Primacor Side Effects

Generic Name: milrinone

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

Primacor

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 Primacor:

Dizziness; headache.

Seek medical attention right away if any of these SEVERE side effects occur when using Primacor:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; severe dizziness or lightheadedness.

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.

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Primacor Side Effects - for the Professional

Primacor

Cardiovascular Effects

In patients receiving Primacor in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%: Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (2 patients experienced more than one type of arrhythmia). Holter recordings demonstrated that in some patients injection of Primacor increased ventricular ectopy, including nonsustained ventricular tachycardia. Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g. hypokalemia), abnormal digoxin levels and catheter insertion. Primacor was not shown to be arrhythmogenic in an electrophysiology study. Supraventricular arrhythmias were reported in 3.8% of the patients receiving Primacor. The incidence of both supraventricular and ventricular arrhythmias has not been related to the dose or plasma milrinone concentration.

Other cardiovascular adverse reactions include hypotension, 2.9% and angina/chest pain, 1.2%.

In the post marketing experience, there have been rare cases of "torsades de pointes" reported.

CNS Effects

Headaches, usually mild to moderate in severity, have been reported in 2.9% of patients receiving Primacor.

Other Effects

Other adverse reactions reported, but not definitely related to the administration of Primacor include hypokalemia, 0.6%; tremor, 0.4%; and thrombocytopenia, 0.4%.

Post-Marketing Adverse Event Reports

In addition to adverse events reported from clinical trials, the following events have been reported from worldwide post-marketing experience with Primacor:

Isolated spontaneous reports of bronchospasm and anaphylactic shock.

Liver function test abnormalities and skin reactions such as rash.

Administration site conditions: Infusion site reaction.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included ventricular arrhythmias (12%), ventricular ectopic activity (8%), supraventricular arrhythmias (3.8%), sustained and nonsustained ventricular tachycardia (1% and 2.8%, respectively), ventricular fibrillation (0.2%), and atrial fibrillation. Hypotension (2.9%) and angina/chest pain (1.2%) have occurred. In addition, rare reports of torsades de pointes have been reported in postmarketing experience.

Nervous system

Nervous system side effects have included headaches (2.9%) and tremor (0.4%). Dizziness is most often associated with hypotension.

Hematologic

Hematologic side effects of reversible thrombocytopenia (0.4%), inhibition of platelet activity, and increased bleeding time have occurred. While these effects have been described in patients undergoing cardiac surgery who had received milrinone for 12 to 24 hours, they have not been associated with acute administration of milrinone. The hematologic side effects of milrinone may be important in some patients who are awaiting cardiac catheterization, transplant, or other significant invasive procedures.

Milrinone has been shown to inhibit human platelet thromboxane A2 synthesis and calcium uptake.

Gastrointestinal

General gastrointestinal complaints have been reported rarely.

Hypersensitivity

Hypersensitivity reactions including rare instances of bronchospasm and anaphylactic shock have been reported in postmarketing experience.

Hepatic

Hepatic side effects including liver function test abnormalities have been reported in postmarketing experience.

Other

Other side effects including rash and skin reactions have been reported in postmarketing experience.

Metabolic

Metabolic side effects have included rare reports of hypokalemia (0.6%).

Respiratory

Respiratory side effects have been reported including isolated, spontaneous reports of bronchospasm.

Dermatologic

Dermatologic side effects including rash has been reported in postmarketing experience.

Local

Local side effects including infusion site reaction has been reported in postmarketing experience.

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