Trazodone Side Effects

Applies to trazodone: oral tablet, oral tablet extended release.

Serious side effects of Trazodone

Along with its needed effects, trazodone 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 trazodone:

More common

• Blurred vision
• confusion
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• lightheadedness
• sweating
• unusual tiredness or weakness

Less common

• Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• confusion about identity, place, and time
• decreased concentration
• fainting
• general feeling of discomfort or illness
• headache
• lack of coordination
• muscle tremors
• nervousness
• pounding in the ears
• shortness of breath
• slow or fast heartbeat
• swelling

Rare

• Skin rash
• unusual excitement

Other side effects of Trazodone

Some side effects of trazodone 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:

More common

• Dry mouth (usually mild)
• muscle or bone pain
• trouble sleeping
• trouble with remembering
• unpleasant taste

Less common

• Constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• diarrhea
• hearing loss
• muscle aches or pains
• weight loss

 

For Healthcare Professionals

Applies to trazodone: compounding powder, oral tablet, oral tablet extended release.

General

The most commonly reported side effects included drowsiness, dry mouth, dizziness, and lightheadedness.

Nervous system

Drowsiness has occurred during the first few days of treatment, and usually disappeared with continue administration.

Very common (10% or more): Drowsiness (up to 41%), dizziness (up to 28%), lightheadedness (up to 28%), headache (up to 20%)

Common (1% to 10%): Decreased concentration, head full-heavy, incoordination, syncope, tremor

Frequency not reported: Akathisia, altered taste, convulsion, decreased alertness, dystonia, expressive aphasia, impaired memory, impaired speech, memory disturbance, motor impairment, neuroleptic malignant syndrome, numbness, paresthesia, serotonin syndrome, vertigo

Postmarketing reports: Aphasia, ataxia, cerebrovascular accident, extrapyramidal symptoms, grand mal seizures, stupor, tardive dyskinesia

Gastrointestinal

Very common (10% or more): Dry mouth (up to 34%), nausea (up to 13%), vomiting (up to 13%)

Common (1% to 10%): Abdominal disorder, constipation, diarrhea, gastric disorder

Frequency not reported: Dyspepsia, flatulence, gastroenteritis, hypersalivation, increased salivation, paralytic ileus, stomach pain

Postmarketing reports: Increased amylase

Cardiovascular

Very common (10% or more): Hypertension (up to 20%)

Common (1% to 10%): Edema, hypotension

Frequency not reported: Bradycardia, cardiac arrhythmias, chest pain, ECG abnormalities, increased risk of bleeding, orthostatic hypotension, palpitations, premature ventricular beats, QT prolongation, sinus bradycardia, tachycardia, Torsade de pointes, ventricular couplets, ventricular tachycardia

Postmarketing reports: Atrial fibrillation, cardiac arrest, cardiospasm, conduction block, congestive heart failure, myocardial infarction, vasodilation, ventricular ectopic activity

QT prolongation, Torsade de pointes, and ventricular tachycardia have been reported in patients with doses up to 100 mg/day.

Ocular

Very common (10% or more): Blurred vision (up to 15%)

Common (1% to 10%): Itching eyes, red eyes, tired eyes

Frequency not reported: Angle-closure glaucoma, myoclonus

Postmarketing reports: Diplopia

Psychiatric

Very common (10% or more): Nervousness (up to 15%)

Common (1% to 10%): Confusion

Frequency not reported: Activation of mania/hypomania, aggressive reaction, agitation (sometimes exacerbating to delirium), anxiety, cognitive impairment, confusional state, delusions, discontinuation syndrome, hallucinations, hypomania, increased libido, insomnia, libido decreased, mania, nightmares, restlessness, suicidal behavior, suicidal ideation, suicidal thoughts, withdrawal syndrome

Postmarketing reports: Abnormal dreams, paranoid reaction, psychoses

Other

Very common (10% or more): Fatigue (up to 11%)

Common (1% to 10%): Aches, malaise, pain

Frequency not reported: Fever, weakness

Postmarketing reports: Chills, unexplained death

Metabolic

Common (1% to 10%): Weight gain, weight loss

Frequency not reported: Anorexia, hyponatremia, increased appetite

Respiratory

Common (1% to 10%): Nasal congestion, sinus congestion

Frequency not reported: Dyspnea, shortness of breath

Postmarketing reports: Apnea

Dermatologic

Common (1% to 10%): Skin condition

Frequency not reported: Hyperhidrosis, pruritus, skin rash

Postmarketing reports: Alopecia, hirsutism, leuconychia, psoriasis, urticaria

Genitourinary

Frequency not reported: Delayed urine flow, early menses, hematuria, impotence, increased urinary frequency, micturition disorders, missed periods, priapism, retrograde ejaculation

Postmarketing reports: Breast engorgement, breast enlargement, clitorism, lactation, urinary incontinence, urinary retention

Hepatic

Frequency not reported: Cholestasis intrahepatic, elevated liver enzymes, fulminant hepatitis, hepatic failure with potentially fatal outcome, hepatic function abnormalities, hepatitis, hepatocellular damage, jaundice, severe hepatic disorders

Postmarketing reports: Cholestasis, hyperbilirubinemia, liver enzyme alterations

Hematologic

Frequency not reported: Agranulocytosis, anemia, blood dyscrasias, eosinophilia, leukopenia, thrombocytopenia

Postmarketing reports: Hemolytic anemia, leukocytosis, methemoglobinemia

Musculoskeletal

Frequency not reported: Arthralgia, back pain, limb pain, muscle twitches, myalgia

Hypersensitivity

Frequency not reported: Allergic reactions

Immunologic

Frequency not reported: Influenza-like symptoms

Endocrine

Frequency not reported: Syndrome of inappropriate antidiuretic hormone (SIADH) secretion