Selective Noradrenaline Reuptake Inhibitor (SNRI) — ADHD (Non-Stimulant) Pregnancy: 'Atomoxetine should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus.' Clinical data on exposed pregnancies are limited and insufficient to indicate either an association or a lack of association with adverse pregnancy/lactation outcomes; animal studies in general do not indicate direct harmful effects. Breast-feeding: atomoxetine and/or its metabolites were excreted in the milk of rats and it is not known if it is excreted in human milk — 'because of the lack of data, atomoxetine should be avoided during breastfeeding' (§4.6).

Atomoxetine

Brand names: Strattera

Atomoxetine is a non-stimulant treatment for attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults, taken orally.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Initiate at a total daily dose of 40 mg, maintained for a minimum of 7 days before upward titration according to clinical response and tolerability; recommended maintenance daily dose 80 mg to 100 mg

Route: Oral — can be administered with or without food

Frequency: As a single daily dose in the morning; patients who do not achieve a satisfactory clinical response (tolerability, e.g. nausea or somnolence, or efficacy) on a single daily dose might benefit from twice daily evenly divided doses in the morning and late afternoon or early evening

Max: 'The maximum recommended total daily dose is 100 mg. The safety of single doses over 120mg and total daily doses above 150 mg have not been systematically evaluated'

SOURCE: eMC UK SPC, productName 'ATOMAID 10 mg Capsules, Hard', §4.2. PRE-TREATMENT SCREENING: take an appropriate medical history and conduct a baseline evaluation of cardiovascular status including blood pressure and heart rate before prescribing (§4.3, §4.4). ONGOING MONITORING: record blood pressure and pulse after each dose adjustment and then at least every 6 months; use a centile chart for paediatric patients and current hypertension reference guidelines for adults. WITHDRAWAL: no distinct withdrawal symptoms described — atomoxetine may be stopped abruptly in cases of significant adverse effects, otherwise it may be tapered over a suitable period; re-evaluate the need for continued therapy beyond 1 year, particularly once a stable and satisfactory response is reached. HEPATIC IMPAIRMENT: reduce initial and target doses to 50% of the usual dose in moderate hepatic insufficiency (Child-Pugh B) and to 25% of the usual dose in severe hepatic insufficiency (Child-Pugh C). CYP2D6: approximately 7% of Caucasians are CYP2D6 poor metabolisers with several-fold higher exposure and higher risk of adverse events — a lower starting dose and slower up-titration may be considered for a known poor metaboliser genotype. ELDERLY: use in patients over 65 years has not been systematically evaluated. Source §4.4 and §4.8 were truncated at the source-fetch limit and §4.5 was not retrieved.

Paediatric dose

Dose: 1.2 mg/kg/day/kg

Route: Oral — can be administered with or without food

Frequency: Total daily dose given as a single daily dose in the morning, or as two evenly divided doses in the morning and late afternoon/early evening if a single daily dose is not satisfactory. Applies to paediatric patients UP TO 70 kg body weight

Max: 'No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day. The safety of single doses over 1.8 mg/kg/day and total daily doses above 1.8 mg/kg have not been systematically evaluated.' For paediatric patients OVER 70 kg the maximum recommended total daily dose is 100 mg (safety of single doses over 120 mg and total daily doses above 150 mg not systematically evaluated)

The 1.2 value is the recommended MAINTENANCE TOTAL DAILY dose in mg/kg/day for paediatric patients up to 70 kg — it is not a per-dose figure. VERBATIM §4.2: 'Atomoxetine should be initiated at a total daily dose of approximately 0.5 mg/kg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance dose is approximately 1.2 mg/kg/day (depending on the patient's weight and available dosage strengths of atomoxetine).' PAEDIATRIC PATIENTS OVER 70 kg: initiate at a total daily dose of 40 mg, maintained for a minimum of 7 days before upward titration; recommended maintenance dose 80 mg, with no additional benefit demonstrated above 80 mg and a maximum recommended total daily dose of 100 mg. UNDER 6 YEARS: 'the safety and efficacy of Atomoxetine in children under 6 years of age have not been established. Therefore Atomoxetine should not be used in children under 6 years of age.' In some cases it might be appropriate to continue treatment into adulthood. Verify all under-18 dosing against a children's formulary.

Dose adjustments

Renal

'Atomoxetine can therefore be administered to ADHD patients with end stage renal disease or lesser degrees of renal insufficiency using the usual dosing regimen.' Subjects with end stage renal disease had about 65% higher systemic exposure than healthy subjects, but there was no difference when exposure was corrected for mg/kg dose. Atomoxetine may exacerbate hypertension in patients with end stage renal disease (§4.2).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Paediatric weight-based calculator

Patient weight (kg)

Verify in a children's formulary

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Combination with monoamine oxidase inhibitors (MAOI), or use within a minimum of 2 weeks after discontinuing an MAOI; MAOI treatment should not be initiated within 2 weeks after discontinuing atomoxetine
Narrow angle glaucoma (atomoxetine was associated with an increased incidence of mydriasis in clinical trials)
Severe cardiovascular disorders — which may include severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies
Severe cerebrovascular disorders — which may include cerebral aneurysm or stroke
Phaeochromocytoma or a history of phaeochromocytoma

Side effects

Headache — reported by about 19% of paediatric patients in placebo-controlled trials (discontinuation rate 0.1%)
Abdominal pain — about 18% (discontinuation 0.2%), usually transient
Decreased appetite — about 16% (discontinuation 0.0%), usually transient; associated growth retardation in weight and height gain early in therapy, with recovery to mean predicted weight and height over long-term treatment
Nausea, vomiting and somnolence — about 10% to 11% of patients, particularly during the first month, usually mild to moderate and transient
Increases in heart rate and systolic and diastolic blood pressure; orthostatic hypotension (0.2%) and syncope (0.8%)

Interactions

Monoamine oxidase inhibitors — serious, sometimes fatal reactions (hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes progressing to delirium and coma), some resembling neuroleptic malignant syndrome; contraindicated (SPC §4.3; US label §7.1)
CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, quinidine) — increase atomoxetine steady-state plasma concentrations in extensive metabolisers to exposures similar to poor metabolisers (atomoxetine AUC approximately 6- to 8-fold higher with paroxetine or fluoxetine) (US label §7.2)
Antihypertensive drugs and pressor agents — possible effects on blood pressure (US label §7.3)
Salbutamol/albuterol or other beta-2 agonists — action on the cardiovascular system can be potentiated (US label §7.4)
NOTE: the UK SPC §4.5 interaction section was NOT retrieved in this source bundle — items above marked 'US label' must be verified against the UK SPC

Clinical monograph

How it works

It is a selective noradrenaline reuptake inhibitor that increases noradrenaline availability in brain regions involved in attention and impulse control.

Prescribing in practice

There is an MHRA warning of suicidal ideation and self-harm, particularly early in treatment, so monitor mood and behaviour closely in children and young people.
It can raise heart rate and blood pressure, so assess cardiovascular history and baseline observations before starting, and rare hepatic injury has been reported.
Therapeutic benefit builds over several weeks rather than immediately, unlike stimulant ADHD treatments.

Monitoring

Monitor heart rate, blood pressure, weight, growth and mood, and review for any emergent suicidal thoughts.

Counselling the patient

Full benefit may take several weeks to appear.
Report any new low mood, agitation or thoughts of self-harm without delay.
Seek medical advice if there is unexplained abdominal pain, dark urine or jaundice.

Evidence & guidelines

NICE recognises atomoxetine as an option for ADHD, and MHRA has highlighted its suicidal-ideation and cardiovascular monitoring requirements.

Reference: NICE NG87 (ADHD); MHRA Drug Safety Update 2019 (Atomoxetine Hepatotoxicity); Strattera SPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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