Amitriptyline is used to treat symptoms of depression. It works on the central nervous system (CNS) to increase levels of certain chemicals in the brain. This medicine is a tricyclic antidepressant (TCA).

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a medication guide. Read and follow the instructions in the guide carefully. Ask your doctor if you have any questions.

Along with its needed effects, a medicine 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:

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:

Symptoms of Overdose

Clumsiness

drowsiness

low body temperature

muscle aches

muscle weakness

sleepiness

tiredness

weak or feeble pulse

Some side effects 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

Amitriptyline may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

Do not take amitriptyline if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks. Do not start taking a MAO inhibitor within 5 days of stopping amitriptyline. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.

Do not take other medicines unless they have been discussed with your doctor. Using this medicine together with cisapride (Propulsid®), may increase the chance of having serious side effects.

Do not suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as headache, nausea, or a general feeling of discomfort or illness.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop taking this medicine. Check with your doctor before taking any of the above while you are using this medicine.

Before having any kind of surgery, tell the medical doctor in charge that you are using this medicine. Taking amitriptyline together with medicines used during surgery may increase the risk of side effects.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

This medicine may cause some people to become drowsy. Make sure you know how you react to this medicine before you drive, use medicines, or do anything else that could be dangerous if you are drowsy or not alert .