Carnitor Side Effects

Generic name: levocarnitine

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

Some side effects of Carnitor 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 levocarnitine: oral capsule, oral solution, oral tablet

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

Call your doctor at once if you have:

• seizure (convulsions).

Common side effects may include:

• stomach pain;

• nausea, vomiting; or

• diarrhea.

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 levocarnitine: injectable solution, oral capsule, oral solution, oral tablet

Gastrointestinal

Gastrointestinal side effects associated with levocarnitine (the active ingredient contained in Carnitor) oral solution may be minimized or avoided by slow consumption or greater dilution of the solution. Decreasing the dosage may also help alleviate gastrointestinal effects.

Gastrointestinal side effects are generally mild and have been reported in 41% of patients.

Taste fatigue may be reduced by mixing the oral solution with drinks or liquid foods.

Gastrointestinal side effects have included transient nausea and vomiting, nausea, gastritis, and taste fatigue. Gastrointestinal side effects, in chronic hemodialysis patients, for levocarnitine in relation to placebo therapy have included transient nausea (5% to 12% vs 10%), vomiting (9% to 21% vs 16%), and diarrhea (9% to 35% vs 19%) abdominal pain (5% to 21% vs 17%), anorexia (3% to 6% vs 3%), constipation (3% vs 6%), dyspepsia (5% to 9% vs 10%), gastrointestinal disorder (2% to 6% vs 2%), melena (2% to 6% vs 3%), and taste perversion (2% to 9% vs 0%).

Nervous system

Nervous system side effects have included seizures in patients with or without preexisting seizure activity, and increases in seizure frequency and/or severity in patients with preexisting seizure activity.

Nervous system side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included anxiety (1% to 2% vs 5%), dizziness (10% to 18% vs 11%), hypertonia (1% to 3% vs 5%), insomnia (3% to 6% vs 6%), paresthesia (3% to 12% vs 3%), and vertigo (2% to 6% vs 0%).

Metabolic

There are reports from clinical trials of significant hypertriglyceridemia associated with high doses of levocarnitine (the active ingredient contained in Carnitor) (3 g/day) given to uremic dialysis patients.

Metabolic side effects have included hypertriglyceridemia, decreases in triglyceride levels, and no effects on triglyceride levels. Metabolic side effects, in hemodialysis patients, for levocarnitine in relation to placebo therapy have included hypercalcemia (6% to 15% vs 3%), hyperkalemia (6% vs 6%), and hypervolemia (3% to 12% vs 17%).

Other

Other side effects have included body odor (11%). Other side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included accidental injury (8% to 12% vs 10%), fever (5% to 12% vs 5%), peripheral edema (3% to 5% vs 3%), weight decrease (3% to 8% vs 3%), and weight increase (2% to 6% vs 2%), headache (3% to 36% vs 16%), back pain (6% to 9% vs 10%), and pain (21% to 35% vs 49%).

Body odor may be decreased or minimized by decreasing the dosage.

Local

Local side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo have included injection site reactions (27% to 38% vs 59%).

Musculoskeletal

Musculoskeletal side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included asthenia (8% to 12% vs 8%) and leg cramps (4% to 8% vs 13%). Mild myasthenia has occurred in uremic patients receiving D,L-carnitine (but not levocarnitine).

Hematologic

Hematologic side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included anemia (3% to 12% vs 3%). Other side effects have included significant increases in platelet aggregation and lack of effect on platelet activity.

There have been reports from clinical trials of significant increases in platelet aggregation associated with high doses of levocarnitine (3 g/day) given to hemodialysis patients.

Endocrine

Endocrine side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included parathyroid disorder (2% to 6% vs 2%).

Respiratory

Respiratory side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included bronchitis (3% to 5% vs 0%), cough increase (9% to 18% vs 16%), dyspnea (3% to 11% vs 19%), pharyngitis (15% to 27% vs 33%), rhinitis (6% to 11% vs 10%), and sinusitis (2% to 3% vs 5%).

Dermatologic

Dermatologic side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included pruritus (3% to 8% vs 13%) and rash (3% to 5% vs 3%).

Ocular

Ocular side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included amblyopia (3% to 6% vs 2%) and eye disorder (3% to 6% vs 3%).

Genitourinary

Genitourinary side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included urinary tract infection (2% to 3% vs 6%) and kidney failure (6% vs 5%).

Cardiovascular

Cardiovascular side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included arrhythmia (2% to 3% vs 5%), atrial fibrillation (2% to 6% vs 0%), cardiovascular disorder (3% to 6% vs 6%), chest pain (6% to 15% vs 14%), electrocardiogram abnormalities (2% to 6% vs 0%), hemorrhage (2% to 9% vs 6%), hypertension (18% to 21% vs 14%), hypotension (3% to 19% vs 19%), palpitations (3% to 8% vs 0%), tachycardia (5% to 9% vs 5%), and vascular disorder (2% to 6% vs 2%).

Hypersensitivity

Hypersensitivity side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included allergic reactions (2% to 6% vs 5%).

General

Causality has not been determined for side effects mentioned in chronic hemodialysis patients.

Psychiatric

Psychiatric side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included depression (5% to 6% vs 3%) and drug dependence (2% to 6% vs 2%).

Immunologic

Immunologic side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in Carnitor) in relation to placebo therapy have included flu syndrome (15% to 29% vs 40%), infection (10% to 24% vs 17%).

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