Imipramine Side Effects

Brand Names: Tofranil, Tofranil-PM

Please note - some side effects for Imipramine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Imipramine - for the Consumer

Imipramine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Imipramine:

Dizziness; drowsiness; dry mouth; excitement; headache; impotence; nausea; nightmares; pupil dilation; sensitivity to sunlight; sweating; tiredness; upset stomach; vomiting; weakness; weight loss or gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; changes in sex drive; chest pain; confusion; constipation; fainting; fast, slow, or irregular heartbeat; fever; frequent or difficult urination; hallucinations; impulsive behavior or other unusual changes in behavior; jaw, neck, or muscle spasms; mental or mood changes (eg, increased anxiety, mood swings, agitation, irritability, nervousness, restlessness); panic attacks; ringing in the ears; seizures; severe dizziness or drowsiness; sore throat; stomach pain; suicidal thinking or behavior; swelling of the testicles; tremor; trouble sleeping; trouble walking or keeping your balance; twitching of the face or tongue; uncontrolled movements of arms and legs or stiffness; unusual bleeding or bruising; worsening of depression; yellowing of the skin or eyes.

Imipramine Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Imipramine Capsules:

Dizziness; drowsiness; dry mouth; excitement; headache; impotence; nausea; nightmares; pupil dilation; sensitivity to sunlight; sweating; tiredness; upset stomach; vomiting; weakness; weight loss or gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; changes in sex drive; chest pain; confusion; constipation; fainting; fast, slow, or irregular heartbeat; fever; frequent or difficult urination; hallucinations; impulsive behavior or other unusual changes in behavior; jaw, neck, or muscle spasms; mental or mood changes (eg, increased anxiety, mood swings, agitation, irritability, nervousness, restlessness); panic attacks; ringing in the ears; seizures; severe dizziness or drowsiness; sore throat; stomach pain; suicidal thinking or behavior; swelling of the testicles; tremor; trouble sleeping; trouble walking or keeping your balance; twitching of the face or tongue; uncontrolled movements of arms and legs or stiffness; unusual bleeding or bruising; worsening of depression; yellowing of the skin or eyes.

Imipramine Side Effects - for the Professional

Imipramine

Note: Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when Imipramine is administered.

Cardiovascular: Orthostatic hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, ECG changes, precipitation of congestive heart failure, stroke.

Psychiatric: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis.

Neurological: Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus.

Anticholinergic: Dry mouth, and, rarely, associated sublingual adenitis; blurred vision, disturbances of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.

Allergic: Skin rash, petechiae, urticaria, itching, photosensitization; edema (general or of face and tongue); drug fever; cross-sensitivity with desipramine.

Hematologic: Bone marrow depression including agranulocytosis; eosinophilia; purpura; thrombocytopenia.

Gastrointestinal: Nausea and vomiting, anorexia, epigastric distress, diarrhea; peculiar taste, stomatitis, abdominal cramps, black tongue.

Endocrine: Gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; inappropriate antidiuretic hormone (ADH) secretion syndrome.

Other: Jaundice (simulating obstructive); altered liver function; weight gain or loss; perspiration; flushing; urinary frequency; drowsiness, dizziness, weakness and fatigue; headache; parotid swelling; alopecia; proneness to falling.

Withdrawal Symptoms: Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache and malaise.

Note: In enuretic children treated with Imipramine the most common adverse reactions have been nervousness, sleep disorders, tiredness, and mild gastrointestinal disturbances. These usually disappear during continued drug administration or when dosage is decreased. Other reactions which have been reported include constipation, convulsions, anxiety, emotional instability, syncope, and collapse. All of the adverse effects reported with adult use should be considered.

Side Effects by Body System

Other

One study has suggested that as many as 85% of treated patients may experience dry mouth.

Several cases of acute angle closure glaucoma have been attributed to the anticholinergic effects of imipramine.

Anticholinergic side effects have been reported in as many as 50% of patients taking imipramine and include dry mouth, blurry vision, constipation and urinary retention.

Nervous system

Nervous system side effects are common. General stimulation (manifested by insomnia and subjective and objective evidence of increased activity) have been reported frequently. Drowsiness, lightheadedness, dizziness, sleep abnormalities, myoclonus, tinnitus, jitteriness, tremor, delirium, cognitive impairment (especially in the elderly), and seizures have also been reported.

One study has suggested that as many as 34% of treated patients may develop myoclonus.

Some investigators have estimated an incidence of 4 to 5 imipramine- induced seizures per 1000 treated patients.

A case of the neuroleptic malignant syndrome has been reported in one patient taking neuroleptics whose imipramine was abruptly discontinued.

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Cardiovascular

Cardiovascular side effects associated with imipramine can be clinically significant. Orthostatic hypotension, tachycardia, PR interval prolongation, QRS widening, other conduction abnormalities and malignant arrhythmias have been reported. Vasospasm involving the extremities has been reported rarely. One study has found the relative risk of myocardial infarction to be 2.2 times greater in patients receiving tricyclic antidepressants including imipramine.

Both antiarrhythmic and proarrhythmic effects have been reported in association with tricyclic therapy. Caution should be exercised if imipramine must be used in patients with cardiovascular disease.

Psychiatric

Psychiatric side effects have included mania, hypomania, suicidal ideation, paradoxical aggressiveness, mental status changes, and worsening of other psychiatric illnesses.

Gastrointestinal

A study of 26,005 antidepressant users has reported 2.3 times more upper GI bleeding episodes with the use of non-SSRI's. Upper gastrointestinal tract bleeding was observed in 3.5 times more frequently in patients receiving imipramine.

Gastrointestinal side effects most frequently include dry mouth and constipation. Nausea, vomiting and diarrhea have also been reported. Fatal adynamic ileus has also been reported (usually during concomitant treatment with other psychotropic agents).

Other

Although imipramine is not addicting, withdrawal symptoms, including nervousness, anxiety, restlessness, akathisia, nausea, malaise, sweating and salivation have been reported after abrupt discontinuation.

Genitourinary

One study of patients treated with various antidepressants has reported that 16 of 29 patients treated with imipramine admitted to sexual dysfunction. Decreased libido, more time reaching orgasm and difficulty reaching orgasm were cited as the most common dysfunctions.

Genitourinary problems have included urinary retention and male and female sexual dysfunction.

Hematologic

Hematologic side effects have included rare instances of reversible agranulocytosis and eosinophilia.

Endocrine

Endocrinologic side effects are rare and have included hypoglycemia and hyponatremia (in association with the syndrome of inappropriate secretion of antidiuretic hormone).

Hepatic

Hepatic side effects are rare and have included elevated liver function tests, drug-induced hepatitis, and acute hepatic failure.

Dermatologic

Dermatologic side effects include sweating most frequently. Urticaria, angioedema, pruritus, and hyperpigmentation have been reported more rarely. Several cases of alopecia have also been reported.

All cases of alopecia have been reported in women. All patients reported resolution or improvement from the hair loss within several months of discontinuation of the drug.

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