Imipramine
Tofranil · ATC code N06AA02
Also known as: Imipramin, İmipramin
- Key facts
- Active substance
- Imipramine
- Drug class
- Antidepressant
- ATC code
- N06AA02
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
Boxed warning
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents , and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of imipramine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Imipramine hydrochloride is not approved for use in pediatric patients (see WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS, Information for Patients , and PRECAUTIONS: Pediatric Use ).
Key facts
Imipramine is a tricyclic antidepressant. Per the US prescribing information, it is used to relieve symptoms of depression and as temporary adjunctive therapy for enuresis in children aged 6 years and older.
What it is used for
- Relief of symptoms of depression; one to three weeks may be needed for optimal effect
- Temporary adjunctive therapy for enuresis in children aged 6 years and older after organic causes are excluded
Dosing
- Start low and increase gradually; lower doses for elderly patients, adolescents and outpatients
- Hospitalized patients: initially 100 mg/day in divided doses, increased to 200 mg/day as required; if no response after two weeks, 250 to 300 mg/day
- Outpatients: initially 75 mg/day increased to 150 mg/day; over 200 mg/day not recommended; maintenance 50 to 150 mg/day
- Adolescent and geriatric patients: initially 30 to 40 mg/day, generally not exceeding 100 mg/day
- Enuresis: 25 mg/day one hour before bedtime; after one week may increase to 50 mg (under 12 years) or up to 75 mg (over 12 years); do not exceed 2.5 mg/kg/day
- Taper gradually rather than stopping abruptly
Contraindications
- Concomitant monoamine oxidase inhibitors; allow at least 14 days between
- Acute recovery period after myocardial infarction
- Known hypersensitivity; possible cross-sensitivity to other dibenzazepines
Important warnings
- Boxed warning: increased risk of suicidal thinking and behavior in children, adolescents and young adults; monitor all patients for worsening and suicidality; not approved for pediatric patients
- Screen for bipolar disorder before treatment (risk of mixed/manic episodes)
- Extreme caution in cardiovascular disease (conduction defects, arrhythmias), urinary retention, narrow angle glaucoma, hyperthyroidism and history of seizures
- May lower the seizure threshold
- In children do not exceed 2.5 mg/kg/day; ECG changes reported at twice this dose
Side effects
- Cardiovascular: orthostatic hypotension, tachycardia, arrhythmias, heart block, ECG changes
- Anticholinergic: dry mouth, blurred vision, constipation, urinary retention
- Psychiatric and neurological: confusion (especially in the elderly), restlessness, insomnia, tremor, seizures
- Allergic and hematologic: rash, photosensitization, bone marrow depression including agranulocytosis
Interactions
- MAO inhibitors: hyperpyretic crises and severe convulsive seizures may occur
- P450 2D6 inhibitors such as quinidine, cimetidine and SSRIs (e.g. fluoxetine, sertraline, paroxetine): imipramine levels may rise
- Guanethidine, clonidine: their effects may be blocked
- Alcohol: enhanced CNS depressant effects; thyroid medication: cardiovascular toxicity
Pregnancy and breastfeeding
- Congenital malformations have been reported, causality not established; use only if the clinical condition clearly justifies the potential risk to the fetus
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Germany
- Imipramin NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- TofranilASSOS İLAÇ KİMYA GIDA ÜRÜNLERİ ÜRETİM VE TİC. A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 11 more European countries
- Belgium
- Tofranil
- Cyprus
- Imipramine Remedica
- Czechia
- Melipramin
- Denmark
- Imipramin
- France
- Tofranil
- Hungary
- Melipramin
- Malta
- Imipramine
- Netherlands
- Imipramine Hcl Cf
- Portugal
- Tofranil
- Slovakia
- Melipramin
- Spain
- Tofranil
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. Imipramine Hydrochloride (Leading Pharma, LLC) – Prescribing Information, 2026-08-11. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=490263ce-b4d2-428a-87da-fcd07f85499a
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC N06AA.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.