Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Quetiapine
Drug ID BADD_D01888
Description Initially approved by the FDA in 1997, quetiapine is a second-generation atypical antipsychotic used in schizophrenia, major depression, and bipolar disorder.[L8546] Quetiapine demonstrates a high level of therapeutic efficacy and low risk of adverse effects during long-term treatment. It is well-tolerated and a suitable option for some patients with high sensitivity to other drugs, such as [Clozapine] and [Olanzapine].[A2189]
Indications and Usage Quetiapine is used in the symptomatic treatment of schizophrenia. In addition, it may be used for the management of acute manic or mixed episodes in patients with bipolar I disorder, as a monotherapy or combined with other drugs. It may be used to manage depressive episodes in bipolar disorder. In addition to the above indications, quetiapine is used in combination with antidepressant drugs for the treatment of major depression.[L8546] Some off-label uses for this drug include the management of post-traumatic stress disorder (PTSD), generalized anxiety disorder, and psychosis associated with Parkinson's disease.[A185438,A185447,T685]
Marketing Status approved
ATC Code N05AH04
DrugBank ID DB01224
KEGG ID D08456
MeSH ID D000069348
PubChem ID 5002
TTD Drug ID D0H7KF
NDC Product Code 0310-0530; 16729-145; 16729-149; 16714-453; 16714-454; 0093-8163; 50228-380; 0310-0280; 0310-0283; 60687-327; 65862-877; 68001-182; 68001-183; 68001-185; 80425-0107; 16729-146; 16729-150; 0310-0282; 60687-338; 63629-2479; 63629-2481; 65862-875; 70518-0752; 71093-136; 71205-402; 16729-147; 16714-455; 16714-457; 0093-8162; 42291-695; 42291-698; 42291-700; 43547-020; 0310-0272; 0310-0274; 0310-0278; 0310-0284; 68001-181; 70518-0239; 0310-0279; 60687-382; 65862-874; 71093-137; 0615-7987; 0310-0505; 43547-019; 50090-2830; 60687-349; 60687-371; 63629-2478; 63629-2480; 63629-2482; 63629-7116; 71093-138; 0615-7986; 0615-8119; 16714-452; 16714-456; 0093-8166; 33342-135; 43547-519; 71093-135; 72789-255; 80425-0143; 0093-2063; 0093-8164; 42291-699; 43547-520; 43547-522; 43547-523; 50090-2338; 50228-382; 50228-383; 0310-0271; 68001-184; 70518-0289; 71093-139; 16729-148; 29300-309; 50090-4788; 53002-1516; 0310-0275; 0310-0281; 60687-360; 65862-876; 70518-0570; 71205-026; 71610-702; 0310-0515; 0093-8165; 29300-308; 29300-310; 29300-311; 29300-312; 33342-136; 42291-696; 43547-021; 68001-180; 68788-7186; 70518-2828; 0615-7988; 0310-0520; 0310-0540; 33342-137; 42291-697; 43547-518; 43547-521; 50228-384; 65862-873; 71205-401; 0615-8118; 33342-134; 43547-022; 50228-381; 53002-1529
UNII BGL0JSY5SI
Synonyms Quetiapine Fumarate | Ethanol, 2-(2-(4-dibenzo(b,f)(1,4)thiazepin-11-yl-1-piperazinyl)ethoxy)-, (E)-2-butenedioate (2:1) (salt) | Seroquel | ICI 204,636 | ICI-204636 | ICI204636 | ICI 204636 | Quetiapine | 2-(2-(4-dibenzo(b,f)(1,4)thiazepine-11-yl-1-piperazinyl)ethoxy)ethanol
Chemical Information
Molecular Formula C21H25N3O2S
CAS Registry Number 111974-69-7
SMILES C1CN(CCN1CCOCCO)C2=NC3=CC=CC=C3SC4=CC=CC=C42
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)
Withdrawal syndrome19.07.06.023; 08.06.02.0120.001052%Not Available
Mental status changes19.07.01.0010.000409%Not Available
Tubulointerstitial nephritis20.05.02.0020.000109%Not Available
Mobility decreased15.03.05.023; 17.02.05.018; 08.01.03.0300.000431%Not Available
Fibromyalgia15.05.02.0020.000120%Not Available
Acute generalised exanthematous pustulosis12.03.01.005; 11.07.01.018; 10.01.01.034; 23.03.10.0020.000082%Not Available
Seasonal allergy22.04.04.008; 10.01.04.001; 06.04.01.013--Not Available
Performance status decreased08.01.03.0420.000055%Not Available
Peripheral swelling08.01.03.053; 02.05.04.015--Not Available
Brain oedema12.01.10.010; 17.07.02.0030.000136%
Emotional distress19.04.02.008--Not Available
Drug screen positive13.17.02.006--Not Available
Psychomotor skills impaired19.22.01.002; 17.02.10.0050.000082%Not Available
Sudden cardiac death08.04.01.008; 02.03.04.0160.000055%Not Available
General physical health deterioration08.01.03.0180.000769%Not Available
Tachyarrhythmia02.03.02.0080.000109%Not Available
Homicidal ideation19.05.01.0080.000055%Not Available
Quadriparesis17.01.04.0120.000136%Not Available
Left ventricular hypertrophy02.04.02.0140.000055%Not Available
Muscle tightness15.05.03.0070.000174%Not Available
Balance disorder08.01.03.081; 17.02.02.0070.000550%Not Available
Bradyphrenia19.10.03.002; 17.03.03.0040.001254%Not Available
Dysstasia15.03.05.011; 08.01.03.089; 17.02.02.0120.000109%Not Available
Electrocardiogram T wave abnormal13.14.05.009--
Subileus07.13.01.0040.000055%Not Available
Contusion15.03.05.007; 24.07.06.001; 23.03.11.002; 12.01.06.001--
Deep vein thrombosis24.01.02.003--Not Available
Lacunar infarction24.04.06.009; 17.08.01.0160.000055%Not Available
Self-injurious ideation19.12.01.0070.000147%Not Available
Viral diarrhoea11.05.04.012; 07.19.02.008--Not Available
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