Note: This document contains side effect information about chorionic gonadotropin (hcg). Some dosage forms listed on this page may not apply to the brand name Ovidrel.

Applies to chorionic gonadotropin (hcg): powder for solution, solution.

Serious side effects of Ovidrel

Along with its needed effects, chorionic gonadotropin (hcg) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking chorionic gonadotropin (hcg):

For females only

More common

• Bloating (mild)
• stomach or pelvic pain

Less common or rare

• Bloating (moderate to severe)
• decreased amount of urine
• diarrhea
• feeling of indigestion
• nausea
• pelvic pain (severe)
• rapid weight gain
• stomach pain, severe
• swelling of feet or lower legs
• trouble breathing
• vomiting

For boys only

Less common

• Acne
• enlargement of penis and testes
• growth of pubic hair
• increase in height (rapid)

Incidence not known

• Chest tightness
• flushing of the skin
• hives or welts
• itching of the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• pain in chest, groin, or legs, especially in the calves
• redness of the skin
• severe, sudden headache
• skin rash
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• unusually warm skin
• vision changes

Other side effects of Ovidrel

Some side effects of chorionic gonadotropin (hcg) may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• discouragement
• enlargement of breasts
• feeling sad or empty
• headache
• irritability
• lack of appetite
• loss of interest or pleasure
• trouble concentrating
• trouble sleeping
• tiredness

For Healthcare Professionals

Applies to chorionic gonadotropin (hcg): injectable powder for injection, intramuscular powder for injection, subcutaneous powder for injection, subcutaneous solution.

General

HCG: The most commonly reported side effects included rash, groin pain, loin pain, and fever.

r-HCG: The most commonly reported side effects included injection site pain, headache not otherwise specified (NOS), nausea, and application site disorders.^[Ref]

Local

HCG:

Frequency not reported: injection site pain, injection site rash, localized hypersensitivity reaction

r-HCG:

Very common (10% or more): Injection site pain (up to 19.5%), application site disorder (up to 14.6%)

Common (1% to 10%): Injection site bruising, injection site inflammation, injection site reaction, vessel site hemorrhage^[Ref]

Nervous system

HCG:

Frequency not reported: Headache

r-HCG:

Very common (10% or more): Headache NOS (up to 18%)

Common (1% to 10%): Headache

Frequency not reported: Dizziness, hypesthesia, paresthesia, twitching^[Ref]

Other

HCG:

Rare (0.01% to 0.1%: Fever

Frequency not reported: Fatigue, pain, swelling, tiredness

r-HCG:

Very common (10% or more): Post-operative pain (up to 15.7%)

Common (1% to 10%): Pain, pyrexia, rigors, tiredness

Frequency not reported: Body pain, chromosomal abnormality (47, XXX), congenital anomaly of the fetus/newborn, Down's syndrome, fever, major congenital malformations, malaise, missed abortion, placenta previa, premature birth, premature labor, spontaneous abortion^[Ref]

Gastrointestinal

HCG:

Frequency not reported: Abdominal discomfort, abdominal pain, acute abdominal pain, ascites, bloating, diarrhea, gastrointestinal symptoms, nausea

r-HCG:

Very common (10% or more): Nausea (up to 14.6%), abdominal pain (up to 11.2%)

Common (1% to 10%): Abdominal pain lower, mouth ulceration, vomiting

Uncommon (0.1% to 1%): Diarrhea

Frequency not reported: Abdominal enlargement, flatulence, hemoperitoneum^[Ref]

Genitourinary

HCG:

Frequency not reported: Large ovarian cysts (prone to rupture), mild ovarian hyperstimulation syndrome (OHSS), mild to moderate enlargement of ovaries, ovarian cysts, painful breasts, severe OHSS, unwanted ovarian hyperstimulation

r-HCG:

Common (1% to 10%): Dysmenorrhea, intermenstrual bleeding, ovarian cyst, ovarian hyperstimulation, mild/moderate OHSS

Uncommon (0.1% to 1%): Breast pain, severe OHSS

Frequency not reported: Adnexal torsion, albuminuria, cervical lesion, dysuria, ectopic pregnancy, genital herpes, genital moniliasis, leukorrhea, mild to moderate ovarian enlargement, ovarian enlargement, ovarian torsion, postpartum fever, urinary incontinence, urinary tract infection, uterine disorders, vaginal discomfort, vaginal hemorrhage, vaginitis^[Ref]

Respiratory

HCG:

Frequency not reported: Dyspnea, hydrothorax, shortness of breath

r-HCG:

Common (1% to 10%): Pharyngolaryngeal pain, rhinorrhea, upper respiratory tract infections NOS

Frequency not reported: Acute pulmonary distress, cough, hiccup, pharyngitis, pulmonary complications, upper respiratory tract infection^[Ref]

Dermatologic

HCG:

Common (1% to 10%): Rash

Rare (0.01% to 0.1%): Generalized rash

Frequency not reported: Acne, erythema/redness, itching, urticaria

r-HCG:

Common (1% to 10%): Ecchymosis

Very rare (less than 0.01%): Mild reversible skin reactions, rash

Frequency not reported: Pruritus^[Ref]

Musculoskeletal

r-HCG:

Common (1% to 10%): Groin pain, loin pain

Frequency not reported: Back pain, cranial malformation^[Ref]

Psychiatric

HCG:

Frequency not reported: Depression, irritability, mood changes, restlessness

r-HCG:

Common (1% to 10%): Emotional disturbance NOS

Uncommon (0.1% to 1%): Depression, irritability, restlessness

Frequency not reported: Emotional lability, insomnia^[Ref]

Cardiovascular

Human Chorionic Gonadotropin (HCG):

Frequency not reported: Bruising, edema, thromboembolism

Recombinant Chorionic Gonadotropin (r-HCG):

Common (1% to 10%): Peripheral swelling

Very rare (less than 0.01%): Shock, thromboembolism

Frequency not reported: Atrial septal defect, cardiac arrhythmia, heart murmur, hot flashes, vascular complications

Postmarketing reports: Thromboembolic events^[Ref]

Renal

r-HCG:

Common (1% to 10%): Pyelonephritis NOS^[Ref]

Hypersensitivity

HCG:

Frequency not reported: Allergic reactions, angioedema, systemic hypersensitivity reactions

r-HCG:

Very rare (less than 0.01%): Anaphylactic reactions, mild to severe hypersensitivity reactions

Postmarketing reports: Allergic reactions, mild systemic allergic reactions^[Ref]

Metabolic

HCG:

Frequency not reported: Sodium retention, water retention, weight gain

r-HCG:

Frequency not reported: Hyperglycemia^[Ref]

Endocrine

HCG:

Frequency not reported: Excessive androgen production, gynecomastia, precocious puberty^[Ref]

Oncologic

r-HCG:

Frequency not reported: Benign/malignant ovarian neoplasms, cervical carcinoma^[Ref]

Hematologic

r-HCG:

Frequency not reported: Leukocytosis^[Ref]