Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Approximately 5 % of patients can be expected to experience adverse drug reactions (ADRs).
The table below lists adverse reactions reported with pantoprazole, ranked under the following frequency classification:

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); very rare (<1/10,000), not known (cannot be estimated from the available data).
For all adverse reactions reported from post‐marketing experience, it is not possible to apply any Adverse Reaction frequency and therefore they are mentioned with a “not known” frequency.

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1. Adverse reactions with pantoprazole in clinical trials and post‐marketing experience 
Frequency/
System Organ         Common           Uncommon                  Rare              Very rare               Not known Class
Blood      and                                           Agranulocytosis     Thrombocytopenia lymphatic                                                                      ; Leukopenia system disorders                                                               Pancytopenia 


Frequency/
System Organ          Common           Uncommon                    Rare                Very rare         Not known Class
Immune system                                               Hypersensitivity disorders                                                  (including anaphylactic reactions and anaphylactic shock)


Metabolism and                                              Hyperlipidaemias                         Hyponatraemia nutrition                                                   and lipid increases                      Hypomagnesaemia disorders                                                   (triglycerides,                          (see section 4.4); cholesterol); Weight                     Hypocalcaemia(1);
changes                                  Hypokalaemia (1)


Psychiatric                           Sleep disorders       Depression (and all    Disorientation    Hallucination; disorders                                                   aggravations)          (and all          Confusion aggravations)     (especially in pre‐ disposed patients,
as well as the aggravation      of these symptoms in case      of   pre‐ existence)

Nervous system                        Headache;             Taste disorders                         Parasthesia disorders                             Dizziness

Eye disorders                                               Disturbances in      vision/ blurred vision
Gastrointestinal Fundic gland polyps Diarrhoea;                                                     Microscopic colitis disorders        (benign)            Nausea/ vomiting
Abdominal distension and bloating;
Constipation; Dry mouth; abdominal pain and discomfort;
Hepatobiliary                        Liver enzymes       Bilirubin                                  Hepatocellular injury; disorders                            increased           increased                                  jaundice; (transaminases, γ ‐                                            Hepatocellular failure GT);

Skin and                            Rash /exanthema/ Urticaria;                                      Stevens‐Johnson subcutaneous                        eruption; Pruritus Angioedema                                    syndrome, Lyell‐ tissue disorders                                                                                     syndrome; Erythema multiforme;
Photosensitivity;
Subacute cutaneous lupus erythematosus

Frequency/
System Organ             Common           Uncommon                    Rare          Very rare         Not known Class
(see section 4.4). Drug reaction with eosinophilia and systemic symptoms
(DRESS)

Musculoskeletal                         Fracture of the     Arthralgia;                            Muscle spasm (2) and connective                          hip, wrist or spine Myalgia tissue disorders                        (see section 4.4)

Renal and urinary                                                                                 Tubolointers titial disorders                                                                                         nephritis (with possible progression to renal failure)
Reproductive                                                    Gynaecomasti system and                                                      a breast disorders

General disorders Injection site        Asthenia, fatigue       Body temperature and               thrombophle           and malaise             increased; Oedema administration bitis;                                           peripheral site conditions


1.
Hypocalcemia and/or hypokalaemia may be related to the occurrence ofhypomagnesemia (see section 4.4)        2.
Muscle spasm as a consequence of electrolyte disturbance


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