Adverse reactions : תופעות לוואי

4.8     Undesirable effects

4.8     Undesirable effects

The most frequently reported adverse drug reactions (ADRs)within the pooled safety analysis of clinical studies with Mezavant, including 3,611 patients, were colitis (including ulcerative colitis) 5.8%, abdominal pain 4.9%, headache 4.5%, liver function test abnormal, 2.1%, diarrhoea 2.0%, and nausea 1.9%.


Adverse reactions are listed by System Organ Class (see table below). Within each system organ class, adverse reactions are listed under headings of frequency using the categories: 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); not known (cannot be estimated from the available data)”.
Adverse Drug Reactions (ADRs) Associated with Mezavant


System/Organ Class            Incidence Category   Adverse drug reaction 

Blood and lymphatic system    Uncommon             Thrombocytopenia* disorders

Rare                 Agranulocytosis*

Not known            Aplastic anaemia*, Leukopenia*,
Neutropenia*, Pancytopenia*


Immune system disorders       Rare                 Face oedema

Not known            Hypersensitivity*, Anaphylactic shock, Angioedema, Stevens-Johnson syndrome, Drug rash with eosinophilia and systemic symptoms
(DRESS)
Nervous system disorders      Common               Headache*

Uncommon             Dizziness, Somnolence, Tremor


Not known            Neuropathy

Ear and labyrinth disorders   Uncommon             Ear pain

Cardiac disorders             Uncommon             Tachycardia

Not known            Myocarditis*, Pericarditis*

Vascular disorders            Common               Hypertension
Uncommon             Hypotension

Respiratory, thoracic and     Uncommon             Pharyngolaryngeal pain* mediastinal disorders

Not known            Hypersensitivity pneumonitis
(including interstitial Pneumonitis,
allergic alveolitis, eosinophilic pneumonitis)
Bronchospasm
Gastrointestinal disorders       Common              Abdominal distension, Abdominal pain*, Colitis, Diarrhoea*,
Dyspepsia, Vomiting, Flatulence,
Nausea


Uncommon            Pancreatitis, Rectal polyp
Hepatobiliary disorders          Common              Liver Function Test abnormal* (e.g.
ALT; AST, Bilirubin)


Not known           Hepatitis, Cholelithiasis

Skin and subcutaneous tissue     Common              Pruritus, Rash* disorders

Uncommon            Acne, Alopecia, Urticaria

Musculoskeletal and              Common              Arthralgia, Back pain connective tissue disorders

Uncommon            Myalgia
Not known           Systemic-lupus erythematosus-like syndrome

Renal and urinary disorders      Rare                Renal failure* 

Not known           Interstitial nephritis*, Nephrotic syndrome*

General disorders and            Common              Asthenia, Fatigue, Pyrexia* administration site conditions



*See 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 http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il 


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