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)
Skin induration23.03.03.020--
Metabolic syndrome14.06.02.007; 05.06.02.007; 24.08.02.0140.000293%Not Available
Ear canal erythema23.03.06.018; 04.03.01.013--Not Available
Respiratory tract congestion22.02.07.003--Not Available
Lymphatic disorder01.09.01.003--Not Available
Wound23.03.11.043; 12.01.08.009--Not Available
Drug tolerance decreased08.06.01.0240.000174%Not Available
Nerve injury17.02.10.007; 12.01.12.002--Not Available
Musculoskeletal stiffness15.03.05.0270.002592%Not Available
Protein urine present13.13.02.006--Not Available
Epigastric discomfort07.01.02.0040.000119%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.0010.000634%Not Available
Walking disability26.01.01.009--Not Available
Skin swelling23.03.03.0390.000174%Not Available
Injection site swelling12.07.03.018; 08.02.03.017--Not Available
Altered visual depth perception17.17.01.002; 06.02.04.0060.000079%Not Available
Bronchopneumopathy22.02.07.010--Not Available
Electrocardiogram PR prolongation13.14.05.012--Not Available
Depressive symptom19.15.02.0030.000626%Not Available
Affect lability19.04.01.001--Not Available
Injection site discomfort12.07.03.019; 08.02.03.018--Not Available
Transaminases increased13.03.04.036--Not Available
Cerebral disorder17.02.10.0170.000079%Not Available
Dysphemia19.19.03.005; 17.02.08.0100.000269%Not Available
Haemorrhage24.07.01.002--Not Available
Parkinsonian gait17.01.05.005; 08.01.02.0050.000333%Not Available
Faecaloma07.01.03.0040.000277%Not Available
Endometrial thickening21.07.01.0130.000079%Not Available
Parkinsonian rest tremor17.01.05.009--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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