Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lamotrigine
Drug ID BADD_D01243
Description Lamotrigine is an antiepileptic drug belonging in the phenyltriazine class. It is used in the treatment of both epilepsy and as a mood stabilizer in bipolar disorder. Lamotrigine is the first medication since lithium granted Food and Drug Administration (FDA) approval for the maintenance treatment of bipolar type I. It is approved for use in more than 30 countries.[A191350] Lamotrigine has relatively few side-effects and does not require laboratory monitoring. While it is indicated for epilepsy and bipolar disorders, there is evidence that lamotrigine could have some clinical efficacy in certain neuropathic pain states.[A849,A850]
Indications and Usage Lamotrigine is indicated as adjunctive therapy for the following seizure types in patients ≥2 years of age: partial seizures, primary generalized tonic-clonic seizures, and generalized seizures due to Lennox-Gastaut syndrome.[L9404] It is also indicated for the process of conversion to drug monotherapy for those at least 16 years of age or older with partial seizures and currently are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED).[L9404] In addition to the above, lamotrigine is also indicated for the maintenance treatment of bipolar I disorder, delaying the time to mood episodes (which may include mania, hypomania, depression, mixed episodes) in adults at least 18 years or older, who have been treated for acute mood symptoms with standard therapy.[L9404] Limitations of use It is important to note that lamotirigine should not be used in the treatment of acute mood episodes, as efficacy has not been established in this context.[L9404]
Marketing Status approved; investigational
ATC Code N03AX09
DrugBank ID DB00555
KEGG ID D00354
MeSH ID D000077213
PubChem ID 3878
TTD Drug ID D03FLC
NDC Product Code 17511-103; 58437-020; 58437-021; 65862-228; 65862-266; 66406-0283; 16714-197; 16714-626; 0115-1527; 0115-1529; 42291-368; 0173-0643; 0173-0699; 0173-0759; 49884-880; 51655-719; 53002-2513; 55111-222; 55111-223; 55154-2065; 62332-040; 65162-990; 68071-2873; 68071-2960; 68382-009; 68462-228; 69102-137; 69102-301; 69102-312; 69918-370; 70518-1978; 70518-2716; 71335-1110; 0615-8267; 12666-0005; 0904-7007; 0904-7008; 59285-023; 59917-077; 27241-185; 0115-1528; 42291-448; 43598-550; 0173-0527; 0173-0756; 0173-0777; 0173-0778; 49884-484; 49884-487; 50090-3914; 0228-1435; 0228-1453; 55111-226; 63187-487; 63629-4697; 63629-8283; 65841-685; 65841-686; 69102-300; 69102-306; 69102-320; 69918-360; 70518-2563; 70518-2697; 70518-3425; 0615-7975; 0615-8150; 72789-206; 53296-0059; 16714-700; 42291-444; 42291-447; 43063-238; 0173-0594; 0173-0644; 0173-0757; 0173-0758; 46708-275; 46708-276; 49884-486; 50228-322; 55111-220; 55111-428; 55111-717; 55154-2331; 55700-626; 65162-986; 68071-2054; 68071-2729; 68382-980; 68462-229; 70518-3139; 70518-3602; 71335-0044; 55111-419; 60687-693; 65841-687; 67877-167; 68382-008; 68382-011; 68382-982; 68382-983; 68382-984; 68788-8392; 69097-151; 70518-2503; 70518-2535; 70518-3187; 70518-3740; 71335-0830; 58437-022; 65015-626; 65862-229; 66406-0281; 68022-7036; 13668-266; 27241-186; 29300-112; 29300-113; 42291-367; 0173-0633; 0173-0781; 49884-882; 50090-2129; 50090-6028; 51672-4132; 58118-1111; 58118-2148; 59746-245; 59746-246; 60760-543; 61919-534; 62332-096; 65162-988; 67877-164; 68382-006; 68382-979; 68788-6868; 68788-7223; 69097-149; 69102-319; 70518-2889; 70518-3043; 70934-975; 71335-2071; 72888-025; 72888-028; 65862-230; 13668-049; 13668-342; 16714-196; 42291-369; 0173-0772; 0173-0780; 46708-277; 50090-2131; 50090-5827; 0228-1410; 0228-1638; 53002-1512; 59746-247; 65841-689; 65862-227; 67877-166; 68084-318; 69102-639; 70518-2406; 70518-3109; 71205-245; 71335-0706; 0615-7964; 76420-182; 51552-1361; 51927-0021; 59917-079; 65372-1103; 13668-339; 13668-340; 27241-183; 27241-184; 42291-446; 43598-553; 0173-0761; 49884-881; 50090-2130; 50090-5850; 50228-320; 51672-4133; 53002-2512; 60687-704; 63187-744; 65841-682; 65841-683; 68382-010; 68382-109; 68788-7544; 70518-2755; 71335-1919; 72189-063; 72888-027; 14799-2011; 16714-624; 29300-114; 42291-366; 43598-551; 43598-552; 0173-0754; 0173-0776; 0228-1580; 59746-248; 62332-037; 62332-038; 65162-956; 65862-361; 67877-165; 68788-7168; 69097-152; 69918-380; 70518-1479; 72888-026; 42419-012; 58437-019; 59917-078; 62331-047; 66406-0284; 67835-0016; 13668-045; 13668-048; 13668-341; 16714-195; 16714-702; 16714-703; 16714-893; 0115-1526; 43063-203; 0173-0526; 0173-0755; 0173-0760; 0173-0779; 51672-4131; 55111-719; 55154-2330; 65162-958; 65841-684; 65841-690; 65862-362; 68071-2974; 68382-108; 68382-981; 69102-150; 69102-359; 69918-350; 70518-1523; 71335-1179; 55111-043; 58437-024; 59917-080; 66406-0282; 16571-786; 16714-625; 16714-627; 16714-701; 29300-111; 42291-445; 0173-0774; 0173-0817; 46708-274; 0228-1422; 51672-4130; 55111-225; 55700-683; 62332-039; 62332-095; 65162-949; 68084-319; 68382-007; 68788-7647; 69097-148; 70518-1908; 70518-2108; 70518-3150; 71335-1469; 80425-0289; 53104-7606; 53747-016; 58437-023; 82891-004; 13668-047; 16571-785; 16714-194; 16714-623; 42291-443; 0173-0642; 49884-485; 50228-319; 50228-321; 51655-855; 53002-1513; 55111-221; 55111-718; 55111-720
UNII U3H27498KS
Synonyms Lamotrigine | 3,5-Diamino-6-(2,3-dichlorophenyl)-as-triazine | 3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine | Lamictal | Crisomet | Lamiktal | BW-430C | BW 430C | BW430C | Labileno
Chemical Information
Molecular Formula C9H7Cl2N5
CAS Registry Number 84057-84-1
SMILES C1=CC(=C(C(=C1)Cl)Cl)C2=C(N=C(N=N2)N)N
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Conjunctivitis allergic10.01.04.002; 06.04.01.0030.000121%Not Available
Constipation07.02.02.001--
Coordination abnormal17.02.02.0040.000618%Not Available
Corneal opacity06.06.03.0050.000248%Not Available
Cough22.02.03.001--
Crying19.04.02.002; 17.02.05.013; 12.02.11.001; 08.01.03.0050.001788%Not Available
Cushing's syndrome05.01.01.001; 24.08.04.001; 14.11.01.007; 19.07.03.002--Not Available
Cutaneous vasculitis24.12.04.008; 23.06.02.001; 10.02.02.0030.000166%Not Available
Cyanosis23.06.04.005; 02.11.04.004; 24.03.01.007; 22.02.02.0070.000535%
Cystitis20.03.02.002; 11.01.14.001--
Deafness04.02.01.001--Not Available
Deafness neurosensory17.04.07.001; 04.02.01.0020.000138%Not Available
Death neonatal18.04.01.002; 08.04.01.0020.000110%
Decubitus ulcer23.03.11.0060.000083%Not Available
Defect conduction intraventricular02.03.01.0180.000055%Not Available
Delirium19.13.02.0010.001198%
Delusion19.10.01.0010.000193%
Dependence19.07.06.0080.000055%Not Available
Depressed level of consciousness17.02.04.0020.001860%
Depressed mood19.15.02.0010.000657%Not Available
Depression19.15.01.001--
Dermatitis23.03.04.0020.000728%Not Available
Dermatitis acneiform23.02.01.0040.000110%
Dermatitis allergic23.03.04.003; 10.01.03.0140.000491%Not Available
Dermatitis bullous23.03.01.0020.000949%
Dermatitis contact10.01.01.003; 23.03.04.004; 12.03.01.040--Not Available
Dermatitis exfoliative23.03.07.001; 10.01.01.0040.000497%
Developmental delay08.01.03.037; 19.07.05.0030.000579%Not Available
Diarrhoea07.02.01.001--
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.000110%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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