pharmacopeia
GET
/api/v1/drug/lamotrigine

Boxed warning

SERIOUS SKIN RASHES Lamotrigine can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 17 years) and 0.08% to 0.3% in adults receiving lamotrigine. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking lamotrigine as adjunctive therapy. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate. In addition to age, factors that may increase the risk of occurrence or the severity of rash caused by lamotrigine include (1) coadministration of lamotrigine with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of lamotrigine, (3) exceeding the recommended dose escalation for lamotrigine, or (4) the presence of the HLA-B*1502 allele However, cases have occurred in the absence of these factors. Nearly all cases of life-threatening rashes caused by lamotrigine have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months).

2D structure
6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine
SMILES C1=CC(=C(C(=C1)Cl)Cl)C2=C(N=C(N=N2)N)N
InChIKey PYZRQGJRPPTADH-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

The precise mechanism(s) by which lamotrigine exerts its anticonvulsant action are unknown. In animal models designed to detect anticonvulsant activity, lamotrigine was effective in preventing seizure spread in the maximum electroshock (MES) and pentylenetetrazol (scMet) tests, and prevented seizures in the visually and electrically evoked after-discharge (EEAD) tests for antiepileptic activity.

Dihydrofolate ReductaseOrganic Cation Transporter 2Sodium Channel

Indications

Sourced from openFDA
  • Lamotrigine orally disintegrating tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older : partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures.ICD-10: G40.909

Contraindications

Sourced from openFDA
  • Lamotrigine is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning , Warnings and Precautions ( 5.1 , 5.3 )]. Hypersensitivity to the drug or its ingredients.contraindicated

Dosage & administration

Sourced from openFDA

Dosing is based on concomitant medications, indication, and patient age. ( 2.1 , 2.2 , 2.3 , 2.4 ) To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should not be exceeded. Lamotrigine Orally Disintegrating Tablets Patient Titration Kits are available for the first 5 weeks of treatment. ( 2.1 , 16 ) Do not restart lamotrigine orally disintegrating tablets in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks. ( 2.1 , 5.1 ) Adjustments to maintenance doses will be necessary in most patients starting or stopping estrogen-containing products, including oral contraceptives. ( 2.1 , 5.9 ) Discontinuation: Taper over a period of at least 2 weeks (approximately 50% dose reduction per week). ( 2.1 , 5.10 ) Epilepsy: Adjunctive therapy—See Table 1 for patients older than 12 years and Tables 2 and 3 for patients aged 2 to 12 years. ( 2.2 ) Conversion to monotherapy—See Table 4. ( 2.3 ) Bipolar disorde r: See Tables 5 and 6. ( 2.4 ) 2.1 General Dosing Considerations Rash There are suggestions that the risk of severe, potentially life-threatening rash may be increased by (1) coadministration of lamotrigine with valproate, (2) exceeding the recommended initial dose of lamotrigine, or (3) exceeding the recommended dose escalation for lamotrigine. However, cases have occurred in the absence of these factors [see Boxed Warning ]. Therefore, it is important that the dosing recommendations be followed closely.

Warnings & precautions

Sourced from openFDA

Life-threatening serious rash and/or rash-related death: Discontinue at the first sign of rash, unless the rash is clearly not drug related. ( Boxed Warning , 5.1 ) Hemophagocytic lymphohistiocytosis: Consider this diagnosis and evaluate patients immediately if they develop signs or symptoms of systemic inflammation. Discontinue lamotrigine if an alternative etiology is not established. ( 5.2 ) Fatal or life-threatening hypersensitivity reaction: Multiorgan hypersensitivity reactions, also known as drug reaction with eosinophilia and systemic symptoms, may be fatal or life threatening. Early signs may include rash, fever, and lymphadenopathy. These reactions may be associated with other organ involvement, such as hepatitis, hepatic failure, blood dyscrasias, or acute multiorgan failure. Lamotrigine should be discontinued if alternate etiology for this reaction is not found. ( 5.3 ) Cardiac rhythm and conduction abnormalities: Based on in vitro findings, lamotrigine could cause serious arrhythmias and/or death in patients with certain underlying cardiac disorders or arrhythmias. Any expected or observed benefit of lamotrigine in an individual patient with clinically important structural or functional heart disease must be carefully weighed against the risk for serious arrhythmias and/or death for that patient. (5.4) Blood dyscrasias (e.g., neutropenia, thrombocytopenia, pancytopenia): May occur, either with or without an associated hypersensitivity syndrome. Monitor for signs of anemia, unexpected infection, or bleeding.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described in more detail in the Warnings and Precautions section of the labeling: Serious Skin Rashes [see Warnings and Precautions (5.1) ] Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions (5.2) ] Multiorgan Hypersensitivity Reactions and Organ Failure [see Warnings and Precautions (5.3) ] Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions (5.4) ] Blood Dyscrasias [see Warnings and Precautions (5.5) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.6) ] Aseptic Meningitis [see Warnings and Precautions (5.7) ] Withdrawal Seizures [see Warnings and Precautions (5.10) ] Status Epilepticus [see Warnings and Precautions (5.11) ] Epilepsy : Most common adverse reactions (incidence ≥10%) in adults were dizziness, headache, diplopia, ataxia, nausea, blurred vision, somnolence, rhinitis, pharyngitis, and rash. Additional adverse reactions (incidence ≥10%) reported in children included vomiting, infection, fever, accidental injury, diarrhea, abdominal pain, and tremor. ( 6.1 ) Bipolar disorder : Most common adverse reactions (incidence >5%) in adults were nausea, insomnia, somnolence, back pain, fatigue, rash, rhinitis, abdominal pain, and xerostomia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

Pregnancy: Based on animal data may cause fetal harm. ( 8.1 ) Hepatic impairment: Dosage adjustments required in patients with moderate and severe liver impairment. ( 2.1 , 8.6 ) Renal impairment: Reduced maintenance doses may be effective for patients with significant renal impairment. ( 2.1 , 8.7 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, including lamotrigine, during pregnancy. Encourage women who are taking lamotrigine during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/ . Risk Summary Data from several prospective pregnancy exposure registries and epidemiological studies of pregnant women have not detected an increased frequency of major congenital malformations or a consistent pattern of malformations among women exposed to lamotrigine compared with the general population (see Data) . The majority of lamotrigine pregnancy exposure data are from women with epilepsy. In animal studies, administration of lamotrigine during pregnancy resulted in developmental toxicity (increased mortality, decreased body weight, increased structural variation, neurobehavioral abnormalities) at doses lower than those administered clinically.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of lamotrigine have been studied in subjects with epilepsy, healthy young and elderly volunteers, and volunteers with chronic renal failure. Lamotrigine pharmacokinetic parameters for adult and pediatric subjects and healthy normal volunteers are summarized in Tables 14 and 16.

Overdosage

Sourced from openFDA

10.1 Human Overdose Experience Overdoses involving quantities up to 15 g have been reported for lamotrigine, some of which have been fatal. Overdose has resulted in ataxia, nystagmus, seizures (including tonic-clonic seizures), decreased level of consciousness, coma, and intraventricular conduction delay. 10.2 Management of Overdose There are no specific antidotes for lamotrigine. Following a suspected overdose, hospitalization of the patient is advised. General supportive care is indicated, including frequent monitoring of vital signs and close observation of the patient. If indicated, emesis should be induced; usual precautions should be taken to protect the airway. It should be kept in mind that immediate-release lamotrigine is rapidly absorbed [see Clinical Pharmacology (12.3) ]. It is uncertain whether hemodialysis is an effective means of removing lamotrigine from the blood. In 6 renal failure patients, about 20% of the amount of lamotrigine in the body was removed by hemodialysis during a 4-hour session. A Poison Control Center should be contacted for information on the management of overdosage of lamotrigine.

Approval history

Sourced from openFDA
  • Dec 27, 1994NDANDA020241Glaxosmithkline Llc
  • Aug 24, 1998NDANDA020764Glaxosmithkline Llc
  • Jan 22, 2009ANDAANDA076701Dr Reddys Labs Ltd
  • Jan 22, 2009ANDAANDA078009Zydus Pharms Usa Inc
  • Jan 27, 2009ANDAANDA076708Dr Reddys Labs Ltd
  • May 8, 2009NDANDA022251Glaxosmithkline Llc
  • May 29, 2009NDANDA022115Glaxosmithkline Llc
  • Sep 16, 2025NDANDA218879Owp Pharms

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Lamotrigine, Tablet, Extended Release, 100 mg (NDC 49884-563-11)To be discontinued
    Sponsor: Par Health, Inc.
    Updated
  • Lamotrigine, Tablet, Extended Release, 200 mg (NDC 49884-564-11)To be discontinued
    Sponsor: Par Health, Inc.
    Updated
  • Lamotrigine, Tablet, Extended Release, 25 mg (NDC 49884-561-11)To be discontinued
    Sponsor: Par Health, Inc.
    Updated
  • Lamotrigine, Tablet, Extended Release, 250 mg (NDC 49884-604-11)To be discontinued
    Sponsor: Par Health, Inc.
    Updated
  • Lamotrigine, Tablet, Extended Release, 300 mg (NDC 49884-605-11)To be discontinued
    Sponsor: Par Health, Inc.
    Updated
  • Lamotrigine, Tablet, Extended Release, 50 mg (NDC 49884-562-11)To be discontinued
    Sponsor: Par Health, Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
129,251 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective10,0877.8%
  2. 2Rash8,4916.6%
  3. 3Seizure6,7065.2%
  4. 4Nausea6,2894.9%
  5. 5Fatigue6,0484.7%
  6. 6Off Label Use6,0174.7%
  7. 7Dizziness5,8954.6%
  8. 8Headache5,6744.4%
  9. 9Depression5,0793.9%
  10. 10Vomiting4,6683.6%
  11. 11Somnolence4,4263.4%
  12. 12Pyrexia4,4073.4%
  13. 13Anxiety4,3873.4%
  14. 14Drug Interaction4,3663.4%
  15. 15Toxicity To Various Agents4,1893.2%

Literature

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Recent PubMed references pinned to Lamotrigine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 228 ClinicalTrials.gov registrations naming Lamotrigine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Lamotrigine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • UGT1A4CPIC D (provisional)ClinPGx 3

Frequently asked questions

How does Lamotrigine work?
The precise mechanism(s) by which lamotrigine exerts its anticonvulsant action are unknown. In animal models designed to detect anticonvulsant activity, lamotrigine was effective in preventing seizure spread in the maximum electroshock (MES) and pentylenetetrazol (scMet) tests, and prevented seizures in the visually and electrically evoked after-discharge (EEAD) tests for antiepileptic activity.
What is Lamotrigine used for?
According to FDA labeling, Lamotrigine carries indications including: Lamotrigine orally disintegrating tablets are indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older : partial-onset seizures. primary generalized tonic-clonic (PGTC) seizures.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Lamotrigine?
Lamotrigine is classified as Other antiepileptics, Anti-epileptic Agent, Mood Stabilizer, Dihydrofolate Reductase Inhibitors, Organic Cation Transporter 2 Inhibitors, Sodium Channel Antagonists, Decreased Central Nervous System Disorganized Electrical Activity, Decreased Glutamate Activity.
What are the brand names for Lamotrigine?
Lamotrigine is marketed under brand names including Lamictal, Subvenite.
What are the contraindications for Lamotrigine?
Lamotrigine labeling lists contraindications including: Lamotrigine is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see Boxed Warning , Warnings and Precautions ( 5.1 , 5.3 )]. Hypersensitivity to the drug or its ingredients.. Always consult the full prescribing information and a clinician.
Note. Data for lamotrigine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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