Drug · FAERS side-effect profile with label screen
Levocarnitine Oral side effects: what 2,935 FDA adverse event reports show
Drug class
Carnitine Analog
FDA label (Established Pharmacologic Class)
Who reports
2,935 reports · 78% serious · 299 with death outcome · 50% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. For the prevention and treatment of carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.
FDA label, Indications and Usage
What it is
DESCRIPTION Levocarnitine, USP is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 1Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 4Not in label — unassessed 30
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 84 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Status epilepticus | 35 | 22.2 15.9–30.8ROR 22.4 · χ² 684 / p 4e-151 | 21.9 EB05 16.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Seizure | 288 | 18.0 16.1–20.1ROR 19.8 · χ² 4,611 / p <1e-300 | 17.9 EB05 16.2 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 | no trial data cached |
| Generalised tonic-clonic seizure | 31 | 13.6 9.5–19.2ROR 13.7 · χ² 348 / p 7e-78 | 13.2 EB05 9.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Epilepsy | 56 | 13.1 10.1–17.0ROR 13.4 · χ² 615 / p 4e-136 | 12.9 EB05 10.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Hepatic encephalopathy | 16 | 12.3 7.5–20.0ROR 12.3 · χ² 154 / p 1e-35 | 11.1 EB05 6.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Device related infection | 26 | 12.1 8.2–17.7ROR 12.2 · χ² 252 / p 4e-57 | 11.4 EB05 7.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial data cached |
| Prescribed underdose | 33 | 11.8 8.4–16.6ROR 12.0 · χ² 316 / p 5e-71 | 11.3 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Tachypnoea | 22 | 11.6 7.7–17.6ROR 11.7 · χ² 203 / p 3e-46 | 10.8 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Clostridium difficile colitis | 16 | 10.8 6.6–17.6ROR 10.8 · χ² 132 / p 7e-31 | 9.5 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Gastroenteritis viral | 25 | 9.9 6.7–14.6ROR 9.9 · χ² 190 / p 1e-43 | 9.0 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Metabolic acidosis | 38 | 8.6 6.3–11.8ROR 8.7 · χ² 247 / p 6e-56 | 8.0 EB05 6.0 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.4 · 92% clinician | no trial data cached |
| Spinal pain | 14 | 8.5 5.1–14.4ROR 8.6 · χ² 86 / p 1e-20 | 7.1 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Neutrophil count increased | 12 | 8.3 4.7–14.7ROR 8.4 · χ² 70 / p 2e-17 | 6.8 EB05 4.0 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 6.8 | no trial data cached |
| Pneumonia aspiration | 27 | 7.7 5.3–11.3ROR 7.8 · χ² 152 / p 3e-35 | 7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Blood urea increased | 18 | 7.6 4.8–12.1ROR 7.7 · χ² 97 / p 3e-23 | 6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 | no trial data cached |
| Pulmonary congestion | 14 | 7.6 4.5–12.8ROR 7.6 · χ² 73 / p 6e-18 | 6.3 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Multiple organ dysfunction syndrome | 26 | 6.7 4.5–9.8ROR 6.7 · χ² 119 / p 4e-28 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 96% clinician | no trial data cached |
| Obesity | 14 | 6.3 3.7–10.6ROR 6.3 · χ² 57 / p 2e-14 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Bacteraemia | 10 | 6.1 3.3–11.3ROR 6.1 · χ² 37 / p 5e-10 | 4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Acute respiratory distress syndrome | 15 | 6.1 3.7–10.0ROR 6.1 · χ² 58 / p 1e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Retching | 18 | 6.0 3.8–9.6ROR 6.1 · χ² 71 / p 2e-17 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Viral infection | 28 | 6.0 4.2–8.7ROR 6.1 · χ² 112 / p 2e-26 | 5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Gastroenteritis | 12 | 5.9 3.3–10.4ROR 5.9 · χ² 44 / p 2e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Cholestasis (bile flow blockage) | 15 | 5.6 3.4–9.3ROR 5.6 · χ² 52 / p 2e-13 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Hypophagia | 19 | 5.4 3.4–8.4ROR 5.4 · χ² 63 / p 1e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Shock | 17 | 5.3 3.3–8.6ROR 5.3 · χ² 55 / p 5e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Lymphocyte count decreased | 13 | 5.3 3.1–9.0ROR 5.3 · χ² 41 / p 9e-11 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 4.8 | no trial data cached |
| Altered state of consciousness | 15 | 5.0 3.0–8.2ROR 5.0 · χ² 44 / p 2e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Hepatic failure | 21 | 5.0 3.2–7.6ROR 5.0 · χ² 63 / p 1e-15 | 4.5 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 95% clinician | no trial data cached |
| Encephalopathy | 17 | 5.0 3.1–8.0ROR 5.0 · χ² 50 / p 8e-13 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Product prescribing error | 16 | 4.8 3.0–7.9ROR 4.8 · χ² 45 / p 1e-11 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 | no trial data cached |
| Prescribed overdose | 13 | 4.8 2.8–8.3ROR 4.8 · χ² 35 / p 1e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Coagulopathy | 11 | 4.7 2.6–8.5ROR 4.7 · χ² 29 / p 4e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Product use complaint | 10 | 4.6 2.5–8.6ROR 4.6 · χ² 25 / p 3e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious n=3 | no trial data cached |
| Blood bilirubin increased | 17 | 4.5 2.8–7.2ROR 4.5 · χ² 43 / p 3e-11 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 3.8 | no trial data cached |
| Respiratory tract infection | 16 | 4.4 2.7–7.2ROR 4.4 · χ² 39 / p 2e-10 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | no trial data cached |
| Feeding disorder | 12 | 4.3 2.4–7.6ROR 4.3 · χ² 27 / p 9e-8 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Hypersomnia | 17 | 4.2 2.6–6.8ROR 4.3 · χ² 39 / p 2e-10 | 3.8 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Bacterial infection | 11 | 4.2 2.3–7.6ROR 4.2 · χ² 24 / p 5e-7 | 3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Febrile neutropenia | 39 | 4.2 3.1–5.7ROR 4.3 · χ² 92 / p 3e-22 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 95% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Seizure | 288 | 18.0 16.1–20.1ROR 19.8 · χ² 4,611 / p <1e-300 | 17.9 EB05 16.2 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.6 | no trial data cached |
| Product dose omission issue | 110 | 2.8 2.3–3.3ROR 2.8 · χ² 123 / p 6e-29 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 78% consumer | no trial data cached |
| Somnolence (drowsiness) | 105 | 3.7 3.1–4.5ROR 3.8 · χ² 209 / p 1e-47 | 3.7 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Covid-19 | 67 | 2.7 2.1–3.4ROR 2.7 · χ² 71 / p 2e-17 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Hospitalisation | 66 | 3.1 2.4–3.9ROR 3.1 · χ² 92 / p 4e-22 | 3.0 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Epilepsy | 56 | 13.1 10.1–17.0ROR 13.4 · χ² 615 / p 4e-136 | 12.9 EB05 10.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Influenza | 54 | 3.5 2.6–4.5ROR 3.5 · χ² 92 / p 4e-22 | 3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Overdose | 51 | 1.7 1.3–2.2ROR 1.7 · χ² 14 / p 1e-4 | 1.7 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.3 | no trial data cached |
| Respiratory failure | 42 | 4.1 3.0–5.6ROR 4.2 · χ² 96 / p 5e-23 | 3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial data cached |
| Febrile neutropenia | 39 | 4.2 3.1–5.7ROR 4.3 · χ² 92 / p 3e-22 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 95% clinician | no trial data cached |
| Metabolic acidosis | 38 | 8.6 6.3–11.8ROR 8.7 · χ² 247 / p 6e-56 | 8.0 EB05 6.0 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.4 · 92% clinician | no trial data cached |
| Status epilepticus | 35 | 22.2 15.9–30.8ROR 22.4 · χ² 684 / p 4e-151 | 21.9 EB05 16.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 | no trial data cached |
| Prescribed underdose | 33 | 11.8 8.4–16.6ROR 12.0 · χ² 316 / p 5e-71 | 11.3 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Agitation | 32 | 3.1 2.2–4.4ROR 3.1 · χ² 44 / p 2e-11 | 3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Underdose | 31 | 3.0 2.1–4.3ROR 3.1 · χ² 40 / p 1e-10 | 2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · 83% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Status epilepticus — n=35, PRR 22.2
- Generalised tonic-clonic seizure — n=31, PRR 13.6
- Epilepsy — n=56, PRR 13.1
- Prescribed underdose — n=33, PRR 11.8
- Tachypnoea — n=22, PRR 11.6
- Gastroenteritis viral — n=25, PRR 9.9
- Pneumonia aspiration — n=27, PRR 7.7
- Multiple organ dysfunction syndrome — n=26, PRR 6.7
- Viral infection — n=28, PRR 6.0
- Hepatic failure — n=21, PRR 5.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Minoxidil (oral) ↔ Pericardial effusion.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Levocarnitine?
In FDA FAERS, the most frequently co-reported reaction terms for Levocarnitine are seizure, somnolence, covid-19, epilepsy, influenza, respiratory failure. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Levocarnitine have an FDA boxed warning?
No. The FDA label retrieved for Levocarnitine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Levocarnitine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 1f38ab0d-ef89-4e92-990f-9da190057e17, effective 20260702; matched on
openfda.generic_name.exact:"LEVOCARNITINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 124 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.