Oleptro Side Effects Center

Last updated on RxList: 5/5/2022
Oleptro Side Effects Center

What Is Oleptro?

Oleptro (trazodone hydrochloride extended-release tablets) is a triazolopyridine antidepressant used to treat major depressive disorder (MDD) in adults.

What Are Side Effects of Oleptro?

Common side effects of Oleptro include:

Tell your doctor if you have serious side effects of Oleptro including:

  • extreme mood swings,
  • restlessness,
  • sleep problems,
  • dizziness,
  • fainting,
  • fast or pounding heartbeat,
  • easy bruising or bleeding,
  • agitation,
  • hallucinations,
  • fast heart rate,
  • overactive reflexes,
  • diarrhea,
  • loss of coordination,
  • very stiff (rigid) muscles,
  • high fever,
  • confusion,
  • fast or uneven heartbeats,
  • tremors,
  • trouble concentrating,
  • memory problems,
  • weakness,
  • loss of appetite,
  • unsteadiness,
  • seizures,
  • shallow breathing or breathing that stops,
  • chest pain or heavy feeling,
  • pain spreading to the arm or shoulder,
  • nausea,
  • sweating, or
  • general ill feeling (malaise).

Dosage for Oleptro

The recommended starting dose of Oleptro is 150 mg once daily in adults. The dose may be increased by 75 mg/day every three days (i.e., start 225 mg on Day 4 of therapy). The maximum daily dose should not exceed 375 mg.

What Drugs, Substances, or Supplements Interact with Oleptro?

Oleptro may interact with monoamine oxidase inhibitors (MAOIs), alcohol, barbiturates, other CNS depressants, ritonavir, ketoconazole, indinavir, itraconazole, carbamazepine, digoxin, phenytoin, serotonergic drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, other drugs affecting coagulation or bleeding, or warfarin. Tell your doctor all medications you use.

Oleptro During Pregnancy or Breastfeeding

During pregnancy, Oleptro should be used only if prescribed. This medication may be passed in breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Oleptro (trazodone hydrochloride extended-release tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Depression is a(n) __________ . See Answer
Oleptro Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking trazodone and call your doctor at once if you have a penis erection that is painful or lasts 6 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • slow heartbeats;
  • unusual thoughts or behavior;
  • easy bruising, unusual bleeding; or
  • low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

  • drowsiness, dizziness, tiredness;
  • swelling;
  • weight loss;
  • blurred vision;
  • diarrhea, constipation; or
  • stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Learn to Spot Depression: Symptoms, Warning Signs, Medication See Slideshow
Oleptro Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

The most common adverse reactions (reported in ≥ 5% and at twice the rate of placebo) are: somnolence/sedation, dizziness, constipation, vision blurred.

Table 2 presents the summary of adverse events (AEs) leading to discontinuation of Oleptro treatment with an incidence of at least 1% and at least twice that for placebo.

Table 2: AEs with discontinuation as action taken ( ≥ 1% incidence and incidence 2x placebo)

  Oleptro
N = 202
Somnolence/Sedation 8 (4.0%)
Dizziness 7 (3.5%)
Confusional state 2 (1.0%)
Coordination abnormal 2 (1.0%)
Headache 2 (1.0%)
Nausea 2 (1.0%)
Balance disorder / Gait disturbance 2 (1.0%)

Clinical Studies Experience

The data described below reflects exposure in a clinical trial of 406 patients, including 204 exposed to placebo and 202 exposed to Oleptro. Patients were between 18-80 years of age and 69.3% and 67.5% of patients had at least one previous episode of depression in the last 24 months in the placebo and active-treated group, respectively. In individual patients, doses were flexible and ranged from 150 to 375 mg per day. The mean daily dose during the 6-week treatment period was 310 mg. The tablets were administered orally and were given once a day for a total duration of 8 weeks, including the titration period.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 3 presents the summary of all treatment emergent AEs that occurred at an incidence of ≥ 5% in the Oleptro group, whether considered by the clinical investigator to be related to the study drug or not.

Table 3: Most Common Treatment Emergent Adverse Events ( ≥ 5% of Patients on Active Treatment)

Preferred Term Placebo
N = 204
Oleptro
N = 202
Somnolence/Sedation 39 (19%) 93 (46%)
Headache 55 (27%) 67 (33%)
Dry mouth 26 (13%) 51 (25%)
Dizziness 25 (12%) 50 (25%)
Nausea 26 (13%) 42 (21%)
Fatigue 17 (8%) 30 (15%)
Diarrhea 23 (11%) 19 (9%)
Constipation 4 (2%) 16 (8%)
Back pain 7 (3%) 11 (5%)
Vision blurred 0 (0%) 11 (5%)

Sexual Dysfunction

Adverse events related to sexual dysfunction (regardless of causality) were reported by 4.9% and 1.5% of patients treated with Oleptro and placebo, respectively. In the Oleptro group, ejaculation disorders occurred in 1.5% of patients, decreased libido occurred in 1.5% of patients, and erectile dysfunction and abnormal orgasm < 1% of patients.

Vital Signs and Weight

There were no notable changes in vital signs (blood pressure, respiratory rate, pulse) or weight in either treatment group.

Following is a list of treatment-emergent adverse reactions with an incidence of ≥ 1% to < 5% (i.e., less common) in patients treated with Oleptro. This listing is not intended to include reactions (i) already listed in previous tables or elsewhere in the labeling (ii) for which the association with treatment is remote, (iii) which were so general as to be uninformative, and (iv) which were not considered to have significant clinical implications. Reactions are classified by body-system using the following definitions: frequent adverse reactions are those occurring in at least 1/100 patients; Infrequent adverse reactions are those occurring in less than 1/100 patients.

Ear and Labyrinth Disorders— Infrequent: hypoacusis, tinnitus, vertigo

Eye Disorders— Frequent: visual disturbance; Infrequent: dry eye, eye pain, photophobia

Gastrointestinal Disorders— Frequent: abdominal pain, vomiting; Infrequent: reflux esophagitis

General Disorders and Administration Site Conditions— Frequent: edema; Infrequent: gait disturbance

Immune System Disorders— Infrequent: hypersensitivity

Musculoskeletal and Connective Tissue Disorders— Frequent: musculoskeletal complaints, myalgia; Infrequent: muscle twitching

Nervous System Disorders— Frequent: coordination abnormal, dysgeusia, memory impairment, migraine, paraesthesia, tremor; Infrequent: amnesia, aphasia, hypoesthesia, speech disorder

Psychiatric Disorders— Frequent: agitation, confusional state, disorientation

Renal and Urinary Disorders— Frequent: micturition urgency; Infrequent: bladder pain, urinary incontinence

Respiratory, Thoracic and Mediastinal Disorders— Frequent: dyspnea

Skin and Subcutaneous Tissue Disorders— Frequent: night sweats; Infrequent: acne, hyperhidrosis, photosensitivity reaction

Vascular Disorders— Infrequent: flushing

Postmarketing Experience

Spontaneous reports regarding trazodone hydrochloride received from postmarketing experience include the following: abnormal dreams, agitation, alopecia, anxiety, aphasia, apnea, ataxia, breast enlargement or engorgement, cardiospasm, cerebrovascular accident, chills, cholestasis, clitorism, congestive heart failure, diplopia, edema, extrapyramidal symptoms, grand mal seizures, hallucinations, hemolytic anemia, hirsutism, hyperbilirubinemia, increased amylase, increased salivation, insomnia, leukocytosis, leukonychia, jaundice, lactation, liver enzyme alterations, methemoglobinemia, nausea/vomiting (most frequently), paresthesia, paranoid reaction, priapism [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION], pruritus, psoriasis, psychosis, rash, stupor, inappropriate ADH syndrome, tardive dyskinesia, unexplained death, urinary incontinence, urinary retention, urticaria, vasodilation, vertigo, and weakness.

Cardiovascular system effects which have been reported include the following: conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. In postmarketing surveillance, prolonged QT interval, Torsades de Pointes, and ventricular tachycardia have been reported with the immediate-release form of trazodone at doses of 100 mg per day or less [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Oleptro (Trazodone Hydrochloride Extended-Release Tablets)

© Oleptro Patient Information is supplied by Cerner Multum, Inc. and Oleptro Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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