Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Aripiprazole
Drug ID BADD_D00165
Description Aripiprazole is an atypical antipsychotic orally indicated for treatment of schizophrenia, bipolar I, major depressive disorder, irritability associated with autism, and Tourette's[Label]. It is also indicated as an injection for agitation associated with schizophrenia or bipolar mania[Label]. Aripiprazole exerts its effects through agonism of dopaminic and 5-HT1A receptors and antagonism of alpha adrenergic and 5-HT2A receptors[Label,A4393]. Aripiprazole was given FDA approval on November 15, 2002[L6136].
Indications and Usage Aripiprazole is indicated for manic and mixed episodes associated with bipolar I disorder, irritability associated with autism spectrum disorder, treatment of schizophrenia, treatment of Tourette's disorder, and as an adjunctive treatment of major depressive disorder[Label]. An injectable formulation of aripiprazole is indicated for agitation associated with schizophrenia or bipolar mania[Label].
Marketing Status approved; investigational
ATC Code N05AX12
DrugBank ID DB01238
KEGG ID D01164
MeSH ID D000068180
PubChem ID 60795
TTD Drug ID D0H3HM
NDC Product Code 82009-090; 12658-0524; 46602-0009; 46602-0102; 46602-1030; 46602-1032; 49706-1889; 13668-219; 16729-279; 16729-280; 29300-176; 29300-179; 31722-820; 31722-829; 33342-126; 43547-302; 43598-969; 46708-260; 59148-031; 59148-033; 59148-114; 60505-2677; 60687-157; 65162-896; 65162-898; 67877-431; 68071-2705; 68382-083; 70518-3692; 71335-1515; 71335-1893; 72865-156; 76483-103; 82009-091; 0904-6512; 46602-1034; 53747-031; 65691-0052; 65841-140; 65862-680; 68554-0020; 13668-217; 27241-051; 31722-819; 31722-920; 31722-921; 43353-147; 43353-148; 43547-305; 48433-115; 48433-119; 50228-478; 59148-006; 59148-011; 59148-034; 59148-102; 60505-2674; 65162-899; 65862-664; 65862-666; 67877-435; 68382-439; 69452-339; 70518-2643; 70518-2736; 70518-2820; 70518-2869; 70771-1451; 72578-106; 76483-102; 0904-6656; 46602-0026; 65372-1121; 65862-661; 65862-663; 69037-0058; 27241-052; 27241-053; 27241-054; 31722-830; 33342-125; 48433-117; 50090-4800; 50268-091; 50268-092; 59148-009; 59148-019; 60687-168; 62332-097; 65162-893; 65162-897; 68788-7808; 70518-2515; 70518-2557; 70518-2825; 70518-2974; 70518-3090; 70771-1452; 71335-1832; 71428-018; 72189-476; 53808-1101; 59148-007; 59148-010; 59148-045; 60505-2673; 63739-074; 63739-078; 63739-413; 65162-902; 65862-662; 67877-434; 70518-2508; 70518-2584; 71205-392; 71335-1903; 72865-182; 72865-185; 76483-100; 0904-6511; 0904-6513; 46602-1029; 63415-0085; 13668-220; 16714-142; 16729-282; 16729-283; 43598-559; 43598-966; 46708-257; 46708-258; 50090-3941; 50090-4665; 50090-6563; 50228-326; 59148-008; 60505-2675; 60687-191; 60687-202; 60687-213; 62332-101; 63187-965; 63629-7774; 63739-069; 68382-084; 70518-2536; 70771-1454; 71205-480; 71335-1980; 72189-455; 72189-456; 72865-157; 72865-180; 82009-089; 12658-0602; 46602-1031; 50370-0009; 53104-7628; 13668-216; 16714-145; 29300-178; 43598-556; 43598-968; 46708-261; 50228-476; 50228-477; 50268-089; 50268-090; 59148-018; 59148-032; 60505-2676; 60505-3075; 62332-098; 62332-103; 65162-901; 67877-433; 70518-2827; 0615-8375; 72865-183; 76282-044; 76282-045; 76483-101; 12658-0599; 12828-0088; 46602-0006; 46602-0025; 58032-2005; 72761-020; 13668-221; 16714-143; 16729-278; 16729-281; 27241-055; 31722-919; 31722-922; 31722-924; 43598-557; 46708-259; 48433-120; 59148-029; 59651-110; 62332-102; 68382-085; 68788-7006; 68788-7063; 68788-7733; 68788-7749; 68788-8089; 70518-0970; 70518-2580; 70518-2958; 70771-1455; 72865-153; 72865-155; 72865-181; 82009-088; 0904-6510; 12658-0577; 46602-1033; 50370-0044; 50370-0055; 29300-175; 29300-180; 43547-303; 43547-304; 43598-554; 43598-965; 43598-970; 46708-255; 50090-6063; 50228-325; 50228-475; 60505-0404; 65862-665; 69452-338; 70518-2567; 70771-1453; 70771-1456; 71335-1513; 72865-184; 76282-048; 0904-6514; 12658-0542; 46602-0010; 46602-0072; 58623-0127; 65096-0107; 16714-146; 33342-122; 33342-127; 43353-140; 43547-306; 43598-967; 46708-256; 48433-116; 50090-6403; 60687-179; 62332-099; 63739-070; 66689-735; 67877-430; 67877-432; 68382-086; 70518-1295; 70518-2806; 70518-2950; 71335-1682; 71335-1892; 72578-107; 72865-154; 72888-100; 76282-047; 76282-049; 46602-0007; 46602-0008; 46602-0045; 46602-0114; 59116-2900; 59116-2901; 67835-0009; 68554-0095; 76072-1002; 13668-218; 29300-177; 31722-828; 33342-123; 33342-124; 43547-307; 46708-254; 50228-329; 50268-088; 54838-570; 62332-100; 62332-104; 63629-7108; 68071-2676; 68071-2708; 68382-082; 70518-2765; 70518-2897; 70518-2921; 70518-3380; 71335-1687; 71335-1935; 72189-466; 72865-158; 76282-046; 0904-6509; 12658-0576; 12658-0601; 14445-019; 46602-0011; 64220-112; 16714-141; 16714-144; 16714-785; 27241-056; 31722-827; 31722-923; 43353-180; 43598-555; 43598-558; 48433-118; 50090-5839; 50090-6409; 50228-324; 50228-327; 50228-328; 50228-479; 50228-480; 50268-087; 59148-030; 59148-072
UNII 82VFR53I78
Synonyms Aripiprazole | 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butyloxy)-3,4-dihydro-2(1H)-quinolinone | Aripiprazol | Abilify | OPC 14597 | OPC-14597
Chemical Information
Molecular Formula C23H27Cl2N3O2
CAS Registry Number 129722-12-9
SMILES C1CC(=O)NC2=C1C=CC(=C2)OCCCCN3CCN(CC3)C4=C(C(=CC=C4)Cl)Cl
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)
Tachycardia foetal02.03.02.017; 18.03.02.0050.000119%Not Available
Tardive dyskinesia17.01.02.0120.013727%Not Available
Tearfulness19.15.02.0050.000293%Not Available
Tenderness08.01.08.0050.000238%Not Available
Tendonitis15.07.01.003; 12.01.07.007--Not Available
Tenosynovitis15.07.01.004--Not Available
Tension19.06.02.0050.000444%Not Available
Tension headache19.24.01.009; 17.14.01.0040.000079%Not Available
Testicular pain21.13.01.005--
Therapeutic response decreased08.06.01.0160.004438%Not Available
Therapeutic response unexpected08.06.01.0010.001181%Not Available
Thinking abnormal19.10.03.001; 17.02.05.0230.000999%Not Available
Thirst14.03.02.007; 08.01.09.021--Not Available
Throat tightness19.01.02.005; 22.12.03.031--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombocytopenic purpura23.06.01.007; 01.08.01.0030.000079%Not Available
Thrombocytosis01.08.02.0010.000238%Not Available
Thrombophlebitis24.01.02.0010.000159%Not Available
Tic19.11.04.001; 17.02.05.0240.001054%Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tongue discolouration07.14.02.006--Not Available
Tongue disorder07.14.01.0020.000697%Not Available
Tongue oedema23.04.01.009; 10.01.05.008; 07.14.02.007--Not Available
Tongue paralysis17.04.09.001; 07.14.02.012--Not Available
Tongue spasm07.14.02.008--Not Available
Tonsillar hypertrophy22.04.05.006--Not Available
Tooth abscess07.09.01.003; 11.01.04.003--Not Available
Tooth loss12.01.17.026; 07.09.09.0010.000293%Not Available
Toothache07.09.06.001--
Torsade de pointes02.03.04.0050.000198%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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