Generic Name: amitriptyline (a mee TRIP ti leen)
Brand Names: Vanatrip, Elavil, Endep
What is amitriptyline?
Amitriptyline is a tricyclic
antidepressant. Amitriptyline affects chemicals in the brain that may be unbalanced in people with depression.
Amitriptyline is used to treat symptoms of
depression.
Amitriptyline may also be used for purposes not listed in this medication guide.
Important information
You should not use this medicine if you have recently had a heart attack.
Do not use amitriptyline if you have used a
MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Before taking amitriptyline, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).
You may have thoughts about suicide when you first start taking an antidepressant such as amitriptyline, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Before taking this medicine
You should not use this medicine if you are allergic to amitriptyline, or:
Do not use amitriptyline if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
To make sure amitriptyline is safe for you, tell your doctor if you have:
bipolar disorder (manic-depression) or schizophrenia;
a history of mental illness or psychosis;
liver disease;
heart disease;
a history of heart attack, stroke, or seizures;
diabetes (amitriptyline may raise or lower blood sugar);
glaucoma; or
problems with urination.
Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
It is not known whether amitriptyline will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
Amitriptyline can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using amitriptyline.
Amitriptyline is not approved for use by anyone younger than 12 years old.
How should I take amitriptyline?
Take amitriptyline exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.
If you need surgery, tell the surgeon ahead of time that you are using amitriptyline. You may need to stop using the medicine for a short time.
Do not stop using amitriptyline suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using amitriptyline.
Store at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amitriptyline can be fatal.
Overdose symptoms may include uneven heartbeats, extreme drowsiness, confusion, agitation, vomiting, hallucinations, feeling hot or cold, muscle stiffness, seizure (convulsions), or fainting.
What should I avoid while taking amitriptyline?
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with amitriptyline.
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid exposure to sunlight or tanning beds. Amitriptyline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Amitriptyline side effects
Get emergency medical help if you have signs of an allergic reaction to amitriptyline: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
unusual thoughts or behavior;
a light-headed feeling, like you might pass out;
chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
pounding heartbeats or fluttering in your chest;
confusion, hallucinations;
a seizure (convulsions);
painful or difficult urination;
severe constipation;
easy bruising, unusual bleeding; or
sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing.
Common amitriptyline side effects may include:
constipation, diarrhea;
nausea, vomiting, upset stomach;
mouth pain, unusual taste, black tongue;
appetite or weight changes;
urinating less than usual;
itching or rash;
breast swelling (in men or women); or
decreased sex drive, impotence, or difficulty having an orgasm.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect amitriptyline?
Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking amitriptyline with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone.
Tell your doctor about all your current medicines and any you start or stop using, especially:
other antidepressants;
cimetidine;
heart rhythm medicine such as flecainide, propafenone, quinidine, and others; or
medicine to treat mental illness.
This list is not complete. Other drugs may interact with amitriptyline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use amitriptyline only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Amitriptyline Side Effects
For the Consumer
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
For Healthcare Professionals
Applies to amitriptyline: compounding powder, intramuscular solution, oral tablet
General
The most commonly reported side effects were tremors, dizziness, headache, dry mouth, constipation, and
nausea.
[Ref]
Nervous system
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
[Ref]
Cardiovascular
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
[Ref]
Gastrointestinal
Common (1% to 10%): Constipation, diarrhea, dry mouth, nausea, tongue edema, vomiting
Frequency not reported: Black tongue, epigastric distress, parotid swelling,
stomatitis[Ref]
Respiratory
Common (1% to 10%): Allergic inflammation of the pulmonary alveoli, allergic inflammation of the lung tissue, alveolitis, congested nose, Loffler's syndrome
[Ref]
Psychiatric
Common (1% to 10%): Aggression, agitation, confusional states, libido decrease
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
[Ref]
Metabolic
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
[Ref]
Genitourinary
Frequency not reported: Breast enlargement, dilation of urinary tract,
impotence, interference with sexual function, testicular swelling,
urinary frequency[Ref]
Ocular
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
[Ref]
Dermatologic
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
[Ref]
Other
Common (1% to 10%): Fatigue
Rare (0.01% to 0.1%): Pyrexia
Frequency not reported: Fever/hyperpyrexia, hyperthermia, malaise, weakness
[Ref]
Hepatic
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
[Ref]
Hematologic
Endocrine
Rare (0.01% to 0.1%): Gynecomastia
Frequency not reported: Syndrome of inappropriate antidiuretic hormone (SIADH) secretion
[Ref]
Immunologic
Musculoskeletal
Frequency not reported: Increased risk of bone fractures,
lupus-like syndrome, migratory arthritis
Postmarketing reports: Muscle rigidity
[Ref]
References
1. Cerner Multum, Inc. "Australian Product Information." O 0
2. "Product Information. Elavil (amitriptyline)." Stuart Pharmaceuticals, Wilmington, DE.
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the
FDA.
GIVEN INFORMATION IS REFERENCE PURPOSE ONLY FOR FURTHER INFORMATION PLEASE CONTACT YOUR DOCTOR
