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)
Torticollis17.01.03.003; 15.05.04.0030.000452%Not Available
Toxic encephalopathy17.13.01.004; 12.03.01.0270.000159%Not Available
Toxic epidermal necrolysis10.01.01.006; 23.03.01.008; 12.03.01.015; 11.07.01.0060.000317%
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tremor17.01.06.0020.009297%
Trichotillomania23.02.06.010; 19.06.05.0070.004470%Not Available
Trismus17.01.03.004; 15.05.04.0040.001189%
Tuberculin test positive13.08.05.001--Not Available
Ulcer08.03.06.001--Not Available
Unintended pregnancy18.08.01.0010.001427%Not Available
Unresponsive to stimuli17.02.05.031--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral discharge20.07.01.006--Not Available
Urethral disorder20.07.01.002--Not Available
Urinary hesitation20.02.02.009--Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.001213%
Urinary retention20.02.02.0110.000872%
Urinary tract disorder20.08.01.0010.000293%Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Uterine atony21.07.03.001; 18.07.02.0120.000079%Not Available
Uterine haemorrhage24.07.03.004; 21.07.01.005--
Vaginal discharge21.08.02.002--
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vaginal infection21.14.02.002; 11.01.10.002--
Varicose vein24.10.04.001--Not Available
Venous thrombosis24.01.01.0080.000119%Not Available
Ventricular arrhythmia02.03.04.006--
Ventricular extrasystoles02.03.04.0070.000119%Not Available
Ventricular tachycardia02.03.04.010--
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ADReCS-Target
Drug Name ADR Term Target
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