Tofranil-PM Side Effects

Generic name: imipramine

Medically reviewed by Drugs.com. Last updated on Apr 14, 2024.

Note: This document provides detailed information about Tofranil-PM Side Effects associated with imipramine. Some dosage forms listed on this page may not apply specifically to the brand name Tofranil-PM.

Applies to imipramine: oral capsule, oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

In short-term studies, antidepressants increased the risk of suicidal thinking and behavior compared with placebo in children, adolescents, and young adults with psychiatric disorders, including major depressive disorder (MDD); there was not an increased risk of suicidality with antidepressants in adults older than 24 years and there was a decreased risk in adults aged 65 years or older.

The risk of suicidal thinking and behavior should be balanced with the clinical need for therapy and patients should be monitored closely; instruct families and caregivers to communicate any changes in behavior with the prescriber.

Not approved for use in pediatric patients.

Oral route (capsule)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders.

This risk must be balanced with the clinical need.

Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.

Monitor all patients closely for clinical worsening, suicidality, or unusual changes in behavior.

Families and caregivers should be advised of the need for close observation and communication with the prescriber.

Imipramine pamoate is not approved for use in pediatric patients.

Serious side effects of Tofranil-PM

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

Other side effects of Tofranil-PM

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 adverse events

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]

Further information

Tofranil-PM side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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