Pamelor Side Effects

Generic Name: nortriptyline

Please note - some side effects for Pamelor 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 Pamelor - for the Consumer

Pamelor

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 Pamelor:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Pamelor Solution

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 Pamelor Solution:

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.

Pamelor Side Effects - for the Professional

Pamelor

Note – Included in the following list are a few adverse reactions that have not been reported with this specific drug. However, the pharmacologic similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when nortriptyline is administered.

Cardiovascular – Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke.

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

Neurologic – Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alteration in EEG patterns; tinnitus.

Anticholinergic – Dry mouth and, rarely, associated sublingual adenitis; blurred vision, disturbance of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.

Allergic – Skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive exposure to sunlight); edema (general or of face and tongue), drug fever, cross-sensitivity with other tricyclic drugs.

Hematologic – Bone marrow depression, including agranulocytosis; eosinophilia; purpura; thrombocytopenia.

Gastrointestinal – Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, blacktongue.

Endocrine – Gynecomastia in the male, breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; syndrome of inappropriate ADH (antidiuretic hormone) secretion.

Other – Jaundice (simulating obstructive), altered liver function; weight gain or loss; perspiration; flushing; urinary frequency, nocturia; drowsiness, dizziness, weakness, fatigue; headache; parotid swelling; alopecia.

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

Side Effects by Body System

Nervous system

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.

Nervous system side effects have been common. Although nortriptyline is one of the least sedating tricyclic antidepressants, drowsiness has been reported. General stimulation (manifested by insomnia and subjective and objective evidence of increased activity) has been reported. Dizziness, sleep abnormalities, myoclonus, and cognitive impairment (especially in the elderly) have also been reported.

Other

One study has suggested that use of parasympathomimetic agents, such as bethanechol chloride, may ameliorate some of the anticholinergic effects of nortriptyline, particularly in elderly patients.

Other side effects have included anticholinergic effects such as dry mouth, blurry vision, constipation, and urinary retention which have been reported frequently.

Cardiovascular

Both antiarrhythmic and proarrhythmic effects have been reported in association with nortriptyline therapy. Caution should be exercised if nortriptyline must be used in patients with cardiovascular disease.

One study has found a the relative risk of myocardial infarction to be 2.2 times greater in patients receiving tricyclic antidepressants including nortriptyline.

Cardiovascular side effects have included orthostatic hypotension, tachycardia, syncope, PR interval prolongation, bundle branch blocks, and ventricular arrhythmias.

General

General side effects have included weight gain which has been frequently associated with the use of nortriptyline.

Endocrine

Endocrine side effects have been uncommon. Increased insulin sensitivity and hyponatremia (in association with SIADH) have been reported.

Gastrointestinal

Gastrointestinal side effects have most frequently included constipation and dry mouth. Diarrhea and vomiting have also been reported.

Other

Although nortriptyline is not addicting, physical symptoms of withdrawal after abrupt discontinuation of tricyclic antidepressants have occurred. (Withdrawal from nortriptyline, however, has been reported less frequently than with other tricyclics.)

Hematologic

Hematologic side effects have been rare. A case of reversible neutropenia has been associated with the use of this drug.

Respiratory

Respiratory system side effects have been rare. A case report has suggested that nortriptyline may depress CO2 sensitivity and ventilatory control in patients with chronic obstructive pulmonary disease.

Hepatic

Hepatic side effects have included case reports of hepatotoxicity associated with the use of nortriptyline. A case of fulminant hepatic failure has also been reported.

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