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
Common           Uncommon              Rare               Very rare              Not known 
System Organ
Class
Blood and                                               Agranulocytosis        Thrombocytopenia; lymphatic system                                                               Leukopenia; disorders                                                                      Pancytopenia Immune system                                           Hypersensitivity disorders                                               (including anaphylactic reactions and anaphylactic shock)
Metabolism and                                          Hyperlipidaemias                              Hyponatraemia; nutrition disorders                                     and lipid increases                           Hypomagnesaemia (triglycerides,                               (see section 4.4);
cholesterol);                                 Hypocalcaemia(1);
Weight changes                                Hypokalaemia(1)
Psychiatric                   Sleep disorders   Depression         Disorientation   Hallucination; disorders                                       (and all           (and all         Confusion aggravations)      aggravations)    (especially in pre- disposed patients,
as well as the aggravation of these symptoms in case of pre- existence)


Nervous system                Headache;         Taste disorders                     Paraesthesia disorders                     Dizziness


Eye disorders                                   Disturbances in vision / blurred vision
Gastrointestinal   Fundic     Diarrhoea;                                            Microscopic colitis disorders          gland      Nausea / polyps     vomiting;
(benign)   Abdominal distension and bloating;
Constipation;
Dry mouth;
Abdominal pain and discomfort

Hepatobiliary                 Liver enzymes     Bilirubin                           Hepatocellular disorders                     increased         increased                           injury; Jaundice; (transaminases,                                       Hepatocellular
γ-GT)                                                 failure
Skin and                             Rash/              Urticaria;                                      Stevens-Johnson subcutaneous tissue                  exanthema/         Angioedema                                      syndrome; disorders                            eruption;                                                          Lyell syndrome Pruritus                                                           (TEN); Drug reaction with eosinophilia and systemic symptoms
(DRESS);
Erythema multiforme;
Photosensitivity;
Subacute cutaneous lupus erythematosus
(see section 4.4)



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

Renal and urinary                                                                                      Tubulointerstitial disorders                                                                                              nephritis (TIN) (with possible progression to renal failure)

Reproductive                                            Gynaecomastia system and breast disorders

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

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

Reporting suspected adverse reactions after authorization 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