Vivactil Side Effects

Please note - some side effects for Vivactil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Vivactil - for the Consumer

Vivactil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Vivactil:

Dizziness; drowsiness; dry mouth; excitement; headache; impotence; nausea; nightmares; pupil dilation; sensitivity to sunlight; sweating; tiredness; upset stomach; vomiting; weakness; weight loss or gain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; changes in sex drive; chest pain; confusion; constipation; fainting; fast, slow, or irregular heartbeat; fever; frequent or difficult urination; hallucinations; impulsive behavior or other unusual changes in behavior; jaw, neck, or muscle spasms; mental or mood changes (eg, increased anxiety, mood swings, agitation, irritability, nervousness, restlessness); panic attacks; ringing in the ears; seizures; severe dizziness or drowsiness; sore throat; stomach pain; suicidal thinking or behavior; swelling of the testicles; tremor; trouble sleeping; trouble walking or keeping your balance; twitching of the face or tongue; uncontrolled movements of arms and legs or stiffness; unusual bleeding or bruising; worsening of depression; yellowing of the skin or eyes.

Vivactil Side Effects - for the Professional

Vivactil

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, the pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when protriptyline is administered. Protriptyline is more likely to aggravate agitation and anxiety and produce cardiovascular reactions such as tachycardia and hypotension.

Cardiovascular: Myocardial infarction; stroke; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; hypertension; tachycardia; palpitation.

Psychiatric: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions, anxiety, restlessness, agitation; hypomania; exacerbation of psychosis; insomnia, panic, and nightmares.

Neurological: Seizures; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling, and paresthesias of extremities; extrapyramidal symptoms; drowsiness; dizziness; weakness and fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns.

Anticholinergic: Paralytic ileus; hyperpyrexia; urinary retention, delayed micturition, dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased intraocular pressure, mydriasis; dry mouth and rarely associated sublingual adenitis.

Allergic: Drug fever; petechiae, skin rash, urticaria, itching, photosensitization (avoid excessive exposure to sunlight); edema (general, or of face and tongue).

Hematologic: Agranulocytosis; bone marrow depression; leukopenia; thrombocytopenia; purpura; eosinophilia.

Gastrointestinal: Nausea and vomiting; anorexia; epigastric distress; diarrhea; peculiar taste; stomatitis; abdominal cramps; black tongue.

Endocrine: Impotence, increased or decreased libido; gynecomastia in the male; breast enlargement and galactorrhea in the female; testicular swelling; elevation or depression of blood sugar levels.

Other: Jaundice (simulating obstructive); altered liver function; parotid swelling; alopecia; flushing; weight gain or loss; urinary frequency, nocturia; perspiration.

Withdrawal Symptoms: Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.

Side Effects by Body System

Other

Some of the adverse reactions listed below may not have been reported with protriptyline. However, these adverse effects have been reported with other tricyclic antidepressants which are pharmacologically similar to protriptyline.

Cardiovascular

Cardiovascular side effects include myocardial infarction, stroke, heart block, arrhythmias, hypotension (particularly orthostatic hypotension), hypertension, tachycardia, and palpitation.

Psychiatric

Psychiatric side effects include confusional states (particularly in the elderly) with hallucinations, disorientation, delusions, anxiety, restlessness, agitation, hypomania, exacerbation of psychosis, insomnia, panic, and nightmares.

Nervous system

Nervous system side effects include seizures, incoordination, ataxia, tremors, peripheral neuropathy, numbness, tingling and paresthesias of extremities, sleep abnormalities, extrapyramidal symptoms, drowsiness, dizziness, weakness and fatigue, headache, syndrome of inappropriate antidiuretic hormone secretion, tinnitus, and alteration in EEG patterns.

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Other

Anticholinergic side effects include paralytic ileus, hyperpyrexia, urinary retention, delayed micturition, dilation of the urinary tract, constipation, blurred vision, disturbance of accommodation, increased intraocular pressure, mydriasis, dry mouth, and rarely associated sublingual adenitis.

Dermatologic

Dermatologic side effects include petechiae, skin rash, urticaria, itching, alopecia, flushing, and photosensitization.

Hematologic

Hematologic side effects include agranulocytosis, bone marrow depression, leukopenia, thrombocytopenia, purpura, and eosinophilia.

Gastrointestinal

Gastrointestinal side effects include nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, and black tongue.

Endocrine

Endocrine side effects include impotence, increased or decreased libido, gynecomastia in the male, breast enlargement and galactorrhea in the female, testicular swelling, and elevation or depression of blood sugar levels.

Hepatic

Hepatic side effects include jaundice and altered liver function.

Other

Other side effects include parotid swelling, perspiration, tinnitus, and weight gain or loss.

Genitourinary

Genitourinary side effects include urinary frequency, and nocturia.

Other

After prolonged therapy, abrupt cessation of protriptyline may lead to nausea, headache, and malaise.

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