Tofranil-PM Side Effects

Generic name: imipramine

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

Some side effects of Tofranil-PM may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to imipramine: oral capsule, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking imipramine (the active ingredient contained in Tofranil-PM) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• feeling like you might pass out;

• new or worsening chest pain, pounding heartbeats or fluttering in your chest;

• sudden numbness or weakness, problems with vision, speech, or balance;

• fever, sore throat;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• confusion, hallucinations, unusual thoughts or behavior;

• painful or difficult urination;

• seizure (convulsions); or

• jaundice (yellowing of the skin or eyes).

Other common side effects may include:

• tingly feeling, weakness, lack of coordination;

• dry mouth, nausea, vomiting, constipation, diarrhea;

• blurred vision, ringing in your ears;

• breast swelling (in men or women); or

• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

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 (the active ingredient contained in Tofranil-PM)

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 (the active ingredient contained in Tofranil-PM) 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 (the active ingredient contained in Tofranil-PM)

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 (the active ingredient contained in Tofranil-PM) 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 (the active ingredient contained in Tofranil-PM) 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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