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)
Abdominal distension07.01.04.0010.002463%
Abdominal pain07.01.05.0020.006715%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Abdominal tenderness07.01.05.0040.000210%Not Available
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Abnormal weight gain14.03.02.0100.001831%Not Available
Accommodation disorder06.02.04.001--Not Available
Acidosis14.01.03.0020.000526%
Acne23.02.01.001--Not Available
Acute hepatic failure09.01.03.0010.001263%Not Available
Acute lymphocytic leukaemia16.01.01.001; 01.10.01.0010.000421%Not Available
Acute psychosis19.03.01.0010.000947%Not Available
Acute respiratory failure22.02.06.001; 14.01.04.0040.000947%Not Available
Aggression19.05.01.0010.011598%Not Available
Agitation19.06.02.001; 17.02.05.0120.024670%
Agranulocytosis01.02.03.0010.002736%Not Available
Akathisia19.06.02.006; 17.01.02.0020.004315%
Akinesia17.01.02.0030.000737%Not Available
Alanine aminotransferase increased13.03.04.005--
Albuminuria20.02.01.001--Not Available
Alcohol abuse19.07.06.0010.000421%Not Available
Alcoholism19.07.06.006--Not Available
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.0030.003684%Not Available
Amblyopia06.02.01.001--Not Available
Amenorrhoea21.01.02.001; 05.05.01.0020.001263%
Amnesia19.20.01.001; 17.03.02.001--
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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