Prescription medicine
Lamotrigine Brand names: Lamictal, Subvenite
Lamotrigine (Lamictal) is a prescription medicine with an FDA approval on record since 1994. FDA's NDC Directory lists it from 49 generic labelers, and pharmacies paid $0.0268 per lamotrigine 25 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $2.86 per mL (Subvenite 10 mg/mL suspension).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the lamotrigine FDA label on DailyMed (effective October 10, 2025); the NDA 20241 record on Drugs@FDA; every lamotrigine label on DailyMed.
Highlights of the record
FDA label of October 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS SKIN RASHES.
LAMICTAL 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 LAMICTAL. One rash-related death was reported in a prospectively followed cohort of 1,983 pediatric patients (aged 2 to 16 years) with epilepsy taking LAMICTAL 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 LAMICTAL include (1) coadministration of LAMICTAL with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of LAMICTAL, (3) exceeding the recommended dose escalation for LAMICTAL, 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 LAMICTAL have occurred within 2 to 8 weeks of treatment initiation. However, isolated cases have occurred after prolonged treatment (e.g., 6 months). […]
Used for
From the label: indications and usageLAMICTAL is indicated for: Epilepsy–adjunctive therapy in patients aged 2 years and older:
partial-onset seizures.
Forms and strengths
- 2 mg
- 5 mg
- 25 mg
- 50 mg
- 100 mg
- 150 mg
- 200 mg
- 250 mg
- 300 mg
- 10 mg/ml
Tablet; film-coated extended-release tablet; orally disintegrating tablet; extended-release tablet; kit.
On the market
- Earliest approval on file
- December 27, 1994 Lamictal, Glaxosmithkline Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 53 first June 21, 2006; 37 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 50 of which 49 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- January 7, 2029 Lamictal XR tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0268 per tablet Lamotrigine 25 mg tablet
- Shortage (FDA)
- None current 6 past records
- Recalls by its makers (FDA)
- 10 since 2013 1 Class I among all firms' recalls; latest July 20, 2022; 1 more by firms not listed as its makers
- FAERS reports
- 130,994 through July 30, 2026
What is lamotrigine used for?
From the label: indications and usageLAMICTAL is indicated for: Epilepsy–adjunctive therapy in patients aged 2 years and older:
partial-onset seizures.
primary generalized tonic-clonic (PGTC) seizures.
generalized seizures of Lennox-Gastaut syndrome. ( 1.1 ) Epilepsy–monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. ( 1.1 ) Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. […]
Conditions named in the indications of lamotrigine's FDA labels, with every medicine labeled for each:
From other lamotrigine labelsBipolar disorder: Bipolar Disorder LAMICTAL is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with …
FDA pharmacologic class: Anti-epileptic Agent and Mood Stabilizer.
Source: FDA drug label (LAMICTAL), GlaxoSmithKline LLC, effective October 10, 2025 (SPL set d7e3572d-56fe-4727-2bb4-013ccca22678), via openFDA; the full label on DailyMed
What does the patient leaflet for lamotrigine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about LAMICTAL?LAMICTAL may cause a serious skin rash that may cause you to be hospitalized or even cause death. There is no way to tell if a mild rash will become more serious. A serious skin rash can happen at any time during your treatment with LAMICTAL, but is more likely to happen within the first 2 to 8 weeks of treatment. Children and teenagers aged between 2 and 17 years have a higher chance of getting this serious skin rash while taking LAMICTAL. The risk of getting a serious skin rash is higher if you: 1. take LAMICTAL while taking valproate [DEPAKENE (valproic acid) or DEPAKOTE (divalproex sodium)]. 2. take a higher starting dose of LAMICTAL than your healthcare provider prescribed. 3. increase your dose of LAMICTAL faster than prescribed. The risk of serious skin reactions may be associated with a variant in genes called HLA B*1502 in people from Asian origin (mainly of Han Chinese and Thai origin). See, “ Before taking LAMICTAL, tell your healthcare provider about all of your health conditions”. Call your healthcare provider right away if you have any of the following: 4. a skin rash 5. blistering or peeling of your skin 6. hives 7. painful sores in your mouth or around your eyes These symptoms may be the first signs of a serious skin reaction. A healthcare provider should examine you to decide if you should continue taking LAMICTAL. 2. Other serious reactions, including serious blood problems or liver problems. LAMICTAL can also cause other types of allergic reactions or serious problems that may affect organs and other parts of your body like your liver or blood cells. You may or may not have a rash with these types of reactions. […]
From the patient leaflet: What should I avoid while taking LAMICTAL?Do not drive, operate machinery, or do other dangerous activities until you know how LAMICTAL affects you.
From the patient leaflet: How should I store LAMICTAL?Store LAMICTAL at room temperature between 68°F and 77°F (20°C and 25°C). Keep LAMICTAL and all medicines out of the reach of children.
Source: FDA drug label (LAMICTAL), GlaxoSmithKline LLC, effective October 10, 2025 (SPL set d7e3572d-56fe-4727-2bb4-013ccca22678), via openFDA; the full label on DailyMed
Is there a generic for lamotrigine (Lamictal)?
The FDA approved the first generic lamotrigine on June 21, 2006. 53 generic applications are approved; 37 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists lamotrigine from 49 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Lamictal XR tablets, the last expiring on January 7, 2029; a patent listed only for Subvenite oral suspension runs to May 29, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1994 earliest approval on file
- 2006 first generic approved
- 2029 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lamotrigine (Lamictal)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0268 per Lamotrigine 25 mg tablet, down 12% from $0.0305 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lamotrigine 25 mg tablet (generic)
- Subvenite 10 mg/mL suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lamotrigine 100 mg tablet | Generic | $0.0487 per tablet | $1.46 | +2% |
| Lamotrigine 150 mg tablet | Generic | $0.0695 per tablet | $2.08 | +7% |
| Lamotrigine 200 mg tablet | Generic | $0.0825 per tablet | $2.48 | +5% |
| Lamotrigine 25 mg disper tablet | Generic | $0.147 per tablet | $4.42 | -10% |
| Lamotrigine 25 mg tablet | Generic | $0.0268 per tablet | $0.803 | -12% |
| Lamotrigine 5 mg disper tablet | Generic | $0.167 per tablet | $5.02 | +8% |
| Lamotrigine ER 100 mg tablet | Generic | $0.673 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $20.19 | -7% |
| Lamotrigine ER 200 mg tablet | Generic | $0.609 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $18.26 | -26% |
| Lamotrigine ER 25 mg tablet | Generic | $0.275 per tablet | $8.25 | -41% |
| Lamotrigine ER 250 mg tablet | Generic | $1.30 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $39.08 | +17% |
| Lamotrigine ER 300 mg tablet | Generic | $1.26 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $37.79 | +3% |
| Lamotrigine ER 50 mg tablet | Generic | $0.594 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $17.82 | -18% |
| Lamotrigine ODT 100 mg tablet | Generic | $1.63 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $48.75 | -33% |
| Lamotrigine ODT 200 mg tablet | Generic | $1.64 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $49.30 | -37% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is lamotrigine in shortage?
No lamotrigine presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 6 records are all marked to be discontinued, the latest updated April 29, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Lamotrigine, Tablet, Extended Release, 100 mg (NDC 49884-563-11) | Par Health, Inc. | To Be Discontinued | April 29, 2026 |
| Lamotrigine, Tablet, Extended Release, 200 mg (NDC 49884-564-11) | Par Health, Inc. | To Be Discontinued | April 29, 2026 |
| Lamotrigine, Tablet, Extended Release, 25 mg (NDC 49884-561-11) | Par Health, Inc. | To Be Discontinued | April 29, 2026 |
| Lamotrigine, Tablet, Extended Release, 250 mg (NDC 49884-604-11) | Par Health, Inc. | To Be Discontinued | April 29, 2026 |
| Lamotrigine, Tablet, Extended Release, 300 mg (NDC 49884-605-11) | Par Health, Inc. | To Be Discontinued | April 29, 2026 |
| Lamotrigine, Tablet, Extended Release, 50 mg (NDC 49884-562-11) | Par Health, Inc. | To Be Discontinued | April 29, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has lamotrigine been recalled?
The FDA's Enforcement Report lists 11 recalls naming lamotrigine since 2013: 1 Class I (the most serious), 6 Class II, 4 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of lamotrigine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 20, 2022 | Class III | AVKARE Inc. | Labeling: Label Error on Declared Strength |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| May 28, 2020 | Class III | AVKARE Inc. | Presence of Foreign Substance consistent with granules from desiccant packs used during storage |
| May 26, 2020 | Class III | Jubilant Cadista Pharmaceuticals, Inc. | Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product. |
| December 20, 2019 | Class I | Taro Pharmaceuticals U.S.A., Inc. | Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. |
| September 11, 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. |
| August 19, 2016 | Class III | Unichem Pharmaceuticals Usa Inc | Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets. |
| April 22, 2015 | Class II | Wockhardt Usa Inc. | CGMP Deviations: Firm did not adequately investigate customer complaints. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lamotrigine label say about other medicines?
The lamotrigine label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 34 other medicines name lamotrigine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions | Concomitant Drug: Atazanavir/ritonavir; Effect on Concentration of Lamotrigine or Concomitant Drug: ↓ lamotrigine; Clinical Comment: Decreased lamotrigine AUC approximately 32%. |
| Carbamazepine | drug interactions | Concomitant Drug: Carbamazepine and carbamazepine epoxide; Effect on Concentration of Lamotrigine or Concomitant Drug: ↓ lamotrigine ? carbamazepine epoxide; Clinical Comment: Addition of carbamazepine decreases lamotrigine concentration approximately 40%. May increase carbamazepine epoxide levels. |
| Divalproex | boxed warning | In addition to age, factors that may increase the risk of occurrence or the severity of rash caused by LAMICTAL include (1) coadministration of LAMICTAL with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of LAMICTAL, (3) exceeding the recommended dose escalation … |
| Dofetilide | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Levonorgestrel | drug interactions | Concomitant Drug: Estrogen-containing oral contraceptive preparations containing 30 mcg ethinylestradiol and 150 mcg levonorgestrel; Effect on Concentration of Lamotrigine or Concomitant Drug: ↓ lamotrigine ↓ levonorgestrel; Clinical Comment: Decreased lamotrigine concentrations approximately 50%. … |
| Lopinavir and ritonavir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Phenobarbital | drug interactions | Concomitant Drug: Phenobarbital/primidone; Effect on Concentration of Lamotrigine or Concomitant Drug: ↓ lamotrigine; Clinical Comment: Decreased lamotrigine concentration approximately 40%. |
| Phenytoin | drug interactions | Concomitant Drug: Phenytoin; Effect on Concentration of Lamotrigine or Concomitant Drug: ↓ lamotrigine; Clinical Comment: Decreased lamotrigine concentration approximately 40%. |
| Primidone | drug interactions | Concomitant Drug: Phenobarbital/primidone; Effect on Concentration of Lamotrigine or Concomitant Drug: ↓ lamotrigine; Clinical Comment: Decreased lamotrigine concentration approximately 40%. |
| Rifampin | drug interactions | Concomitant Drug: Rifampin; Effect on Concentration of Lamotrigine or Concomitant Drug: ↓ lamotrigine; Clinical Comment: Decreased lamotrigine AUC approximately 40%. |
| Ritonavir | drug interactions | Concomitant Drug: Lopinavir/ritonavir; Effect on Concentration of Lamotrigine or Concomitant Drug: ↓ lamotrigine; Clinical Comment: Decreased lamotrigine concentration approximately 50%. |
| Valproic acid | boxed warning | In addition to age, factors that may increase the risk of occurrence or the severity of rash caused by LAMICTAL include (1) coadministration of LAMICTAL with valproate (includes valproic acid and divalproex sodium), (2) exceeding the recommended initial dose of LAMICTAL, (3) exceeding the recommended dose escalation … |
Other labels that name lamotrigine
- Acetaminophen and oxycodone
- Aripiprazole
- Clonazepam
- Desmopressin
- Dienogest and estradiol
- Drospirenone and estetrol
- Drospirenone and ethinyl estradiol
- Drospirenone and ethinyl estradiol and levomefolate
- Ethinyl estradiol and ferrous fumarate and norethindrone
- Ethinyl estradiol and norelgestromin
- Ethinyl estradiol and norethindrone
- Ethinyl estradiol and norgestimate
- Ethinyl estradiol and segesterone
- Etonogestrel
Source: FDA drug label (LAMICTAL), GlaxoSmithKline LLC, effective October 10, 2025 (SPL set d7e3572d-56fe-4727-2bb4-013ccca22678), via openFDA; the full label on DailyMed
What do FAERS reports show for lamotrigine?
The FDA Adverse Event Reporting System holds 130,994 reports that list lamotrigine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,279 are coded as a death and 40,119 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as lamotrigine?
22 other medicines are given the same way (oral) and in the same FDA class as lamotrigine or labeled mainly for the same use (seizures and epilepsy), the same class first. Seizures and epilepsy lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Gabapentin | Seizures and epilepsy | 87 labelers | $0.0218 per capsule 100 mg capsule | No current entry |
| Divalproex | Bipolar disorder, Seizures and epilepsy | 44 labelers | $0.194 per tablet 500 mg tablet | No current entry |
| Carbamazepine | Bipolar disorder, Seizures and epilepsy | 42 labelers | $0.119 per tablet 200 mg tablet | A presentation being discontinued |
| Oxcarbazepine | Seizures and epilepsy | 43 labelers | $0.167 per tablet 300 mg tablet | No current entry |
| Lithium | Bipolar disorder | 24 labelers | $0.104 per capsule 300 mg capsule | No current entry |
| Zonisamide | Seizures and epilepsy | 20 labelers | $0.106 per capsule 100 mg capsule | No current entry |
| Valproic acid | Seizures and epilepsy | 19 labelers | $0.243 per capsule 250 mg capsule | Listed; available |
| Phenytoin | Seizures and epilepsy | 23 labelers | $0.145 per capsule 100 mg capsule | No current entry |
Every medicine labeled for the same conditions as lamotrigine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does lamotrigine compare with medicines for the same use?
19 side-by-side pages set lamotrigine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to lamotrigine
- 22 medicines for the same use
- Other anti-seizure medicines
- the pharmacologic class, with prices and generics
- Lamotrigine side effects
- the label's list beside FAERS reports
- Lamotrigine shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other