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Oleptro Side Effects

Generic Name: trazodone

Note: This document contains side effect information about trazodone. Some of the dosage forms listed on this page may not apply to the brand name Oleptro.

For the Consumer

Applies to trazodone: oral tablet, oral tablet extended release

Along with its needed effects, trazodone (the active ingredient contained in Oleptro) 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

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

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.[Ref]

Nervous system

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[Ref]

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

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[Ref]

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[Ref]

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

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[Ref]

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[Ref]

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[Ref]

Metabolic

Common (1% to 10%): Weight gain, weight loss
Frequency not reported: Anorexia, hyponatremia, increased appetite[Ref]

Respiratory

Common (1% to 10%): Nasal congestion, sinus congestion
Frequency not reported: Dyspnea, shortness of breath
Postmarketing reports: Apnea[Ref]

Dermatologic

Common (1% to 10%): Skin condition
Frequency not reported: Hyperhidrosis, pruritus, skin rash
Postmarketing reports: Alopecia, hirsutism, leuconychia, psoriasis, urticaria[Ref]

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[Ref]

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[Ref]

Hematologic

Frequency not reported: Agranulocytosis, anemia, blood dyscrasias, eosinophilia, leukopenia, thrombocytopenia
Postmarketing reports: Hemolytic anemia, leukocytosis, methemoglobinemia[Ref]

Musculoskeletal

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

Hypersensitivity

Frequency not reported: Allergic reactions[Ref]

Immunologic

Frequency not reported: Influenza-like symptoms[Ref]

Endocrine

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

References

1. "Product Information. Desyrel (trazodone)." Bristol-Myers Squibb, Princeton, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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