Adverse reactions : תופעות לוואי

4.8.    Undesirable effects

Overall, about 75% of ADRs occur within 3 months of starting therapy, and over 90% by 6 months.
Some undesirable effects are dose-dependent and symptoms can often be alleviated by reduction of the dose.

General
Sulfasalazine is split by intestinal bacteria to sulfapyridine and 5-amino salicylate so ADRs to either sulfonamide or salicylate are possible. Patients with slow acetylator status are more likely to experience ADRs related to sulfapyridine. The most commonly encountered ADRs are nausea, headache, rash, loss of appetite and raised temperature.

Specific
The adverse reactions observed during clinical studies conducted with Sulfasalazine have been provided in a single list below by class and frequency (very common (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1000 to < 1/100) ); rare (1/10000 to <1/1000); very rare (<1/10000); not known (cannot be estimated from available data)). Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.

Additional reactions reported from post-marketing experience are included as frequency Not known (cannot be estimated from the available data) in the table below.

MedDRA System Organ Class            Frequency                        Adverse Drug Reaction 
Infections and Infestations         Not known       Aseptic meningitis, Pseudomembranous colitis
Blood and lymphatic system          Common          Leukopenia disorders                           Uncommon        Thrombocytopenia** Not known       Agranulocytosis, Aplastic anaemia,
Hemolytic anaemia, Heinz body anaemia,
Hypoprothrombinaemia, Lymphadenopathy,
Macrocytosis, Megaloblastic anaemia,
Methaemoglobinaemina, Neutropenia,
Pancytopenia, pseudomononucleosis**
Immune system disorders             Not known       Anaphylaxis*, Polyarteritis nodosa, Serum sickness
Metabolism and nutrition system     Common          Loss of appetite disorders                           Not known       folate deficiency** Psychiatric disorders               Common          Insomnia
Uncommon        Depression
Not known       Hallucinations
Nervous system disorders            Common          Dizziness, Headache, Taste disorders Uncommon        Convulsions
Not known       aseptic meningitis, Ataxia, Encephalopathy,
Peripheral neuropathy, Smell disorders
Ear and labyrinth disorders         Common          Tinnitus
Uncommon        Vertigo
Cardiac disorders                   Not known       Allergic myocarditis**, Cyanosis, Pericarditis Vascular disorders                  Uncommon        Vasculitis
Not known       pallor**
Respiratory, thoracic and           Common          Cough mediastinal disorders               Uncommon        Dyspnoea
Not known       Fibrosing alveolitis, Eosinophilic infiltration,
Interstitial lung disease* , oropharyngeal pain**
Gastrointestinal disorders          Very common     Gastric distress, Nausea Common          Abdominal pain, Diarrhea*, Vomiting*,
Stomatitis
Not known       Aggravation of ulcerative colitis*,
Pancreatitis, parotitis
Hepatobiliary disorders             Uncommon        jaundice**
Not known       Hepatic failure*, Hepatitis fulminant*,
Hepatitis**, hepatitis cholestatic*,
cholestasis**
Skin and subcutaneous tissue        Common          Pruritus, purpura** disorders                           Uncommon        Alopecia, Urticaria Not known       Drug rash with eosinophilia and systemic symptoms (DRESS) **, Epidermal necrolysis
(Lyell’s syndrome)**, Stevens-Johnson syndrome**, Exanthema, Exfoliative dermatitis**, Angioedema*, Toxic pustuloderma, Lichen planus, Photosensitvity,
Erythema
Musculoskeletal and connective      Common          Arthralgia tissue disorders                    Not known       System lupus erythematosus, Sjogren’s syndrome
Renal and urinary disorders         Common          Proteinuria
                                       Not known            Nephrotic syndrome, Interstitial nephritis,
nephrolithiasis* Hematuria, Crystalluria**
Reproductive system and breast         Not known            Reversible oligospermia** disorders
General disorders and                 Common               Fever** administration site conditions        Uncommon             Facial edema Not known            Yellow discoloration of skin and body fluids*
Investigations                        Uncommon             Elevation of liver enzymes Not known            Induction of autoantibodies
Frequency categories: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1000 to <1/100; Rare ≥1/10000 to <1/1000; Very rare <1/10000; Not known (cannot be estimated from available data) * ADR identified post-marketing
** see section 4.4 Special warnings and precautions for use

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 event should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il .