Sinequan Side Effects

Generic Name: doxepin,doxepin hydrochloride

Please note - some side effects for Sinequan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Sinequan - for the Consumer

Sinequan

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 Sinequan:

Appetite loss; constipation; diarrhea; dizziness; drowsiness; dry mouth; excess sweating; headache; heartburn; increased appetite; indigestion; nausea; unpleasant taste; urinary retention; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Sinequan:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal movements; aggressive or bizarre behavior; agitation; anxiety; blurred vision or other vision changes; chest pain; difficulty speaking and swallowing; disorientation; eye pain; fainting; fast, slow, or irregular heartbeat; hair loss; hallucinations; hostility; irritability; loss of balance; mood swings; nervousness or restlessness; panic attacks; ringing in the ears; seizures; shakiness; sore throat or fever; trouble sleeping; twitching of the face or tongue; unusual bleeding or bruising; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Sinequan Concentrate

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 Sinequan Concentrate:

Appetite loss; constipation; diarrhea; dizziness; drowsiness; dry mouth; excess sweating; headache; heartburn; increased appetite; indigestion; nausea; unpleasant taste; urinary retention; vomiting; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur when using Sinequan Concentrate:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal movements; aggressive or bizarre behavior; agitation; anxiety; blurred vision or other vision changes; chest pain; difficulty speaking and swallowing; disorientation; eye pain; fainting; fast, slow, or irregular heartbeat; hair loss; hallucinations; hostility; irritability; loss of balance; mood swings; nervousness or restlessness; panic attacks; ringing in the ears; seizures; shakiness; sore throat or fever; trouble sleeping; twitching of the face or tongue; unusual bleeding or bruising; 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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Sinequan Side Effects - for the Professional

Sinequan

NOTE: Some of the adverse reactions noted below have not been specifically reported with Sinequan use. However, due to the close pharmacological similarities among the tricyclics, the reactions should be considered when prescribing Sinequan (doxepin HCl).

Anticholinergic Effects: Dry mouth, blurred vision, constipation, and urinary retention have been reported. If they do not subside with continued therapy, or become severe, it may be necessary to reduce the dosage.

Central Nervous System Effects: Drowsiness is the most commonly noticed side effect. This tends to disappear as therapy is continued. Other infrequently reported CNS side effects are confusion, disorientation, hallucinations, numbness, paresthesias, ataxia, extrapyramidal symptoms, seizures, tardive dyskinesia, and tremor.

Cardiovascular: Cardiovascular effects including hypotension, hypertension, and tachycardia have been reported occasionally.

Allergic: Skin rash, edema, photosensitization, and pruritus have occasionally occurred.

Hematologic: Eosinophilia has been reported in a few patients. There have been occasional reports of bone marrow depression manifesting as agranulocytosis, leukopenia, thrombocytopenia, and purpura.

Gastrointestinal: Nausea, vomiting, indigestion, taste disturbances, diarrhea, anorexia, and aphthous stomatitis have been reported.

Endocrine: Raised or lowered libido, testicular swelling, gynecomastia in males, enlargement of breasts and galactorrhea in the female, raising or lowering of blood sugar levels, and syndrome of inappropriate antidiuretic hormone secretion have been reported with tricyclic administration.

Other: Dizziness, tinnitus, weight gain, sweating, chills, fatigue, weakness, flushing, jaundice, alopecia, headache, exacerbation of asthma, and hyperpyrexia (in association with chlorpromazine) have been occasionally observed as adverse effects.

Withdrawal Symptoms: The possibility of development of withdrawal symptoms upon abrupt cessation of treatment after prolonged Sinequan administration should be borne in mind. These are not indicative of addiction and gradual withdrawal of medication should not cause these symptoms.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have been reported more frequently with drowsiness as the most cited adverse effect. Dystonia, myoclonus, worsening of seizure control, hoarseness, aphonia, visual hallucinations, and tinnitus have also been reported. Mania can occur and is a particular risk in patients with bipolar disease.

Other

Anticholinergic side effects have been reported frequently and include blurry vision, dry mouth, constipation and urinary retention.

Other

Although doxepin is not addicting, withdrawal symptoms after abrupt discontinuation may occur and include hypertension, tachycardia, restlessness, abdominal distress and emesis. A case of doxepin withdrawal mania has also been reported.

Gastrointestinal

Gastrointestinal side effects have included constipation and dry mouth and less frequently nausea and vomiting.

A study of 26,005 antidepressant users has reported 2.3 times more upper GI bleeding episodes with the use of non-SSRI's. Upper gastrointestinal tract bleeding was observed in 2.0 times more frequently in patients receiving doxepin.

Cardiovascular

The incidence of orthostatic hypotension is thought to be higher with doxepin than with other tricyclic antidepressants. Both antiarrhythmic and proarrhythmic effects have been reported in association with doxepin therapy, however, the incidence of proarrhythmic effects may be lower with doxepin than other tricyclic antidepressants. Caution, however, should be exercised if doxepin must be used in patients with cardiovascular disease.

Cardiovascular side effects have included orthostatic hypotension, tachycardia, syncope, intracardiac conduction blocks, and ventricular arrhythmias. Torsades de pointes tachycardia has been reported in a woman who swallowed 6 g of doxepin in an attempt to commit suicide.

Endocrine

A retrospective register study of the World Health Organization (WHO) database for spontaneous reporting of adverse drug reactions (n=668) suggests that the risk of hyponatremia during treatment with antidepressants seems to be highest in women, in the elderly, during the summer season, and during the first weeks of therapy.

Endocrine side effects have included hyperprolactinemia and hyponatremia (in association with the syndrome of inappropriate secretion of antidiuretic hormone).

Oncologic

Oncologic side effects have included a case of breast cancer occurring in a male taking doxepin.

Hematologic

Hematologic side effects have included immune hemolytic anemia and thrombocytopenia.

General

General side effects commonly reported have included weight gain. Anorexia has also been reported.

Hepatic

Hepatic side effects have included induction of cholestatic and hepatic reactions generally related to idiosyncratic hypersensitivity associated with the use of tricyclic antidepressants. Although these have generally been mild, severe injuries with fulminant hepatitis have been reported. A single case report has suggested that doxepin may induce recurrent acute hepatitis.

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