Dosing & Uses
Dosage Forms & Strengths
capsule
- 10mg
- 18mg
- 25mg
- 40mg
- 60mg
- 80mg
- 100mg
Attention-Deficit/Hyperactivity Disorder
40 mg PO once daily initially; increased after ≥3 days to 80 mg PO once daily or divided q12hr; may be increased to ≤100 mg if optimal response is not achieved
Dosing considerations
- When drug is coadministered with strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) or used in patients known to be poor CYP2D6 metabolizers, decrease dosage; initiate with 40 mg/day, but do not exceed 80 mg/day
Dosing Modifications
Renal impairment: Dosage adjustment not necessary
Mild hepatic impairment (Child-Pugh class A): Dosage adjustment not necessary
Moderate hepatic impairment (Child-Pugh class B): Decrease initial and target dosage by 50%
Severe hepatic impairment (Child-Pugh class C): Decrease initial and target dosage by 75%
Dosage Forms & Strengths
capsule
- 10mg
- 18mg
- 25mg
- 40mg
- 60mg
- 80mg
- 100mg
Attention-Deficit/Hyperactivity Disorder
>6 years and ≤70 kg: 0.5 mg/kg PO once daily; increased after ≥3 days to target dosage of ~1.2 mg/kg PO once daily or divided q12hr; total daily dose not to exceed 1.4 mg/kg or 100 mg, whichever is less; no benefit observed with higher doses
>70 kg: 40 mg PO once daily initially; increased after ≥3 days to 80 mg PO once daily or divided q12hr; if necessary, may be increased after 2-4 additional weeks to 100 mg PO once daily
Dosing considerations
- When drug is coadministered with strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) or used in patients known to be poor CYP2D6 metabolizers, decrease dosage
- ≤70 kg: 0.5 mg/kg/day initially; increased to usual target dosage of 1.2 mg/kg/day only if symptoms fail to improve after 4 weeks and initial dosage is well tolerated
- >70 kg: 40 mg/day initially; not to exceed 80 mg/day
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (9)
- iobenguane I 123
atomoxetine decreases effects of iobenguane I 123 by receptor binding competition. Contraindicated. If clinically appropriate, discontinue drugs that compete for NE receptor sites for at least 5 half-lives; may cause false-negative imaging results.
- isocarboxazid
isocarboxazid increases effects of atomoxetine by pharmacodynamic synergism. Contraindicated. The use of atomoxetine with monoamine oxidase inhibitors (MAOIs) is contraindicated. Risk of acute hypertensive episode.
- linezolid
linezolid increases effects of atomoxetine by pharmacodynamic synergism. Contraindicated. The use of atomoxetine with monoamine oxidase inhibitors (MAOIs) is contraindicated. Risk of acute hypertensive episode.
- phenelzine
phenelzine increases effects of atomoxetine by pharmacodynamic synergism. Contraindicated. The use of atomoxetine with monoamine oxidase inhibitors (MAOIs) is contraindicated. Risk of acute hypertensive episode.
- procarbazine
procarbazine increases effects of atomoxetine by pharmacodynamic synergism. Contraindicated. The use of atomoxetine with monoamine oxidase inhibitors (MAOIs) is contraindicated. Risk of acute hypertensive episode.
- rasagiline
rasagiline increases effects of atomoxetine by pharmacodynamic synergism. Contraindicated. The use of atomoxetine with monoamine oxidase inhibitors (MAOIs) is contraindicated. Risk of acute hypertensive episode.
- selegiline
selegiline increases effects of atomoxetine by pharmacodynamic synergism. Contraindicated. The use of atomoxetine with monoamine oxidase inhibitors (MAOIs) is contraindicated. Risk of acute hypertensive episode.
- selegiline transdermal
selegiline transdermal increases effects of atomoxetine by pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode.
- tranylcypromine
tranylcypromine increases effects of atomoxetine by pharmacodynamic synergism. Contraindicated. The use of atomoxetine with monoamine oxidase inhibitors (MAOIs) is contraindicated. Risk of acute hypertensive episode.
Serious - Use Alternative (5)
- dacomitinib
dacomitinib will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.
- fexinidazole
fexinidazole and atomoxetine both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.
- givosiran
givosiran will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP2D6 substrates with givosiran. If unavoidable, decrease the CYP2D6 substrate dosage in accordance with approved product labeling.
- iobenguane I 131
atomoxetine will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.
- lefamulin
lefamulin and atomoxetine both increase QTc interval. Avoid or Use Alternate Drug.
Monitor Closely (62)
- abiraterone
abiraterone increases levels of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Reduced initial doses of atomoxetine are recommended with strong CYP2D6 inhibitors.
- albuterol
atomoxetine, albuterol. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Risk of tachycardia, increased blood pressure.
- amiodarone
amiodarone will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- arformoterol
arformoterol, atomoxetine. Other (see comment). Use Caution/Monitor. Comment: Exercise caution if beta-agonists and atomoxetine are coadministered. Interaction may be less likely with inhaled beta-agonists versus those given systemically. .
- artemether/lumefantrine
artemether/lumefantrine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- asenapine
asenapine will increase the level or effect of atomoxetine by Other (see comment). Use Caution/Monitor. Potential for enhanced CNS depression. Monitor closely during conurrent use.
- bupropion
bupropion will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- celecoxib
celecoxib will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- chloroquine
chloroquine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- cimetidine
cimetidine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- citalopram
citalopram increases levels of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Although citalopram is a weak inhibitor of 2D6, the potential for an interaction exists.
- clomipramine
clomipramine increases levels of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- darifenacin
darifenacin will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- desvenlafaxine
desvenlafaxine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Desvenlafaxine inhibits CYP2D6; with higher desvenlafaxine doses (ie, 400 mg) decrease the CYP2D6 substrate dose by up to 50%; no dosage adjustment needed with desvenlafaxine doses <100 mg
- diphenhydramine
diphenhydramine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- dobutamine
atomoxetine, dobutamine. Other (see comment). Use Caution/Monitor. Comment: Due to the potential for increases in blood pressure and heart rate, atomoxetine should be used cautiously with vasopressors such as dobutamine.
- dopamine
atomoxetine, dopamine. Other (see comment). Use Caution/Monitor. Comment: Due to the potential for increases in blood pressure and heart rate, atomoxetine should be used cautiously with vasopressors such as dopamine.
- dronedarone
dronedarone will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- duloxetine
duloxetine increases levels of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- eliglustat
eliglustat increases levels of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the concomitant drug and titrate to clinical effect.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP2D6 inhibitor; caution with CYP2D6 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.
- ephedrine
atomoxetine, ephedrine. Other (see comment). Use Caution/Monitor. Comment: Due to the potential for increases in blood pressure and heart rate, atomoxetine should be used cautiously.
- epinephrine
atomoxetine, epinephrine. Other (see comment). Use Caution/Monitor. Comment: Due to the potential for increases in blood pressure and heart rate, atomoxetine should be used cautiously with vasopressors such as epinephrine.
- epinephrine inhaled
atomoxetine, epinephrine inhaled. Either increases effects of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.
- escitalopram
escitalopram increases levels of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- esketamine intranasal
esketamine intranasal, atomoxetine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .
- fedratinib
fedratinib will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP2D6 substrates as necessary.
- fluoxetine
fluoxetine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Reduced initial doses of atomoxetine are recommended with strong CYP2D6 inhibitors.
- formoterol
formoterol, atomoxetine. Other (see comment). Use Caution/Monitor. Comment: Exercise caution if beta-agonists and atomoxetine are coadministered. Interaction may be less likely with inhaled beta-agonists versus those given systemically. .
- fostemsavir
atomoxetine and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.
- haloperidol
haloperidol will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- imatinib
imatinib will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- levalbuterol
levalbuterol, atomoxetine. Other (see comment). Use Caution/Monitor. Comment: Exercise caution if beta-agonists and atomoxetine are coadministered. Interaction may be less likely with inhaled beta-agonists versus those given systemically. .
- lorcaserin
lorcaserin will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- lumefantrine
lumefantrine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- lurasidone
lurasidone, atomoxetine. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.
- maraviroc
maraviroc will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- metaproterenol
metaproterenol, atomoxetine. Other (see comment). Use Caution/Monitor. Comment: Exercise caution if beta-agonists and atomoxetine are coadministered. Interaction may be less likely with inhaled beta-agonists versus those given systemically. .
- methylphenidate
methylphenidate will increase the level or effect of atomoxetine by pharmacodynamic synergism. Use Caution/Monitor. Risk of acute hypertensive episode.
- midodrine
atomoxetine, midodrine. Other (see comment). Use Caution/Monitor. Comment: Due to the potential for increases in blood pressure and heart rate, atomoxetine should be used cautiously with vasopressors such as midodrine.
- mirabegron
mirabegron will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- nilotinib
nilotinib will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- norepinephrine
atomoxetine, norepinephrine. Other (see comment). Use Caution/Monitor. Comment: Due to the potential for increases in blood pressure and heart rate, atomoxetine should be used cautiously with vasopressors such as norepinephrine.
- osilodrostat
osilodrostat and atomoxetine both increase QTc interval. Use Caution/Monitor.
- panobinostat
panobinostat will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Panobinostat can increase the levels and effects of sensitive CYP2D6 substrates or those with a narrow therapeutic index CYP2D6.
- paroxetine
paroxetine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Reduced initial doses of atomoxetine are recommended with strong CYP2D6 inhibitors.
- peginterferon alfa 2b
peginterferon alfa 2b, atomoxetine. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.
- perphenazine
perphenazine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- phenylephrine
atomoxetine, phenylephrine. Other (see comment). Use Caution/Monitor. Comment: Due to the potential for increases in blood pressure and heart rate, atomoxetine should be used cautiously with vasopressors such as phenylephrine.
- pirbuterol
pirbuterol, atomoxetine. Other (see comment). Use Caution/Monitor. Comment: Exercise caution if beta-agonists and atomoxetine are coadministered. Interaction may be less likely with inhaled beta-agonists versus those given systemically. .
- propafenone
propafenone will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- quinidine
quinidine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Reduced initial doses of atomoxetine are recommended with strong CYP2D6 inhibitors.
- ranolazine
ranolazine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- ritonavir
ritonavir will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- rolapitant
rolapitant will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Rolapitant may increase plasma concentrations of CYP2D6 substrates for at least 28 days following rolapitant administration.
- salmeterol
salmeterol, atomoxetine. Other (see comment). Use Caution/Monitor. Comment: Exercise caution if beta-agonists and atomoxetine are coadministered. Interaction may be less likely with inhaled beta-agonists versus those given systemically. .
- sertraline
sertraline will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- terbinafine
terbinafine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Assess need to reduce dose of CYP2D6-metabolized drug.
- terbutaline
terbutaline, atomoxetine. Other (see comment). Use Caution/Monitor. Comment: Exercise caution if beta-agonists and atomoxetine are coadministered. Interaction may be less likely with inhaled beta-agonists versus those given systemically. .
- thioridazine
thioridazine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- tipranavir
tipranavir will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
- venlafaxine
venlafaxine will increase the level or effect of atomoxetine by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.
Minor (0)
Adverse Effects
>10%
Xerostomia (dry mouth) (21%)
Headache (2-19%)
Abdominal pain (7-18%)
Decreased appetite (11-16%)
Insomnia (2-15%)
Cough (11%)
Somnolence (11%)
Vomiting (3-11%)
1-10%
Nausea (10%)
Increases in blood pressure (BP; ≥15-20 mm Hg) and heart rate (HR; ≥20 beats/min) (5-10%)
Erectile dysfunction (9%)
Hot flashes (8%)
Dizziness (5-8%)
Urinary hesitation or retention (7%)
Decreased weight (4-7%)
Depression (4-7%)
Irritability (<6%)
Dyspepsia (4%)
Ejaculation disorder (3%)
Sinus headache (3%)
Constipation (2%)
Dermatitis (2%)
Menstrual disorder (2%)
Mood swings (1-2%)
Postmarketing Reports
Paresthesia
Cardiovascular: QT prolongation, syncope
Peripheral vascular: Raynaud phenomenon
General: Lethargy
Neurologic: Hypesthesia, paresthesia in children and adolescents, sensory disturbances, tics
Psychiatric: Depression and depressed mood, anxiety
Seizures: Cases include patients with preexisting seizure disorders and those with identified risk factors for seizures, as well as patients with neither history of nor identified risk factors for seizures; exact relation between atomoxetine and seizures is difficult to evaluate because of uncertainty about background risk of seizures in patients with attention-deficit/hyperactivity disorder (ADHD)
Skin: Hyperhidrosis
Urogenital: Male pelvic pain, urinary hesitation or retention in children and adolescents
Musculoskeletal: Rhabdomyolysis
Alopecia
Warnings
Black Box Warnings
Atomoxetine use has been associated with increased risk of suicidal ideation in short-term studies in children or adolescents with ADHD; this risk must be balanced against clinical need in patients with ADHD
Monitor patients closely for suicidal thinking and behavior, clinical worsening, or unusual behavioral changes; families and caregivers should be advised of need for close observation and communication with prescribing healthcare provider
Average risk of suicidal ideation in patients receiving atomoxetine has been shown to be ~0.4% (5/1357 patients)
Contraindications
Hypersensitivity
Narrow-angle glaucoma
Administration concomitantly with or within 14 days of monoamine oxidase inhibitor (MAOI) therapy; risk of potentially fatal reaction, including hyperthermia, myoclonus, altered mental status, and neuroleptic malignant syndrome (NMS)-like symptoms
Pheochromocytoma: Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with current or previous pheochromocytoma
Severe cardiovascular disorders where condition would deteriorate because BP increases by 15-20 mm Hg or HR increases by 20 beats/min; risk is greater in poor CYP2D6 metabolizers
Cautions
If drug is given concomitantly with CYP2D6 inhibitor, wait 4 weeks after initiation before adjusting dosage
Liver injury reported within 120 days of initiation of atomoxetine; patients may present with elevated liver enzymes (>20 × ULN) and jaundice with significantly elevated bilirubin levels (>2 × ULN), followed by recovery upon discontinuance of atomoxetine
Orthostatic hypotension and syncope reported
Risk of suicidal thoughts in children and adolescents
Small risk of allergic reaction
Use caution in hypertension, tachycardia (see Contraindications)
Sudden deaths, stroke, and myocardial infarction reported in patients with structural cardiac abnormalities or other serious heart problems taking stimulants at usual doses; patients should have a careful history and physical exam to assess for presence of cardiovascular disease; consider not using atomoxetine in adults with clinically significant cardiac abnormalities
Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation
Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients
Aggressive behavior or hostility is often observed in children and adolescents with ADHD; monitor for the appearance of or worsening of aggressive behavior or hostility
Monitor growth of children ages 7 to 10 years during treatment with stimulants; may need to interrupt therapy in patients not growing or gaining weight as expected
Urinary hesitancy or sexual dysfunction may occur
Rare instances of priapism reported, sometimes necessitating surgical intervention; typically not reported during initiation but often occurring subsequent to dosage increase; immediate medical attention should be sought for abnormally sustained or frequent and painful erections
Drug can be discontinued without being tapered
Hypesthesia, paresthesia in children and adolescents, sensory disturbances
Rare reports of allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash
Use with caution in patietns with bipolar disorder, history of hypertension, hepatic impairment, existing anxiety disorder, history of urinary retention, or tics related to Tourette disorder
Pregnancy & Lactation
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications
Available published studies with atomoxetine use in pregnant women are insufficient to establish drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal data
- Some animal reproduction studies of atomoxetine had adverse developmental outcomes; one of 3 studies in pregnant rabbits dosed during organogenesis resulted in decreased live fetuses and an increase in early resorptions, as well as slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery
- These effects were observed at plasma levels (AUC) 3 times and 0.4 times the human plasma levels in extensive and poor metabolizers receiving the maximum recommended human dose (MRHD), respectively; in rats dosed prior to mating and during organogenesis a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at a dose approximately 5 times the MRHD on a mg/m2 basis
- In one of 2 studies in which rats were dosed prior to mating through periods of organogenesis and lactation, decreased pup weight and decreased pup survival were observed at doses corresponding to 5-6 times MRHD on a mg/m2 basis; no adverse fetal effects were seen in pregnant rats dosed during the organogenesis period
Lactation
There are no data on presence of atomoxetine or its metabolite in human milk, effects on breastfed child, or on milk production; drug is present in animal milk; when a drug is present in animal milk, it is likely that drug will be present in human milk
Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Selective inhibition of presynaptic norepinephrine reuptake
Absorption
Bioavailability: 63-94%
Onset: 2-4 wk
Peak plasma time: 1-2 hr
Distribution
Vd: 0.85 L/kg (IV)
Protein bound: 98%
Vd: 0.85 L/kg
Metabolism
Metabolized in liver by CYP2D6
Metabolites: 4-Hydroxyatomoxetine (equipotent), N-desmethylatomoxetine (less potent)
Elimination
Half-life: 5.2 hr
Total body clearance: 0.35 L/hr/kg
Excretion: Urine (80%), feces (17%)
Administration
Administer either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening
Therapy may be discontinued without being tapered
Do not open capsules; must be swallowed whole with aid of liquids; must not be chewed, divided, or crushed
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| atomoxetine oral - | 100 mg capsule |  | |
| atomoxetine oral - | 80 mg capsule |  | |
| atomoxetine oral - | 60 mg capsule |  | |
| atomoxetine oral - | 40 mg capsule |  | |
| atomoxetine oral - | 25 mg capsule |  | |
| atomoxetine oral - | 18 mg capsule |  | |
| atomoxetine oral - | 10 mg capsule |  | |
| atomoxetine oral - | 40 mg capsule |  | |
| atomoxetine oral - | 25 mg capsule |  | |
| atomoxetine oral - | 40 mg capsule |  | |
| atomoxetine oral - | 25 mg capsule |  | |
| atomoxetine oral - | 10 mg capsule |  | |
| atomoxetine oral - | 18 mg capsule |  | |
| atomoxetine oral - | 100 mg capsule |  | |
| atomoxetine oral - | 80 mg capsule |  | |
| atomoxetine oral - | 60 mg capsule |  | |
| atomoxetine oral - | 18 mg capsule |  | |
| atomoxetine oral - | 10 mg capsule |  | |
| atomoxetine oral - | 100 mg capsule |  | |
| atomoxetine oral - | 80 mg capsule |  | |
| atomoxetine oral - | 60 mg capsule |  | |
| atomoxetine oral - | 100 mg capsule |  | |
| atomoxetine oral - | 80 mg capsule |  | |
| atomoxetine oral - | 60 mg capsule |  | |
| atomoxetine oral - | 40 mg capsule |  | |
| atomoxetine oral - | 25 mg capsule |  | |
| atomoxetine oral - | 18 mg capsule |  | |
| atomoxetine oral - | 10 mg capsule |  | |
| atomoxetine oral - | 60 mg capsule |  | |
| atomoxetine oral - | 25 mg capsule |  | |
| atomoxetine oral - | 40 mg capsule |  | |
| atomoxetine oral - | 100 mg capsule |  | |
| atomoxetine oral - | 80 mg capsule |  | |
| atomoxetine oral - | 40 mg capsule |  | |
| atomoxetine oral - | 18 mg capsule |  | |
| atomoxetine oral - | 10 mg capsule |  | |
| atomoxetine oral - | 60 mg capsule |  | |
| atomoxetine oral - | 25 mg capsule |  | |
| Strattera oral - | 40 mg capsule | | |
| Strattera oral - | 25 mg capsule | | |
| Strattera oral - | 10 mg capsule | | |
| Strattera oral - | 60 mg capsule | | |
| Strattera oral - | 18 mg capsule | | |
| Strattera oral - | 100 mg capsule | | |
| Strattera oral - | 80 mg capsule | |
Copyright © 2010 First DataBank, Inc.
Patient Handout
atomoxetine oral
ATOMOXETINE - ORAL
(A-toe-MOX-e-teen)
COMMON BRAND NAME(S): Strattera
WARNING: A small number of people (especially children/teenagers) who take atomoxetine for attention-deficit hyperactivity disorder (ADHD) may experience worsening of their condition, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of this medication (especially for children/teenagers).Tell the doctor right away if you notice worsening of your condition/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, hallucinations, delusions, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when you first start this medication or when the dose is changed.
USES: Atomoxetine is used to treat attention-deficit hyperactivity disorder (ADHD) as part of a total treatment plan, including psychological, social, and other treatments. It may help to increase the ability to pay attention, concentrate, stay focused, and stop fidgeting. It is thought to work by restoring the balance of certain natural substances (neurotransmitters) in the brain.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using atomoxetine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication with or without food as directed by your doctor, usually 1 to 2 times a day. The first dose is usually taken when you wake up in the morning. If a second dose is prescribed, take it as directed by your doctor, usually in the late afternoon/early evening. Taking this medication late in the day may cause trouble sleeping (insomnia).Swallow the capsules whole. Do not crush, chew, or open the capsules. If the capsule is accidentally opened or broken, avoid contact with the powder and wash away any loose powder as soon as possible with water. If the powder gets in your eyes, flush with plenty of water right away and contact your doctor.The dosage is based on your medical condition, response to treatment, and other drugs you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not increase your dose or take this drug more often than directed.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: See also Warning section.Stomach upset, nausea, vomiting, constipation, tiredness, loss of appetite/weight loss, dry mouth, dizziness, drowsiness, trouble sleeping, or decrease in sexual ability/desire may occur. In women, menstrual cramps or missed/irregular periods may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To lessen the chance of dizziness, get up slowly from a sitting or lying position.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.Tell your doctor right away if you have any serious side effects, including: difficulty urinating, unusually fast/irregular heartbeat, fainting, numbness/tingling.Atomoxetine may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, stomach/abdominal pain, yellowing eyes/skin.This medication may rarely cause serious problems such as a heart attack or stroke. Get medical help right away if you experience any of the following: chest/jaw/left arm pain, shortness of breath, unusual sweating, weakness on one side of the body, confusion, trouble speaking, sudden vision changes.Rarely, males (including young boys and teens) may have a painful or prolonged erection lasting 4 or more hours while using this medication. Caregivers/parents should also be watchful for this serious side effect in boys. If a painful or prolonged erection occurs, stop using this drug and get medical help right away, or permanent problems could occur. Ask your doctor or pharmacist for more details.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking atomoxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain adrenal problem (pheochromocytoma), bladder or prostate problems, glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), high blood pressure, liver disease, personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychosis, suicidal thoughts), stroke.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If used for a long time, this drug may affect a child's growth rate, weight, and final adult height. To reduce the risk, the doctor may recommend briefly stopping the medication from time to time. Check the child's weight and height regularly, and consult your doctor or pharmacist for more details.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids).
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: unusually fast heartbeat, severe headache.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as pulse, blood pressure, liver function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.If you have heart problems, your doctor may perform certain heart tests (EKG, echocardiogram) before you start this medication.Keep all regular medical and laboratory appointments.
MISSED DOSE: If you miss a dose, take it as soon as you remember if it is the same day. If it is the next day, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2020. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
