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
• 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

Get emergency help immediately if any of the following symptoms of overdose occur while taking amitriptyline:

Symptoms of Overdose

• Clumsiness
• drowsiness
• low body temperature
• muscle aches
• muscle weakness
• sleepiness
• tiredness
• 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
• 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

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

The most commonly reported side effects were tremors, dizziness, headache, dry mouth, constipation, and nausea.

Common (1% to 10%): Ataxia, disturbance in attention, dizziness, dysarthria/speech disorders, dysgeusia, drowsiness, headache, paresthesia, somnolence, tremors

Uncommon (0.1% to 1%): Convulsions

Very rare (less than 0.01%): Akathisia, polyneuropathy

Frequency not reported: Abnormal voluntary movements, ageusia, alteration in cognition, alteration in electroencephalogram patterns, anticholinergic effects, autonomic nervous system function alterations, coma, disturbed concentration, extrapyramidal effects, extremity paresthesia, incoordination, neuromuscular activity alterations, numbness, peculiar taste, peripheral neuropathy, seizures, serotonin syndrome, stroke, syncope, tardive dyskinesia, tingling

Postmarketing reports: Neuroleptic malignant syndrome

Common (1% to 10%): Atrioventricular (AV) block, bundle branch block, electrocardiogram (ECG) abnormal, electrocardiogram QRS complex prolonged, electrocardiogram QT prolonged, orthostatic hypotension, palpitations, tachycardia

Uncommon (0.1% to 1%): Collapse conditions, hypertension, worsening of cardiac failure

Rare (0.01% to 0.1%): Arrhythmias

Very rare (less than 0.01%): Cardiomyopathies, torsade de pointes

Frequency not reported: Changes in AV conduction, edema, heart block, hypersensitivity myocarditis, hypotension, myocardial infarction, nonspecific ECG changes

Common (1% to 10%): Constipation, diarrhea, dry mouth, nausea, tongue edema, vomiting

Rare (0.01% to 0.1%): Paralytic ileus, salivary gland enlargement

Frequency not reported: Black tongue, epigastric distress, parotid swelling, stomatitis

Common (1% to 10%): Allergic inflammation of the pulmonary alveoli, allergic inflammation of the lung tissue, alveolitis, congested nose, Loffler's syndrome

Common (1% to 10%): Aggression, agitation, confusional states, libido decrease

Uncommon (0.1% to 1%): Anxiety, hypomania, insomnia, mania, nightmares

Rare (0.01% to 0.1%): Delirium (in elderly patients), hallucinations (in schizophrenic patients), suicidal behavior, suicidal thoughts

Frequency not reported: Behavioral changes, delusions, disorientation, dream disturbances, excitement, increased libido, irritability, libido fluctuations, nightmares, paranoia, restlessness, sleep disturbances

Postmarketing reports: Mental status changes

Common (1% to 10%): Hyponatremia, thirst, weight increased

Rare (0.01% to 0.1%): Blood alkaline phosphatase increased, decreased appetite, weight decreased

Frequency not reported: Anorexia, blood sugar level elevation/lowering, increased appetite

Common (1% to 10%): Erectile dysfunction, micturition disorders

Frequency not reported: Breast enlargement, dilation of urinary tract, impotence, interference with sexual function, testicular swelling, urinary frequency

Common (1% to 10%): Accommodation disorder, mydriasis

Uncommon (0.1% to 1%): Intraocular pressure increased

Very rare (less than 0.01%): Acute glaucoma

Frequency not reported: Blurred vision, disturbance in accommodation, increased intraocular pressure

Common (1% to 10%): Hyperhidrosis

Uncommon (0.1% to 1%): Face edema, rash/skin rash, urticaria

Rare (0.01% to 0.1%): Alopecia, photosensitivity reaction

Frequency not reported: Diaphoresis, increased perspiration, itching/pruritus, mild sweating, photosensitization

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Tinnitus

Rare (0.01% to 0.1%): Pyrexia

Frequency not reported: Fever/hyperpyrexia, hyperthermia, malaise, weakness

Uncommon (0.1% to 1%): Cholestatic liver disease, hepatic impairment

Rare (0.01% to 0.1%): Jaundice, liver function test abnormal, transaminases increased

Frequency not reported: Altered liver function, hepatic failure, hepatitis

Rare (0.01% to 0.1%): Agranulocytosis, bone marrow depression, eosinophilia, leukopenia, purpura, thrombocytopenia

Rare (0.01% to 0.1%): Gynecomastia

Frequency not reported: Syndrome of inappropriate antidiuretic hormone (SIADH) secretion

Frequency not reported: Positive antinuclear antibodies (ANA), positive rheumatoid factor

Frequency not reported: Increased risk of bone fractures, lupus-like syndrome, migratory arthritis

Postmarketing reports: Muscle rigidity