Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Quetiapine fumarate
Drug ID BADD_D01889
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 D00458
MeSH ID D000069348
PubChem ID 441261
TTD Drug ID D0H7KF
NDC Product Code 80425-0184; 82009-097; 16364-147; 65096-0106; 76072-1009; 16571-722; 16729-097; 29300-149; 29300-150; 33342-099; 47335-902; 47335-903; 50090-3983; 50742-635; 51407-073; 63629-4841; 65862-495; 67296-1243; 68071-2158; 68071-2712; 68071-2728; 68180-448; 68180-449; 68180-450; 68180-615; 0054-0223; 0054-0229; 70518-1018; 70518-3190; 70518-3656; 72189-366; 72189-477; 0615-8471; 0615-8474; 0781-5343; 82009-098; 0904-6639; 15894-0005; 16364-150; 48087-0068; 65015-699; 65862-494; 69037-0064; 73005-0003; 16729-095; 29300-148; 29300-151; 31722-767; 31722-768; 46708-135; 50090-3342; 50090-5884; 50268-630; 50268-632; 50742-638; 51407-071; 55700-941; 63629-4964; 63739-690; 65862-489; 67877-242; 68071-3463; 68788-7950; 68788-8348; 68788-8444; 71335-9697; 72789-266; 0781-5344; 82009-095; 0904-6638; 0904-6641; 0904-6803; 12666-0008; 59765-150; 65862-490; 65862-491; 66577-033; 68069-0006; 16571-718; 16571-721; 16714-379; 29300-147; 33342-104; 46708-139; 47335-906; 50742-637; 51407-070; 51407-074; 55154-7881; 55700-903; 63739-677; 67296-1394; 67877-246; 67877-250; 68071-1892; 68180-445; 68180-616; 0054-0222; 68788-8390; 70518-2424; 70518-2466; 71205-788; 71610-128; 0615-8473; 67877-245; 68001-511; 68001-512; 0054-0220; 68788-8065; 70518-0767; 70518-2102; 70518-2175; 71335-2176; 0781-5348; 0904-6642; 11712-700; 12780-4930; 16364-146; 49711-1506; 59765-149; 62331-039; 16571-809; 16729-132; 31722-764; 33342-105; 34908-636; 46708-136; 46708-138; 47335-907; 55154-3359; 67877-247; 68180-612; 68180-614; 70518-0645; 70518-2502; 70518-2523; 70518-2726; 70518-2752; 70518-2901; 71335-0926; 71335-1519; 71335-9627; 82009-096; 0904-6802; 16364-145; 50923-0483; 53296-0061; 59765-148; 68554-0024; 68554-0089; 16571-720; 16714-375; 31722-766; 33342-100; 50090-3333; 50268-634; 51407-075; 55111-249; 55111-606; 63629-4776; 68001-515; 68180-447; 70518-2522; 70518-3609; 71335-1462; 71610-127; 71610-141; 72189-340; 72189-446; 72189-465; 0781-5342; 0904-6801; 16364-149; 53747-101; 65862-493; 16571-717; 16571-719; 16714-380; 29300-152; 31722-769; 33342-103; 34908-637; 34908-639; 43353-004; 46708-137; 51407-066; 55111-186; 55111-188; 55111-190; 55154-8092; 61919-084; 63187-452; 63739-665; 67296-1336; 68180-613; 0054-0230; 70518-0638; 70518-0974; 70518-1918; 70518-2454; 70518-3429; 71335-0772; 0781-5345; 0781-5346; 16364-148; 59765-147; 65372-1114; 16714-378; 31722-765; 43353-011; 43353-957; 50090-6337; 50268-633; 50268-635; 50742-639; 67877-249; 68180-446; 0054-0221; 70518-0975; 70518-2672; 71205-031; 71335-1562; 71335-9623; 0781-5347; 80425-0186; 0904-6643; 59765-145; 59765-146; 16714-376; 34908-638; 43353-008; 46708-134; 51407-067; 51407-077; 63187-269; 65862-492; 68001-513; 68788-7813; 68788-7960; 70518-0594; 70518-2701; 70518-3761; 71335-1353; 71335-1709; 0615-8470; 0615-8472; 0904-6805; 14799-1102; 15308-0320; 52932-0735; 65862-262; 66651-910; 16729-109; 33342-101; 43353-955; 50268-631; 50742-636; 51407-068; 51407-069; 51407-076; 55111-189; 63187-219; 67296-1582; 67877-248; 68001-514; 70518-1034; 70518-3581; 71335-1362; 71335-2157; 71610-136; 71610-140; 0904-6640; 0904-6804; 16436-0061; 55111-053; 59285-024; 77777-114; 16714-377; 16729-096; 47335-904; 47335-905; 50090-5473; 55111-169; 55154-7894
UNII 2S3PL1B6UJ
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 C46H54N6O8S2
CAS Registry Number 111974-72-2
SMILES C1CN(CCN1CCOCCO)C2=NC3=CC=CC=C3SC4=CC=CC=C42.C1CN(CCN1CCOCCO)C2=NC3=CC=CC=C3SC4= CC=CC=C42.C(=CC(=O)O)C(=O)O
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)
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rash maculo-papular23.03.13.004--
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Restlessness19.11.02.002; 17.02.05.021--
Rhabdomyolysis15.05.05.002--
Rhinitis11.01.13.004; 22.07.03.006--
Salivary hypersecretion07.06.01.009--Not Available
Seborrhoea23.02.07.001--Not Available
Sinus congestion22.04.06.001--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Skin discolouration23.03.03.005--Not Available
Skin ulcer24.04.03.007; 23.07.03.003--
Somnambulism19.02.03.006; 17.15.02.004--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.003--Not Available
Stevens-Johnson syndrome11.07.01.005; 10.01.01.045; 23.03.01.007; 12.03.01.014--
Stomatitis07.05.06.005--
Stupor19.02.05.004; 17.02.04.007--Not Available
Subdural haematoma17.08.05.002; 12.01.10.003; 24.07.04.005--Not Available
Suicide attempt19.12.01.004--
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Tardive dyskinesia17.01.02.012--Not Available
Thinking abnormal19.10.03.001; 17.02.05.023--Not Available
Thirst08.01.09.021; 14.03.02.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombophlebitis24.01.02.001--Not Available
Thyroxine abnormal13.10.06.006--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
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