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. |
| D | P | D | P |
| * Incidence less than 1% |
| D = DESYREL P = PLACEBO |
| Number of Patients | 142 | 95 | 157 | 158 |
| % of Patients Reporting | | | | |
| Allergic | | | | |
| Skin Condition/Edema | 2.8 | 1.1 | 7.0 | 1.3 |
| Autonomic | | | | |
| Blurred Vision | 6.3 | 4.2 | 14.7 | 3.8 |
| Constipation | 7.0 | 4.2 | 7.6 | 5.7 |
| Dry Mouth | 14.8 | 8.4 | 33.8 | 20.3 |
| Cardiovascular | | | | |
| Hypertension | 2.1 | 1.1 | 1.3 | * |
| Hypotension | 7.0 | 1.1 | 3.8 | 0.0 |
| Shortness of Breath | * | 1.1 | 1.3 | 0.0 |
| Syncope | 2.8 | 2.1 | 4.5 | 1.3 |
| Tachycardia/Palpitations | 0.0 | 0.0 | 7.0 | 7.0 |
| CNS | | | | |
| Anger/Hostility | 3.5 | 6.3 | 1.3 | 2.5 |
| Confusion | 4.9 | 0.0 | 5.7 | 7.6 |
| Decreased Concentration | 2.8 | 2.1 | 1.3 | 0.0 |
| Disorientation | 2.1 | 0.0 | * | 0.0 |
| Dizziness/Lightheadedness | 19.7 | 5.3 | 28.0 | 15.2 |
| Drowsiness | 23.9 | 6.3 | 40.8 | 19.6 |
| Excitement | 1.4 | 1.1 | 5.1 | 5.7 |
| Fatigue | 11.3 | 4.2 | 5.7 | 2.5 |
| Headache | 9.9 | 5.3 | 19.8 | 15.8 |
| Insomnia | 9.9 | 10.5 | 6.4 | 12.0 |
| Impaired Memory | 1.4 | 0.0 | * | * |
| Nervousness | 14.8 | 10.5 | 6.4 | 8.2 |
| Gastrointestinal | | | | |
| Abdominal/Gastric Disorder | 3.5 | 4.2 | 5.7 | 4.4 |
| Bad Taste in Mouth | 1.4 | 0.0 | 0.0 | 0.0 |
| Diarrhea | 0.0 | 1.1 | 4.5 | 1.9 |
| Nausea/Vomiting | 9.9 | 1.1 | 12.7 | 9.5 |
| Musculoskeletal | | | | |
| Musculoskeletal Aches/Pains | 5.6 | 3.2 | 5.1 | 2.5 |
| Neurological | | | | |
| Incoordination | 4.9 | 0.0 | 1.9 | 0.0 |
| Paresthesia | 1.4 | 0.0 | 0.0 | * |
| Tremors | 2.8 | 1.1 | 5.1 | 3.8 |
| Sexual Function | | | | |
| Decreased Libido | * | 1.1 | 1.3 | * |
| Other | | | | |
| Decreased Appetite | 3.5 | 5.3 | 0.0 | * |
| Eyes Red/Tired/Itching | 2.8 | 0.0 | 0.0 | 0.0 |
| Head Full-Heavy | 2.8 | 0.0 | 0.0 | 0.0 |
| Malaise | 2.8 | 0.0 | 0.0 | 0.0 |
| Nasal/Sinus Congestion | 2.8 | 0.0 | 5.7 | 3.2 |
| Nightmares/Vivid Dreams | * | 1.1 | 5.1 | 5.7 |
| Sweating/Clamminess | 1.4 | 1.1 | * | * |
| Tinnitus | 1.4 | 0.0 | 0.0 | * |
| Weight Gain | 1.4 | 0.0 | 4.5 | 1.9 |
| Weight Loss | * | 3.2 | 5.7 | 2.5 |
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
|
