Etrafon Side Effects

Generic name: amitriptyline / perphenazine

Medically reviewed by Drugs.com. Last updated on Oct 16, 2023.

Note: This document provides detailed information about Etrafon Side Effects associated with amitriptyline / perphenazine. Some dosage forms listed on this page may not apply specifically to the brand name Etrafon.

Applies to amitriptyline / perphenazine: oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.

Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature.

Observational studies suggest that antipsychotic drugs may increase mortality.

It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Perphenazine and amitriptyline hydrochloride is not approved for the treatment of patients with dementia-related psychosis.Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with 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.

Perphenazine and amitriptyline hydrochloride is not approved for use in pediatric patients.

Serious side effects of Etrafon

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
• 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

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

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)

Other side effects of Etrafon

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]

Further information

Etrafon side effects can vary depending on the individual. 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.

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