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Tofranil Side Effects

Generic name: imipramine

Medically reviewed by Last updated on Apr 17, 2024.

Note: This document contains side effect information about imipramine. Some dosage forms listed on this page may not apply to the brand name Tofranil.

Applies to imipramine: oral capsule, oral tablet.


Oral route (Tablet)

In short-term studies, antidepressants increased the risk of suicidal thinking and behavior compared with placebo in children, adolescents, and young adults with psychiatric disorders, including major depressive disorder (MDD); there was not an increased risk of suicidality with antidepressants in adults older than 24 years and there was a decreased risk in adults aged 65 years or older. The risk of suicidal thinking and behavior should be balanced with the clinical need for therapy and patients should be monitored closely; instruct families and caregivers to communicate any changes in behavior with the prescriber. Not approved for use in pediatric patients.

Oral route (Capsule)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. This risk must be balanced 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, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Monitor all patients 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 pamoate is not approved for use in pediatric patients.

Serious side effects of Tofranil

Along with its needed effects, imipramine (the active ingredient contained in Tofranil) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking imipramine:

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking imipramine:

Symptoms of overdose

Other side effects of Tofranil

Some side effects of imipramine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

For Healthcare Professionals

Applies to imipramine: compounding powder, intramuscular solution, oral capsule, oral tablet.


The most commonly reported side effects were tremors, increased weight, dry mouth, and constipation.[Ref]


Very rare (less than 0.01%): Anaphylactic reactions, systemic anaphylactic/anaphylactoid reactions

Frequency not reported: Cross-sensitivity with desipramine[Ref]


Common (1% to 10%): Agitation, anxiety, confusion, delirium, disorientation, drug withdrawal symptoms, hallucinations, hypomania, insomnia, libido disorder, mania, nervousness, restlessness, sleep disorders

Uncommon (0.1% to 1%): Sleep disturbances, swings from depression to hypomania/mania

Rare (0.01% to 0.1%): Psychotic disorder

Very rare (less than 0.01%): Aggression/aggressiveness

Frequency not reported: Confusional states (especially in the elderly), delusions, emotional instability, exacerbation of psychosis, increased/decreased libido, nightmares[Ref]


Common (1% to 10%): Arrhythmias, bundle branch block, clinically irrelevant ECG changes, conduction disorders, electrocardiogram abnormalities, hot flushes, orthostatic hypotension, palpitations, postural hypotension, PR changes, sinus tachycardia, ST wave changes, T wave changes, widening of QRS complex

Very rare (less than 0.01%): Blood pressure decrease, cardiac decompensation, cardiac failure, generalized edema, hypotension, increased blood pressure, localized edema, peripheral vasospastic reactions, QT interval prolongation, stroke, torsades de pointes, vasospasm, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia

Frequency not reported: Collapse, flushing, heart block, hypertension, myocardial infarction, precipitation of congestive heart failure, tachycardia[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, paresthesia, somnolence, tremors

Uncommon (0.1% to 1%): Drowsiness

Rare (less than 0.1%): Convulsions, epileptic seizures/seizures

Very rare (less than 0.01%): Abnormal electroencephalogram (EEG), ataxia, EEG changes, extrapyramidal disorder, myoclonus, speech disorders

Frequency not reported: Extremity paresthesia, numbness, peculiar taste, syncope, tingling[Ref]


Common (1% to 10%): Abnormal liver function test, elevated transaminases

Rare (0.01% to 0.1%): Impaired liver function

Very rare (less than 0.01%): Acute hepatitis, hepatic necrosis, hepatitis (with or without jaundice)

Frequency not reported: Altered liver function, jaundice (simulating obstructive)[Ref]


Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone (SIADH) secretion

Frequency not reported: Gynecomastia[Ref]


Very rare: (less than 0.01%): Agranulocytosis, bone marrow depression, eosinophilia, leukopenia, purpura, thrombocytopenia[Ref]


Common (1% to 10%): Abdominal pain, constipation, diarrhea, dry mouth, nausea, vomiting

Very rare (less than 0.01%): Abdominal disorders, dental caries, ileus paralytic, stomatitis, tongue ulceration

Frequency not reported: Abdominal cramps, black tongue, epigastric distress, mild gastrointestinal disturbances, parotid swelling, stomatitis, sublingual adenitis, tongue edema, tongue lesions[Ref]


Common (1% to 10%): Anorexia, increased weight

Very rare (less than 0.01%): Elevation or depression of blood sugar levels, weight loss

Frequency not reported: Hyponatremia[Ref]


Common (1% to 10%): Allergic dermatitis/skin reactions, excessive perspiration, hyperhidrosis/sweating/perspiration, skin rash, urticaria

Very rare (less than 0.01%): Alopecia, hair loss, petechia, photosensitivity reactions, pruritus, skin hyperpigmentation

Frequency not reported: Itching[Ref]


Common (1% to 10%): Fatigue

Very rare (less than 0.01%): Asthenia, drug fever, pyrexia, sudden death, tinnitus, weakness

Frequency not reported: Malaise, proneness to falling, tiredness[Ref]


Common (1% to 10%): Micturition disorder

Uncommon (0.1% to 1%): Abnormal ejaculation, impotence

Very rare (less than 0.01%): Breast enlargement/hypertrophy, enlarged mammary glands, galactorrhea, urinary retention

Frequency not reported: Dilation of the urinary tract, testicular swelling, urinary frequency[Ref]


Common (1% to 10%): Blurred vision, decreased lacrimation, disturbances of accommodation/disorders of visual accommodation

Very rare (less than 0.01%): Glaucoma, mydriasis

Post-marketing reports: Angle-closure glaucoma[Ref]


Very rare (less than 0.01%): Allergic alveolitis (pneumonitis) with or without eosinophilia

Frequency not reported: Respiratory depression[Ref]


Frequency not reported: Increased risk of bone fractures[Ref]


1. (2002) "Product Information. Tofranil (imipramine)." Novartis Pharmaceuticals

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. Cerner Multum, Inc. "Australian Product Information."

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.