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 L-Carnitine.

For the Consumer

Applies to levocarnitine: capsule, solution, tablet

Along with its needed effects, levocarnitine (the active ingredient contained in L-Carnitine) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking levocarnitine:

More common

• High blood pressure

Less common

• Fast heartbeat
• fever

Rare

• Seizures

Some side effects of levocarnitine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach cramps
• diarrhea
• headache
• nausea or vomiting

Less common

• Abdominal discomfort
• body odor
• depression
• dizziness
• impaired vision
• loss of appetite or weight
• swelling in hands, lower legs, and feet
• tingling sensation
• weakness

For Healthcare Professionals

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

Gastrointestinal

Very common (10% or more): Diarrhea (35%), abdominal pain (21%), vomiting (21%), nausea (12%)

Common (1% to 10%): Constipation, dyspepsia, gastrointestinal disorder, melena

Very rare (less than 0.01%): Abdominal cramps

Nervous system

Very common (10% or more): Headache (37%), dizziness (18%), paresthesia (12%)

Common (1% to 10%): Hypertonia, vertigo, taste perversion

Frequency not reported: Seizures (with or without pre-existing seizure activity), increase in seizure frequency and/or severity

Metabolic

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

Very common (10% or more): Hypercalcemia (15%), hypervolemia (12%)

Common (1% to 10%): Anorexia, hyperkalemia

Other

Very common (10% or more): Pain (35%), flu syndrome (29%), chest pain (15%), accidental injury (12%), asthenia (12%), fever (12%)

Common (1% to 10%): Peripheral edema, weight decrease, weight increase

Very rare (less than 0.01%): Body odor, International Normalized Ratio (INR) increased

Local

Very common (10% or more): Injection site reaction (38%)

Musculoskeletal

Musculoskeletal side effects, in chronic hemodialysis patients, for levocarnitine (the active ingredient contained in L-Carnitine) 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

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

Very common (10% or more): Anemia (12%)

Renal

Common (1% to 10%): Kidney failure (chronic hemodialysis patients)

Endocrine

Common (1% to 10%): Parathyroid disorder

Respiratory

Very common (10% or more): Pharyngitis (27%), cough increase (18%), dyspnea (11%), rhinitis (11%)

Common (1% to 10%): Bronchitis, sinusitis

Dermatologic

Common (1% to 10%): Pruritus, rash

Ocular

Common (1% to 10%): Amblyopia, eye disorder

Genitourinary

Common (1% to 10%): Urinary tract infection

Cardiovascular

Very common (10% or more): Hypertension (21%), hypotension (19%)

Common (1% to 10%): Atrial fibrillation, arrhythmia, cardiovascular disorder, electrocardiogram abnormal, palpitations, tachycardia, vascular disorder

Hypersensitivity

Common (1% to 10%): Allergic reaction

Psychiatric

Common (1% to 10%): Depression, anxiety, drug dependence, insomnia

Immunologic

Very common (10% or more): Infection (24%)