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Desyrel (Trazodone Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Because the frequency of adverse drug effects is affected by diverse factors (eg, drug dose, method of detection, physician judgment, disease under treatment, etc.) a single meaningful estimate of adverse event incidence is difficult to obtain. This problem is illustrated by the variation in adverse event incidence observed and reported from the inpatients and outpatients treated with DESYREL. It is impossible to determine precisely what accounts for the differences observed.

Clinical Trial Reports

The table below is presented solely to indicate the relative frequency of adverse events reported in representative controlled clinical studies conducted to evaluate the safety and efficacy of DESYREL® (trazodone hydrochloride).

The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors often differ from those which prevailed in the clinical trials. These incidence figures, also, cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials is conducted under a different set of conditions.

Treatment-Emergent Symptom Incidence
Inpts.Outpts.
DPDP
* Incidence less than 1%
D = DESYREL P = PLACEBO
Number of Patients14295157158
% of Patients Reporting
Allergic
   Skin Condition/Edema2.81.17.01.3
Autonomic
   Blurred Vision6.34.214.73.8
   Constipation7.04.27.65.7
   Dry Mouth14.88.433.820.3
Cardiovascular
   Hypertension2.11.11.3*
   Hypotension7.01.13.80.0
   Shortness of Breath*1.11.30.0
   Syncope2.82.14.51.3
   Tachycardia/Palpitations0.00.07.07.0
CNS
   Anger/Hostility3.56.31.32.5
   Confusion4.90.05.77.6
   Decreased Concentration2.82.11.30.0
   Disorientation2.10.0*0.0
   Dizziness/Lightheadedness19.75.328.015.2
   Drowsiness23.96.340.819.6
   Excitement1.41.15.15.7
   Fatigue11.34.25.72.5
   Headache9.95.319.815.8
   Insomnia9.910.56.412.0
   Impaired Memory1.40.0**
   Nervousness14.810.56.48.2
Gastrointestinal
   Abdominal/Gastric Disorder3.54.25.74.4
   Bad Taste in Mouth1.40.00.00.0
   Diarrhea0.01.14.51.9
   Nausea/Vomiting9.91.112.79.5
Musculoskeletal
   Musculoskeletal Aches/Pains5.63.25.12.5
Neurological
   Incoordination4.90.01.90.0
   Paresthesia1.40.00.0*
   Tremors2.81.15.13.8
Sexual Function
   Decreased Libido*1.11.3*
Other
   Decreased Appetite3.55.30.0*
   Eyes Red/Tired/Itching2.80.00.00.0
   Head Full-Heavy2.80.00.00.0
   Malaise2.80.00.00.0
   Nasal/Sinus Congestion2.80.05.73.2
   Nightmares/Vivid Dreams*1.15.15.7
   Sweating/Clamminess1.41.1**
   Tinnitus1.40.00.0*
   Weight Gain1.40.04.51.9
   Weight Loss*3.25.72.5

Occasional sinus bradycardia has occurred in long-term studies.

In addition to the relatively common (ie, greater than 1%) untoward events enumerated above, the following adverse events have been reported to occur in association with the use of DESYREL® (trazodone hydrochloride) in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, and retrograde ejaculation.

Post-Introduction Reports

Although the following adverse reactions have been reported in DESYREL users, the causal association has neither been confirmed nor refuted.

Voluntary reports received since market introduction include the following: abnormal dreams, agitation, alopecia, anxiety, aphasia, apnea, ataxia, breast enlargement or engorgement, cardiospasm, cerebrovascular accident, chills, cholestatis, 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: Information for Patients ; some patients have required surgical intervention), 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, and ventricular ectopic activity, including ventricular tachycardia (see WARNINGS).



REPORTS OF SUSPECTED DESYREL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Desyrel. The information is not vetted and should not be considered as verified clinical evidence.

Possible Desyrel side effects / adverse reactions in 55 year old male

Reported by a physician from United States on 2011-11-23

Patient: 55 year old male weighing 94.8 kg (208.6 pounds)

Reactions: Lymphadenopathy, Angioedema, Wheezing, Aphasia, Swollen Tongue, OFF Label USE, Abdominal Discomfort, Therapy Cessation, Diarrhoea, Oral Pain, Obstructive Airways Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
PEG-Intron
    Dosage: sc
    Indication: Prophylaxis
    Start date: 2011-09-01

PEG-Intron
    Dosage: sc
    Indication: Hepatitis C
    Start date: 2011-09-01

Ribavirin
    Dosage: 200 mg;po
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-09-01

Ribavirin
    Dosage: 200 mg;po
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-09-01

Desyrel

Lisinopril

Victrelis
    Dosage: 200 mg;tid;po
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-10-10

Victrelis
    Dosage: 200 mg;tid;po
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2011-10-10

Other drugs received by patient: Flexeril; Flovent; Theragran-M; Ambroxol; Hydrodiuril; Angiotensin-Converting Enzyme Inhibitors; Lopressor; Albuterol; Medrol



Possible Desyrel side effects / adverse reactions in 54 year old female

Reported by a individual with unspecified qualification from Japan on 2011-11-29

Patient: 54 year old female weighing 61.3 kg (134.9 pounds)

Reactions: Cerebral Vasoconstriction, Hemiparesis, Headache

Adverse event resulted in: hospitalization

Suspect drug(s):
Remeron
    Dosage: 15 mg;tid;po
    Administration route: Oral
    Indication: Depression
    Start date: 2010-02-04
    End date: 2011-02-20

Desyrel
    Dosage: 50 mg;po
    Administration route: Oral
    Indication: Depression
    Start date: 2009-03-11
    End date: 2011-01-25

Desyrel
    Dosage: 50 mg;po
    Administration route: Oral
    Indication: Sleep Disorder
    Start date: 2009-03-11
    End date: 2011-01-25



Possible Desyrel side effects / adverse reactions in male

Reported by a physician from Japan on 2011-12-01

Patient: male weighing 74.2 kg (163.2 pounds)

Reactions: OFF Label USE, Diabetic Ketoacidosis

Adverse event resulted in: life threatening event

Suspect drug(s):
Rohypnol
    Administration route: Oral

Allopurinol
    Administration route: Oral
    Indication: Hyperlipidaemia
    Start date: 2007-06-11

Desyrel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Depression
    Start date: 2010-11-29
    End date: 2011-01-13

Paxil
    Administration route: Oral
    Indication: Depression
    Start date: 2010-11-26

Livalo
    Administration route: Oral
    Indication: Hyperlipidaemia
    Start date: 2007-06-11



See index of all Desyrel side effect reports >>

Drug label data at the top of this Page last updated: 2009-02-20

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