Gonal-f Side Effects

Generic name: follicle stimulating hormone

Note: This document contains side effect information about follicle stimulating hormone. Some of the dosage forms listed on this page may not apply to the brand name Gonal-f.

Some side effects of Gonal-f 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 follicle stimulating hormone: injectable solution, subcutaneous powder for injection, subcutaneous solution

Some women using this medicine have developed a sudden buildup of fluid in the stomach or chest area. This condition is called ovarian hyperstimulation syndrome (OHSS), and can be a life-threatening. Avoid having sex and call your doctor right away if you have any of the following symptoms of OHSS:

• severe pain in your lower stomach;

• nausea, vomiting, diarrhea, bloating;

• feeling short of breath;

• swelling in your hands or legs;

• weight gain;

• urinating less than usual.

Get emergency medical help if you have any of these signs of an allergic reaction while taking follicle stimulating hormone (the active ingredient contained in Gonal-f) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using follicle stimulating hormone and call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness (especially on one side of the body);

• pain, swelling, warmth, or redness in your arms or legs; or

• severe pelvic pain on one side.

Less serious side effects of follicle stimulating hormone may include:

• headache;

• mild nausea or stomach pain;

• mild numbness or tingly feeling;

• mild pelvic pain, tenderness, or discomfort;

• runny or stuffy nose, sore throat;

• breast swelling or tenderness;

• acne;

• mild skin rash; or

• pain, bruising, redness, or irritation where the injection was 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 follicle stimulating hormone: injectable powder for injection, injectable solution, subcutaneous powder for injection, subcutaneous solution

Genitourinary

Mild to moderate uncomplicated ovarian enlargement has been reported to generally regress without treatment within two or three weeks.

Severe OHSS may progress over one to several days to become a serious medical event. Severe OHSS is characterized by an apparent dramatic increase in vascular permeability which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially the pericardium. Early warning signs include severe pelvic pain, nausea, vomiting, and weight gain. Cases of OHSS may include abdominal pain, abdominal distension, nausea, vomiting, diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events. Transient liver function test abnormalities have also been associated with OHSS.

Genitourinary side effects have included mild to moderate ovarian enlargement sometimes accompanied by abdominal distention and/or abdominal pain, severe ovarian hyperstimulation syndrome (OHSS), miscarriage, ectopic pregnancy and ovarian cysts. Other genitourinary side effects have included intermenstrual bleeding, dysmenorrhea, breast tenderness, urinary tract infection, vaginal hemorrhage and moniliasis genital.

Respiratory

Other respiratory tract side effects have included sinusitis, pharyngitis, coughing, rhinitis, dyspnea, tachypnea and upper respiratory tract infection.

Respiratory effects have included atelectasis, pulmonary embolism, pulmonary infarction, and acute respiratory distress syndrome. In rare cases, pulmonary complications have resulted in death.

Cardiovascular

Cardiovascular effects have included venous thrombophlebitis, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, thromboembolic events have resulted in death.

Other cardiovascular side effects have included chest pain, palpitations, and tachycardia.

Other

Other side effects have included febrile reactions and flu-like symptoms which included fever, chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue.

It is not clear whether the febrile reactions were pyrogenic responses or possible allergic reactions.

Gastrointestinal

Gastrointestinal effects have included anorexia, nausea, vomiting, diarrhea, abdominal pain, flatulence, and dyspepsia.

Local

Local side effects have included pain, rash, swelling, and/or irritation at the site of injection.

Dermatologic

Dermatologic side effects have included dry skin, body rash, hair loss, acne, pruritus and hives.

Psychiatric

Psychiatric side effects have included emotional liability.

Metabolic

Metabolic side effects have included weight gain.

Nervous system

Nervous system side effects have included headache, paresthesias somnolence, anxiety and dizziness.

Musculoskeletal

Musculoskeletal side effects have included myalgia, back pain and joint pains.

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