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* Thrombocytopae lymphatic system                                                 , Aplastic       nia* disorders                                                        anaemia*, Pancytopaenia*,
Neutropaenia*
Immune system                                                    Anaphylactic disorders                                                        reaction* Endocrine disorders                                              Inappropriate    Blood prolactin antidiuretic     increased* hormone secretion*
Metabolism and                      Decreased                    Hyponatraemia* nutrition disorders                 appetite
Psychiatric           Insomnia      Confusional Mania,            Delirium*                         Suicidal ideation disorders                           state*,        Hypomania,                                       and suicidal Depersonalizat Hallucination,                                   behavioursa, ion*,          Derealization,                                   Aggressionb Abnormal       Abnormal dreams,        orgasm,
Nervousness, Bruxism*,
Libido         Apathy decreased,
Agitation*,
Anorgasmia
Nervous system        Headache*c, Akathisia*,     Syncope,       Neuroleptic      Tardive disorders             Dizziness,  Tremor,         Myoclonus,     Malignant        dyskinaesia* Sedation    Paraesthesia,   Balance        Syndrome
Dysgeusia       disorder*,     (NMS)*,
Coordination   Serotonin abnormal*,     syndrome*,
Dyskinaesia*   Convulsion,
Dystonia*
Body System          Very         Common          Uncommon              Rare         Very Rare     Not Known Common

Eye disorders                     Visual                            Angle-closure impairment,                       glaucoma*
Accommodatio n disorder,
including vision blurred,
Mydriasis
Ear and labyrinth                 Tinnitus*                                                         Vertigo disorders
Cardiac disorders                 Tachycardia,                      Torsade de                      Stress Palpitations*                     pointes*,                       cardiomyopathy Ventricular                     (takotsubo tachycardia*,                   cardiomyopathy)
Ventricular                     * fibrillation,
Electrocardiogra m QT prolonged*
Vascular disorders                Hypertension, Orthostatic
Hot flush     hypotension,
Hypotension*
Respiratory,                      Dyspnoea*,                        Interstitial lung thoracic and                      Yawning                           disease*, mediastinal                                                         Pulmonary disorders                                                           eosinophilia* Gastrointestinal      Nausea, Dry Diarrhoea*,       Gastrointestin Pancreatitis* disorders             mouth,       Vomiting         al
Constipation                  haemorrhage*
Hepatobiliary                                       Liver function Hepatitis* disorders                                           test abnormal*
Skin and            Hyperhidrosis Rash, Pruritus* Urticaria*, Stevens-Johnson subcutaneous tissue * (including                  Alopecia *, syndrome*, disorders           night                         Ecchymosis, Toxic epidermal sweats)*                      Angioedema* necrolysis*,
,              Erythema
Photosensitivi multiforme* ty reaction
Musculoskeletal and               Hypertonia                        Rhabdomyolysis connective tissue                                                   * disorders
Renal and urinary                 Urinary           Urinary disorders                         hesitation,       incontinence*
Urinary retention,
Pollakiuria*
Reproductive                      Menorrhagia*,
system and breast                 Metrorrhagia*,
disorders                         Erectile
Body System          Very           Common         Uncommon             Rare            Very Rare        Not Known Common dysfunctionb,
Ejaculation disorderb
General disorders                   Fatigue,                                           Mucosal and administration                  Asthenia,                                          haemorrhage* site conditions                     Chills*
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