Natrecor Side Effects

Generic name: nesiritide

Note: This document contains side effect information about nesiritide. Some of the dosage forms listed on this page may not apply to the brand name Natrecor.

Some side effects of Natrecor 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 nesiritide: intravenous powder for injection

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

Tell your caregivers at once if you have:

• confusion, feeling light-headed, fainting;

• fast, slow, or irregular heartbeats;

• urinating less than usual;

• chest pain; or

• fever, unusual weakness or tiredness.

Other common side effects may include:

• headache, mild dizziness;

• nausea, vomiting;

• back pain;

• numbness or tingly feeling;

• tremors; or

• vision changes.

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 nesiritide: intravenous powder for injection

Cardiovascular

Cardiovascular side effects have included hypotension (11% to 35%), ventricular tachycardia (3% to 10%), ventricular extrasystoles (3% to 4%), angina pectoris (2% to 6%), and bradycardia (1% to 5%). Other side effects occurring in at least 1% of patients have included tachycardia, atrial fibrillation, and AV node conduction abnormalities.

The mean duration of symptomatic hypotension was 2.2 hours with nesiritide, compared to 0.7 hours with nitroglycerin.

Nesiritide was associated with a lower incidence of severe ventricular arrhythmias than dobutamine: sustained ventricular tachycardia (1% vs 7%), nonsustained ventricular tachycardia (11% vs 17%), cardiac arrest (0 vs 5%).

Nervous system

Nervous system side effects have included headache (up to 4.2%), insomnia (2% to 6%), dizziness (3% to 6%), and anxiety (2% to 3%). Other side effects occurring in at least 1% of patients have included confusion, paresthesia, somnolence, tremor, and fever.

Gastrointestinal

Gastrointestinal side effects have included dry mouth (up to 20.1%), constipation (up to 9.6%), upper abdominal pain (up to 1.5%), constipation (up to 1.4%), dyspepsia (up to 1.2%), and flatulence (up to 1.2%).

Local

Local reactions reported in at least 1% of patients have included catheter pain and injection site reactions.

Respiratory

Respiratory side effects reported in at least 1% of patients have included increased cough and apnea.

Renal

Renal side effects reported have included increases in serum creatinine of greater than 0.5 mg/dL above baseline (17% in patients receiving 0.015 mcg/kg/min, 19% in patients receiving 0.03 mcg/kg/min, 28% in patients receiving a 2 mcg/kg bolus followed by 0.020 mcg/kg/min).

Other

Other side effects have included anticholinergic central nervous system (CNS) effects including dizziness, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

Ocular

Ocular side effects have included amblyopia (up to 1%) and dry eyes (up to 1.2%).

Dermatologic

Dermatologic side effects have included pruritus and rash in at least 1% of patients. Angioedema of the face, lips, tongue, and/or larynx has been reported postmarketing.

Endocrine

Endocrine side effects have included sweating in at least 1% of patients.

Musculoskeletal

Musculoskeletal side effects have included back pain (1% to 4%) and leg cramps (at least 1%).

Hematologic

Hematologic side effects have included anemia in at least 1% of patients.

Metabolic

Metabolic side effects have included hypokalemia (3%) and hypomagnesemia (1% to 3%) in a trial with 103 CHF patients.

Hypersensitivity

Hypersensitivity side effects including postmarketing reports of hypersensitivity reactions have been reported.

Genitourinary

Genitourinary side effects have included urinary retention (up to 1.2%).

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