Adverse reactions : תופעות לוואי

4.8     Undesirable effects
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, including 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
reactions incl.
anaphylactic
Immune system                                          reaction, Drug disorders                                              Reaction with
Eosinophilia and
Systemic Symptoms
(DRESS)
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)
Alopecia                    Stevens-Johnson
Skin and           Rash (incl.
(Reversible),               Syndrome
subcutaneous       urticaria,
Photosensitivity** dermatitis allergic,        (SJS)/Toxic
tissue disorders   erythematous
erythema multiforme         epidermal
rash)
necrolysis (TEN)
Musculoskeletal
Myalgia, arthralgia,
connective
lupus erythematosus-
tissue and bone
like syndrome
disorders
Renal function
impairment (incl.
interstitial nephritis
Renal and
(acute and chronic)*,
urinary                                                                           Nephrolithiasis*** nephrotic syndrome,
disorders
renal insufficiency
(acute and chronic)
urine discolouration
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/