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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; 17.15.02.0010.000174%Not Available
Abnormal weight gain14.03.02.0100.000283%Not Available
Accidental overdose12.09.03.001--Not Available
Accommodation disorder06.02.04.001--Not Available
Acidosis14.01.03.0020.000147%
Acne23.02.01.001--Not Available
Acute abdomen07.01.06.0150.000082%Not Available
Acute hepatic failure09.01.03.0010.000136%Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000300%
Affective disorder19.04.04.0010.000240%Not Available
Aggression19.05.01.0010.001275%Not Available
Agitation19.06.02.001; 17.02.05.0120.002518%
Agitation neonatal17.02.05.028; 18.04.04.0020.000055%Not Available
Agranulocytosis01.02.03.001--Not Available
Akathisia17.01.02.002; 19.06.02.0060.001319%
Akinesia17.01.02.0030.000082%Not Available
Alanine aminotransferase increased13.03.04.005--
Alcohol abuse19.07.06.0010.000164%Not Available
Alcohol intolerance14.02.01.001--
Alcoholism19.07.06.0060.000332%Not Available
Altered state of consciousness17.02.04.001; 19.07.01.0030.001117%Not Available
Amblyopia06.02.01.001--Not Available
Amenorrhoea21.01.02.001; 05.05.01.0020.000267%
Amnesia19.20.01.001; 17.03.02.0010.000670%
Anaemia01.03.02.001--
Anaemia macrocytic01.03.02.002; 14.12.01.0020.000055%Not Available
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