Home FDA labels 114eaeda-8965-4c92-a3ff-15021b305464 Levocarnitine openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Levocarnitine
Generic name LEVOCARNITINE
Manufacturer American Regent, Inc.
Product type HUMAN PRESCRIPTION DRUG
SPL set ID cc4da2c3-f939-444d-9b5b-a57b6051c190
SPL ID 114eaeda-8965-4c92-a3ff-15021b305464
Version 11
Effective date 2023-06-23
Source export date 2026-10-12
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:39:41 Harmonized routes table Harmonized routes INTRAVENOUS
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warnings WARNINGS Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following levocarnitine administration, mostly in patients with end stage renal disease who are undergoing dialysis. Some reactions occurred within minutes after intravenous administration of levocarnitine. If a severe hypersensitivity reaction occurs, discontinue levocarnitine treatment and initiate appropriate medical treatment. Consider the risks and benefits of re-administering levocarnitine to individual patients following a severe reaction. If the decision is made to re-administer the product, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction.
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adverse reactions ADVERSE REACTIONS Clinical Trials Experience 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. 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 Pruritus 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 Postmarketing Experience The following adverse reactions have been reported: Neurologic Reactions: 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. Hypersensitivity reactions : Anaphylaxis, laryngeal edema and bronchospasm (see WARNINGS ).
adverse reactions table <table cellspacing="0" cellpadding="0" border="1"><col/><col/><col/><col/><col/><col/><tbody><tr><td/><td><paragraph><content styleCode="bold"><content styleCode="italics">Placebo</content></content></paragraph><paragraph><content styleCode="bold"><content styleCode="italics">(n=63)</content></content></paragraph></td><td><paragraph><content styleCode="bold"><content styleCode="italics">Levocarnitine</content></content></paragraph><paragraph><content styleCode="bold"><content styleCode="italics">10 mg (n=34)</content></content></paragraph></td><td><paragraph><content styleCode="bold"><content styleCode="italics">Levocarnitine</content></content></paragraph><paragraph><content styleCode="bold"><content styleCode="italics">20 mg (n=62)</content></content></paragraph></td><td><paragraph><content styleCode="bold"><content styleCode="italics">Levocarnitine</content></content></paragraph><paragraph><content styleCode="bold"><content styleCode="italics">40 mg (n=34)</content></content></paragraph></td><td><paragraph><content styleCode="bold"><content styleCode="italics">Levocarnitine 10, 20 & 40 mg (n=130)</content></content></paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Body as Whole</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Abdominal pain</paragraph></td><td><paragraph>17</paragraph></td><td><paragraph>21</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>9</paragraph></td></tr><tr><td><paragraph> Accidental injury</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>8</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>10</paragraph></td></tr><tr><td><paragraph> Allergic reaction</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>6</paragraph></td><td/><td/><td><paragraph>2</paragraph></td></tr><tr><td><paragraph> Asthenia</paragraph></td><td><paragraph>8</paragraph></td><td><paragraph>9</paragraph></td><td><paragraph>8</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>9</paragraph></td></tr><tr><td><paragraph> Back pain</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>9</paragraph></td><td><paragraph>8</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>8</paragraph></td></tr><tr><td><paragraph> Chest pain</paragraph></td><td><paragraph>14</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>15</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>12</paragraph></td></tr><tr><td><paragraph> Fever</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>7</paragraph></td></tr><tr><td><paragraph> Flu syndrome</paragraph></td><td><paragraph>40</paragraph></td><td><paragraph>15</paragraph></td><td><paragraph>27</paragraph></td><td><paragraph>29</paragraph></td><td><paragraph>25</paragraph></td></tr><tr><td><paragraph> Headache</paragraph></td><td><paragraph>16</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>37</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>22</paragraph></td></tr><tr><td><paragraph> Infection</paragraph></td><td><paragraph>17</paragraph></td><td><paragraph>15</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>24</paragraph></td><td><paragraph>15</paragraph></td></tr><tr><td><paragraph> Injection site reaction</paragraph></td><td><paragraph>59</paragraph></td><td><paragraph>38</paragraph></td><td><paragraph>27</paragraph></td><td><paragraph>38</paragraph></td><td><paragraph>33</paragraph></td></tr><tr><td><paragraph> Pain</paragraph></td><td><paragraph>49</paragraph></td><td><paragraph>21</paragraph></td><td><paragraph>32</paragraph></td><td><paragraph>35</paragraph></td><td><paragraph>30</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Cardiovascular</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Arrhythmia</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>3</paragraph></td><td/><td><paragraph>3</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph> Atrial fibrillation</paragraph></td><td/><td/><td><paragraph>2</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph> Cardiovascular</paragraph><paragraph> disorder</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph> Electrocardiogram</paragraph><paragraph> abnormal </paragraph></td><td/><td><paragraph>3</paragraph></td><td/><td><paragraph>6</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph> Hemorrhage</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>9</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>4</paragraph></td></tr><tr><td><paragraph> Hypertension</paragraph></td><td><paragraph>14</paragraph></td><td><paragraph>18</paragraph></td><td><paragraph>21</paragraph></td><td><paragraph>21</paragraph></td><td><paragraph>20</paragraph></td></tr><tr><td><paragraph> Hypotension</paragraph></td><td><paragraph>19</paragraph></td><td><paragraph>15</paragraph></td><td><paragraph>19</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>14</paragraph></td></tr><tr><td><paragraph> Palpitations</paragraph></td><td/><td><paragraph>3</paragraph></td><td><paragraph>8</paragraph></td><td/><td><paragraph>5</paragraph></td></tr><tr><td><paragraph> Tachycardia</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>9</paragraph></td><td><paragraph>6</paragraph></td></tr><tr><td><paragraph> Vascular disorder</paragraph></td><td><paragraph>2</paragraph></td><td/><td><paragraph>2</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Digestive</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Anorexia</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph> Constipation</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td></tr><tr><td><paragraph> Diarrhea</paragraph></td><td><paragraph>19</paragraph></td><td><paragraph>9</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>35</paragraph></td><td><paragraph>16</paragraph></td></tr><tr><td><paragraph> Dyspepsia</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>9</paragraph></td><td><paragraph>6</paragraph></td><td/><td><paragraph>5</paragraph></td></tr><tr><td><paragraph> Gastrointestinal disorder</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>3</paragraph></td><td/><td><paragraph>6</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph> Melena</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>6</paragraph></td><td/><td/><td><paragraph>2</paragraph></td></tr><tr><td><paragraph> Nausea</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>9</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>8</paragraph></td></tr><tr><td><paragraph> Stomach atony</paragraph></td><td><paragraph>5</paragraph></td><td/><td/><td/><td/></tr><tr><td><paragraph> Vomiting</paragraph></td><td><paragraph>16</paragraph></td><td><paragraph>9</paragraph></td><td><paragraph>16</paragraph></td><td><paragraph>21</paragraph></td><td><paragraph>15</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Endocrine System</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Parathyroid disorder</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>4</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Hemic/Lymphatic</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Anemia</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>6</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Metabolic/Nutritional</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Hypercalcemia</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>15</paragraph></td><td><paragraph>8</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>9</paragraph></td></tr><tr><td><paragraph> Hyperkalemia</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>6</paragraph></td></tr><tr><td><paragraph> Hypervolemia</paragraph></td><td><paragraph>17</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph> Peripheral edema</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph> Weight decrease</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>8</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph> Weight increase</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>3</paragraph></td><td/><td><paragraph>6</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Musculo-Skeletal</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Leg cramps</paragraph></td><td><paragraph>13</paragraph></td><td/><td><paragraph>8</paragraph></td><td/><td><paragraph>4</paragraph></td></tr><tr><td><paragraph> Myalgia</paragraph></td><td><paragraph>6</paragraph></td><td/><td/><td/><td/></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Nervous</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Anxiety</paragraph></td><td><paragraph>5</paragraph></td><td/><td><paragraph>2</paragraph></td><td/><td><paragraph>1</paragraph></td></tr><tr><td><paragraph> Depression</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph> Dizziness</paragraph></td><td><paragraph>11</paragraph></td><td><paragraph>18</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>15</paragraph></td><td><paragraph>13</paragraph></td></tr><tr><td><paragraph> Drug dependence</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>6</paragraph></td><td/><td/><td><paragraph>2</paragraph></td></tr><tr><td><paragraph> Hypertonia</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>3</paragraph></td><td/><td/><td><paragraph>1</paragraph></td></tr><tr><td><paragraph> Insomnia</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>6</paragraph></td><td/><td><paragraph>4</paragraph></td></tr><tr><td><paragraph> Paresthesia</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>12</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph> Vertigo</paragraph></td><td/><td><paragraph>6</paragraph></td><td/><td/><td><paragraph>2</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Respiratory</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Bronchitis</paragraph></td><td/><td/><td><paragraph>5</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td></tr><tr><td><paragraph> Cough increase</paragraph></td><td><paragraph>16</paragraph></td><td/><td><paragraph>10</paragraph></td><td><paragraph>18</paragraph></td><td><paragraph>9</paragraph></td></tr><tr><td><paragraph> Dyspnea</paragraph></td><td><paragraph>19</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>11</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>7</paragraph></td></tr><tr><td><paragraph> Pharyngitis</paragraph></td><td><paragraph>33</paragraph></td><td><paragraph>24</paragraph></td><td><paragraph>27</paragraph></td><td><paragraph>15</paragraph></td><td><paragraph>23</paragraph></td></tr><tr><td><paragraph> Respiratory disorder</paragraph></td><td><paragraph>5</paragraph></td><td/><td/><td/><td/></tr><tr><td><paragraph> Rhinitis</paragraph></td><td><paragraph>10</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>11</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>9</paragraph></td></tr><tr><td><paragraph> Sinusitis</paragraph></td><td><paragraph>5</paragraph></td><td/><td><paragraph>2</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>2</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Skin And Appendages</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Pruritus</paragraph></td><td><paragraph>13</paragraph></td><td/><td><paragraph>8</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>5</paragraph></td></tr><tr><td><paragraph> Rash</paragraph></td><td><paragraph>3</paragraph></td><td/><td><paragraph>5</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Special Senses</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Amblyopia</paragraph></td><td><paragraph>2</paragraph></td><td/><td><paragraph>6</paragraph></td><td/><td><paragraph>3</paragraph></td></tr><tr><td><paragraph> Eye disorder</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>3</paragraph></td><td/><td><paragraph>3</paragraph></td></tr><tr><td><paragraph> Taste perversion</paragraph></td><td/><td/><td><paragraph>2</paragraph></td><td><paragraph>9</paragraph></td><td><paragraph>3</paragraph></td></tr><tr><td><paragraph><content styleCode="bold"><content styleCode="italics">Urogenital</content></content></paragraph></td><td/><td/><td/><td/><td/></tr><tr><td><paragraph> Urinary tract infect</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td/><td><paragraph>2</paragraph></td></tr><tr><td><paragraph> Kidney failure</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>6</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.