Nortriptyline (capsules)
Generic name: nortriptyline hydrochloride · Brand names: Pamelor, Aventyl
Quick facts
Drug class
Value
tricyclic antidepressant
Source text (exact source wording)
The mechanism of mood elevation by tricyclic antidepressants is at present unknown.
Rx or otc
Value
Rx only
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28), label header 'Rx only'
Forms and strengths
- Capsules, 10 mg, 25 mg, 50 mg, 75 mg (equivalent to base; Sun label How Supplied)
Generic available
Value
yes
Source
Sun label marketing category ANDA (ANDA075520) in Marketing Information; DailyMed list shows many ANDA capsule labelers (Sun, Teva, Zydus, Dr. Reddy's, Mayne)
Common use one line
Treats depression in adults.
What it is used for
Nortriptyline is used to relieve the symptoms of depression. The label says endogenous depressions are more likely to improve than other depressive states.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
INDICATIONS AND USAGE
Confidence
high
Medlineplus source
https://medlineplus.gov/druginfo/meds/a682620.html
Source text (exact source wording)
Nortriptyline hydrochloride is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
Medlineplus source text (exact source wording)
Nortriptyline is used to treat depression. Nortriptyline is in a group of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance. Nortriptyline is also sometimes used to treat panic disorders and post-herpetic neuralgia (the burning, stabbing pains, or aches that may last for months or years after a shingles infection). Nortriptyline is also sometimes used to help people stop smoking.
How it works
The label says how tricyclic antidepressants lift mood is not known. Nortriptyline is not an MAO inhibitor. Studies suggest it interferes with how catecholamines are moved, released, and stored.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
CLINICAL PHARMACOLOGY
Confidence
high
Source text (exact source wording)
The mechanism of mood elevation by tricyclic antidepressants is at present unknown. Nortriptyline hydrochloride is not a monoamine oxidase inhibitor. It inhibits the activity of such diverse agents as histamine, 5-hydroxytryptamine, and acetylcholine. It increases the pressor effect of norepinephrine but blocks the pressor response of phenethylamine. Studies suggest that nortriptyline hydrochloride interferes with the transport, release, and storage of catecholamines. Operant conditioning techniques in rats and pigeons suggest that nortriptyline hydrochloride has a combination of stimulant and depressant properties.
Dosage: adults
The usual adult dose is 25 mg three or four times a day, starting low and increasing as needed. The total daily dose may also be taken once a day. For doses above 100 mg daily, blood levels should be monitored and kept in the range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
DOSAGE AND ADMINISTRATION, Usual Adult Dose
Confidence
high
Source text (exact source wording)
Nortriptyline hydrochloride is administered orally in the form of capsules. Lower than usual dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients than for hospitalized patients who will be under close supervision. The physician should initiate dosage at a low level and increase it gradually, noting carefully the clinical response and any evidence of intolerance. Usual Adult Dose: 25 mg three or four times daily; dosage should begin at a low level and be increased as required. As an alternate regimen, the total daily dosage may be given once a day. When doses above 100 mg daily are administered, plasma levels of nortriptyline should be monitored and maintained in the optimum range of 50 to 150 ng/mL. Doses above 150 mg/day are not recommended.
Dosage: children
Nortriptyline is not recommended for children, and safety and effectiveness in pediatric patients have not been established. For adolescents the label gives 30 to 50 mg/day in divided doses, or once a day.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
DOSAGE AND ADMINISTRATION; PRECAUTIONS, Pediatric Use
Confidence
high
Source text (exact source wording)
Nortriptyline hydrochloride is not recommended for children. Safety and effectiveness in the pediatric population have not been established ( see BOX WARNING and WARNINGS - Clinical Worsening and Suicide Risk). Anyone considering the use of nortriptyline hydrochloride in a child or adolescent must balance the potential risks with the clinical need. Elderly and Adolescent Patients: 30 to 50 mg/day, in divided doses, or the total daily dosage may be given once a day.
Dosage adjustments
Drug interaction caps
Lower doses of the tricyclic antidepressant or the other drug may be needed when used with drugs that block the P450 2D6 enzyme. When that other drug is stopped, a higher tricyclic dose may be needed. Blood levels should be monitored.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
PRECAUTIONS, Drugs Metabolized by P450 2D6
Confidence
high
Source text (exact source wording)
Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.
Kidney
The label text read has no kidney dosing statement.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Confidence
low
Liver
The label text read has no liver dosing statement.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Confidence
low
Elderly
For elderly patients the label gives 30 to 50 mg/day in divided doses, or once a day, and says to limit the dose to the smallest effective total daily dose.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
DOSAGE AND ADMINISTRATION; PRECAUTIONS, Geriatric Use
Confidence
high
Source text (exact source wording)
Elderly and Adolescent Patients: 30 to 50 mg/day, in divided doses, or the total daily dosage may be given once a day. As with other tricyclic antidepressants, dose selection for an elderly patient should usually be limited to the smallest effective total daily dose ( see DOSAGE AND ADMINISTRATION).
Missed dose
MedlinePlus says to take a missed dose as soon as you remember. If it is almost time for the next dose, skip it, and do not double up.
Label
The label has no missed-dose instruction.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Medlineplus source
https://medlineplus.gov/druginfo/meds/a682620.html
Confidence
medium
Medlineplus source text (exact source wording)
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Overdose
Overdose of this drug class can be fatal and signs develop quickly, so hospital monitoring is needed as soon as possible. Serious effects include heart rhythm problems, very low blood pressure, shock, heart failure, fluid in the lungs, seizures, and coma. In case of overdose call poison control at 1-800-222-1222.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
OVERDOSAGE
Confidence
high
Medlineplus source
https://medlineplus.gov/druginfo/meds/a682620.html
Source text (exact source wording)
Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose, therefore, hospital monitoring is required as soon as possible. Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, shock, congestive heart failure, pulmonary edema, convulsions, and CNS depression, including coma. There have been reports of patients recovering from nortriptyline overdoses of up to 525 mg.
Medlineplus source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Symptoms of overdose may include irregular heartbeat; seizures; coma (loss of consciousness for a period of time); confusion; hallucination (seeing things that do not exist); widened pupils (dark circles in the middle of the eyes); drowsiness; agitation; fever; low body temperature; stiff muscles; vomiting
Storage
Store at 20° to 25°C (68° to 77°F). Details are from the Sun/Taro label and may differ for other makers.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
HOW SUPPLIED, Store and Dispense (Sun/Taro labeler-specific)
Confidence
high
Source text (exact source wording)
Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Dispense in tight container (USP) with a child-resistant closure.
Medlineplus source text (exact source wording)
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Boxed warning
Antidepressants raised the risk of suicidal thoughts and behavior in children, teenagers, and young adults in short studies. They did not raise it in adults older than 24 and lowered it in adults aged 65 and older. Everyone starting an antidepressant should be watched closely for worsening or unusual behavior changes, and families should stay in close contact with the prescriber. Nortriptyline is not approved for pediatric patients.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
Boxed warning 'Suicidality and Antidepressant Drugs' (top of label)
Confidence
high
Source text (exact source wording)
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of nortriptyline hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed 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. Nortriptyline hydrochloride is not approved for use in pediatric patients ( seeWARNINGS, Clinical Worsening and Suicide Risk; PRECAUTIONS, Information for Patients, and PRECAUTIONS, Pediatric Use).
Contraindications
Do not use nortriptyline with an MAOI used for psychiatric conditions, or within 14 days of stopping either one. Do not start it in someone being treated with linezolid or intravenous methylene blue, because of the risk of serotonin syndrome.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
CONTRAINDICATIONS, Monoamine Oxidase Inhibitors (MAOIs)
Confidence
high
Source text (exact source wording)
The use of MAOIs intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of nortriptyline hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated ( see WARNINGSandDOSAGE AND ADMINISTRATION). Starting nortriptyline hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome ( see WARNINGS and DOSAGE AND ADMINISTRATION).
Cross-sensitivity with other dibenzazepines is possible.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
CONTRAINDICATIONS, Hypersensitivity to Tricyclic Antidepressants
Confidence
high
Source text (exact source wording)
Cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility.
Do not use during the acute recovery period after a heart attack.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
CONTRAINDICATIONS, Myocardial Infarction
Confidence
high
Source text (exact source wording)
Nortriptyline hydrochloride is contraindicated during the acute recovery period after myocardial infarction.
Warnings and precautions
Depression can worsen and suicidal thoughts can appear, especially in the first few months and at dose changes, so patients are watched closely. Prescriptions should be for the smallest quantity that fits good care to lower overdose risk. Per 1000 patients, antidepressants caused 14 additional cases in people under 18, 5 additional in ages 18 to 24, 1 fewer in ages 25 to 64, and 6 fewer in ages 65 and older.
Heading
Clinical Worsening and Suicide Risk
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
WARNINGS: Clinical Worsening and Suicide Risk
Confidence
high
Source text (exact source wording)
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Prescriptions for nortriptyline hydrochloride should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose. Table 1: <18: 14 additional cases; 18-24: 5 additional cases; 25-64: 1 fewer case; ≥65: 6 fewer cases (drug-placebo difference in number of cases of suicidality per 1000 patients treated).
Before treatment, people with depression should be screened for bipolar disorder risk. Nortriptyline is not approved to treat bipolar depression.
Heading
Screening Patients for Bipolar Disorder
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
WARNINGS: Screening Patients for Bipolar Disorder
Confidence
high
Source text (exact source wording)
A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. It should be noted that nortriptyline hydrochloride is not approved for use in treating bipolar depression.
People with heart disease need close supervision because the drug can speed the heart rate and slow conduction, and heart attack, arrhythmia, and stroke have occurred. Use great caution with a history of urinary retention or seizures, and with thyroid problems or thyroid medicine. It may impair driving and machinery use. Heavy alcohol use with it can add to the danger of overdose and suicide attempts.
Heading
Cardiovascular, urinary retention, seizures, thyroid, driving, alcohol, quinidine (unlabeled paragraphs)
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
WARNINGS: Cardiovascular, urinary retention, seizures, thyroid, driving, alcohol, quinidine (unlabeled paragraphs)
Confidence
high
Source text (exact source wording)
Patients with cardiovascular disease should be given nortriptyline hydrochloride only under close supervision because of the tendency of the drug to produce sinus tachycardia and to prolong the conduction time. Myocardial infarction, arrhythmia, and strokes have occurred. Because of its anticholinergic activity, nortriptyline hydrochloride should be used with great caution in patients who have a history of urinary retention. Patients with a history of seizures should be followed closely when nortriptyline hydrochloride is administered, inasmuch as this drug is known to lower the convulsive threshold. Great care is required if nortriptyline hydrochloride is given to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop. Nortriptyline hydrochloride may impair the mental and/or physical abilities required for the performance of hazardous tasks, such as operating machinery or driving a car; therefore, the patient should be warned accordingly. Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating effect, which may lead to the danger of increased suicidal attempts or overdosage, especially in patients with histories of emotional disturbances or suicidal ideation.
A life-threatening condition called serotonin syndrome can occur, especially with other serotonin-raising drugs (triptans, other tricyclics, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) and with MAOIs including linezolid and intravenous methylene blue. Signs include agitation, hallucinations, delirium, coma, fast heartbeat, unstable blood pressure, dizziness, sweating, flushing, high body temperature, tremor, stiffness, muscle jerks, seizures, nausea, vomiting, and diarrhea.
Heading
Serotonin Syndrome
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
WARNINGS: Serotonin Syndrome
Confidence
high
Source text (exact source wording)
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including nortriptyline hydrochloride, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.
Nortriptyline has been linked to unmasking Brugada syndrome (fainting, abnormal ECG, risk of sudden death) and should generally be avoided in people who have or may have it.
Heading
Unmasking of Brugada Syndrome
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
WARNINGS: Unmasking of Brugada Syndrome
Confidence
high
Source text (exact source wording)
There have been postmarketing reports of an association between treatment with nortriptyline hydrochloride and the unmasking of Brugada syndrome. Brugada syndrome is a disorder characterized by syncope, abnormal electrocardiographic (ECG) findings, and a risk of sudden death. Nortriptyline hydrochloride should generally be avoided in patients with Brugada syndrome or those suspected of having Brugada syndrome.
Pupil widening from the drug may trigger an angle-closure glaucoma attack in people with narrow eye angles.
Heading
Angle-Closure Glaucoma
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
WARNINGS: Angle-Closure Glaucoma
Confidence
high
Source text (exact source wording)
The pupillary dilation that occurs following use of many antidepressant drugs including nortriptyline hydrochloride may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Pregnancy and breastfeeding
Safe use in pregnancy and breastfeeding has not been established, so benefits are weighed against possible hazards. Animal studies were inconclusive.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
WARNINGS, Use in Pregnancy
Confidence
high
Medlineplus source
https://medlineplus.gov/druginfo/meds/a682620.html
Source text (exact source wording)
Safe use of nortriptyline hydrochloride during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards. Animal reproduction studies have yielded inconclusive results.
Medlineplus source text (exact source wording)
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking nortriptyline, call your doctor.
Side effects
Common
This older-format label does not give a most-common list or a frequency threshold, so no 'common' list is stated.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
ADVERSE REACTIONS
Confidence
high
Note
Reactions are listed by body system below with no incidence figures.
Less common
The label lists reactions by body system without saying how often they happen. They include dry mouth, blurred vision, constipation, urinary retention, nausea, drowsiness, dizziness, weight changes, rash, and heart rhythm changes. The label notes that a few listed reactions have not been reported with nortriptyline itself but are included because of the drug class.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
ADVERSE REACTIONS (listed by body system; no frequencies given)
Confidence
medium
Source text (exact source wording)
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.
Serious
After approval, Brugada syndrome and angle-closure glaucoma were reported. Stopping suddenly after long use may cause nausea, headache, and malaise. The label warnings also cover suicidality, serotonin syndrome, heart problems, and seizures.
MedlinePlus says to call your doctor right away or get emergency help for muscle spasms in the jaw, neck, and back, slow or difficult speech, a shuffling walk, uncontrollable shaking, fever, trouble breathing or swallowing, rash, yellow skin or eyes, or irregular heartbeat. Report side effects to FDA MedWatch at 1-800-FDA-1088.
Label source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Label section
ADVERSE REACTIONS, Postmarketing Experience; WARNINGS
Medlineplus source
https://medlineplus.gov/druginfo/meds/a682620.html
Medlineplus section
What side effects can this medication cause?
Confidence
high
Label source text (exact source wording)
Postmarketing Experience: The following adverse drug reaction has been reported during post-approval use of nortriptyline hydrochloride. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency. Cardiac Disorders- Brugada syndrome. Eye Disorders- angle-closure glaucoma. Withdrawal Symptoms- Though these are not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.
Medlineplus source text (exact source wording)
Some side effects may be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment: jaw, neck, and back muscle spasms; slow or difficult speech; shuffling walk; uncontrollable shaking of a part of the body; fever; difficulty breathing or swallowing; rash; yellowing of the skin or eyes; irregular heartbeat
Led to discontinuation
The label says to stop the drug promptly if serious side effects or allergic reactions occur. No discontinuation percentages are given.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
DOSAGE AND ADMINISTRATION
Confidence
medium
Source text (exact source wording)
The drug should be discontinued promptly if adverse effects of a serious nature or allergic manifestations occur.
Interactions
Drugs
Do not combine with MAOIs. Leave at least 14 days between stopping one and starting the other.
Name
MAOIs (including linezolid and intravenous methylene blue)
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
CONTRAINDICATIONS; DOSAGE AND ADMINISTRATION
Source text (exact source wording)
The use of MAOIs intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with nortriptyline hydrochloride. Conversely, at least 14 days should be allowed after stopping nortriptyline hydrochloride before starting an MAOI intended to treat psychiatric disorders.
Using it with triptans, other tricyclics, fentanyl, lithium, tramadol, buspirone, tryptophan, or St. John's Wort raises the risk of serotonin syndrome, especially at the start and when doses go up.
Name
Other serotonergic drugs
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
WARNINGS, Serotonin Syndrome
Source text (exact source wording)
If concomitant use of nortriptyline hydrochloride with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John's Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Quinidine can make nortriptyline stay longer in the body at higher levels.
Name
Quinidine
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
WARNINGS
Source text (exact source wording)
The concomitant administration of quinidine and nortriptyline may result in a significantly longer plasma half-life, higher AUC, and lower clearance of nortriptyline.
Cimetidine can raise tricyclic antidepressant blood levels.
Name
Cimetidine
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
PRECAUTIONS, Drug Interactions
Source text (exact source wording)
Concurrent administration of cimetidine and tricyclic antidepressants can produce clinically significant increases in the plasma concentrations of the tricyclic antidepressant.
Drugs that block the P450 2D6 enzyme (such as quinidine, cimetidine, other antidepressants, phenothiazines, propafenone, flecainide, and SSRIs like fluoxetine, sertraline, and paroxetine) can raise nortriptyline levels. After stopping fluoxetine, at least 5 weeks may be needed before starting a tricyclic.
Name
Drugs that inhibit P450 2D6 (including SSRIs)
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
PRECAUTIONS, Drugs Metabolized by P450 2D6
Source text (exact source wording)
The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).
Reserpine can cause a stimulating effect. Anticholinergic and sympathomimetic drugs need close supervision and careful dosing. The blood-pressure lowering effect of guanethidine may be blocked. One case of significant low blood sugar was reported with chlorpropamide (250 mg/day) plus nortriptyline (125 mg/day).
Name
Reserpine, anticholinergic and sympathomimetic drugs, guanethidine, chlorpropamide
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
WARNINGS; PRECAUTIONS
Source text (exact source wording)
Administration of reserpine during therapy with a tricyclic antidepressant has been shown to produce a "stimulating" effect in some depressed patients. Close supervision and careful adjustment of the dosage are required when nortriptyline hydrochloride is used with other anticholinergic drugs and sympathomimetic drugs. The antihypertensive action of guanethidine and similar agents may be blocked. A case of significant hypoglycemia has been reported in a type II diabetic patient maintained on chlorpropamide (250 mg/day), after the addition of nortriptyline (125 mg/day).
Food and alcohol
Heavy alcohol use can add to the danger of suicide attempts or overdose, and the response to alcohol may be exaggerated.
Name
Alcohol
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
WARNINGS; PRECAUTIONS, Drug Interactions
Source text (exact source wording)
Excessive consumption of alcohol in combination with nortriptyline therapy may have a potentiating effect, which may lead to the danger of increased suicidal attempts or overdosage, especially in patients with histories of emotional disturbances or suicidal ideation. The patient should be informed that the response to alcohol may be exaggerated.
MedlinePlus says to keep your normal diet and that it may be taken with or without food. No grapefruit statement was found in the sources read.
Name
Food and grapefruit
Source
https://medlineplus.gov/druginfo/meds/a682620.html
Section
What special dietary instructions should I follow? / How should this medicine be used?
Source text (exact source wording)
Unless your doctor tells you otherwise, continue your normal diet. It is usually taken one to four times a day and may be taken with or without food.
Other
Avoid unnecessary or prolonged sun exposure because the drug may make skin sensitive to sunlight.
Name
Sunlight (patient wording)
Source
https://medlineplus.gov/druginfo/meds/a682620.html
Section
What special precautions should I follow?
Source text (exact source wording)
plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Nortriptyline may make your skin sensitive to sunlight.
Patient tips
Label
Never stop an antidepressant suddenly without talking to your provider. Report new or sudden changes in mood, behavior, thoughts, or feelings right away, keep follow-up visits, and keep a list of all your medicines.
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Section
Medication Guide
Source text (exact source wording)
Never stop an antidepressant medicine without first talking to a healthcare provider.Stopping an antidepressant medicine suddenly can cause other symptoms. Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with the healthcare provider as scheduled. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medlineplus
Take it at about the same times each day. Keep taking it even if you feel well, and do not stop without talking to your doctor, because stopping suddenly can cause headache, nausea, and weakness. It may make you drowsy, so do not drive or use machinery until you know how it affects you.
Source
https://medlineplus.gov/druginfo/meds/a682620.html
Section
How should this medicine be used?
Source text (exact source wording)
Take nortriptyline at around the same times every day. Your doctor will probably start you on a low dose of nortriptyline and gradually increase your dose. Continue to take nortriptyline even if you feel well. Do not stop taking nortriptyline without talking to your doctor. If you suddenly stop taking nortriptyline, you may experience withdrawal symptoms such as headache, nausea, and weakness. Your doctor will probably want to decrease your dose gradually. you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
Alternatives
Class source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28) (tricyclic antidepressants) and MedlinePlus https://medlineplus.gov/druginfo/meds/a682620.html
Indication source
Label INDICATIONS AND USAGE
Recommendation
none
Frequently asked questions
Question
What is nortriptyline used for?
Answer
Nortriptyline is used to relieve the symptoms of depression.
Source section
INDICATIONS AND USAGE
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Question
How do I take nortriptyline?
Answer
The usual adult dose is 25 mg three or four times a day, starting low and increasing as needed, or the daily dose may be taken once a day. Doses above 150 mg/day are not recommended. MedlinePlus says it may be taken with or without food.
Source section
DOSAGE AND ADMINISTRATION; MedlinePlus
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28) ; https://medlineplus.gov/druginfo/meds/a682620.html
Question
What if I miss a dose?
Answer
The label has no missed-dose instruction. MedlinePlus says to take it when you remember, skip it if it is almost time for the next dose, and never double up.
Source section
MedlinePlus: What should I do if I forget a dose?
Source
https://medlineplus.gov/druginfo/meds/a682620.html
Question
Can I drink alcohol with it?
Answer
Heavy alcohol use can add to the danger of overdose and suicide attempts, and your response to alcohol may be exaggerated. MedlinePlus says to talk to your doctor about safe alcohol use.
Source section
WARNINGS; PRECAUTIONS; MedlinePlus
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28) ; https://medlineplus.gov/druginfo/meds/a682620.html
Question
What is the boxed warning about?
Answer
Antidepressants raised the risk of suicidal thoughts and behavior in children, teenagers, and young adults in short studies. Patients of all ages should be watched closely, especially early in treatment and at dose changes. Nortriptyline is not approved for pediatric patients.
Source section
Boxed warning; WARNINGS
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Question
What should I not take with nortriptyline?
Answer
Do not use it with an MAOI or within 14 days of stopping one, and do not start it in someone taking linezolid or intravenous methylene blue. Other serotonin-raising drugs such as tramadol, triptans, and St. John's Wort raise the risk of serotonin syndrome.
Source section
CONTRAINDICATIONS; WARNINGS
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28)
Question
Is it safe in pregnancy or while breastfeeding?
Answer
Safe use in pregnancy and breastfeeding has not been established, so benefits are weighed against possible hazards. Tell your doctor if you are pregnant or breastfeeding.
Source section
WARNINGS, Use in Pregnancy; MedlinePlus
Source
Sun Pharmaceutical nortriptyline hydrochloride capsules label (DailyMed set ID aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28) ; https://medlineplus.gov/druginfo/meds/a682620.html
Question
Should I stop taking it when I feel better?
Answer
No. MedlinePlus says to keep taking it even if you feel well and not to stop without talking to your doctor, because stopping suddenly can cause withdrawal symptoms such as headache, nausea, and weakness.
Source section
MedlinePlus: How should this medicine be used?
Source
https://medlineplus.gov/druginfo/meds/a682620.html
Sources
- Sun Pharmaceutical nortriptyline capsules (primary generic label)
Set id: aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28 · Label effective or revised date: Revised: 7/2026 (end of label); body text also shows Revised: April 2020 · Dailymed version date: Jul 16, 2026 (DailyMed publish date) · Fetched at: 2026-11-02 · Sections used: entire label via get_page_text - Teva nortriptyline capsules (alternate 1)
Set id: b58d473a-b19f-4d2a-b1ae-dd398d7a29e1 · Label effective or revised date: Revised: 9/2025 · Dailymed version date: Oct 02, 2025 · Fetched at: 2026-11-02 · Sections used: revised date only - Pamelor brand label (SpecGx)
Set id: e17dc299-f52d-414d-ab6e-e809bd6f8acb · Label effective or revised date: Revised: 12/2024 · Dailymed version date: Sep 22, 2025 · Fetched at: 2026-11-02 · Sections used: revised date, indication, adult dose, storage lines only - MedlinePlus Nortriptyline
Label effective or revised date: Last Revised - 08/15/2017 · Fetched at: 2026-11-02 · Sections used: all patient sections - DailyMed SPL list (nortriptyline)
Fetched at: 2026-11-02 · Sections used: set IDs and publish dates - openFDA label API
Fetched at: 2026-11-02 · Sections used: class query returned NOT FOUND
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug