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Transient nausea and vomiting have been observed. Less frequent adverse reactions are body odor, nausea, and gastritis. An incidence for these reactions is difficult to estimate due to the confounding effects of the underlying pathology.
Seizures have been reported to occur in patients, with or without pre-existing seizure activity, receiving either oral or intravenous levocarnitine. In patients with pre-existing seizure activity, an increase in seizure frequency and/or severity has been reported.
The table below lists the adverse events that have been reported in two double-blind, placebo-controlled trials in patients on chronic hemodialysis. Events occurring at ≥ 5% are reported without regard to causality.
Adverse Events with a Frequency ≥ 5% Regardless of Causality
by Body System
| Placebo (n=63) |
Levocarnitine 10 mg (n=34) |
Levocarnitine 20 mg (n=62) |
Levocarnitine 40 mg (n=34) |
Levocarnitine 10, 20 & 40 mg (n=130) |
|
| Body as Whole | |||||
| Abdominal pain | 17 | 21 | 5 | 6 | 9 |
| Accidental injury | 10 | 12 | 8 | 12 | 10 |
| Allergic reaction | 5 | 6 | 2 | ||
| Asthenia | 8 | 9 | 8 | 12 | 9 |
| Back pain | 10 | 9 | 8 | 6 | 8 |
| Chest pain | 14 | 6 | 15 | 12 | 12 |
| Fever | 5 | 6 | 5 | 12 | 7 |
| Flu syndrome | 40 | 15 | 27 | 29 | 25 |
| Headache | 16 | 12 | 37 | 3 | 22 |
| Infection | 17 | 15 | 10 | 24 | 15 |
| Injection site reaction | 59 | 38 | 27 | 38 | 33 |
| Pain | 49 | 21 | 32 | 35 | 30 |
| Cardiovascular | |||||
| Arrhythmia | 5 | 3 | 3 | 2 | |
| Atrial fibrillation | 2 | 6 | 2 | ||
| Cardiovascular disorder | 6 | 3 | 5 | 6 | 5 |
| Electrocardiogram abnormal | 3 | 6 | 2 | ||
| Hemorrhage | 6 | 9 | 2 | 3 | 4 |
| Hypertension | 14 | 18 | 21 | 21 | 20 |
| Hypotension | 19 | 15 | 19 | 3 | 14 |
| Palpitations | 3 | 8 | 5 | ||
| Tachycardia | 5 | 6 | 5 | 9 | 6 |
| Vascular disorder | 2 | 2 | 6 | 2 | |
| Digestive | |||||
| Anorexia | 3 | 3 | 5 | 6 | 5 |
| Constipation | 6 | 3 | 3 | 3 | 3 |
| Diarrhea | 19 | 9 | 10 | 35 | 16 |
| Dyspepsia | 10 | 9 | 6 | 5 | |
| Gastrointestinal disorder | 2 | 3 | 6 | 2 | |
| Melena | 3 | 6 | 2 | ||
| Nausea | 10 | 9 | 5 | 12 | 8 |
| Stomach atony | 5 | ||||
| Vomiting | 16 | 9 | 16 | 21 | 15 |
| Endocrine System | |||||
| Parathyroid disorder | 2 | 6 | 2 | 6 | 4 |
| Hemic/Lymphatic | |||||
| Anemia | 3 | 3 | 5 | 12 | 6 |
| Metabolic/Nutritional | |||||
| Hypercalcemia | 3 | 15 | 8 | 6 | 9 |
| Hyperkalemia | 6 | 6 | 6 | 6 | 6 |
| Hypervolemia | 17 | 3 | 3 | 12 | 5 |
| Peripheral edema | 3 | 6 | 5 | 3 | 5 |
| Weight decrease | 3 | 3 | 8 | 3 | 5 |
| Weight increase | 2 | 3 | 6 | 2 | |
| Musculo-Skeletal | |||||
| Leg cramps | 13 | 8 | 4 | ||
| Myalgia | 6 | ||||
| Nervous | |||||
| Anxiety | 5 | 2 | 1 | ||
| Depression | 3 | 6 | 5 | 6 | 5 |
| Dizziness | 11 | 18 | 10 | 15 | 13 |
| Drug dependence | 2 | 6 | 2 | ||
| Hypertonia | 5 | 3 | 1 | ||
| Insomnia | 6 | 3 | 6 | 4 | |
| Paresthesia | 3 | 3 | 3 | 12 | 5 |
| Vertigo | 6 | 2 | |||
| Respiratory | |||||
| Bronchitis | 5 | 3 | 3 | ||
| Cough increase | 16 | 10 | 18 | 9 | |
| Dyspnea | 19 | 3 | 11 | 3 | 7 |
| Pharyngitis | 33 | 24 | 27 | 15 | 23 |
| Respiratory disorder | 5 | ||||
| Rhinitis | 10 | 6 | 11 | 6 | 9 |
| Sinusitis | 5 | 2 | 3 | 2 | |
| Skin and Appendages | |||||
| Pruritis | 13 | 8 | 3 | 5 | |
| Rash | 3 | 5 | 3 | 3 | |
| Special Senses | |||||
| Amblyopia | 2 | 6 | 3 | ||
| Eye disorder | 3 | 6 | 3 | 3 | |
| Taste perversion | 2 | 9 | 3 | ||
| Urogenital | |||||
| Urinary tract infect | 6 | 3 | 3 | 2 | |
| Kidney failure | 5 | 6 | 6 | 6 | 6 |
No information provided.
Last reviewed on RxList: 5/28/2009
This monograph has been modified to include the generic and brand name in many instances.
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