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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.
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.
You should not use this medicine if you are allergic to amitriptyline, or:
if you have recently had a heart attack.
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.
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.
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.
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.
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.
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.
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.
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.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Amitriptyline Hcl (www.drugs.com/amitriptyline.html).
Applies to amitriptyline: oral tablet
Oral route (Tablet)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients.
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
Get emergency help immediately if any of the following symptoms of overdose occur while taking amitriptyline:
Symptoms of Overdose
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
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
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Amitriptyline Hcl (www.drugs.com/amitriptyline.html).
July 13, 2020
July 13, 2020
July 13, 2020
July 13, 2020
July 13, 2020
June 26, 2020
