Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Summary of the safety profile
The most frequent adverse reactions seen in clinical trials are diarrhoea, nausea, abdominal pain, headache, vomiting, and rash. Hypersensitivity reactions and drug fever may occasionally occur, and 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).
Frequency of adverse effects, based on clinical trials and reports from post-marketing surveillance

Common                                                          Not known ≥1/100 to           Rare                                        (cannot be Very rare
SOC              <1/10         ≥1/10,000 to ≤                              estimated from the ≤ 1/10,000
1/1,000                                    available data).
 altered blood counts
(anaemia aplastic anaemia,
agranulocytosis,
Blood and the                                          neutropenia,
lymphatic                                              leucopenia (incl.
system                                                 granulocytopenia), disorders                                              pancytopenia,
thrombocytopenia,
and eosinophilia (as part of an allergic reaction))
Hypersensitivity
Immune system                                          reactions incl.
disorders                                              anaphylactic reaction,
Nervous system                     Dizziness
Headache                             Peripheral neuropathy disorders
Cardiac                           Myocarditis* disorders                         Pericarditis*
Allergic alveolitis,
allergic and fibrotic lung reactions (incl.
dyspnoea, coughing,
Respiratory,
bronchospasm,
thoracic and pulmonary mediastinal eosinophilia,
disorders interstitial lung disease, pulmonary infiltration,
pneumonitis)


Diarrhoea,
Acute
Abdominal pancreatitis*
Gastrointestinal    pain, Nausea,
Increased amylase       Pancolitis disorders           Vomiting
(blood and/or
Flatulence urine)
Increased liver enzymes, cholestasis parameters and
Hepato-biliary                                                 bilirubin, disorders                                                      hepatotoxicity(incl.
hepatitis*, cholestatic hepatitis, cirrhosis,
hepatic failure)
Stevens-Johnson
Syndrome
(SJS)/Toxic
Alopecia
Skin and            Rash (incl.                                                            epidermal (Reversible),
subcutaneous        urticaria,                                                             necrolysis (TEN) Photosensitivity** dermatitis allergic,
tissue disorders    erythematous                                                           Drug Reaction erythema multiforme rash)                                                                  with Eosinophilia and Systemic
Symptoms
(DRESS)
Musculoskeletal
Myalgia, arthralgia,
connective lupus erythematosus- tissue and bone like syndrome disorders
Renal function impairment (incl.
interstitial nephritis*     Nephrolithiasis***
Renal and
(acute and chronic),
urinary nephrotic syndrome,         urine disorders renal insufficiency         discolouration***
(acute and chronic)

Reproductive
Oligospermia system
(reversible) disorders
General disorders and
Drug fever administration site conditions

(*) The mechanism of mesalazine induced myo- and pericarditis, pancreatitis, nephritis and hepatitis is unknown, but it might be of allergic origin.

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

(***)see section 4.4 for further information.

It is important to note that several of these disorders can also be attributed to the inflammatory bowel disease itself.
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.
Healthcare professionals are asked to report any suspected adverse reactions to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/