Tofranil-PM Side Effects

Generic name: imipramine

Medically reviewed by Drugs.com. Last updated on Mar 2, 2025.

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.

Precautions

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects. Blood tests may be needed to check for any unwanted effects. Check with your doctor right away if you start having a fever or sore throat while taking this medicine.

Do not take imipramine (the active ingredient contained in Tofranil-PM) with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®, or tranylcypromine [Parnate®]). Do not start taking imipramine during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping imipramine before you start taking a MAO inhibitor. If you do take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Imipramine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Imipramine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use imipramine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), methylene blue injection, tryptophan, St. John's wort, or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with imipramine.

Do not suddenly Stop taking imipramine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This will decrease the chance of having withdrawal symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking imipramine together with medicines used during surgery may increase the risk of side effects.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine may cause some people to become drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Tofranil-PM

Along with its needed effects, imipramine 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:

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:

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]

See also:

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.

Medical Disclaimer