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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.

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
  • agitation
  • 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 the ears
  • cough or hoarseness
  • dark urine
  • decrease in the frequency of urination
  • difficulty in passing urine (dribbling)
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • double vision
  • dry mouth
  • false beliefs that cannot be changed by facts
  • fast, pounding, or irregular heartbeat or pulse
  • 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
  • general feeling of tiredness or weakness
  • hearing loss
  • hostility
  • hyperventilation
  • inability to move the arms, legs, or facial muscles
  • irritability
  • itching or rash
  • lack of coordination
  • lethargy
  • 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
  • nightmares
  • pain or discomfort in the arms, jaw, back, or neck
  • painful or difficult urination
  • pinpoint red or purple spots on the skin
  • rapid weight gain
  • redness of the face, neck, arms, and occasionally, upper chest
  • restlessness
  • seizures
  • shakiness and unsteady walk
  • slow speech
  • sore throat
  • stiffness of the limbs
  • stupor
  • sweating
  • swelling of the face, ankles, legs, or hands
  • talking, feeling, and acting with excitement
  • trouble sleeping
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back
  • unusual behavior
  • unusual tiredness or weakness
  • weakness in the arms, hands, legs, or feet
  • 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
  • cold, clammy skin
  • decreased awareness or responsiveness
  • difficult or troubled breathing
  • disorientation
  • fast, weak pulse
  • hallucinations
  • irregular, fast, slow, or shallow breathing
  • 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

  • Bigger, dilated, or enlarged pupils (black part of the eye)
  • black tongue
  • decreased interest or ability in sexual intercourse
  • difficulty having a bowel movement (stool)
  • enlargement of the breast
  • hives or welts
  • increase in sexual ability, desire, drive, or performance
  • increased sensitivity of the eyes to light
  • increased urge to urinate during the night
  • peculiar taste
  • redness or other discoloration of the skin
  • severe sunburn
  • swelling of the testicles
  • swelling of the breasts or breast soreness in both females and males
  • swollen, painful, or tender lymph glands on the side of the face or neck
  • unexpected or excess milk flow from the breasts
  • waking to urinate at night

For Healthcare Professionals

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

General

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

Hypersensitivity

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

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

Psychiatric

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]

Cardiovascular

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]

Hepatic

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]

Endocrine

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

Frequency not reported: Gynecomastia[Ref]

Hematologic

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

Gastrointestinal

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]

Metabolic

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]

Dermatologic

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]

Other

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]

Genitourinary

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]

Ocular

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]

Respiratory

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

Frequency not reported: Respiratory depression[Ref]

Musculoskeletal

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

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Tofranil (imipramine)." Novartis Pharmaceuticals, East Hanover, NJ.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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.

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