Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Atomoxetine hydrochloride
Drug ID BADD_D00181
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 D02574
MeSH ID D000069445
PubChem ID 54840
NDC Product Code 0110-3250; 0002-3239; 51407-101; 51407-103; 0110-3227; 0110-3229; 0110-3251; 0002-3228; 50090-4244; 50268-057; 50268-058; 60505-2831; 60505-2835; 65862-269; 68554-0021; 69037-0046; 0002-3229; 63629-7828; 60505-2836; 66039-950; 50090-4235; 51407-100; 0110-3228; 68108-0772; 0110-3238; 50379-0018; 55111-071; 63419-0440; 65015-665; 50090-4236; 51407-104; 65841-155; 0002-3227; 0002-3250; 0002-3251; 60505-2833; 60505-2834; 51407-105; 60505-2830; 0110-3239; 65691-0078; 76072-1011; 0002-3238; 50090-4237; 51407-106; 60505-2832; 50370-0010; 53747-059; 51407-102
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 C17H22ClNO
CAS Registry Number 82248-59-7
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 discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; Available
Aggression19.05.01.001--Not Available
Asthenia08.01.01.001--Not Available
Autonomic nervous system imbalance24.06.01.005;; Available
Back pain15.03.04.005--
Blood pressure increased13.14.03.005--Not Available
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.004--Not Available
Chest pain08.01.08.002;; Available
Coma17.02.09.001--Not Available
Completed suicide19.12.01.001; Available
Crying19.04.02.002;;; Available
Dependence19.07.06.008--Not Available
Depressed mood19.15.02.001--Not Available
Dermatitis23.03.04.002--Not Available
Disorientation19.13.01.002; Available
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