Endep Side Effects

Generic Name: amitriptyline

Note: This page contains information about the side effects of amitriptyline. Some of the dosage forms included on this document may not apply to the brand name Endep.

Not all side effects for Endep may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to amitriptyline: oral tablet

In addition to its needed effects, some unwanted effects may be caused by amitriptyline (the active ingredient contained in Endep). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking amitriptyline:

Incidence not known
  • Abdominal or stomach pain
  • agitation
  • black, tarry stools
  • bleeding gums
  • blood in urine or stools
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in consciousness
  • changes in patterns and rhythms of speech
  • chest pain or discomfort
  • chills
  • cold sweats
  • coma
  • confusion
  • confusion about identity, place, and time
  • continuing ringing, buzzing, or other unexplained noise in ears
  • convulsions
  • cool, pale skin
  • cough or hoarseness
  • dark urine
  • decrease in frequency of urination
  • decrease in urine volume
  • decreased urine output
  • difficulty in breathing
  • difficulty in passing urine (dribbling)
  • difficulty in speaking
  • disturbance of accommodation
  • disturbed concentration
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • double vision
  • drooling
  • dry mouth
  • excitement
  • fainting
  • false beliefs that cannot be changed by facts
  • fast, slow, or irregular heartbeat
  • fear or nervousness
  • fever with or without chills
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of tiredness or weakness
  • headache
  • hearing loss
  • high fever
  • high or low blood pressure
  • hostility
  • inability to move arms, legs, or facial muscles
  • inability to speak
  • increased hunger
  • increased need to urinate
  • increased ocular pressure
  • increased sweating
  • increased thirst
  • increased urination
  • irritability
  • lack of coordination
  • lethargy
  • light-colored stools
  • lip smacking or puckering
  • loss of appetite
  • loss of balance control
  • loss of bladder control
  • loss of consciousness
  • lower back or side pain
  • mental depression or anxiety
  • muscle spasm or jerking of all extremities
  • muscle tightness
  • muscle trembling, jerking, or stiffness
  • muscle twitching
  • nausea and vomiting
  • nightmares or unusually vivid dreams
  • overactive reflexes
  • painful or difficult urination
  • passing urine more often
  • pinpoint red spots on skin
  • poor coordination
  • pounding in the ears
  • puffing of cheeks
  • rapid or worm-like movements of tongue
  • rapid weight gain
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • seizures
  • severe muscle stiffness
  • shakiness and unsteady walk
  • shivering
  • shortness of breath
  • shuffling walk
  • sleeplessness
  • slow speech
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • stiffness of limbs
  • stupor
  • sudden loss of consciousness
  • sweating
  • swelling of face, ankles, or hands
  • swelling or puffiness of face
  • swollen glands
  • talking or acting with excitement you cannot control
  • trouble in speaking
  • trouble sleeping
  • troubled breathing
  • twisting movements of body pain or discomfort in arms, jaw, back, or neck
  • unable to sleep
  • uncontrolled chewing movements
  • uncontrolled movements, especially of arms, face, neck, back, and legs
  • unexplained weight loss
  • unpleasant breath odor
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusually pale skin
  • upper right abdominal pain
  • vomiting of blood
  • weakness in arms, hands, legs, or feet
  • weight gain or loss
  • yellow eyes and skin

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

Symptoms of Overdose
  • Clumsiness
  • drowsiness
  • low body temperature
  • muscle aches
  • muscle weakness
  • sleepiness
  • tiredness
  • weak or feeble pulse

Some of the side effects that can occur with amitriptyline may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known
  • Bigger, dilated, or enlarged pupils (black part of eye)
  • black tongue
  • bloating
  • breast enlargement in females
  • constipation
  • decreased interest in sexual intercourse
  • diarrhea
  • hair loss, thinning of hair
  • hives or welts
  • inability to have or keep an erection
  • increased in sexual ability, desire, drive, or performance
  • increased interest in sexual intercourse
  • increased sensitivity of eyes to light
  • loss in sexual ability, desire, drive, or performance
  • loss of sense of taste
  • redness or other discoloration of skin
  • severe sunburn
  • skin rash
  • swelling of testicles
  • swelling of the breasts or breast soreness in males
  • swelling of the parotid glands
  • swelling or inflammation of the mouth
  • unexpected or excess milk flow from breasts

For Healthcare Professionals

Applies to amitriptyline: compounding powder, intramuscular solution, oral tablet

Other

Anticholinergic effects have been reported in more than 50% of patients taking amitriptyline (the active ingredient contained in Endep) and include dry mouth, blurry vision, constipation and urinary retention. In one study, anticholinergic and antimuscarinic side effects occurred in 84% of patients.[Ref]

Nervous system

Some investigators have estimated an incidence of 4 to 5 tricyclic- induced seizures per 1,000 treated patients.

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]

Nervous system side effects are among the most common. Drowsiness, dizziness, sedation and fatigue occur commonly. Delirium, tinnitus, sleep abnormalities, cognitive impairment (especially in the elderly), a tardive dyskinesia- like syndrome, dystonic reactions and seizures have also been reported.[Ref]

Cardiovascular

Cardiovascular side effects have included orthostatic hypotension, tachycardia, QRS widening, conduction abnormalities, malignant arrhythmias, and malignant hypertension. Very rare cases of cardiomyopathy have also been reported.[Ref]

Both antiarrhythmic and proarrhythmic effects have been associated with the use of tricyclic antidepressant therapy. Caution is recommended if amitriptyline must be used in patients with cardiovascular disease.[Ref]

Psychiatric

Psychiatric side effects associated with the use of amitriptyline (the active ingredient contained in Endep) have included hypomania and visual hallucinations. Suicidal ideation, paradoxical aggressiveness, and mental status changes have also been reported with use of this and other tricyclic antidepressants.[Ref]

Gastrointestinal

Gastrointestinal side effects are most likely due to the anticholinergic properties of the drug and commonly include dry mouth (79%) and constipation (55%). Nausea, vomiting, and diarrhea have also been reported. In addition, ischemic colitis has been associated with the use of amitriptyline (the active ingredient contained in Endep) [Ref]

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 2.5 times more frequently in patients receiving amitriptyline.[Ref]

General

Increased appetite and weight gain have been associated with use of amitriptyline (the active ingredient contained in Endep) [Ref]

Other

Withdrawal symptoms, including nervousness, anxiety, restlessness, akathisia, nausea, malaise, sweating and salivation have been reported after abrupt discontinuation of other tricyclic antidepressants.[Ref]

Genitourinary

Genitourinary side effects have included urinary retention and sexual dysfunction (including decreased penile circumference and decreased amplitude and duration of nocturnal erections).[Ref]

Hematologic

Hematologic side effects are rare. Cases of reversible agranulocytosis and eosinophilia have been rarely associated with use of tricyclic antidepressants.[Ref]

Endocrine

Endocrinologic problems associated with the use of amitriptyline (the active ingredient contained in Endep) are rare, and include hyponatremia in association with the syndrome of inappropriate secretion of antidiuretic hormone.[Ref]

Hepatic

Hepatic side effects are rare. Elevated liver function tests, drug-induced hepatitis, and acute hepatic necrosis have been rarely reported.[Ref]

Dermatologic

Dermatologic side effects have included rare cases of rashes and a single report of erythema annulare centrifigum.[Ref]

Immunologic

Immunologic side effects of amitriptyline (the active ingredient contained in Endep) have included rare associated cases of a lupoid- like reaction.[Ref]

References

1. Judd FK, Moore K, Norman TR, Burrows GD, Gupta RK, Parker G "A multicentre double blind trial of fluoxetine versus amitriptyline in the treatment of depressive illness." Aust N Z J Psychiatry 27 (1993): 49-55

2. Mattila M, Saarialho-Kere U, Mattila M "Acute effects of sertraline, amitriptyline, and placebo on the psychomotor performance of healthy subjects over 50 years of age." J Clin Psychiatry 49 Suppl (1988): 52-8

3. Robinson DS, Nies A, Corcella J, Cooper TB, Spencer C, Kefover R "Cardiovascular effects of phenelzine and amitriptyline in depressed outpatients." J Clin Psychiatry 43 (1982): 8-15

4. Reimherr F, Chouinard G, Cohn C, et al. "Antidepressant efficacy of sertraline: A double blind, placebo- and amitriptyline-controlled, multicenter comparison study in outpatients with major depression." J Clin Psychiatry 51 Suppl B (1990): 18-27

5. Bryant SG, Fisher S, Kluge RM "Long-term versus short-term amitriptyline side effects as measured by a postmarketing surveillance system." J Clin Psychopharmacol 7 (1987): 78-82

6. Remick RA, Campos PE, Misri S, Miles JE, Van Wyck, Fleet J "A comparison of the safety and efficacy of buproprion HCL and amitriptyline HCL in depressed outpatients." Prog Neuropsychopharmacol Biol Psychiatry 6 (1982): 523-7

7. Ophoven AV, Hertle L "LONG-TERM RESULTS OF AMITRIPTYLINE TREATMENT FOR INTERSTITIAL CYSTITIS." J Urol 174 (2005): 1837-1840

8. Lowry MR, Dunner FJ "Seizures during tricyclic therapy." Am J Psychiatry 137 (1980): 1461-2

9. Woogen S, Graham J, Angrist B "A tardive dyskinesia-like syndrome after amitriptyline treatment." J Clin Psychopharmacol 1 (1981): 34-6

10. Finder E, Lin K-M, Ananth J "Dystonic reaction to amitriptyline." Am J Psychiatry 139 (1982): 1220

11. Preskorn SH, Fast GA "Tricyclic antidepressant-induced seizures and plasma drug concentration." J Clin Psychiatry 53 (1992): 160-2

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

13. Feder R "Tinnitus associated with amitriptyline." J Clin Psychiatry 51 (1990): 85-6

14. Preskorn SH, Simpson S "Tricyclic-antidepressant-induced delirium and plasma drug concentration." Am J Psychiatry 139 (1982): 822-3

15. Guy W, McEvoy JM, Ban TA, Wilson WH, Pate K "A double-blind clinical trial of mianserin versus amitriptyline: differentiation by adverse symptomatology." Pharmacotherapy 3 (1983): 45-51

16. Christensen P, Thomsen HY, Pedersen OL, et al "Cardiovascular effects of amitriptyline in the treatment of elderly depressed patients." Psychopharmacology (Berl) 87 (1985): 212-5

17. Dunn FG "Malignant hypertension associated with use of amitriptyline hydrochloride." South Med J 75 (1982): 1124-5

18. Veith RC, Bloom V, Bielski R, Friedel RO "ECG effects of comparable plasma concentrations of desipramine and amitriptyline." J Clin Psychopharmacol 2 (1982): 394-8

19. Henry JF, Altamura C, Gomeni R, Hervy MP, Forette F, Morselli PL "Pharmacokinetics of amitriptyline in the elderly." Int J Clin Pharmacol Ther Toxicol 19 (1981): 1-5

20. Holmes VF, Fricchione GL "Hypomania in an AIDS patient receiving amitriptyline for neuropathic pain." Neurology 39 (1989): 305

21. Hemmingsen R, Rafaelsen OJ "Hypnagogic and hypnopompic hallucinations during amitriptyline treatment." Acta Psychiatr Scand 62 (1980): 364-8

22. 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

23. Gollock JM, Thomson JP "Ischaemic colitis associated with psychotropic drugs." Postgrad Med J 60 (1984): 564-5

24. Berken GH, Weinstein DO, Stern WC "Weight gain: a side-effect of tricyclic antidepressants." J Affect Disord 7 (1984): 133-8

25. Kazes M, Danion JM, Grange D, Pradignac A, Simon C, Burrusmehl F, Schlienger JL, Singer L "Eating behaviour and depression before and after antidepressant treatment - a prospective, naturalistic study." J Affect Disord 30 (1994): 193-207

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

27. Patterson JF "Psychosis after discontinuation of nortriptyline." J Clin Psychopharmacol 4 (1984): 117-8

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

29. Kowalski A, Stanley RO, Dennerstein L, Burrows G, Maguire KP "The sexual side-effects of antidepressant medication: a double-blind comparison of two antidepressants in a non-psychiatric population." Br J Psychiatry 147 (1985): 413-8

30. Draper BM, Manoharan A "Neutropenia with cross-intolerance between two tricyclic antidepressant agents." Med J Aust 146 (1987): 452-3

31. 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

32. Henkin Y, Kaplan Z, Alkan M "Psychiatric presentation of hyponatremia associated with the use of amitriptyline: a report of two cases." Isr J Med Sci 25 (1989): 587-9

33. Danan G, Bernuau J, Moullot X, Degott C, Pessayre D "Amitriptyline-induced fulminant hepatitis." Digestion 30 (1984): 179-84

34. Larrey D, Amouyal G, Pessayre D, et al "Amitriptyline-induced prolonged cholestasis." Gastroenterology 94 (1988): 200-3

35. GarciaDoval I, Peteiro C, Toribio J "Amitriptyline-induced erythema annulare centrifugum." Cutis 63 (1999): 35-6

36. Dove FB "Drug-induced lupus." Hosp Pract (Off Ed) 28 (1993): 14

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
(web3)