Follistim AQ Side Effects

Generic name: follicle stimulating hormone

Please note - some side effects for Follistim AQ may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Follistim AQ - for the consumer

Follistim AQ

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Follistim AQ:

Breast tenderness; dizziness; dry skin; flu-like symptoms (fever, chills, muscle aches, joint pain, nausea); general body discomfort; headache; stomach discomfort; swelling.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; chest pain; diarrhea; fast, slow, or irregular heartbeat; indigestion; infrequent urination; nausea; pain or redness at the injection site; severe pelvic pain; sharp pain in the groin or calves; stomach pain or bloating; sudden, severe headache; vomiting; weakness; weight gain.

For the professional

Follistim AQ

Assisted Reproductive Technologies (ART)

Rates of adverse events from a randomized, assessor-blind, group comparative, multicenter safety and efficacy study of Follistim® in 989 infertile women treated with in vitro fertilization with Follistim® or urofollitropin after pituitary suppression with a GnRH agonist are summarized in Table 5.

Ovulation Induction

Rates of adverse events from a randomized, assessor-blind, group comparative, multicenter safety and efficacy study of Follistim® in 172 chronic anovulatory women who failed to ovulate and/or conceive during clomiphene citrate treatment are summarized in Table 6.

The following adverse events have been reported in women treated with gonadotropins: pulmonary and vascular complications, hemoperitoneum, adnexal torsion (as a complication of ovarian enlargement), dizziness, tachycardia, dyspnea, tachypnea, febrile reactions, flu-like symptoms including fever, chills, musculoskeletal aches, joint pains, nausea, headache and malaise, breast tenderness, and dermatological symptoms (dry skin, erythema, body rash, hair loss, and hives).

There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.

Congenital Anomalies

The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multiple gestations after ART. There are no indications that the use of gonadotropins during ART is associated with an increased risk of congenital malformations.

By body system

Genitourinary side effects

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 side effects

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

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

Cardiovascular side effects

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 side effects

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 side effects

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

Local side effects

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

Dermatologic side effects

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

Psychiatric side effects

Psychiatric side effects have included emotional liability.

Metabolic side effects

Metabolic side effects have included weight gain.

Nervous system side effects

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

Musculoskeletal side effects

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

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