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)
Drug-disease interaction08.06.03.0120.000210%Not Available
Dysdiadochokinesis17.02.02.018--Not Available
Hanging08.04.01.0160.000210%Not Available
Heavy menstrual bleeding21.01.03.005--Not Available
Hepatic cytolysis09.01.07.0360.000947%Not Available
Histrionic personality disorder19.05.03.0010.000631%Not Available
Hyperglycaemic hyperosmolar nonketotic syndrome17.02.04.022; 14.07.04.009; 05.07.04.0090.001368%Not Available
Hyperleukocytosis01.02.01.0180.000526%Not Available
Hypometabolism14.11.01.0190.000316%Not Available
Intermenstrual bleeding21.01.01.015--Not Available
Malignant catatonia19.11.01.0030.000526%Not Available
Mucosal disorder08.01.06.0290.000316%Not Available
Neonatal respiratory distress22.11.02.015; 18.04.10.0040.000210%Not Available
Neonatal seizure18.04.04.019; 17.12.03.0380.000842%Not Available
Pharyngeal dystonia22.12.03.019; 19.19.03.011; 07.01.06.038; 17.01.03.0130.000316%Not Available
Plasma cell mastitis21.05.03.0070.000210%Not Available
Post-injection delirium sedation syndrome17.02.04.024; 19.13.02.004; 12.02.05.0570.016208%Not Available
Potentiating drug interaction08.06.03.0150.000210%Not Available
Poverty of thought content19.10.03.0150.000421%Not Available
Pseudogynaecomastia21.05.04.019; 14.03.02.0320.000210%Not Available
Pseudohyponatraemia14.05.04.0140.000463%Not Available
Psychotic symptom19.03.01.0120.000737%Not Available
Reduced facial expression19.01.02.021; 17.01.05.016--Not Available
Superficial vein thrombosis24.01.02.0160.001095%Not Available
Suspected suicide19.12.01.009; 08.04.01.0170.000316%Not Available
Symptom recurrence08.01.03.1010.000631%Not Available
Taste disorder17.02.07.029; 07.14.03.004--Not Available
Therapeutic product ineffective08.06.01.0570.000421%Not Available
Therapeutic response changed08.06.01.0590.000316%Not Available
Therapy non-responder08.06.01.0630.005178%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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