Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Atomoxetine
Drug ID BADD_D00180
Description Atomoxetine is a selective norepinephrine (NE) reuptake inhibitor used for the treatment of attention deficit hyperactivity disorder (ADHD). Also known as the marketed product Strattera, atomoxetine is used with other treatment modalities (psychological, educational, cognitive behaviour therapy, etc) to improve developmentally inappropriate symptoms associated with ADHD including distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. Although the underlying pathophysiology that causes ADHD remains unclear, evidence suggests that dysregulation in noradrenergic and dopaminergic pathways plays a critical role in suboptimal executive functioning within prefrontal regions of the brain, which are involved in attention and memory.[A178090] Atomoxetine has been shown to specifically increase NA and DA within the prefrontal cortex, but not in the nucleus accumbens (NA) or striatum.[A18262] This is beneficial in the treatment of ADHD as DA activation in the subcortical NA and striatum is associated with many stimulant-associated side effects and an increase in abuse potential, which is a limiting factor associated with the use of stimulant medications such as [DB00422], [DB01576], and [DB01255].[A18262] Use of non-stimulant medications such as atomoxetine is therefore thought to offer a clinical advantage over the use of traditional medications for the management of ADHD. More recently, positron emission tomography (PET) imaging studies in rhesus monkeys have shown that atomoxetine also binds to the serotonin transporter (SERT),[A178111] and blocks the N-methyl-d-aspartate (NMDA) receptor,[A18263] indicating a role for the glutamatergic system in the pathophysiology of ADHD. Long-acting formulations of psychostimulants (such as [DB00422], [DB01576], and [DB01255]) are typically considered the most effective and first-line treatment for ADHD in adults and children as recommended by CADDRA (Canadian ADHD Resource Alliance).[L6037] However, these stimulant medications are limited by dose-related side effects and concerns of abuse. Many contain a blackbox warning stating that CNS stimulants, including methylphenidate-containing products and amphetamines, have a high potential for abuse and dependence. In particular, increased dopamine in key areas caused by these stimulant medications is associated with their reinforcing and addictive properties, and even amplifies the potency and reinforcing effects of other drugs of abuse such as amphetamines, making ADHD sufferers more susceptible to their addictive effects.[A177556] Concerns about abuse potential have spurred research into medications with fewer effects on DA and the use of non-stimulant ADHD medications including atomoxetine, [DB00745] and [DB01018]. The non-stimulant norepinephrine/dopamine reuptake inhibitor [DB01156] (commonly used for the treatment of depression and for smoking cessation) has also been shown to be effective in the treatment of ADHD.[A178099]
Indications and Usage Atomoxetine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adults.
Marketing Status approved
ATC Code N06BA09
DrugBank ID DB00289
KEGG ID D07473
MeSH ID D000069445
PubChem ID 54841
TTD Drug ID D04CRN
NDC Product Code 16714-757; 0093-3542; 31722-719; 35573-416; 35573-421; 42291-064; 50090-6127; 50090-6444; 64980-377; 65862-243; 0093-3545; 31722-716; 42291-067; 42291-068; 50090-6143; 50090-6254; 50090-6513; 55111-521; 65862-238; 65862-244; 68462-270; 65862-240; 16714-758; 16714-761; 0093-3543; 31722-715; 35573-419; 42291-070; 64980-379; 68382-217; 55111-520; 65841-606; 68382-216; 68382-220; 68382-223; 65862-241; 16714-759; 35573-417; 64980-374; 65862-242; 68462-271; 0904-6908; 31722-717; 42291-066; 42291-069; 55111-519; 64980-373; 65841-611; 0093-3544; 0093-3546; 35573-418; 42291-065; 50090-6289; 50090-6511; 64980-375; 65841-607; 65841-609; 65862-239; 31722-718; 55111-528; 63629-9428; 65841-610; 68462-266; 68462-267; 68462-268; 0093-3547; 50090-6512; 60687-567; 63629-9427; 64980-376; 64980-378; 68382-218; 68382-219; 68462-265; 71335-2162; 16714-755; 0093-3548; 31722-714; 31722-720; 35573-420; 55111-522; 55111-563; 60687-326; 65841-608; 68462-269; 71335-9702; 16714-756; 16714-760; 35573-415; 50090-6144; 55111-564
UNII ASW034S0B8
Synonyms Atomoxetine Hydrochloride | Hydrochloride, Atomoxetine | N-methyl-gamma-(2-methylphenoxy)benzenepropanamine hydrochloride | Atomoxetine HCl | HCl, Atomoxetine | Tomoxetine Hydrochloride, (-)-isomer | Tomoxetine Hydrochloride, (+)-isomer - T351671 | Atomoxetine | Tomoxetine | Strattera | LY 139603 | 139603, LY | Tomoxetine Hydrochloride, (+-)-isomer
Chemical Information
Molecular Formula C17H21NO
CAS Registry Number 83015-26-3
SMILES CC1=CC=CC=C1OC(CCNC)C2=CC=CC=C2
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)
Trismus15.05.04.004; 17.01.03.004--
Urinary hesitation20.02.02.009--Not Available
Urinary retention20.02.02.0110.001322%
Vaginal haemorrhage24.07.03.005; 21.08.01.0010.000510%
Ventricular extrasystoles02.03.04.0070.000580%Not Available
Vision blurred17.17.01.010; 06.02.06.0070.001020%
Vomiting07.01.07.0030.004916%
Weight decreased13.15.01.005--
Withdrawal syndrome19.07.06.023; 08.06.02.012--Not Available
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.000232%Not Available
Cardiotoxicity12.03.01.007; 02.11.01.0090.000232%Not Available
Food aversion19.09.03.002; 14.03.02.0290.000626%Not Available
Homicidal ideation19.05.01.0080.000232%Not Available
Impatience19.05.01.014--Not Available
Bradyphrenia17.03.03.004; 19.10.03.002--Not Available
Self-injurious ideation19.12.01.0070.000464%Not Available
Exercise tolerance decreased08.01.03.036--Not Available
Growth retardation14.03.02.031; 05.03.02.007; 15.03.05.0160.000788%
Depressive symptom19.15.02.0030.000510%Not Available
Affect lability19.04.01.001--Not Available
Dysphemia19.19.03.005; 17.02.08.0100.000788%Not Available
Urine odour abnormal20.02.01.020--Not Available
Bipolar disorder19.16.01.0030.000510%Not Available
Major depression19.15.01.003--Not Available
Pulseless electrical activity02.03.04.0200.000348%Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.000510%
Appetite disorder19.09.01.002; 14.03.01.0040.000232%Not Available
Cardiac disorder02.11.01.003--Not Available
Eye movement disorder17.02.05.025; 06.05.02.0080.000510%Not Available
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