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)
Nodal arrhythmia02.03.03.0200.000083%Not Available
Normochromic normocytic anaemia01.03.02.0050.000497%Not Available
Nystagmus17.02.02.006; 06.05.02.0060.001473%
Obliterative bronchiolitis12.02.09.036; 10.02.01.096; 22.03.01.0120.000166%Not Available
Obsessive thoughts19.06.05.0010.000083%Not Available
Obsessive-compulsive disorder19.06.05.0020.000138%Not Available
Ocular hyperaemia06.04.05.0040.000745%Not Available
Ocular hypertension06.03.01.0030.000138%Not Available
Oculogyric crisis06.05.02.002; 17.01.03.0020.000552%Not Available
Oculomucocutaneous syndrome23.03.01.022; 07.05.01.010; 06.04.05.0140.000276%Not Available
Odynophagia07.01.06.0360.000386%Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oedema mouth07.05.04.001; 23.04.01.008; 10.01.05.0060.000110%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophagitis07.08.05.0010.000149%
Oligohydramnios18.05.01.0010.000055%Not Available
Oliguria20.01.03.0040.000138%Not Available
Opisthotonus17.01.03.0050.000083%Not Available
Optic atrophy06.09.02.0010.000055%Not Available
Optic ischaemic neuropathy24.04.10.001; 17.04.05.006; 06.07.03.0010.000221%Not Available
Oral discomfort07.05.05.0010.000204%Not Available
Oral mucosal blistering07.05.05.0170.000535%Not Available
Oral mucosal eruption07.05.05.0180.000221%Not Available
Oral pain07.05.05.0340.000497%
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Osteoarthritis15.01.04.001--Not Available
Osteochondrosis15.07.03.0020.000083%Not Available
Osteonecrosis24.04.05.004; 15.02.04.0070.000248%
Pain08.01.08.004--
Pain of skin23.03.03.0030.000166%
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ADReCS-Target
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