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)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abdominal tenderness07.01.05.0040.000083%Not Available
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Abnormal sensation in eye06.01.01.0010.000204%Not Available
Abortion18.01.01.0010.000221%Not Available
Abortion spontaneous18.01.04.0010.001711%Not Available
Abscess11.01.08.001--Not Available
Accommodation disorder06.02.04.001--Not Available
Acidosis14.01.03.0020.000469%
Acne23.02.01.001--Not Available
Acute hepatic failure09.01.03.0010.000386%Not Available
Acute psychosis19.03.01.0010.000055%Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000773%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000359%Not Available
Affective disorder19.04.04.0010.000232%Not Available
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.0010.001771%Not Available
Agitation19.06.02.001; 17.02.05.0120.004774%
Agitation neonatal18.04.04.002; 17.02.05.0280.000138%Not Available
Agranulocytosis01.02.03.0010.000469%Not Available
Akathisia19.06.02.006; 17.01.02.002--
Alanine aminotransferase increased13.03.04.005--
Alcohol abuse19.07.06.0010.000138%Not Available
Alcohol intolerance14.02.01.001--
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.0010.000828%Not Available
Amblyopia06.02.01.001--Not Available
Amenorrhoea21.01.02.001; 05.05.01.002--
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ADReCS-Target
Drug Name ADR Term Target
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