Novarel Side Effects

Please note - some side effects for Novarel 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 Novarel - for the Consumer

Novarel

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 Novarel:

Fatigue; headache; irritability; nausea; pain, swelling, bruising, or redness at the injection site; restlessness; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal breast development; bloating or swelling in the stomach or pelvic area; breast tenderness; depression; infrequent urination; persistent or severe nausea, vomiting, or diarrhea; stomach or pelvic pain; sudden shortness of breath; swelling of the hands, feet, or legs; symptoms of a serious blood clot (eg, calf or leg pain, swelling, redness, or tenderness; chest, jaw, or left arm pain; confusion; fainting; numbness of an arm or leg; one-sided weakness; slurred speech; sudden, severe headache; vision changes); unusual early onset of puberty; 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.

Novarel Side Effects - for the Professional

Novarel

Headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection. Hypersensitivity reactions both localized and systemic in nature, including erythema, urticaria, rash, angioedema, dyspnea and shortness of breath, have been reported. The relationship of these allergic-like events to the polypeptide hormone or the diluent containing benzyl alcohol is not clear.

Side Effects by Body System - for Healthcare Professionals

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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