Amitriptyline Side Effects
Some side effects of amitriptyline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to amitriptyline: oral tablet
Along with its needed effects, amitriptyline 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 amitriptyline:Incidence not known
- Abdominal or stomach pain
- 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
- cold sweats
- confusion about identity, place, and time
- continuing ringing, buzzing, or other unexplained noise in ears
- 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
- dry mouth
- 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
- hearing loss
- high fever
- high or low blood pressure
- 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
- lack of coordination
- 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
- seeing, hearing, or feeling things that are not there
- severe muscle stiffness
- shakiness and unsteady walk
- shortness of breath
- shuffling walk
- slow speech
- slurred speech
- sore throat
- sores, ulcers, or white spots on lips or in mouth
- stiffness of limbs
- sudden loss of consciousness
- 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
Get emergency help immediately if any of the following symptoms of overdose occur while taking amitriptyline:Symptoms of Overdose
- low body temperature
- muscle aches
- muscle weakness
- weak or feeble pulse
Some side effects of amitriptyline 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 eye)
- black tongue
- breast enlargement in females
- decreased interest in sexual intercourse
- 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
Anticholinergic effects have been reported in more than 50% of patients taking amitriptyline and include dry mouth, blurry vision, constipation and urinary retention. In one study, anticholinergic and antimuscarinic side effects occurred in 84% of patients.
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.
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.
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.
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.
Psychiatric side effects associated with the use of amitriptyline 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.
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.
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.
Increased appetite and weight gain have been associated with use of amitriptyline.
Withdrawal symptoms, including nervousness, anxiety, restlessness, akathisia, nausea, malaise, sweating and salivation have been reported after abrupt discontinuation of other tricyclic antidepressants.
Genitourinary side effects have included urinary retention and sexual dysfunction (including decreased penile circumference and decreased amplitude and duration of nocturnal erections).
Hematologic side effects are rare. Cases of reversible agranulocytosis and eosinophilia have been rarely associated with use of tricyclic antidepressants.
Endocrinologic problems associated with the use of amitriptyline are rare, and include hyponatremia in association with the syndrome of inappropriate secretion of antidiuretic hormone.
Hepatic side effects are rare. Elevated liver function tests, drug-induced hepatitis, and acute hepatic necrosis have been rarely reported.
Dermatologic side effects have included rare cases of rashes and a single report of erythema annulare centrifigum.
Immunologic side effects of amitriptyline have included rare associated cases of a lupoid- like reaction.
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