Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The following undesirable effects have been observed after administration of mesalazine: 
System Organ Class Frequency according to MedDRA convention
Common        Uncommon        Rare             Very rare (< 1/ 10,000) Not known (> 1/100 to   (> 1/1,000 to   (> 1/10,000 to                          (cannot be <1/10)        <1/100)         <1/1,000)                               estimated from the available data)
Blood and lymphatic                                                  Altered blood counts system disorders                                                     (aplastic anaemia, agranulocytosis,
pancytopenia,
neutropenia,
leukopenia,
thrombocytopenia)


Immune system                                                               Hypersensitivity disorders                                                                   reactions such as allergic exanthema,
drug fever, lupus erythematosus syndrome, pancolitis
Nervous system          Headache                        Dizziness           Peripheral neuropathy disorders
Cardiac disorders                                       Myocarditis,
pericarditis

Respiratory, thoracic                                                       Allergic and fibrotic lung and mediastinal                                                             reactions (including disorders                                                                   dyspnoea, cough, bronchospasm,
alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis)
Gastrointestinal                   Abdominal pain,
disorders                          diarrhoea,
dyspepsia,
flatulence,
nausea, vomiting,
acute pancreatitis
Hepatobiliary                                           Hepatotoxicity      Hepatitis disorders                                               (including:
Cholestatic hepatitis and drug-induced liver injury
(DILI))


Skin and            Rash,                               Photosensitivity Alopecia                        Drug reaction with subcutaneous tissue pruritus                                                                             eosinophilia and disorders                                                                                                systemic symptoms
(DRESS),
Stevens-Johnson syndrome (SJS),
toxic epidermal necrolysis (TEN)

Musculoskeletal and                                     Arthralgia          Myalgia connective tissue disorders

Renal and urinary                                                           Impairment of renal      Nephrolithiasis* disorders                                                                   function including acute and chronic interstitial nephritis and renal insufficiency
Reproductive system                                                         Oligospermia and breast disorders                                                        (reversible) General disorders                                       Asthenia, fatigue 

Investigations                       Changes in liver function parameters
(increase in transaminases and parameters of cholestasis),
changes in pancreatic enzymes (lipase and amylase increased),
eosinophil count increased
* see section 4.4 for further information

Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment (see section 4.4).

Photosensitivity
More severe reactions are reported in patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema.


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/