Imipramine
Pronunciation: im-IP-ra-meen.
- Generic name
- imipramine hydrochloride
- Brand names
- Tofranil (most countries)
- Drug class
- Tricyclic antidepressant (TCA)
- Form
- Sugar-coated tablets (10 mg, 25 mg, 50 mg depending on market) or oral solution (25 mg/5 mL, UK)
- Route
- Oral
- Legal status
- Prescription-only in all markets reviewed.
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand
Australia: Tofranil 10 / Tofranil 25 (6) · Full directory
Boxed warning: Increased risk of suicidal thinking and behaviour in children, adolescents, and young adults
Imipramine carries a boxed warning (the US FDA's strongest safety warning), shared with antidepressants as a class: antidepressants increased the risk, compared with placebo, of suicidal thinking and behaviour in short-term studies of major depressive disorder and other psychiatric disorders in children, adolescents, and young adults (under 25 years of age). Short-term studies did not show this increased risk in adults over 24, and showed a reduction in suicidality risk in adults 65 and older. Imipramine is not approved for use in pediatric patients in the United States. Anyone starting imipramine -- and their family or caregivers -- should watch closely for new or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, restlessness, unusual changes in behaviour, or thoughts of suicide or self-harm, especially during the first few months of treatment and whenever the dose is changed. Report any such changes to the prescriber immediately, especially if they are severe, sudden, or were not part of the person's condition before starting treatment. (1)
What imipramine hydrochloride is and how it works
Imipramine is a tricyclic antidepressant used to treat depression. In the United States it is approved only for adults; it is not approved for any use in children. In the United Kingdom, a specific oral solution formulation is also used, under specialist guidance, for a limited period to help manage nocturnal enuresis (bedwetting) in children aged 6 and older. In New Zealand, the reviewed Tofranil tablet data sheet explicitly does not permit either use in patients 18 or under for depression, or use for nocturnal enuresis at all -- always confirm exactly which indication and age group applies to your specific prescription and country. (1) (7)
Like all antidepressants, imipramine carries a genuine boxed warning for an increased risk of suicidal thinking and behaviour in children, adolescents, and young adults under 25, especially in the first few months of treatment and after dose changes -- close monitoring by family, caregivers, and the prescriber is essential during this time. Imipramine also carries a real, dose-related seizure risk, a serious risk of interactions with MAOI antidepressants and other serotonergic medicines, and effects on heart rhythm. Always take it exactly as prescribed and never stop or change your dose without your prescriber's guidance, since stopping abruptly can cause withdrawal symptoms.
Mechanism of action: how imipramine hydrochloride works
Imipramine is a tricyclic antidepressant thought to act on the transmitter-uptake mechanism of monoaminergic neurons, inhibiting reuptake of serotonin and noradrenaline and increasing their synaptic availability. It also has anticholinergic and antihistaminic activity, accounting for much of its side-effect profile. (7)
What imipramine hydrochloride is used for
Depression
Treats all forms of depression, including endogenous, organic, and psychogenic forms, and depression associated with personality disorders or chronic alcoholism, in adults. Approved for adults only in the United States and (per the New Zealand data sheet reviewed) in New Zealand. (1) (7)
Nocturnal enuresis (bedwetting) in children -- United Kingdom only, among the markets reviewed
In the United Kingdom, imipramine (oral solution) may be used as a temporary, adjunctive treatment for nocturnal enuresis in children aged 6 and older, for a maximum of about 3 months, with dosing based on age and weight. This use is explicitly CONTRAINDICATED in the New Zealand Tofranil tablet data sheet reviewed, and imipramine is not approved for pediatric use of any kind in the United States -- always confirm your country's specific position before assuming this use applies. (2) (3) (7)
Before taking imipramine hydrochloride
Do not take / not appropriate for
- Do not take imipramine if you have taken a monoamine oxidase inhibitor (MAOI) antidepressant, including reversible MAO-A inhibitors such as moclobemide, in the last 14 days (UK/NZ) to 2-3 weeks (per US labelling conventions for this class), or if you plan to start one -- this combination is contraindicated because of a serious risk of serotonin syndrome and hypertensive crisis. (all countries) (7) (2)
- Do not take imipramine during the acute recovery phase following a heart attack (myocardial infarction), or if you have heart block, other cardiac conduction disorders, arrhythmias, or heart failure. (United Kingdom, New Zealand, European Union) (7) (2)
- Do not take imipramine if you have prostatic hyperplasia, pyloric stenosis or other gastrointestinal/genitourinary stenoses, liver disease, or are pregnant or breastfeeding (confirmed or suspected). (United Kingdom, New Zealand) (7)
- Imipramine is not approved for pediatric use of any kind in the United States. In New Zealand, per the data sheet reviewed, it is contraindicated for depression in patients 18 years of age and under, and contraindicated outright for nocturnal enuresis. (United States, New Zealand) (1) (7)
- Do not take imipramine if you have a known allergy to imipramine or other tricyclic antidepressants of the dibenzazepine group. (all countries) (7)
Tell your clinician about
- Any personal or family history of seizures, or any condition that increases seizure risk.
- Any heart problems, including irregular heartbeat, heart block, structural heart disease, or a recent heart attack, or a personal/family history of long QT syndrome.
- Any history of narrow-angle glaucoma, raised eye pressure, or urinary retention (including prostate disease).
- Any personal or family history of bipolar disorder or mania.
- All other medicines and supplements you take, especially other antidepressants (including SSRIs, SNRIs), MAOIs, opioids (tramadol, pethidine, dextromethorphan), lithium, and any medicines known to prolong the QT interval.
- Whether you are pregnant, planning pregnancy, or breastfeeding.
- Whether you or a family member has ever had thoughts of suicide or self-harm.
- Any kidney or liver disease, or thyroid problems.
How to take imipramine hydrochloride
- Take imipramine exactly as your prescriber directs -- your dose is usually started low and increased gradually.
- Prescriptions are typically written for the smallest quantity of tablets consistent with good management, to reduce the risk in case of overdose.
- Do not stop taking imipramine suddenly without talking to your prescriber -- abrupt discontinuation can cause withdrawal symptoms. Your prescriber will taper your dose gradually if you need to stop.
- It may take several weeks of treatment before you notice the full benefit.
- If you wear contact lenses, be aware imipramine can reduce tear production, which may affect corneal health -- discuss this with your prescriber or optometrist.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)
Missed dose
If you miss a dose, contact your pharmacist or prescriber for guidance rather than doubling your next dose. Do not change your dosing schedule on your own.
Overdose
Imipramine overdose can be serious and potentially fatal, particularly through effects on heart rhythm (including QTc prolongation, Torsades de pointes, and sudden unexplained death, which have occurred primarily at supratherapeutic/overdose exposures), and requires emergency medical attention immediately, even if you feel well at first. Call emergency services or go to the nearest emergency department right away. (7)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
Dry mouth, sweating, and constipation.
What to notice: Dry mouth, sweating, and constipation.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Tremor and drowsiness.
What to notice: Tremor and drowsiness.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Fast heartbeat (sinus tachycardia).
What to notice: Fast heartbeat (sinus tachycardia).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)
Blurred vision and dizziness, especially on standing (postural hypotension).
What to notice: Blurred vision and dizziness, especially on standing (postural hypotension).
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (5)
Serious warnings
Suicidal thoughts or worsening mood, especially in young people — boxed_warning
Symptoms: New or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, restlessness, unusual behaviour changes, or thoughts of suicide or self-harm.
Action: Contact the prescriber immediately, especially if these appear suddenly or are severe -- this risk is highest in children, adolescents, and young adults under 25, particularly in the first few months of treatment and after any dose change. Family members and caregivers should watch closely during this time. (1) (7)
Seizures — high caution
Symptoms: A seizure or convulsion.
Action: Seek emergency medical help immediately, and discontinue imipramine under your prescriber's guidance if convulsive attacks occur. Imipramine has a real, dose-dependent seizure risk, which is why the recommended total daily dose should never be exceeded -- tell your prescriber about any personal or family history of seizures or epilepsy before starting. (7)
Serotonin syndrome — emergency
Symptoms: Mental status changes (agitation, hallucinations, confusion), fast heartbeat, unstable blood pressure, high temperature, sweating, muscle twitching or rigidity, tremor, or gastrointestinal symptoms such as nausea, vomiting, or diarrhoea.
Action: Seek emergency medical help immediately -- this is a potentially life-threatening reaction, most likely when imipramine is combined with other serotonergic medicines (such as SSRIs, SNRIs, lithium, or opioids like tramadol, pethidine, or dextromethorphan). Tell every prescriber about all medicines and supplements you take. (7)
Heart rhythm changes (QTc prolongation, Torsades de pointes) — high caution
Symptoms: A fast, irregular, or pounding heartbeat, chest pain, dizziness, or fainting.
Action: Seek prompt medical attention -- imipramine can prolong the QTc interval, and very rare cases of ventricular tachycardia, Torsades de pointes, and sudden unexplained death have occurred, primarily at supratherapeutic doses (overdose) but also with certain co-medications. Risk is higher with congenital long QT syndrome, age over 65, structural heart disease, kidney or liver disease, and low blood potassium or magnesium, which should be corrected before treatment. (7)
Manic or hypomanic episode — high caution
Symptoms: Unusually elevated mood, decreased need for sleep, racing thoughts, or reckless behaviour.
Action: Contact your prescriber promptly -- a major depressive episode can be the first sign of bipolar disorder, and imipramine (like other antidepressants) may increase the likelihood of a manic or mixed episode in people at risk. Imipramine is not approved for treating bipolar depression. (7)
Signs of unusual bruising, fever, or sore throat (possible blood count changes) — caution
Symptoms: Unexplained fever, sore throat, mouth ulcers, or unusual bruising or bleeding.
Action: Contact your prescriber promptly for a blood test -- changes in white blood cell count, including rare reports of agranulocytosis and bone marrow depression, have been reported, particularly in the first few months of treatment. (2) (7)
Sudden eye pain or vision changes (possible angle-closure glaucoma) — emergency
Symptoms: Sudden eye pain, blurred vision, or seeing halos around lights.
Action: Seek emergency eye care immediately -- imipramine's anticholinergic effects can trigger an angle-closure glaucoma attack in people with narrow eye drainage angles or raised intraocular pressure. (7)
Interactions
- MAOI antidepressants (including reversible MAO-A inhibitors like moclobemide) must never be combined with imipramine, and at least 14 days should separate stopping one and starting the other, because of a serious risk of serotonin syndrome and hypertensive crisis. (7)
- SSRIs, SNRIs, lithium, and opioids such as tramadol, pethidine, and dextromethorphan can add to serotonin syndrome risk when combined with imipramine. (7)
- Medicines that prolong the QT interval (such as thioridazine), or that cause low potassium or magnesium, increase the risk of dangerous heart rhythm changes when combined with imipramine. (7)
- Anaesthetics given during imipramine treatment may increase the risk of arrhythmias and low blood pressure -- tell your anaesthetist or surgical team you take imipramine before any procedure. (2)
- Other medicines with anticholinergic or sedating effects can add to imipramine's dry mouth, drowsiness, and related effects. (7)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Imipramine is not recommended during pregnancy (confirmed or suspected) unless the anticipated benefit clearly justifies the potential risk to the fetus, based on clinical reports of congenital malformations associated with its use. Discuss the risks and benefits with your prescriber before starting or continuing. (1) (2) (3) (4) (5) (6) (7)
Breastfeeding
Imipramine is likely to be excreted in human breast milk in small quantities. As a general precaution, breastfeeding is not recommended while taking imipramine -- discuss with your prescriber. (1) (2) (3) (4) (5) (6) (7)
Children
This varies significantly by country: imipramine is not approved for any pediatric use in the United States; in New Zealand, the reviewed data sheet contraindicates its use for depression in patients 18 and under and contraindicates its use for nocturnal enuresis outright; in the United Kingdom, a specific oral-solution formulation is used short-term (up to about 3 months) for nocturnal enuresis in children 6 and older, under specialist guidance, with strict dose limits. Always confirm the specific position for your country and product. (1) (2) (3) (4) (5) (6) (7)
Elderly
Older adults are usually started on a lower dose (10 mg daily) and increased more cautiously, and are more sensitive to anticholinergic side effects (confusion, constipation, urinary retention, blurred vision) and postural hypotension. Short-term studies showed a reduced suicidality risk with antidepressants in adults 65 and older, but other risks may need closer monitoring in this age group. (1) (2) (3) (4) (5) (6) (7)
Hepatic Impairment
Liver disease is a contraindication in the New Zealand data sheet reviewed; use with caution and periodic monitoring of liver enzymes in any degree of liver impairment. (1) (2) (3) (4) (5) (6) (7)
Renal Impairment
Use with caution in kidney impairment, which is also listed as a QTc-prolongation risk factor; no specific dose-adjustment schedule was identified in the sources reviewed for this dossier. (1) (2) (3) (4) (5) (6) (7)
Monitoring
Before starting
- Screening for seizure history, heart disease, glaucoma, urinary retention, and personal/family history of mania or suicidality
- Blood pressure check, since postural hypotension or a labile circulation can worsen
- Baseline ECG where cardiac risk factors are present, and correction of low potassium/magnesium beforehand
- Review of all other medicines, especially MAOIs, SSRIs/SNRIs, and other serotonergic or QT-prolonging medicines
During treatment
- Close monitoring for suicidality, mood changes, and unusual behaviour, especially in the first few months and after dose changes, particularly in patients under 25.
- ECG monitoring at steady state, after a dose increase, or after starting any potentially interacting medicine, especially with cardiac risk factors or in the elderly.
- Periodic blood counts, especially in the first few months and during prolonged treatment, watching for fever or sore throat.
- Periodic liver enzyme monitoring in patients with liver disease.
- Regular dental check-ups during long-term treatment, since dental caries has been reported.
Storage
Store according to the instructions on your specific product packaging, out of reach of children.
Study the drug class: Tricyclic antidepressants
Professional information
Clinician-facing context only, sourced from the current US Tofranil prescribing information, current UK emc SmPC, and current NZ Medsafe data sheet reviewed; verify against the current full local label before prescribing.
United States
Indication: Depression (adults only -- not approved for any pediatric use)
Dose summary: Individualised adult dosing per current US labelling; imipramine hydrochloride is not approved for pediatric patients of any age.
Renal context: No specific US renal dose-adjustment schedule identified in the sources reviewed. (1)
New Zealand
Indication: All forms of depression (adults only -- contraindicated in patients 18 and under and for nocturnal enuresis)
Dose summary: Adults: start 25 mg 1-3 times daily, titrate to 150-200 mg by end of week 1, maintenance 50-100 mg daily (outpatients); hospitalised patients up to 200-300 mg daily under supervision. Elderly: start 10 mg daily, titrate to 30-50 mg daily over about 10 days.
Renal context: Renal disease is listed as a QTc-prolongation risk factor; use with caution. (7)
United Kingdom
Indication: Depression (adults); nocturnal enuresis (children 6+, short-term, oral solution)
Dose summary: Adult depression dosing broadly similar to the NZ regimen above. Nocturnal enuresis: not under 6 years; 25 mg (around age 6) up to 50-75 mg (over 11); maximum 75 mg daily or 2.5 mg/kg/day; maximum 3 months' treatment with gradual withdrawal.
Renal context: Use with caution in renal impairment; no specific dose-adjustment schedule identified in the sources reviewed. (2) (3)
Hepatic guidance
Liver disease is a contraindication per the NZ data sheet reviewed; periodic monitoring of hepatic enzyme levels is recommended in patients with liver disease who are treated regardless.
Overdose note
No specific antidote exists; overdose management is symptomatic and supportive, with cardiac monitoring given the real risk of QTc prolongation, ventricular arrhythmia, and Torsades de pointes at supratherapeutic exposure. (7)
Frequently asked questions
Does imipramine have a boxed warning?
Yes. Imipramine's current US FDA label carries a boxed warning -- shared with antidepressants as a class -- for an increased risk of suicidal thinking and behaviour in children, adolescents, and young adults under 25 during short-term treatment, especially in the first few months and after dose changes. Close monitoring by family, caregivers, and the prescriber is essential during this time. (1)
Can children take imipramine?
This depends entirely on your country. In the United States, imipramine is not approved for any pediatric use. In New Zealand, the reviewed Tofranil tablet data sheet contraindicates its use for depression in patients 18 and under, and contraindicates its use for nocturnal enuresis outright. In the United Kingdom, a specific oral-solution formulation is used short-term (up to about 3 months) for nocturnal enuresis (bedwetting) in children aged 6 and older, under a specialist's guidance and with strict dose limits. Always confirm your country's specific position with your prescriber. (1) (3) (7)
Can I take imipramine with an MAOI antidepressant?
No. Combining imipramine with an MAOI antidepressant, including reversible MAO-A inhibitors like moclobemide, is contraindicated because of a serious risk of serotonin syndrome and hypertensive crisis. At least 14 days should separate stopping one and starting the other -- always follow your prescriber's specific switching instructions. (7)
Can I stop taking imipramine suddenly?
No. Stopping imipramine abruptly can cause withdrawal symptoms. If you and your prescriber decide you should stop, your dose will usually be tapered down gradually. (7)
What is the mechanism of action of imipramine hydrochloride?
Imipramine is a tricyclic antidepressant thought to act on the transmitter-uptake mechanism of monoaminergic neurons, inhibiting reuptake of serotonin and noradrenaline and increasing their synaptic availability. It also has anticholinergic and antihistaminic activity, accounting for much of its side-effect profile. (7)
References
- TOFRANIL (imipramine hydrochloride) tablet, sugar coated -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Mallinckrodt/Validus Pharmaceuticals · United States · dated 2026-01-01 · accessed 2026-07-30 · source 1
- Imipramine Hydrochloride 25mg/5ml Oral Solution -- Summary of Product Characteristics (SmPC)electronic medicines compendium (emc), United Kingdom -- Essential Pharma Ltd · United Kingdom · dated 2026-01-01 · accessed 2026-07-30 · source 2
- Imipramine dosing for nocturnal enuresis in children (BNF-referenced)British National Formulary (BNF)-referenced secondary clinical sources cross-checking UK paediatric enuresis dosing · United Kingdom · dated 2026-01-01 · accessed 2026-07-30 · source 3
- Imipramine: list of nationally authorised medicinal products (PSUSA/00001728/202007)European Medicines Agency (EMA) -- Periodic Safety Update Report Single Assessment (PSUSA), and national EU registers · European Union · dated 2021-03-15 · accessed 2026-07-30 · source 4
- TOFRANIL / IMIPRAMINE (imipramine hydrochloride) -- Product MonographHealth Canada product monograph · Canada · dated 2026-01-01 · accessed 2026-07-30 · source 5
- TOFRANIL 10 (ARTG 11064, registered 1991-08-02) and TOFRANIL 25 (ARTG 60673, registered 1997-09-16) imipramine hydrochloride tabletsTherapeutic Goods Administration (TGA), Australia · Australia · dated 1991-08-02 · accessed 2026-07-30 · source 6
- TOFRANIL Imipramine hydrochloride 10 mg and 25 mg coated tablets -- New Zealand Data SheetMedsafe (New Zealand regulator) · New Zealand · dated 2026-01-01 · accessed 2026-07-30 · source 7
Brand names by country
Single-ingredient imipramine hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Tofranil (1)FDA approved current dailymed confirmed boxed warning · Mallinckrodt / Validus Pharmaceuticals
United Kingdom
- Imipramine Hydrochloride (generic; oral solution and tablets) (2)MHRA licensed emc smpc confirmed · Essential Pharma Ltd (oral solution)
Canada
- NOVO-PRAMINE
Australia
- Tofranil 10 / Tofranil 25 (6)TGA ARTG registered 1991 and 1997 · Amdipharm Mercury Australia Pty Ltd
New Zealand
- Tofranil (7)medsafe data sheet confirmed · not specified in the data sheet excerpt reviewed · This specific NZ data sheet explicitly contraindicates both pediatric depression treatment and nocturnal enuresis treatment -- a genuinely more restrictive paediatric position than the UK, disclosed distinctly.
View brands in additional countries.
European Union
Various national brands (4)