Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Cases of suicidal thoughts and behaviour have been reported during trazodone therapy or soon after discontinuation of treatment.
The following symptoms, some of which are commonly reported in cases of untreated depression, have also been recorded in patients receiving trazodone therapy:
MedDRA system organ                                              FREQUENCY class                               not known (cannot be estimated from the available data) 
Blood and lymphatic                 Blood dyscrasias (agranulocytosis, thrombocytopenia,                           eosinophilia, system disorders                    leukopenia and anaemia)
Immune system disorders             Allergic reactions
Endocrine disorders                 Syndrome of Inappropriate Antidiuretic Hormone Secretion Metabolism and nutrition
Hyponatraemia1, weight loss, anorexia, increased appetite disorders
Suicidal ideation or suicidal behaviour2, confusional state, insomnia, disorientation, mania, anxiety, nervousness, agitation (very occasionally Psychiatric disorders exacerbating to delirium), delirium, aggressive reaction, hallucinations, nightmares, libido decreased, withdrawal syndrome
Serotonin syndrome, convulsions, neuroleptic malignant syndrome,
dizziness, vertigo, headache, drowsiness3, restlessness, alertness
Nervous system disorders decreased, tremor, blurred vision, memory disturbance, myoclonus,
expressive aphasia, paraesthesia, dystonia, taste altered.
Cardiac arrhythmias4 (including torsades de pointes, palpitations,
premature ventricular contractions, ventricular couplets, ventricular Cardiac disorders tachycardia), bradycardia, tachycardia, ECG abnormalities (QT prolongation)
Vascular disorders                  Orthostatic hypotension, hypertension, syncope Respiratory, thoracic and
Nasal congestion, dyspnoea mediastinal disorders
Nausea, vomiting, dry mouth, constipation, diarrhoea, dyspepsia, stomach Gastrointestinal disorders pain, gastroenteritis, increased salivation, paralytic ileus
Hepatic function abnormalities (including jaundice and hepatocellular Hepatobiliary disorders damage)5, cholestasis intrahepatic
Skin and subcutaneous
Skin rash, pruritus, hyperhidrosis tissue disorders
Musculoskeletal and
Pain in extremities, back pain, myalgia, arthralgia connective tissue disorders
Renal and urinary disorders         Micturition disorders, urinary incontinence, urinary retention Reproductive system and
Priapism6 breast disorders
General disorders and administration site                 Weakness, oedema, influenza-like symptoms, fatigue, chest pain, fever conditions
Investigations                      Elevated liver enzymes

1
Fluid and electrolyte status should be monitored in symptomatic patients.
2    See also section 4.4
3    Trazodone is an antidepressant with sedative properties and drowsiness is sometimes seen in the first few days of treatment, but this generally disappears as therapy continues
4    Studies in animals have shown that trazodone is less cardiotoxic than tricyclic antidepressants, and clinical studies suggest that it is less likely to cause cardiac arrhythmias in humans. Clinical studies in patients with pre-existing heart disease indicate that trazodone can be arrhythmogenic in some patients of that population.
5    Adverse effects on hepatic function, sometimes severe, have been reported rarely.
6    See also section 4.4.


Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il