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Tofranil-PM Side Effects

Generic Name: imipramine

Note: This page contains side effects data for the generic drug imipramine. It is possible that some of the dosage forms included below may not apply to the brand name Tofranil-PM.

It is possible that some side effects of Tofranil-PM may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to imipramine: oral capsule, oral tablet

As well as its needed effects, imipramine (the active ingredient contained in Tofranil-PM) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking imipramine, check with your doctor immediately:

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

If any of the following symptoms of overdose occur while taking imipramine, get emergency help immediately:

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 imipramine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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


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


Very rare (less than 0.01%): Systemic anaphylactic/anaphylactoid reactions[Ref]


Common (1% to 10%): Confusional states (especially in the elderly), hallucinations, disorientation, delusions, anxiety, restlessness, agitation, insomnia, nightmares, hypomania, exacerbation of psychosis, sleep disorders, emotional instability, swings from depression to hypomania or mania
Very rare (less than 0.01%): Aggression[Ref]


Very common (10% or more): Sinus tachycardia, electrocardiogram abnormalities (e.g., ST and T wave changes), hot flushes, orthostatic hypotension
Common (1% to 10%): Arrhythmias, palpitations, conduction disorders (e.g., widening of QRS complex, bundle branch block, PR changes)
Very rare (less than 0.01%): Cardiac failure, QT interval prolongation, ventricular arrhythmia, ventricular tachycardia, ventricular fibrillation, torsades de pointes, hypertension, stroke, vasospasm
Frequency not reported: Myocardial infarction, heart block, precipitation of congestive heart failure, flushing, collapse, cardiac decompensation, peripheral vasospastic reactions[Ref]

Nervous system

Very common (10% or more): Tremors
Common (1% to 10%): Dizziness, headache, somnolence, paraesthesia
Rare (less than 0.1%): Convulsions
Very rare (less than 0.01%): Myoclonus, extrapyramidal disorder, ataxia, speech
disorders, abnormal electroencephalogram, tinnitus
Frequency not reported: Numbness, tingling, incoordination, peripheral neuropathy, seizures, drowsiness, nervousness, syncope[Ref]


Common (1% to 10%): Elevated transaminases
Very rare (less than 0.01%): Hepatitis (with or without jaundice), acute hepatitis, hepatic
Frequency not reported: Jaundice (simulating obstructive), altered liver function[Ref]


Very rare (less than 0.01%): Inappropriate antidiuretic hormone (ADH) secretion syndrome, breast enlargement (female), galactorrhea (female)
Frequency not reported: Gynecomastia (male), increased or decreased libido, impotence, testicular swelling[Ref]


Very rare: (less than 0.01%): Bone marrow depression (including agranulocytosis, eosinophilia, thrombocytopenia, leucopenia), purpura, petechiae[Ref]


Very common (10% or more): Dry mouth, constipation
Common (1% to 10%): Nausea, vomiting
Rare (less than 0.1%): Sublingual adenitis
Very rare (less than 0.01%): Dental caries, ileus paralytic, stomatitis, abdominal disorders, tongue ulceration
Frequency not reported: Epigastric distress, diarrhea, peculiar taste, abdominal cramps, parotid swelling[Ref]


Very common (10% or more): Increased weight
Common (1% to 10%): Anorexia
Very rare (less than 0.01%): Elevation or depression of blood sugar levels, weight loss
Frequency not reported: Hyponatremia[Ref]


Very common (10% or more): Hyperhidrosis
Common (1% to 10%): Skin rash, urticaria, allergic dermatitis
Very rare (less than 0.01%): Pruritus, photosensitivity reactions, alopecia, skin hyperpigmentation[Ref]


Common (1% to 10%): Fatigue
Very rare (less than 0.01%): Asthenia, edema (localized or generalized), pyrexia, sudden death
Frequency not reported: Weakness, proneness to falling, tiredness, drug fever[Ref]


Common (1% to 10%): Micturition disorder
Very rare (less than 0.01%): Urinary retention
Frequency not reported: Dilation of the urinary tract, urinary frequency[Ref]


Common (1% to 10%): Blurred vision, disturbances of accommodation, decreased lacrimation
Very rare (less than 0.01%): Mydriasis, glaucoma[Ref]


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


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


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

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