Adverse reactions : תופעות לוואי

4.8 Undesirable effects

These adverse reactions have been reported in clinical trials or post-marketing. Frequencies are unknown.

System Organ Class                              Adverse Reaction
Investigations                                  Transaminases increased Cardiac disorders                               Arrhythmia, Tachycardia, Angina Pectoris Blood and lymphatic system disorders            Thrombocytopenia, Leukopenia/neutropenia Nervous system disorders                        Dizziness, headache, meningitis aseptic* Gastrointestinal disorders                      Gastrointestinal disorder, Epigastric discomfort, Abdominal distension, Nausea,
Vomiting, Diarrhoea, Constipation,
Hypersalivation
Skin and subcutaneous tissue disorders           Pruritus, Erythema, Urticaria, Hot flush, Rash Vascular disorders                               Haemorrhage**, Hypotension Immune system disorders                          Anaphylactic reactions, Anaphylactoid reaction, Angioedema
Hepatobiliary disorders                          Cholestasis
Psychiatric disorders                            Agitation, Sleep disorder Respiratory disorders                            Bronchospasm


Description of selected adverse reactions
* Reports of aseptic meningitis were predominantly in patients with underlying connective tissue disorders
** A few very rare events of bleeding (e.g. skin, mucosa) have been reported in patients treated with Pentoxifylline with and without anticoagulants or platelet aggregation inhibitors. The serious cases are predominantly concentrated in the gastrointestinal, genitourinary, multiple site and surgical wound areas and are associated with bleeding risk factors. A causal relationship between Pentoxifylline therapy and bleeding has not been established. Thrombocytopenia has occurred in isolated cases.
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