This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: SERIOUS SKIN RASHES LAMICTAL XR can cause serious rashes requiring hospitalization and discontinuation of treatment. The incidence of these rashes, which have included Stevens-Johnson syndrome, is approximately 0.8% (8 per 1,000) in pediatric patients (aged 2 to 16 years) receiving immediate-release lamotrigine as adjunctive therapy for epilepsy and 0.3% (3 per 1,000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking adjunctive immediate release lamotrigine, there was 1 rash-related death. LAMICTAL XR is not approved for patients younger than 13 years. 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. The risk of serious rash caused by treatment with LAMICTAL XR is not expected to differ from that with immediate-release lamotrigine. However, the relatively limited treatment experience with LAMICTAL XR makes it difficult to characterize the frequency and risk of serious rashes caused by treatment w...
Warnings the FDA chose to announce publicly after approval, as opposed to quiet label edits. Class-wide items name the drug's class, not this drug specifically.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
is indicated for: • adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. ( 1.1 ) • conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). ( 1.2 ) Limitation of use: Safety and effectiveness in patients younger than 13 years have not been established. ( 1.3 ) 1.1 Adjunctive Therapy LAMICTAL XR is indicated as adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. 1.2 Monotherapy LAMICTAL XR is indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug (AED). Safety and effectiveness of LAMICTAL XR have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs. 1.3 Limitation of Use Safety and effectiveness of LAMICTAL XR for use in patients younger than 13 years hav...
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. ( Boxed Warning , 4 )
• 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 LAMICTAL XR 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 (DRESS), 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. LAMICTAL XR should be discontinued if alternate etiology for this reaction is not found. ( 5.3 ) • Cardiac rhythm and conduction abnormalities: Based on in vitro findings, LAMICTAL XR could cause serious arrhythmias and/or death in patients with certain underlying cardiac disorders or arrhythmias. Any expected or observed benefit of LAMICTAL XR in an individual patient with clinically ...
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 )] • Most common adverse reactions with use as adjunctive therapy (treatment difference between LAMICTAL XR and placebo ≥4%) were dizziness, tremor/intention tremor, vomiting, and diplopia. ( 6.1 ) • Most common adverse reactions with use as monotherapy were similar to those seen with previous trials conducted with immediate-release lamotrigine and LAMICTAL XR. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-8...
Boxed Warning Dosage and Administration ( 2.1 , 2.2 ) Warnings and Precautions, Serious Skin Rashes ( 5.1 ) Concomitant Use with Estrogen-Containing Products, Including Oral Contraceptives ( 5.9 ) Sudden Unexplained Death in Epilepsy ( 5.12 ) – removal 10/2025 4/2025 10/2025 4/2025 4/2025
Source: FDA SPL label for LAMICTAL XR (GlaxoSmithKline LLC), effective 20251010. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 9,351 | 8,383 | 7,708 | 6,686 | 7,040 | 7,704 | 7,913 | 3,600 |
4,292 reports blaming this drug for every million Medicare prescriptions filled, which is 1.6× the typical drug on this site. (18,874 reports in 2024–2026, against 4,397,432 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 07/2022 | Class III | AVKARE Inc. | Labeling: Label Error on Declared Strength |
| 05/2020 | Class III | AVKARE Inc. | Presence of Foreign Substance consistent with granules from desiccant packs used during storage |
| 12/2019 | Class I | Taro Pharmaceuticals U.S.A., Inc. | Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. |
| 09/2018 | Class II | Torrent Pharma Inc. | Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing. |
| 08/2016 | Class III | Unichem Pharmaceuticals Usa Inc | Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $7,781 in payments to US physicians and hospitals tied to this drug across 412 transactions (Subvenite $7,781).
No pending federal MDL names this drug or its brands.
Settlements of $100M+ in which this drug (Lamictal) was a named product, as recorded by the Department of Justice. A settlement resolves allegations; civil settlements are not admissions and not findings of wrongdoing. They are shown because off-label promotion cases describe how the evidence many prescribers saw was shaped.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Lamotrigine | 4,154,338 | $14 |
| Lamotrigine ER | 157,313 | $263 |
| Lamictal | 43,491 | $1,382 |
| Lamotrigine ODT | 23,561 | $380 |
| Lamictal XR | 15,467 | $3,124 |
| Lamictal ODT | 1,808 | $1,675 |
| Subvenite | 821 | $15 |
| Lamotrigine (Orange) | 347 | $652 |
No same-class alternatives found in RxClass.