Fertinex Side Effects

Generic Name: urofollitropin

Please note - some side effects for Fertinex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Fertinex - for the Consumer

Fertinex

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 Fertinex:

Breast tenderness; headache; hot flashes; nausea; stomach pain; vaginal bleeding.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chills; continuing diarrhea; fever; infrequent urination; nausea; pain or redness at the injection site; severe headache; severe pelvic pain; severe stomach pain or swelling; shortness of breath; swelling of the lower legs; vomiting; weakness; weight gain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Cardiovascular

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

Dermatologic

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

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, diarrhea, abdominal cramps, and bloating.

General

General side effects have included headache and abdominal pain.

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 (20%), severe ovarian hyperstimulation syndrome (OHSS)(6%), breast tenderness, and ovarian cysts.

Local

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

Oncologic

Oncologic side effects have included infrequent reports of neoplasms (both benign and malignant) in women who have undergone multiple drug regimens for ovulation induction. However, a causal relationship has not been established.

Other

Other side effects have included reactions including chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue.

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

Respiratory

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

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