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
Along with its needed effects, imipramine (the active ingredient contained in Tofranil-PM) 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
- Abdominal or stomach pain
- actions that are out of control
- black, tarry stools
- bleeding and bruising
- bleeding gums
- blood in urine or stools
- blurred vision burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- clay-colored stools
- cold sweats
- confusion about identity, place, and time
- continuing ringing or buzzing or other unexplained noise in ears
- cool, pale skin
- cough or hoarseness
- dark urine
- decrease in frequency of urination
- decreased urine output or volume
- difficulty in passing urine (dribbling)
- difficulty in speaking
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- double vision
- dry mouth
- false beliefs that cannot be changed by facts
- fast, pounding, or irregular heartbeat or pulse
- fear or nervousness
- feeling of warmth
- feeling, seeing, or hearing things that are not there
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- fever with or without chills
- flushed, dry skin
- fruit-like breath odor
- general feeling of tiredness or weakness
- hearing loss
- inability to move arms, legs, or facial muscles
- inability to speak
- increased hunger
- increased need to urinate
- increased thirst
- increased urination
- lack of coordination
- loss of appetite
- loss of balance control
- lower back or side pain
- mood or mental changes
- muscle spasm or jerking of all extremities
- muscle trembling, jerking, or stiffness
- muscle twitching
- pain or discomfort in arms, jaw, back, or neck
- painful or difficult urination
- passing urine more often
- pinpoint red or purple spots on skin
- pounding in the ears
- rapid weight gain
- redness of the face, neck, arms, and occasionally, upper chest
- shakiness and unsteady walk
- shortness of breath
- shuffling walk
- slow speech
- slurred speech
- sore throat
- sores, ulcers, or white spots on lips or in mouth
- stiffness of limbs
- sudden loss of consciousness
- swelling of face, ankles, legs, or hands
- swollen glands
- talking, feeling, and acting with excitement
- trouble in holding or releasing urine
- trouble sleeping
- twisting movements of body
- unable to sleep
- uncontrolled movements, especially of face, neck, and back
- unpleasant breath odor
- unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination
- unusual behavior
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood
- weakness in arms, hands, legs, or feet
- weight gain or loss
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking imipramine:Symptoms of overdose
- Bluish color of fingernails, lips, skin, palms, or nail beds
- change in consciousness
- cold clammy skin
- decreased awareness or responsiveness
- difficult or troubled breathing
- difficulty sleeping
- drowsiness to profound coma
- fast, weak pulse
- hallucination increased or excessive unconscious or jerking movements
- irregular, fast, slow, or shallow breathing
- loss of consciousness
- mood or other mental changes
- muscle stiffness or tightness
- pale or blue lips, fingernails, or skin
- severe sleepiness
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
- Abdominal cramps
- bigger, dilated, or enlarged pupils (black part of eye)
- black tongue
- decreased interest in sexual intercourse
- difficulty having a bowel movement (stool)
- disturbance of accommodation
- enlargement of the breast
- hair loss, thinning of hair
- hives or welts
- inability to have or keep an erection
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- increased sensitivity of eyes to light
- increased sensitivity of skin to sunlight
- increased urge to urinate during the night
- loss in sexual ability, desire, drive, or performance
- pain or discomfort in chest, upper stomach, or throat
- peculiar taste
- redness or other discoloration of skin
- severe sunburn
- small red or purple spots on skin
- swelling of testicles
- swelling of the breasts or breast soreness in both females and males
- swelling or inflammation of the mouth
- swollen, painful, or tender lymph glands on side of face or neck
- unexpected or excess milk flow from breasts
- waking to urinate at night
For Healthcare Professionals
Applies to imipramine: compounding powder, intramuscular solution, oral capsule, oral tablet
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 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 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 side effects have included mania, hypomania, suicidal ideation, paradoxical aggressiveness, mental status changes, and worsening of other psychiatric illnesses.
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).
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.
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 side effects have included rare instances of reversible agranulocytosis and eosinophilia.
Endocrinologic side effects are rare and have included hypoglycemia and hyponatremia (in association with the syndrome of inappropriate secretion of antidiuretic hormone).
Hepatic side effects are rare and have included elevated liver function tests, drug-induced hepatitis, and acute hepatic failure.
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.
More about Tofranil-PM (imipramine)
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