Protriptyline Side Effects

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

For the Consumer

Applies to protriptyline: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking protriptyline: hives; difficult 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:

• a feeling that you might pass out;

• new or worsening chest pain, pounding heartbeats or fluttering in your chest;

• sudden numbness or weakness, problems with vision, speech, or balance;

• fever;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• confusion, hallucinations, unusual thoughts or behavior;

• restless muscle movements in your eyes, tongue, jaw, or neck;

• painful or difficult urination;

• seizure (convulsions); or

• jaundice (yellowing of the skin or eyes).

Common side effects may include:

• tingly feeling, weakness, lack of coordination;

• nausea, vomiting, loss of appetite, constipation, diarrhea;

• dry mouth, blurred vision, ringing in your ears;

• breast swelling (in men or women); or

• decreased sex drive, impotence, or difficulty having an orgasm.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to protriptyline: oral tablet

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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