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Etrafon Side Effects

Generic Name: amitriptyline / perphenazine

Note: This document contains side effect information about amitriptyline / perphenazine. Some of the dosage forms listed on this page may not apply to the brand name Etrafon.

For the Consumer

Applies to amitriptyline / perphenazine: oral tablet

Along with its needed effects, perphenazine (included in this combination medicine) can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. These include severe muscle stiffness, fever, unusual tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, and seizures (neuroleptic malignant syndrome). You and your doctor should discuss the good this medicine will do as well as the risks of taking it.

Stop taking amitriptyline / perphenazine and get emergency help immediately if any of the following effects occur:

Rare
  • Convulsions (seizures)
  • difficulty in breathing
  • fast heartbeat
  • fever
  • high or low blood pressure
  • increased sweating
  • loss of bladder control
  • muscle stiffness (severe)
  • unusual tiredness or weakness
  • unusually pale skin

Check with your doctor as soon as possible if any of the following side effects occur while taking amitriptyline / perphenazine:

More common
  • Blurred vision or any change in vision
  • difficulty in speaking or swallowing
  • fainting
  • inability to move eyes
  • lip smacking or puckering
  • loss of balance control
  • mask-like face
  • muscle spasms, especially of face, neck, and back
  • nervousness, restlessness, or need to keep moving
  • puffing of cheeks
  • rapid or fine, worm-like movements of tongue
  • shuffling walk
  • stiffness of arms and legs
  • trembling and shaking of fingers and hands
  • tic-like or twitching movements
  • twisting movements of body
  • uncontrolled chewing movements
  • uncontrolled movements of arms or legs
  • weakness of arms and legs
Less common
  • Confusion
  • constipation
  • difficult urination
  • eye pain
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • increased skin sensitivity to sun
  • shakiness
  • slow pulse or irregular heartbeat
Rare
  • Abdominal or stomach pain
  • aching muscles or joints
  • back or leg pain
  • fever and chills
  • hair loss
  • hot, dry skin or lack of sweating
  • irritability
  • loss of appetite
  • muscle weakness or twitching
  • nausea, vomiting, or diarrhea
  • nosebleeds
  • prolonged, painful, inappropriate penile erection
  • ringing, buzzing, or other unexplained noises in ears
  • skin discoloration
  • skin rash and itching
  • sore throat and fever
  • swelling of face and tongue
  • swelling of testicles
  • unusual bleeding or bruising
  • yellow eyes or skin
Symptoms of overdose
  • Agitation
  • confusion
  • convulsions (seizures)
  • drowsiness (severe)
  • enlarged pupils
  • fast, slow, or irregular heartbeat
  • fever
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • shortness of breath or troubled breathing
  • unusual tiredness or weakness (severe)
  • vomiting (severe)

Some side effects of amitriptyline / perphenazine 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:

More common
  • Decreased sweating
  • dizziness
  • drowsiness
  • dryness of mouth
  • headache
  • increased appetite for sweets
  • nasal congestion
  • tiredness or weakness (mild)
  • unpleasant taste
  • weight gain (unusual)
Less common
  • Changes in menstrual period
  • decreased sexual ability
  • heartburn
  • increased sweating
  • swelling or pain in breasts or unusual secretion of milk

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Dizziness
  • nausea or vomiting
  • stomach pain
  • trembling of fingers and hands
  • symptoms of tardive dyskinesia, including lip smacking or puckering, puffing of cheeks, rapid or fine, worm-like movements of tongue, uncontrolled chewing movements, or uncontrolled movements of arms or legs

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Diarrhea
  • headache
  • irritability
  • restlessness
  • trouble in sleeping, with vivid dreams
  • unusual excitement

For Healthcare Professionals

Applies to amitriptyline / perphenazine: oral tablet

General

The most commonly reported side effects included sedation, dry mouth, and hypertension.[Ref]

Nervous system

Frequency not reported: Neurological impairments, sedation

Amitriptyline:
Frequency not reported: Altered electroencephalogram patterns, ataxia, coma, disturbed concentration, dizziness, drowsiness, dysarthria, extrapyramidal symptoms, extremity paresthesia, headache, incoordination, numbness, peculiar taste, peripheral neuropathy, seizures, stroke, tingling, tremors

Perphenazine:
Frequency not reported: Acute dyskinesia, akathisia, altered cerebrospinal fluid proteins, ataxia, cerebral edema, dystonia, extrapyramidal symptoms, grand mal convulsions, headache, hyperreflexia, hypnotic effects, motor restlessness, pseudoparkinsonism, tardive dyskinesia[Ref]

Cardiovascular

Frequency not reported: Hypertension

Amitriptyline:
Frequency not reported: Arrhythmias, edema, heart block, hypertension, hypotension, myocardial infarction orthostatic hypotension, palpitation, tachycardia

Perphenazine:
Frequency not reported: ECG abnormalities/quinidine-like effect, hypertension, hypotension, occasional change in pulse rate, peripheral edema, reversed epinephrine effect, tachycardia[Ref]

Gastrointestinal

Frequency not reported: Dry mouth

Amitriptyline:
Frequency not reported: Black tongue, constipation, diarrhea, dry mouth, epigastric distress, nausea, paralytic ileus, parotid swelling, stomatitis, tongue edema, vomiting

Perphenazine:
Frequency not reported: Constipation, dry mouth, nausea, obstipation, salivation, vomiting[Ref]

Psychiatric

Amitriptyline:
Frequency not reported: Anxiety, confusional state, decreased libido, delusions, disorientation, dream disturbance, excitement, hallucinations, hypomania, increased libido, insomnia, irritability, mania, nightmares, restlessness, sleep disturbance

Perphenazine:
Frequency not reported: catatonic-like state production, mild insomnia, paradoxical excitement, reactivation of psychoses[Ref]

Genitourinary

Amitriptyline:
Frequency not reported: Breast enlargement, galactorrhea, testicular swelling, urinary frequency, urinary retention, urinary tract dilation

Perphenazine:
Frequency not reported: Ejaculation failure, galactorrhea, hyperglycemia, lactation, menstrual cycle disturbances, urinary frequency, urinary incontinence[Ref]

Hematologic

Amitriptyline:
Frequency not reported: Agranulocytosis, bone marrow depression, eosinophilia, leukopenia, purpura, thrombocytopenia

Perphenazine:
Frequency not reported: Agranulocytosis, blood dyscrasias, eosinophilia, leukopenia, pancytopenia, thrombocytopenic purpura

Dermatologic

Amitriptyline:
Frequency not reported: Alopecia, facial edema, increased perspiration, photosensitization, skin rash, urticaria

Perphenazine:
Frequency not reported: Eczema, erythema, exfoliative dermatitis, itching, photosensitivity, pigmentation, urticaria[Ref]

Ocular

Amitriptyline:
Frequency not reported: Accommodation disturbance, blurred vision, increased intraocular pressure, mydriasis

Perphenazine:
Frequency not reported: Blurred vision, corneal pigmentation, lens pigmentation, photophobia, pigmentary retinopathy[Ref]

Hepatic

Amitriptyline:
Frequency not reported: Altered liver function, hepatitis, jaundice

Perphenazine:
Frequency not reported: Biliary stasis, jaundice, liver damage

Endocrine

Amitriptyline:
Frequency not reported: Gynecomastia, syndrome of inappropriate antidiuretic hormone secretion

Perphenazine:
Frequency not reported: False positive pregnancy test, gynecomastia[Ref]

Metabolic

Amitriptyline:
Frequency not reported: Anorexia, blood sugar level elevation/lowering, weight gain/loss

Perphenazine:
Frequency not reported: Anorexia, polyphagia[Ref]

Other

Amitriptyline:
Frequency not reported: Fatigue, hyperpyrexia, malaise, tinnitus, weakness

Perphenazine:
Frequency not reported: Lassitude[Ref]

Respiratory

Perphenazine:
Frequency not reported: Asthma, laryngeal edema, nasal congestion[Ref]

Hypersensitivity

Perphenazine:
Frequency not reported: Anaphylactoid reactions, angioneurotic edema[Ref]

Musculoskeletal

Amitriptyline:
Frequency not reported: Muscle weakness[Ref]

Immunologic

Perphenazine:
Frequency not reported: Immunologic reactions[Ref]

References

1. "Product Information. Etrafon (amitriptyline-perphenazine)" Schering Corporation, Kenilworth, NJ.

Some side effects of Etrafon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

More about Etrafon (amitriptyline / perphenazine)

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