Lamotrigine
Lamotrigine is a seizure medicine (anticonvulsant) used to treat epilepsy in children and adults, and, in some immediate-release products, to help prevent mood episodes in bipolar I disorder.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 123 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Lamotrigine (Lamictal) is a mainstay seizure medicine that also helps prevent new mood episodes in bipolar I disorder, likely by blocking sodium channels so overactive nerve cells settle down; it has been on the market since about 1994 and is available as a generic. Most people tolerate it well, with less weight gain and drowsiness than many mood stabilizers, though dizziness, headache, nausea or blurred or double vision can show up as the dose rises. Its boxed warning is for serious skin rash, including Stevens-Johnson syndrome, most often in the first 2 to 8 weeks, so stick exactly to the slow starting schedule and report any rash right away.
Clinical pearls
- Never stop lamotrigine suddenly, even if you feel fine, because the label calls for a taper over at least 2 weeks.
- Valproate (divalproex) more than doubles lamotrigine levels and raises rash risk, so the starting schedule must be much slower with it.
- Estrogen birth control cuts lamotrigine levels about in half, so tell your prescriber before starting or stopping it.
- Swallow extended-release tablets (Lamictal XR) whole, and never chew, crush or split them.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Lamotrigine can cause serious, life-threatening skin rashes. Stop it and contact your doctor at the first sign of any rash, unless a doctor confirms it is clearly not from the drug.
These rashes include Stevens-Johnson syndrome and toxic epidermal necrolysis. They are more common in children than in adults. Risk is higher with valproate, a starting dose that is too high, increasing the dose too fast, or the HLA-B*1502 gene variant. Most serious rashes appear within 2 to 8 weeks, but some occur later. Doctors can't tell which rashes will turn serious, and stopping may not prevent a rash from worsening.
Patient information guide A plain-language walkthrough of Lamotrigine, written from its FDA label.
What Lamotrigine is used for
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Lamotrigine is used for epilepsy and, in some products, bipolar I disorder.
- Lamictal, Subvenite, and lamotrigine tablets, chewable tablets and orally disintegrating tablets: add-on therapy for partial-onset seizures, primary generalized tonic-clonic seizures and Lennox-Gastaut syndrome seizures, ages 2 and older.
- These same products: switching to lamotrigine alone in partial-onset seizures from carbamazepine, phenytoin, phenobarbital, primidone or valproate, ages 16 and older.
- These same products: maintenance treatment of bipolar I disorder to delay mood episodes. Not recommended for acute manic or mixed episodes.
- Lamictal XR and lamotrigine extended-release tablets: add-on therapy for primary generalized tonic-clonic and partial-onset seizures, ages 13 and older.
- Extended-release products: switching to monotherapy in partial-onset seizures, ages 13 and older. They are not labeled for bipolar disorder.
How Lamotrigine works
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The exact way lamotrigine works is unknown. It may block voltage-sensitive sodium channels, which steadies nerve cell membranes and reduces release of excitatory chemicals like glutamate. Its action in bipolar disorder has not been established.
Lamotrigine dosage
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Lamotrigine is taken by mouth. Dosing depends on your other medicines, your condition and your age, with slow step-ups to lower rash risk. Starter kits cover the first 5 weeks for some products.
- Extended-release tablets are taken once a day, with or without food, and swallowed whole.
- Food does not change how well it is absorbed.
- Taper over at least 2 weeks when stopping.
- Follow your label and prescriber for missed doses.
Dosing details from the FDA-approved label
From the Lamotrigine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Discontinuation
- Taper over a period of at least 2 weeks (approximately 50% dose reduction per week)
- Women taking estrogen-containing oral contraceptives (not taking carbamazepine, phenytoin, phenobarbital, primidone, rifampin, lopinavir/ritonavir or atazanavir/ritonavir) - maintenance dose
- The maintenance dose will in most cases need to be increased by as much as 2-fold over the recommended target maintenance dose to maintain a consistent lamotrigine plasma level
- Starting estrogen-containing oral contraceptives in women on a stable dose of SUBVENITE (not taking the inducers listed above)
- Maintenance dose will in most cases need to be increased by as much as 2-fold
- Increases begin when the oral contraceptive is introduced and continue, based on clinical response, no more rapidly than 50 to 100 mg/day every week
- Dose increases should not exceed the recommended rate unless plasma levels or clinical response support larger increases.
- Women taking SUBVENITE in addition to carbamazepine, phenytoin, phenobarbital, primidone, rifampin, lopinavir/ritonavir or atazanavir/ritonavir
- No adjustment to the dose of SUBVENITE should be necessary
- Lamotrigine Extended-Release Tablets administration
- Taken once daily, with or without food
- Tablets must be swallowed whole and must not be chewed, crushed, or divided
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 ( 2.1 , 16 ) Do not restart lamotrigine 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 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 disorder: See Tables 5 and 6. ( 2.4 ) 2.1 General Dosing Considerations Rash There are suggestions, yet to be proven, that the risk of severe, potentially life threatening rash may be increased by (1) coadministration of lamotrigine tablets with valproate, (2) exceeding the recommended initial dose of lamotrigine tablets, or (3) exceeding the recommended dose escalation for lamotrigine tablets. However, cases have occurred in the absence of these factors [ see Boxed Warning ] . Therefore, it is important that the dosing recommendations be followed closely. The risk of nonserious rash may be increased when the recommended initial dose and/or the rate of dose escalation for lamotrigine tablets is exceeded and in patients with a history of allergy or rash to other AEDs. It is recommended that lamotrigine tablets not be restarted in patients who discontinued due to rash associated with prior treatment with lamotrigine unless the potential benefits clearly outweigh the risks. If the decision is made to restart a patient who has discontinued lamotrigine tablets, the need to restart with the initial dosing recommendations should be assessed. The greater the interval of time since the previous dose, the greater consideration should be given to restarting with the initial dosing recommendations. If a patient has discontinued lamotrigine for a period of more than 5 half-lives, it is recommended that initial dosing recommendations and guidelines be followed.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Lamotrigine side effects
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Common side effects include:
Common side effects
- Dizziness
- Headache
- Double vision or blurred vision
- Poor coordination or unsteadiness (ataxia)
- Nausea or vomiting
- Sleepiness
- Runny nose or sore throat
- Rash
When to get medical help
- Get help right away if you develop any skin rash. Lamotrigine can cause life-threatening rashes, including Stevens-Johnson syndrome.
- Call your doctor right away for fever, swollen glands or signs of a multiorgan allergic reaction (DRESS), even without a rash.
- Seek urgent care for signs of severe systemic inflammation, such as fever, rash and organ problems (hemophagocytic lymphohistiocytosis, or HLH).
- Report unusual bruising or bleeding, unexpected infections or signs of anemia. These can be blood problems.
- Report headache, fever and nausea, which may signal aseptic meningitis (irritation of the brain's lining not caused by infection).
- Tell your doctor right away about new or worsening depression, unusual mood changes or thoughts of self-harm.
- Seek help for a racing, irregular or abnormal heartbeat, especially if you have heart disease.
- Don't stop suddenly, because withdrawal seizures can occur.
Lamotrigine warnings and precautions
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Serious skin rash is the biggest risk. Report any rash immediately. Children, people taking valproate, and those who go up in dose too fast are at higher risk.
- Multiorgan allergic reaction (DRESS) and HLH
- Blood disorders
- Aseptic meningitis
- Dangerous heart rhythms in people with heart disease
- Increased risk of suicidal thoughts
- Withdrawal seizures if stopped suddenly
Lamotrigine interactions
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Several medicines change lamotrigine levels.
- Valproate: more than doubles levels and raises rash risk.
- Carbamazepine, phenytoin, phenobarbital, primidone, rifampin: lower levels by about 40%.
- Estrogen-containing birth control: lowers levels by about 50%.
- Lopinavir/ritonavir and atazanavir/ritonavir: lower levels.
- Dofetilide: combination not recommended.
Interactions listed in the FDA-approved label
From the Lamotrigine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Valproate: Increases lamotrigine concentrations slightly more than 2-fold (inhibits glucuronidation); conflicting data on lamotrigine's effect on valproate concentrations. See dosing guidance in Dosage and Administration (Tables 1, 2, 5 to 6, 13).
- Carbamazepine: Decreases lamotrigine concentration approximately 40%; may increase carbamazepine epoxide levels.
- Phenytoin: Decreases lamotrigine concentration approximately 40%.
- Phenobarbital/primidone: Decreases lamotrigine concentration approximately 40%.
- Rifampin: Decreases lamotrigine AUC approximately 40%.
- Estrogen-containing oral contraceptives (30 mcg ethinylestradiol and 150 mcg levonorgestrel): Decrease lamotrigine concentrations approximately 50% and decrease the levonorgestrel component by 19%. Maintenance dose adjustments are needed in most patients starting or stopping estrogen-containing products (see Dosage and Administration 2.1 and Warnings 5.9).
- Lopinavir/ritonavir: Decreases lamotrigine concentration approximately 50%.
- Atazanavir/ritonavir: Decreases lamotrigine AUC approximately 32%.
- Organic cationic transporter 2 (OCT2) substrates with a narrow therapeutic index (e.g., dofetilide): Lamotrigine inhibits renal tubular secretion via OCT2, which may increase plasma levels of drugs excreted by this route. Coadministration is not recommended.
Read the label’s full interactions text
7 DRUG INTERACTIONS Significant drug interactions with lamotrigine are summarized in this section. Uridine 5´-diphospho-glucuronyl transferases (UGT) have been identified as the enzymes responsible for metabolism of lamotrigine. Drugs that induce or inhibit glucuronidation may, therefore, affect the apparent clearance of lamotrigine. Strong or moderate inducers of the cytochrome P450 3A4 (CYP3A4) enzyme, which are also known to induce UGT, may also enhance the metabolism of lamotrigine. Those drugs that have been demonstrated to have a clinically significant impact on lamotrigine metabolism are outlined in Table 13. Specific dosing guidance for these drugs is provided in the Dosage and Administration section, and, for women taking estrogen-containing products, including oral contraceptives, in the Warnings and Precautions section [see Dosage and Administration (2.1) , Warnings and Precautions (5.9) ] . Additional details of these drug interaction studies are provided in the Clinical Pharmacology section [see Clinical Pharmacology (12.3) ] . Table 13. Established and Other Potentially Significant Drug Interactions ↓ = Decreased (induces lamotrigine glucuronidation). ↑ = Increased (inhibits lamotrigine glucuronidation). ? = Conflicting data. Concomitant Drug Effect on Concentration of Lamotrigine or Concomitant Drug Clinical Comment Estrogen-containing oral contraceptive preparations containing 30 mcg ethinylestradiol and 150 mcg levonorgestrel ↓ lamotrigine Decreased lamotrigine concentrations approximately 50%. ↓ levonorgestrel Decrease in levonorgestrel component by 19%. Carbamazepine and carbamazepine epoxide ↓ lamotrigine Addition of carbamazepine decreases lamotrigine concentration approximately 40%. ? carbamazepine epoxide May increase carbamazepine epoxide levels. Lopinavir/ritonavir ↓ lamotrigine Decreased lamotrigine concentration approximately 50%. Atazanavir/ritonavir ↓ lamotrigine Decreased lamotrigine AUC approximately 32%.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Lamotrigine
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- Don't use if allergic to lamotrigine or its ingredients.
- Mention prior rash or allergy to seizure medicines.
- Mention heart disease.
- Tell your doctor if pregnant, planning pregnancy or breastfeeding.
- Liver or kidney impairment may need dose adjustments.
- Age limits apply by product.
Lamotrigine overdose
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Overdoses, some fatal, have caused unsteadiness, abnormal eye movements, seizures, reduced consciousness, coma and heart conduction delay. There is no specific antidote. Seek emergency care and contact Poison Control.
What Lamotrigine does in the body
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In lab studies, lamotrigine blocked sodium channels and lowered folate levels by inhibiting an enzyme called dihydrofolate reductase. It also acts like a Class IB antiarrhythmic on heart sodium channels. In people with significant heart disease, it could slow heart conduction and cause dangerous rhythms.
How your body processes Lamotrigine
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Lamotrigine is rapidly and almost completely absorbed, and food doesn't affect it. Peak levels come about 1.4 to 4.8 hours after a dose. It is about 55% bound to plasma proteins and is broken down mainly by glucuronidation. Most is eliminated in urine. Its half-life varies with other medicines, such as valproate (longer) or carbamazepine (shorter).
How to store Lamotrigine
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Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) in a dry place. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) in a dry place and protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Lamotrigine
116 supplements and herbal products have documented interactions with Lamotrigine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 92
- Minor · 17
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Lamotrigine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Lamotrigine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Lamotrigine — the kind of thing our pharmacy team would talk through with you at the counter.
What is lamotrigine for?
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Why is rash such a big deal?
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How should I take it?
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Can I stop it if I feel fine?
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Do my other medicines matter?
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What if I'm pregnant or plan to be?
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Is Lamotrigine available over the counter?
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When was Lamotrigine first available?
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Who makes Lamotrigine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Lamotrigine on HelloPharmacist
Lamotrigine forms and strengths (how it comes)
Lamotrigine is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Lamictal and Subvenite tablets are used for epilepsy and for bipolar I maintenance treatment.
- Lamotrigine Extended Release tablets are used for epilepsy in ages 13 and older.
- Lamictal Starter Kits and Subvenite Starter Kits are available for the first 5 weeks of treatment.
- Lamotrigine Extended Release tablets are taken once daily and swallowed whole.
Extended-release tablet
How this form is used
- Lamictal XR is used as add-on therapy for primary generalized tonic-clonic and partial-onset seizures in ages 13 and older.
- Lamictal XR is used to convert to monotherapy in partial-onset seizures in ages 13 and older.
- Lamotrigine ER is not established for children under 13.
- Lamotrigine ER tablets are taken once daily, with or without food.
- Lamotrigine ER tablets must be swallowed whole, not chewed, crushed or divided.
Orally disintegrating tablet
How this form is used
- Lamotrigine orally disintegrating tablets are used for epilepsy add-on therapy in ages 2 and older.
- Lamotrigine orally disintegrating tablets are used for bipolar I maintenance treatment.
- Lamictal ODT Patient Titration Kits are available for the first 5 weeks of treatment.
Chewable tablet
How this form is used
- Lamotrigine chewable tablets are used for epilepsy add-on therapy in ages 2 and older.
- Lamotrigine chewable tablets are used to convert to monotherapy in partial-onset seizures in ages 16 and older.
- Lamotrigine chewable tablets are used for bipolar I maintenance treatment.
- Lamotrigine chewable tablets are labeled as chewable, dispersible tablets.
Oral suspension
How this form is used
- Subvenite oral suspension is used for epilepsy add-on therapy in ages 2 and older.
- Subvenite oral suspension is used for bipolar I maintenance treatment.
- Subvenite oral suspension dosing depends on other medicines, condition and age.
Lamotrigine on the U.S. market: products, makers and brands
How Lamotrigine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
46 companies list 300 Lamotrigine product records with the FDA, mostly as tablet, extended-release tablet, orally disintegrating tablet; the earliest marketing or approval year on record is 1995. Brand names on the directory include Lamictal, Lamictal CD, Lamictal Odt and 2 more; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Kit (52) · Powder (21) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Lamotrigine is used (Medicaid data)
A general measure of how commonly Lamotrigine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Lamotrigine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Lamotrigine prescribed? Of the 1,601 medications we measure, Lamotrigine ranks #47 by Medicaid prescriptions — more than 97% of them.
Utilization by Lamotrigine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
lamotrigine 100 MG Oral Tablet Most dispensed
Summed across the 21 of 131 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198427
lamotrigine 25 MG Oral Tablet
Summed across the 20 of 123 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 282401
lamotrigine 200 MG Oral Tablet
Summed across the 18 of 98 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198429
lamotrigine 150 MG Oral Tablet
Summed across the 18 of 115 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198428
24 HR lamotrigine 200 MG Extended Release Oral Tablet
Summed across the 8 of 34 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 900156
24 HR lamotrigine 100 MG Extended Release Oral Tablet
Summed across the 8 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 850087
24 HR lamotrigine 50 MG Extended Release Oral Tablet
Summed across the 9 of 38 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 850091
24 HR lamotrigine 300 MG Extended Release Oral Tablet
Summed across the 8 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1098608
lamotrigine 25 MG Tablet for Oral Suspension
Summed across the 5 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311264
24 HR lamotrigine 250 MG Extended Release Oral Tablet
Summed across the 8 of 29 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1146690
24 HR lamotrigine 25 MG Extended Release Oral Tablet
Summed across the 9 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 900164
lamotrigine 50 MG Disintegrating Oral Tablet
Summed across the 6 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 252478
lamotrigine 100 MG Disintegrating Oral Tablet
Summed across the 6 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 103968
lamotrigine 5 MG Tablet for Oral Suspension
Summed across the 4 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311265
lamotrigine 200 MG Disintegrating Oral Tablet
Summed across the 6 of 22 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 252479
lamotrigine 25 MG Disintegrating Oral Tablet
Summed across the 6 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198430
Other Lamotrigine products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 5 of 150 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lamotrigine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 165 of 968 listed Lamotrigine NDCs with Medicaid activity.
Compare Lamotrigine products
A representative set of FDA-listed product records for Lamotrigine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral suspension | ||||
| 10 mg/mL | Oral | OWP Pharmaceuticals, Inc. | NDA | View NDC → |
| 💊Tablet | ||||
| 25 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 100 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 150 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 200 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Advagen Pharma Limited | ANDA | View NDC → |
| 100 mg | Oral | Advagen Pharma Limited | ANDA | View NDC → |
| 150 mg | Oral | Advagen Pharma Limited | ANDA | View NDC → |
| 200 mg | Oral | Advagen Pharma Limited | ANDA | View NDC → |
| 25 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 25 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 100 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 150 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 200 mg | Oral | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 25 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 100 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 150 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 200 mg | Oral | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 25 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 100 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 150 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 200 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 25 mg | Oral | Amring Pharmaceuticals Inc. | ANDA | View NDC → |
| 50 mg | Oral | Amring Pharmaceuticals Inc. | ANDA | View NDC → |
| 100 mg | Oral | Amring Pharmaceuticals Inc. | ANDA | View NDC → |
| 200 mg | Oral | Amring Pharmaceuticals Inc. | ANDA | View NDC → |
| 25 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 100 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 150 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 200 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 200 mg | Oral | Asclemed USA, Inc. | ANDA | View NDC → |
| 25 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 100 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 150 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 200 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 25 mg | Oral | AvKARE | ANDA | View NDC → |
| 100 mg | Oral | AvKARE | ANDA | View NDC → |
| 150 mg | Oral | AvKARE | ANDA | View NDC → |
| 200 mg | Oral | AvKARE | ANDA | View NDC → |
| 25 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 150 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 200 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Cardinal Health 107, LLC | ANDA | View NDC → |
| 100 mg | Oral | Cardinal Health 107, LLC × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Coupler LLC × 2 listings | ANDA | View NDC → |
| 100 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 150 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 25 mg | Oral | Direct Rx | ANDA | View NDC → |
| 25 mg | Oral | Dr.Reddy's Laboratories Limited | ANDA | View NDC → |
| 100 mg | Oral | Dr.Reddy's Laboratories Limited | ANDA | View NDC → |
| 150 mg | Oral | Dr.Reddy's Laboratories Limited | ANDA | View NDC → |
| 200 mg | Oral | Dr.Reddy's Laboratories Limited | ANDA | View NDC → |
| 💊Kits | ||||
| — | — | GlaxoSmithKline LLC × 8 listings | NDA | View NDC → |
| — | — | OWP Pharmaceuticals, Inc. × 5 listings | ANDA | View NDC → |
| — | — | Par Health USA, LLC × 3 listings | ANDA | View NDC → |
| — | — | Torrent Pharmaceuticals Limited | ANDA | View NDC → |
Showing 79 of 300 products — FDA National Drug Code Directory. See every product, package size and price: browse all 300 Lamotrigine NDCs →
Lamotrigine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Lamotrigine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Lamotrigine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Lamotrigine FDA approval history
How Lamotrigine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Lamotrigine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Lamotrigine recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4 Lots: Lot #: 42581 Exp. 12/2024; 42484 Exp. 11/2024; 41204 Exp. 05/2024; 38723 Exp. 02/2023; 37623 Exp. 10/2022 FDA record D-1329-2022 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 28439 5 dose forms · 21 strengths
-
Dose form (SCDF) Disintegrating Oral Tablet RxCUI 372566In current FDA listings -
Dose form (SCDF) Extended Release Oral Tablet RxCUI 850075In current FDA listingsClinical drug / strength (SCD) 24 HR lamotrigine 100 MGRxCUI 85008724 HR lamotrigine 200 MGRxCUI 90015624 HR lamotrigine 25 MGRxCUI 90016424 HR lamotrigine 250 MGRxCUI 114669024 HR lamotrigine 300 MGRxCUI 109860824 HR lamotrigine 50 MGRxCUI 850091 -
Dose form (SCDF) Oral Suspension RxCUI 2724461In current FDA listingsClinical drug / strength (SCD) 10 MG/MLRxCUI 2724462 -
Dose form (SCDF) Oral Tablet RxCUI 372567In current FDA listings -
Dose form (SCDF) Tablet for Oral Suspension RxCUI 2697774In current FDA listings
Look up RxCUI 28439 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Lamotrigine supply and shortage status
Whether Lamotrigine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Lamotrigine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 100 mg | $10.92 per tablet | NDC details & price history |
| Tablet · Oral | 25 mg | $10.30 per tablet | NDC details & price history |
| Tablet · Oral | 200 mg | $12.05 per tablet | NDC details & price history |
| Tablet · Oral | 150 mg | $11.47 per tablet | NDC details & price history |
| Tablet · Oral | 50 mg | $1.27 per tablet | NDC details & price history |
| Tablet · Oral | 250 mg | $1.30 per tablet | NDC details & price history |
| Tablet · Oral | 300 mg | $1.26 per tablet | NDC details & price history |
| Tablet, Film Coated, Extended Release · Oral | 200 mg | $32.33 per tablet | NDC details & price history |
| Tablet, Film Coated, Extended Release · Oral | 250 mg | $44.21 per tablet | NDC details & price history |
| Tablet, Film Coated, Extended Release · Oral | 300 mg | $48.65 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Lamotrigine brand names
Lamotrigine is sold under 5 brand names in the FDA directory — Lamictal, Lamictal CD, Lamictal Odt, Lamictal Xr and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Lamotrigine: manufacturers and labelers
46 companies list Lamotrigine products with the FDA. By number of product records, the largest are GlaxoSmithKline LLC, Remedyrepack Inc., Par Health USA, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 22 more on the FDA NDC directory.
Lamotrigine drug class (RxNorm)
Lamotrigine belongs to the Mood Stabilizer class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Lamotrigine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. GlaxoSmithKline LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →