Note: This document contains side effect information about trazodone. Some dosage forms listed on this page may not apply to the brand name Oleptro.
Applies to trazodone: oral tablet.
Warning
Oral route (Tablet, Extended Release; Tablet)
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders in short-term studies. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or older. The use of trazodone hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Closely monitor patients of all ages 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. Not approved for pediatric use.
Serious side effects of Oleptro
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
- Skin rash
- unusual excitement
Other side effects of Oleptro
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.[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]
