Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of the safety profile
Adverse reactions reported as very common (>1/10) in clinical studies were nausea, dry mouth, headache and sweating (including night sweats).

Tabulated list of adverse reactions
Adverse reactions are listed below by system organ class, frequency category and decreasing order of medical seriousness within each frequency category.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Body System         Very           Common                Uncommon         Rare                Very Rare            Not Known Common
Blood and                                                                 Agranulocytosis*,   Thrombocytopaenia* lymphatic                                                                 Aplastic system                                                                    anaemia*, disorders                                                                 Pancytopaenia*, Neutropaenia*
Immune system                                                             Anaphylactic disorders                                                                 reaction* Endocrine                                                                 Inappropriate       Blood prolactin disorders                                                                 antidiuretic        increased* hormone secretion*
Metabolism and                     Decreased                              Hyponatraemia* nutrition                          appetite disorders
Psychiatric         Insomnia       Confusional           Mania,           Delirium*                                Suicidal disorders                          state*,               Hypomania,                                                ideation and Depersonalization*,   Hallucination,                                            suicidal Abnormal              Derealization,                                            behavioursa, dreams,               Abnormal                                                  Aggressionb Nervousness,          orgasm,
Libido                Bruxism*,
decreased,            Apathy
Agitation*,
Anorgasmia
Nervous            Headache*c,      Akathisia*,          Syncope,           Neuroleptic         Tardive system             Dizziness,       Tremor,              Myoclonus,         Malignant           dyskinaesia* disorders          Sedation         Paraesthesia,        Balance            Syndrome Dysgeusia            disorder*,         (NMS)*,
Coordination       Serotonin abnormal*,         syndrome*,
Dyskinaesia*       Convulsion,
Dystonia*
Eye disorders                       Visual                                  Angle-closure impairment,                             glaucoma*
Accommodation disorder,
including vision blurred,
Mydriasis
Ear and                             Tinnitus*                                                                  Vertigo labyrinth disorders
Cardiac                             Tachycardia,                            Torsade de                         Stress disorders                           Palpitations*                           pointes*,                          cardiomyopathy Ventricular                        (takotsubo tachycardia*,                      cardiomyopathy)*
Ventricular fibrillation,
Electrocardiogram
QT prolonged*
Vascular                            Hypertension,        Orthostatic disorders                           Hot flush            hypotension, Hypotension*
Respiratory,                        Dyspnoea*,                              Interstitial lung thoracic and                        Yawning                                 disease*, mediastinal                                                                 Pulmonary disorders                                                                   eosinophilia* Gastrointestinal   Nausea,          Diarrhoea*,          Gastrointestinal   Pancreatitis* disorders          Dry mouth,       Vomiting             haemorrhage* Constipation
Hepatobiliary                                            Liver function     Hepatitis* disorders                                                test abnormal*
Skin and           Hyperhidrosis*   Rash, Pruritus*      Urticaria*,        Stevens- subcutaneous       (including                            Alopecia*,         Johnson tissue disorders   night sweats)                         Ecchymosis,        syndrome*, *                                     Angioedema*,       Toxic epidermal Photosensitivity   necrolysis*,
reaction           Erythema multiforme*
Musculoskeletal                     Hypertonia                              Rhabdomyolysis* and connective tissue disorders
Renal and                           Urinary              Urinary urinary                             hesitation,          incontinence* disorders                           Urinary retention,
Pollakiuria*
Reproductive                        Menorrhagia*,
system and                          Metrorrhagia*,
Erectile
breast                         dysfunctionb,
disorders                      Ejaculation disorderb
General                        Fatigue,                                             Mucosal disorders and                  Asthenia, Chills*                                    haemorrhage* administration site conditions
Investigations                 Weight                                               Bleeding time       Postpartum decreased,                                           prolonged*          haemorrhage*d† Weight increased, Blood cholesterol increased


*ADR identified post-marketing.
a
Cases of suicidal ideation and suicidal behaviours have been reported during venlafaxine therapy or early after treatment discontinuation (see section 4.4).
b
See section 4.4 c
In pooled clinical trials, the incidence of headache with venlafaxine and placebo were similar.
d†
This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4 and 4.6).

Discontinuation of treatment
Discontinuation of venlafaxine (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, vertigo, headache, flu syndrome, visual impairment and hypertension are the most commonly reported reactions. Generally, these events are mild to moderate and are self-limiting; however, in some patients, they may be severe and/or prolonged. It is therefore advised that when venlafaxine treatment is no longer required, gradual discontinuation by dose tapering should be carried out.
However, in some patients severe aggression and suicidal ideation occurred when the dose was reduced or during discontinuation (see sections 4.2 and 4.4).

Paediatric population
In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical trials) in children and adolescents (ages 6 to 17) was similar to that seen for adults.
As with adults, decreased appetite, weight loss, increased blood pressure, and increased serum cholesterol were observed (see section 4.4).
In paediatric clinical trials the adverse reaction suicidal ideation was observed. There were also increased reports of hostility and, especially in major depressive disorder, self-harm.
Particularly, the following adverse reactions were observed in paediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis, and myalgia.

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