Profasi Side Effects

Generic name: chorionic gonadotropin (hcg)

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

Some side effects of Profasi may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

Stop using HCG and Get emergency medical help if you have any of these signs of an allergic reaction while taking chorionic gonadotropin (hcg): hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these signs of a blood clot: pain, warmth, redness, numbness, or tingling in your arm or leg; confusion, extreme dizziness, or severe headache.

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any of the following symptoms of OHSS:

• severe pelvic pain;

• swelling of the hands or legs;

• stomach pain and swelling;

• shortness of breath;

• weight gain;

• diarrhea;

• nausea or vomiting; or

• urinating less than normal.

This medication can cause early puberty in young boys. Call your doctor if a boy using this medicine shows early signs of puberty, such as a deepened voice, pubic hair growth, and increased acne or sweating.

Less serious side effects of chorionic gonadotropin (hcg) may include:

• headache;

• feeling restless or irritable;

• mild swelling or water weight gain;

• depression;

• breast tenderness or swelling; or

• pain, swelling, or irritation where the injection is given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

General

General side effects have included headache, irritability, restlessness, fatigue, and edema.

Genitourinary

Genitourinary side effects have included precocious puberty and gynecomastia.

Psychiatric

Psychiatric side effects have included depression.

Local

Local side effects have included pain at the site of injection.

Hypersensitivity

Hypersensitivity side effects have included isolated cases of allergic reactions, manifesting mainly as mild reversible skin rashes. Postmarketing reports have included anaphylactic reactions.

Hematologic

Hematologic side effects have included the occurrence of arterial thromboembolism.

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