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

Other

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) [Ref]

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.[Ref]

Nervous system

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.[Ref]

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.[Ref]

Cardiovascular

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.[Ref]

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.[Ref]

Psychiatric

Psychiatric side effects have included mania, hypomania, suicidal ideation, paradoxical aggressiveness, mental status changes, and worsening of other psychiatric illnesses.[Ref]

Gastrointestinal

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) [Ref]

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).[Ref]

Other

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.[Ref]

Genitourinary

Genitourinary problems have included urinary retention and male and female sexual dysfunction.[Ref]

One study of patients treated with various antidepressants has reported that 16 of 29 patients treated with imipramine admitted to sexual dysfunction. Decreased libido, more time reaching orgasm and difficulty reaching orgasm were cited as the most common dysfunctions.[Ref]

Hematologic

Hematologic side effects have included rare instances of reversible agranulocytosis and eosinophilia.[Ref]

Endocrine

Endocrinologic side effects are rare and have included hypoglycemia and hyponatremia (in association with the syndrome of inappropriate secretion of antidiuretic hormone).[Ref]

Hepatic

Hepatic side effects are rare and have included elevated liver function tests, drug-induced hepatitis, and acute hepatic failure.[Ref]

Dermatologic

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.[Ref]

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.[Ref]

References

1. Gershon S "Comparative side effect profiles of trazodone and imipramine: special reference to the geriatric population." Psychopathology 17 (1984): 39-50

2. Feighner JP, Cohn JB, Fabre LF, Jr Fieve RR, Mendels J, Shrivastava RK, Dunbar GC "A study comparing paroxetine placebo and imipramine in depressed patients." J Affect Disord 28 (1993): 71-9

3. Claghorn JL, Feighner JP "A double-blind comparison of paroxetine with imipramine in the long-term treatment of depression." J Clin Psychopharmacol 13 (1993): S23-7

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

5. Bakish D, Lapierre YD, Weinstein R, Klein J, Wiens A, Jones B, Horn E, Browne M, Bourget D, Blanchard A, Thibaudeau C, Waddell "Ritanserin, imipramine, and placebo in the treatment of dysthymic disorder." J Clin Psychopharmacol 13 (1993): 409-14

6. Lauritzen L, Bendsen BB, Vilmar T, Bendsen EB, Lunde M, Bech P "Post-stroke depression - combined treatment with imipramine or desipramine and mianserin - a controlled clinical study." Psychopharmacology (Berl) 114 (1994): 119-22

7. Ritch R, Krupin T, Henry C, Kurata F "Oral imipramine and acute angle closure glaucoma." Arch Ophthalmol 112 (1994): 67-8

8. Racy J, Ward-Racy EA "Tinnitus in imipramine therapy." Am J Psychiatry 137 (1980): 854-5

9. Wilson S, Argyropoulos S "Antidepressants and sleep: a qualitative review of the literature." Drugs 65 (2005): 927-47

10. Schatzberg AF, Cole JO, Blumer DP "Speech blockage: a tricyclic side effect." Am J Psychiatry 135 (1978): 600-1

11. Dekret JJ, Maany I, Ramsey TA, Mendels J "A case of oral dyskinesia associated with imipramine treatment." Am J Psychiatry 134 (1977): 1297-8

12. Garvey MJ, Tollefson GD "Occurrence of myoclonus in patients treated with cyclic antidepressants." Arch Gen Psychiatry 44 (1987): 269-72

13. Merriam AE "Neuroleptic malignant syndrome after imipramine withdrawal ." J Clin Psychopharmacol 7 (1987): 53-4

14. Peck AW, Stern WC, Watkinson C "Incidence of seizures during treatment with tricyclic antidepressant drugs and bupropion." J Clin Psychiatry 44 (1983): 197-201

15. Appelbaum PS, Kapoor W "Imipramine-induced vasospasm: a case report." Am J Psychiatry 140 (1983): 913-5

16. Ramanathan KB, Davidson C "Cardiac arrhythmia and imipramine therapy." Br Med J 1 (1975): 661-2

17. Kantor SJ, Glassman AH, Bigger JT, Jr Perel JM, Giardina EV "The cardiac effects of therapeutic plasma concentrations of imipramine." Am J Psychiatry 135 (1978): 534-8

18. Cohen HW, Gibson G, Alderman MH "Excess risk of myocardial infarction in patients treated with antidepressant medications: association with use of tricyclic agents." Am J Med 108 (2000): 2-8

19. Laird LK, Lydiard RB, Morton WA, Steele TE, Kellner C, Thompson NM, Ballenger JC "Cardiovascular effects of imipramine, fluvoxamine, and placebo in depressed outpatients." J Clin Psychiatry 54 (1993): 224-8

20. Hardoby W "Imipramine and suicidal thoughts ." Am J Psychiatry 149 (1992): 412-3

21. Rampling D "Aggression: a paradoxical response to tricyclic antidepressants." Am J Psychiatry 135 (1978): 117-8

22. Godwin CD "Case report of tricyclic-induced delirium at a therapeutic drug concentration." Am J Psychiatry 140 (1983): 1517-8

23. Kupfer DJ, Carpenter LL, Frank E "Possible role of antidepressants in precipitating mania and hypomania in recurrent depression." Am J Psychiatry 145 (1988): 804-8

24. Peet M "Induction of mania with selective serotonin re-uptake inhibitors and tricyclic antidepressants." Br J Psychiatry 164 (1994): 549-50

25. Dalton SO, Johansen C, Mellemkjaer L, Norgard B, Sorensen HT, Olsen JH "Use of selective serotonin reuptake inhibitors and risk of upper gastrointestinal tract bleeding: a population-based cohort study." Arch Intern Med 163 (2003): 59-64

26. Warnes H, Lehmann HE, Ban TA "Adynamic ileus during psychoactive medication: a report of three fatal and five severe cases." Can Med Assoc J 96 (1967): 1112-3

27. Stern SL, Mendels J "Withdrawal symptoms during the course of imipramine therapy." J Clin Psychiatry 41 (1980): 66-7

28. Sathananthan GL, Gershon S "Imipramine withdrawal: an akathisia-like syndrome." Am J Psychiatry 130 (1973): 1286-7

29. Balon R, Yeragani VK, Pohl R, Ramesh C "Sexual dysfunction during antidepressant treatment." J Clin Psychiatry 54 (1993): 209-12

30. Harrison WM, Rabkin JG, Ehrhardt AA, Stewart JW, McGrath PJ, Ross D, Quitkin FM "Effects of antidepressant medication on sexual function: a controlled study." J Clin Psychopharmacol 6 (1986): 144-9

31. Shrivastava RK, Edwards D "Hypoglycemia associated with imipramine ." Biol Psychiatry 18 (1983): 1509-10

32. Albertini RS, Penders TM "Agranulocytosis associated with tricyclics." J Clin Psychiatry 39 (1978): 483-5

33. Cutler NR, Anderson DJ "Proven asymptomatic eosinophilia with imipramine." Am J Psychiatry 134 (1977): 1296-7

34. Spigset O, hedenmalm K "Hyponatremia in relation to treatment with antidepressants: a survey of reports in the World Health Organization data base for spontaneous reporting of adverse drug reactions." Pharmacotherapy 17 (1997): 348-52

35. Colgate R "Hyponatraemia and inappropriate secretion of antidiuretic hormone associated with the use of imipramine." Br J Psychiatry 163 (1993): 819-22

36. Parker WA "Imipramine-induced syndrome of inappropriate antidiuretic hormone secretion." Drug Intell Clin Pharm 18 (1984): 890-4

37. Mitsch RA, Lee AK "Syndrome of inappropriate antidiuretic hormone with imipramine." Drug Intell Clin Pharm 20 (1986): 787-9

38. Moskovitz R, DeVane CL, Harris R, Stewart RB "Toxic hepatitis and single daily dosage imipramine therapy." J Clin Psychiatry 43 (1982): 165-6

39. Shaefer MS, Edmunds AL, Markin RS, Wood RP, Pillen TJ, Shaw BW, Jr "Hepatic failure associated with imipramine therapy." Pharmacotherapy 10 (1990): 66-9

40. Weaver GA, Pavlinac D, Davis JS "Hepatic sensitivity to imipramine." Am J Dig Dis 22 (1977): 551-3

41. Gautam M "Alopecia due to psychotropic medications." Ann Pharmacother 33 (1999): 631-7

42. Almeyda J "Cutaneous reactions to imipramine and chlordiazepoxide." Br J Dermatol 84 (1971): 298-300

43. Dean CE, Grund FM "Imipramine-associated hyperpigmentation." Ann Pharmacother 37 (2003): 825-8

44. Hashimoto K, Joselow SA, Tye MJ "Imipramine hyperpigmentation: a slate-gray discoloration caused by long-term imipramine administration." J Am Acad Dermatol 25 (1991): 357-61

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web2)