Applies to protriptyline: oral tablet.

Serious side effects of Protriptyline

Along with its needed effects, protriptyline 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 while taking protriptyline:

Incidence not known

• Abdominal or stomach pain
• agitation or irritability
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in urination
• chest pain or discomfort
• clay-colored stools
• cold sweats
• confusion about identity, place, and time
• continuing ringing, buzzing, or other unexplained noise in the ears
• convulsions
• cool, pale skin
• difficulty with speaking
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• drooling
• false beliefs that cannot be changed by facts
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth
• feeling, seeing, or hearing things that are not there
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• fever with or without chills
• hearing loss
• hostility
• hyperventilation
• inability to move the arms, legs, or facial muscles
• lack of coordination
• lower back or side pain
• mood or mental changes
• muscle spasm or jerking of all extremities
• muscle trembling or twitching
• nightmares
• pain or discomfort in the arms, jaw, back, or neck
• panic
• pinpoint red or purple spots on the skin
• pounding in the ears
• redness of the face, neck, arms, and occasionally, upper chest
• shakiness and unsteady walk
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stiffness of the limbs
• stupor
• sweating
• swelling of face, ankles, or hands
• swollen glands
• talking, feeling, and acting with excitement
• trouble sleeping
• twisting movements of body uncontrolled movements, especially of the face, neck, and back
• unusual behavior
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness in the arms, hands, legs, or feet
• weight gain or loss
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking protriptyline:

Symptoms of overdose

• Change in consciousness
• clumsiness
• disorientation
• disturbed concentration
• drowsiness to profound coma
• enlarged pupils
• increased or excessive unconscious or jerking movements
• low body temperature
• muscle aches or tightness
• muscle weakness
• severe sleepiness
• shivering
• trouble breathing
• weak or feeble pulse

Other side effects of Protriptyline

Some side effects of protriptyline 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

• Abdominal or stomach cramps
• bigger, dilated, or enlarged pupils (black part of the eye)
• black tongue
• difficulty having a bowel movement (stool)
• enlargement or swelling of the breasts
• hair loss or thinning of the hair
• heartburn
• hives or welts
• increased in sexual ability, desire, drive, or performance
• increased sensitivity of the eyes to light
• increased sensitivity of the skin to sunlight
• pain or discomfort in the chest, upper stomach, or throat
• peculiar taste
• severe sunburn
• small red or purple spots on the skin
• swelling of the testicles
• swelling or inflammation of the mouth
• swollen, painful, or tender lymph glands on side of the face or neck
• unexpected or excess milk flow from the breasts
• waking to urinate at night

For Healthcare Professionals

Applies to protriptyline: oral tablet.

General

The most commonly reported side effects were dry mouth, constipation, and blurred vision.^[Ref]

Nervous system

Frequency not reported: Alteration in EEG patterns, ataxia, dizziness, drowsiness, extrapyramidal symptoms, extremity numbness, extremity paresthesia, extremity tingling, headache, incoordination, mydriasis, peripheral neuropathy, taste, seizures, stroke, tremors^[Ref]

Psychiatric

Frequency not reported: Agitation, anxiety, confusional states (particularly in the elderly) with hallucinations, delusions, disorientation, exacerbation of psychosis, hypomania, increased or decreased libido, insomnia, nightmares, panic, restlessness, suicidal behaviors, withdrawal symptoms^[Ref]

Gastrointestinal

Frequency not reported: Abdominal cramps, black tongue, constipation, diarrhea, dry mouth, epigastric distress, nausea, paralytic ileus, parotid swelling, tongue edema, stomatitis, sublingual adenitis, vomiting^[Ref]

Cardiovascular

Frequency not reported: Arrhythmias, edema, flushing, general edema, myocardial infarction, heart block, hypertension, hypotension, orthostatic hypotension, palpitation, tachycardia^[Ref]

Genitourinary

Frequency not reported: Breast enlargement, delayed micturition, dilatation of the urinary tract, galactorrhea, impotence, nocturia, testicular swelling, urinary frequency, urinary retention^[Ref]

Dermatologic

Frequency not reported: Alopecia, face edema, itching, perspiration, petechia, photosensitization, skin rash, urticaria^[Ref]

Other

Frequency not reported: Drug fever, fatigue, hyperpyrexia, malaise, tinnitus, weakness^[Ref]

Hematologic

Frequency not reported: Agranulocytosis, bone marrow depression, eosinophilia, leukopenia, purpura, thrombocytopenia^[Ref]

Metabolic

Frequency not reported: Anorexia, elevation or depression of blood sugar levels, weight gain or loss^[Ref]

Hepatic

Frequency not reported: Altered liver function, jaundice (simulating obstructive)^[Ref]

Ocular

Frequency not reported: Blurred vision, disturbance of accommodation^[Ref]

Endocrine

Frequency not reported: Gynecomastia, syndrome of inappropriate antidiuretic hormone (SIADH) secretion^[Ref]