Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Olanzapine
Drug ID BADD_D01599
Description Olanzapine is a thienobenzodiazepine classified as an atypical or second-generation antipsychotic agent.[A176996] The second-generation antipsychotics were introduced in the 90s and quickly gained traction due to their impressive efficacy, reduced risk for extrapyramidal side effects and reduced susceptibility to drug-drug interactions.[A177011] Olanzapine very closely resembles [clozapine] and only differs by two additional methyl groups and the absence of a chloride moiety.[T554] It was discovered by scientists at Eli Lilly and approved to be marketed in the US in 1996.[T548]
Indications and Usage Olanzapine was initially used orally and intramuscularly for the chronic treatment of schizophrenia in patients over 13 years old and other psychiatric disorders such as bipolar I disorder including mixed or manic episodes.[A177014] Olanzapine is also indicated, in combination with lithium or valproate for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults.[FDA label] As well, olanzapine is indicated, in combination with fluoxetine for the treatment of episodes of depression associated with bipolar disorder type 1 and treatment-resistant depression in patients over 10 years old.[A177014] Olanzapine is also approved for the management of psychomotor agitation associated with schizophrenia and bipolar I mania.[FDA label] Schizophrenia is a complex biochemical brain disorder that affects the person's ability to differentiate reality. It is usually observed as the presence of delusions, hallucinations, social withdrawal and disturbed thinking.[L5936] Bipolar disorder is a mental health condition defined by periods of extreme mood disturbances. It is categorized in different types from which type 1 is known to involve episodes of severe mania and often depression while type 2 presents less severe forms of mania.[L5939] Olanzapine is also indicated in combination with [samidorphan] for the treatment of bipolar I disorder, either as an adjunct to lithium or valproate or as monotherapy for the acute treatment of manic or mixed episodes or as maintenance therapy, and for the treatment of schizophrenia in adults.[L34359]
Marketing Status approved; investigational
ATC Code N05AH03
DrugBank ID DB00334
KEGG ID D00454
MeSH ID D000077152
PubChem ID 135398745
TTD Drug ID D0V4QS
NDC Product Code 53104-7534; 14445-110; 33342-071; 33342-086; 35573-423; 35573-427; 0002-4454; 0002-4455; 51407-263; 60429-620; 60429-625; 63187-429; 64380-175; 0378-5510; 65862-564; 66993-684; 68084-723; 71335-1363; 0615-8243; 72241-055; 58623-0069; 62938-0032; 65372-1183; 65862-562; 65862-566; 66529-0010; 33342-072; 35573-425; 49884-320; 55111-262; 60505-3111; 63187-364; 63629-8718; 0378-5511; 0378-5512; 65862-563; 65862-658; 66993-681; 67877-172; 67877-176; 67877-177; 68071-2720; 68382-364; 69543-381; 70518-1535; 70518-1605; 70518-1635; 70518-1764; 71209-077; 71335-0534; 71335-0714; 71335-1936; 71335-9661; 72241-056; 72789-265; 0904-6376; 49587-103; 63419-0402; 65862-659; 31722-308; 35573-426; 0002-4116; 0002-4117; 0002-4453; 51407-264; 55154-6889; 60505-3112; 64380-174; 65862-657; 66993-682; 69543-384; 69543-385; 70518-0110; 0527-3161; 70518-1582; 70518-2299; 70518-2698; 70771-1416; 71205-487; 71335-1168; 72241-051; 60429-621; 60429-622; 60429-623; 60505-3114; 63187-453; 63629-8719; 64380-173; 68084-529; 0527-3163; 70771-1419; 0615-8245; 0904-6286; 0110-4116; 0110-4117; 0110-4420; 15894-0006; 64567-0017; 65862-561; 65862-656; 65977-0026; 71210-4112; 71210-4117; 13668-086; 14445-107; 33342-085; 49884-321; 0002-4415; 53002-2505; 60505-3110; 60505-3277; 63629-8717; 64380-172; 67877-175; 68084-525; 68382-366; 68382-367; 70518-1501; 70518-3189; 70771-1417; 70771-1421; 71209-076; 0615-8246; 72241-053; 13668-090; 33342-067; 43598-164; 43598-165; 50090-6111; 50268-615; 53002-1505; 55111-263; 55111-264; 55111-265; 63187-844; 65862-565; 66993-683; 67877-174; 68084-528; 70518-3447; 71209-074; 0615-8244; 72189-478; 0110-4112; 0110-4115; 14799-2010; 49867-0056; 62938-0033; 62938-0034; 13668-089; 14445-106; 0093-5246; 0093-5247; 33342-070; 0002-4112; 43598-166; 51407-261; 51407-262; 55150-308; 55154-5896; 55154-6881; 58118-0381; 60505-3276; 69543-380; 69543-382; 70518-1611; 70518-2891; 70518-3568; 71209-078; 72241-052; 0904-6283; 0904-6287; 62938-0030; 71210-4420; 0093-5245; 33342-069; 33342-083; 49884-322; 55111-167; 60505-3113; 60505-3140; 67877-173; 68382-369; 69543-383; 70518-0314; 0527-3162; 70518-0616; 70771-1418; 71209-075; 0781-9105; 0110-4415; 71210-4115; 71210-4116; 72643-023; 0093-5248; 33342-068; 55111-163; 55111-168; 60505-3275; 63629-8714; 66993-680; 66993-685; 68084-740; 68382-368; 68788-7161; 0527-3164; 70518-0921; 70771-1420; 71335-1760; 0781-3159; 58032-0122; 71210-4415; 35573-422; 50268-616; 55700-927; 60429-624; 60505-3278; 63187-340; 0002-7597; 63629-7902; 0378-5513; 68382-365; 68788-8185; 0517-0955; 70518-2623; 71209-073; 71610-419; 72241-054; 0904-6377; 65862-546; 13668-088; 14445-108; 14445-109; 14445-111; 33342-084; 35573-424; 0002-4115; 49884-323; 0002-4420; 0002-4456
UNII N7U69T4SZR
Synonyms Olanzapine | 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno(2,3-b)(1,5)benzodiazepine | LY-170052 | LY 170052 | LY170052 | Zyprexa | Zolafren | LY 170053 | Olanzapine Pamoate
Chemical Information
Molecular Formula C17H20N4S
CAS Registry Number 132539-06-1
SMILES CC1=CC2=C(S1)NC3=CC=CC=C3N=C2N4CCN(CC4)C
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)
Venous thrombosis limb24.01.02.0090.000421%Not Available
Abnormal behaviour19.01.01.0010.005894%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.0010.002926%
Psychiatric symptom19.01.02.0010.000842%Not Available
Respiratory disorder neonatal22.11.01.002; 18.04.09.0020.000421%Not Available
Ill-defined disorder08.01.03.049--Not Available
Inner ear disorder04.04.02.002--Not Available
Parkinson's disease17.01.05.0100.001200%Not Available
Blood disorder01.05.01.004--Not Available
Cardiac fibrillation02.03.02.0210.000526%Not Available
Adverse drug reaction08.06.01.009--Not Available
Disease recurrence08.01.03.0500.001621%Not Available
Drug intolerance08.06.01.013--Not Available
Psychotic disorder19.03.01.0020.014061%
Hepatobiliary disease09.01.08.003--Not Available
Hyperlipidaemia14.08.03.0010.000526%
Respiratory tract infection viral22.07.07.002; 11.05.04.003--Not Available
Sinus disorder22.04.06.0020.000737%
Respiratory tract infection22.07.07.001; 11.01.08.017--Not Available
Brain stem thrombosis24.01.04.011; 17.08.01.0340.000737%Not Available
Muscle contracture15.03.05.0240.000526%Not Available
Facial spasm17.04.03.0100.000316%Not Available
Cystitis noninfective20.03.02.001--
Bowel movement irregularity07.02.03.0030.000737%Not Available
Hypophagia07.01.06.010; 19.09.01.004; 14.03.01.0060.001347%Not Available
Autism spectrum disorder19.22.02.002; 17.03.05.003--Not Available
Skin haemorrhage23.06.07.001; 24.07.01.1030.000526%Not Available
Chronic kidney disease20.01.03.017--
Procedural pain12.02.05.007; 08.01.08.009--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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