Doxepin (Doxepin Hydrochloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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

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. (See Anticholinergic Effects.)

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 doxepin administration should be borne in mind. These are not indicative of addiction and gradual withdrawal of medication should not cause these symptoms.

REPORTS OF SUSPECTED DOXEPIN SIDE EFFECTS / ADVERSE REACTIONS

Possible Doxepin side effects / adverse reactions in 27 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-14

Patient: 27 year old male weighing 99.8 kg (219.5 pounds)

Reactions: Syncope, Restlessness, Gastrointestinal Disorder, Intentional Drug Misuse, Toxicity TO Various Agents, Multiple Drug Overdose, Sinus Tachycardia, Lethargy

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Amphetamines
    Indication: Product Used FOR Unknown Indication

Doxepin
    Indication: Product Used FOR Unknown Indication

Adderall 5
    Indication: Product Used FOR Unknown Indication

Ultram
    Indication: Product Used FOR Unknown Indication

Ethanol
    Indication: Product Used FOR Unknown Indication

Possible Doxepin side effects / adverse reactions in 53 year old female

Reported by a physician from United States on 2011-10-28

Patient: 53 year old female weighing 95.3 kg (209.6 pounds)

Reactions: Weight Decreased, Somnolence, Apathy, Insomnia, Sedation, Somnambulism, Spinal Disorder, Depression, Emotional Poverty

Adverse event resulted in: hospitalization

Suspect drug(s):
Doxepin
    Indication: Insomnia

Unspecified Antideppressants
    Indication: Product Used FOR Unknown Indication

Zolpidem Tartrate
    Dosage: (10 mg, qhs);
    Indication: Middle Insomnia

Diphenhydramine HCL
    Indication: Product Used FOR Unknown Indication

Xyrem
    Dosage: 6 gm (3 gm, 2 in 1 d), oral; ( , 2 in 1 d), oral; (6 gm), oral
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2005-11-25

Other drugs received by patient: Levothyroxine Sodium; Vitamin D; Zaleplon; Iodine

Possible Doxepin side effects / adverse reactions in 66 year old male

Reported by a physician from Germany on 2011-12-12

Patient: 66 year old male

Reactions: Myocardial Infarction

Adverse event resulted in: death

Suspect drug(s):
Doxepin
    Dosage: 25 milligram;
    Administration route: Oral
    Start date: 2011-01-28
    End date: 2011-02-06

Naloxone
    Dosage: 1 dosage forms; oxycodone hydrochloride +naloxonhydrochloride
    Administration route: Oral
    Start date: 2011-01-28
    End date: 2011-02-07

Doxepin
    Dosage: 50 milligram;
    Administration route: Oral
    Start date: 2011-02-07

Other drugs received by patient: Novalgin; Exforge; Pantoprazole Sodium; Bisoprolol Fumarate