at the source: the choriogonadotropin alfa FDA label on DailyMed (effective December 26, 2023, EMD Serono, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactions(see WARNINGS ) The safety of Ovidrel ® was examined in four clinical studies that treated 752 patients of whom 335 received Ovidrel ® 250 µg following follicular recruitment with gonadotropins. When patients enrolled in four clinical studies (3 in ART and one in OI) were injected subcutaneously with either Ovidrel ® or an approved urinary-derived hCG, 14.6 % (49 of 335 patients) in the Ovidrel ® 250 µg group experienced application site disorders compared to 28% (92 of 328 patients) in the approved u-hCG group. Adverse events reported for Ovidrel ® 250 µg occurring in at least 2% of patients (regardless of causality) are listed in Table 9 for the 3 ART studies and in Table 10 for the single OI study.
Table 10: Incidence of Adverse Events of r-hCG in Ovulation Induction (Study 8209)
| Body System Preferred Term | Ovidrel ® 250 µg (n=99) Incidence Rate % (n) |
|---|---|
| At Least One Adverse Event | 26.2% (26) |
| Application Site Disorders | 16.2% (16) |
| Injection site pain | 8.1% (8) |
| Injection site inflammation | 2.0% (2) |
| Injection site bruising | 3.0% (3) |
| Injection site reaction | 3.0% (3) |
| Reproductive Disorders, Female | 7.1% (7) |
| Ovarian cyst | 3.0% (3) |
| Ovarian hyperstimulation | 3.0% (3) |
| Gastro-Intestinal System Disorders | 4.0% (4) |
| Abdominal pain | 3.0% (3) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, EMD Serono, Inc., effective December 26, 2023 (SPL set a683e58a-63ea-44b8-a326-1a99a537bcf2), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,355 reports list choriogonadotropin alfa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 34 are coded as a death and 713 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 14 reactions below, 8 are 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.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Choriogonadotropin alfa: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions