Quick answers
- What is Choriogonadotropin alfa used for?
- The FDA-approved label (Ovidrel, EMD Serono, Inc., December 26, 2023) says: “Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Choriogonadotropin alfa?
- The “Adverse Reactions” section of the FDA label (Ovidrel, EMD Serono, Inc., December 26, 2023) begins: “(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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Choriogonadotropin alfa have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Choriogonadotropin alfa?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Choriogonadotropin alfa been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Choriogonadotropin alfa?
- 1 company lists prescription products of Choriogonadotropin alfa in the FDA NDC Directory, including EMD Serono, Inc.
What Choriogonadotropin alfa is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. …
— FDA label: Ovidrel, EMD Serono, Inc., effective December 26, 2023. Read the full label on DailyMed →
Label quoted: the one for the most common form (injection, solution, subcutaneous), Ovidrel, EMD Serono, Inc.; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Choriogonadotropin alfa side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
(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.
Read more of this section
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 9: Incidence of Adverse Events of r-hCG in ART (Studies 7648, 7927, 9073) Body System Ovidrel ® 250 µg (n=236) Preferred Term Incidence Rate % (n) At Least One Adverse Event 33.1% (78) Application Site Disorders 14.0% (33) Injection Site Pain 7.6% (18) Injection Site Bruising 4.7% (11) Gastro-Intestinal System Disorders 8.5% (20) Abdominal Pain 4.2% (10) Nausea 3.4% (8) Vomiting 2.5% (6) Secondary Terms (Post-Operative Pain) 4.7% (11) Post-Operative Pain 4.7% (11) Adverse events not listed in Table 9 that occurred in less than 2% of patients treated with Ovidrel ® 250 µg whether or not considered causally related to Ovidrel ®, included: injection site inflammation and reaction, flatulence, diarrhea, hiccup, ectopic pregnancy, breast pain, intermenstrual bleeding, vaginal hemorrhage, cervical lesion, leukorrhea, ovarian hyperstimulation, uterine disorders, vaginitis, vaginal discomfort, body pain, back pain, fever, dizziness, headache, hot flashes, malaise, paraesthesias, rash, emotional lability, insomnia, upper respiratory tract infection, cough, dysuria, urinary tract infection, urinary incontinence, albuminuria, cardiac arrhythmia, genital moniliasis, genital herpes, leukocytosis, heart murmur and cervical carcinoma. Table 10: Incidence of Adverse Events of r-hCG in Ovulation Induction (Study 8209) Body System Ovidrel ® 250 µg (n=99) Preferred Term 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) Additional adverse events not listed in Table 10 that occurred in less than 2% of patients treated with Ovidrel ® 250 µg, whether or not considered causally related to Ovidrel ®, included: breast pain, flatulence, abdominal enlargement, pharyngitis, upper respiratory tract infection, hyperglycemia and pruritis.
Table from the label
| Body System | Ovidrel® 250 µg (n=236) |
|---|---|
| Preferred Term | Incidence Rate % (n) |
| At Least One Adverse Event | 33.1% (78) |
| Application Site Disorders | 14.0% (33) |
| Injection Site Pain | 7.6% (18) |
| Injection Site Bruising | 4.7% (11) |
| Gastro-Intestinal System Disorders | 8.5% (20) |
| Abdominal Pain | 4.2% (10) |
| Nausea | 3.4% ( 8) |
| Vomiting | 2.5% ( 6) |
| Secondary Terms (Post-Operative Pain) | 4.7% (11) |
| Post-Operative Pain | 4.7% (11) |
— FDA label: Ovidrel, EMD Serono, Inc., effective December 26, 2023. This is part of the section. Read the full label on DailyMed →
Choriogonadotropin alfa dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
For Subcutaneous Use Only Infertile Women Undergoing Assisted Reproductive Technologies (ART) Ovidrel ® PreFilled Syringe 250 µg should be administered one day following the last dose of the follicle stimulating agent. Ovidrel ® PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography.
Read more of this section
Administration should be withheld in situations where there is an excessive ovarian response, as evidenced by clinically significant ovarian enlargement or excessive estradiol production. Infertile Women Undergoing Ovulation Induction (OI) Ovidrel ® PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. Ovidrel ® PreFilled Syringe 250 µg should be administered one day following the last dose of the follicle stimulating agent. Ovidrel ® PreFilled Syringe administration should be withheld in situations where there is an excessive ovarian response, as evidenced by multiple follicular development, clinically significant ovarian enlargement or excessive estradiol production. Directions for Administration of Ovidrel ® Prefilled Syringe Ovidrel ® PreFilled Syringe is intended for a single subcutaneous injection. Any unused material should be discarded. Ovidrel ® PreFilled Syringe may be self-administered by the patient. Follow the directions below for injecting Ovidrel ® PreFilled Syringe. Step 1: Wash your hands thoroughly with soap and water. Step 2: Carefully clean the injection site. Make yourself comfortable by sitting or lying down. Carefully clean the injection site on the stomach with an alcohol wipe and allow it to air-dry. Step 3: Administer your injection. Carefully remove the needle cap from the syringe. Do not touch the needle or allow the needle to touch any surface. Inject the prescribed dose as directed by your doctor, nurse or pharmacist. Step 4: Gently withdraw the needle. Discard the needle and syringe into your safety container. Place gauze over the injection site. If any bleeding occurs, apply gentle pressure. If bleeding does not stop within a few minutes, place a clean piece of gauze over the injection site and cover it with an adhesive bandage. Step 5: Storage and clean up. Remember that your injection materials must be kept sterile and cannot be reused. Figure 1 Figure 2
— FDA label: Ovidrel, EMD Serono, Inc., effective December 26, 2023. Read the full label on DailyMed →
Choriogonadotropin alfa in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Intrauterine death and impaired parturition were observed in pregnant rats given a dose of urinary-hCG (500 IU) equivalent to three times the maximum human dose of 10,000 USP, based on body surface area.
— FDA label: Ovidrel, EMD Serono, Inc., effective December 26, 2023. Read the full label on DailyMed →
Choriogonadotropin alfa and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if hCG is administered to a nursing woman.
— FDA label: Ovidrel, EMD Serono, Inc., effective December 26, 2023. Read the full label on DailyMed →
When Choriogonadotropin alfa should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Ovidrel ® PreFilled Syringe (choriogonadotropin alfa injection) is contraindicated in women who exhibit: Prior hypersensitivity to hCG preparations or one of their excipients. Primary ovarian failure. Uncontrolled thyroid or adrenal dysfunction. An uncontrolled organic intracranial lesion such as a pituitary tumor. Abnormal uterine bleeding of undetermined origin (see " Selection of Patients ").
Read more of this section
Ovarian cyst or enlargement of undetermined origin (see " Selection of Patients "). Sex hormone dependent tumors of the reproductive tract and accessory organs. Pregnancy.
— FDA label: Ovidrel, EMD Serono, Inc., effective December 26, 2023. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Ovidrel |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| choriogonadotropin alfa 250 ug/0.5 mL injection, solution | Brand: Ovidrel | $485.56 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- EMD Serono, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA021149 OVIDREL | Emd Serono | September 20, 2000 | 18, latest September 30, 2015 2015: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 727505, 727507 |
|---|---|
| SPL set ID of the quoted label | a683e58a-63ea-44b8-a326-1a99a537bcf2 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA021149 |
| Active ingredients (FDA) | CHORIOGONADOTROPIN ALFA |
Next steps
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ovidrel, EMD Serono, Inc., effective December 26, 2023; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →