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                                                          ; disorders                                                                Leukopenia; Pancytopenia

Immune system                                          Hypersensitivit disorders                                               y
(including anaphylactic reactions and anaphylactic shock)
Metabolism                                           Hyperlipidaemias                           Hyponatraemia; andnutrition                                         and lipid                                  Hypomagnesaemia disorders                                            increases                                  (see section 4.4); (triglycerides,                            Hypocalcaemia(1);
cholesterol);                              Hypokalaemia(1)
Weight changes
Frequency       Common     Uncommon         Rare                Very rare            Not known System
Organ Class
Psychiatric                   Sleep            Depression (and     Disorientation(and    Hallucination; disorders                     disorders        all aggravations)   all aggravations)     Confusion (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                                   Disturbance s 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            Bilirubin                                Hepatocellular disorders                     enzymes          increased                                injury; Jaundice; increased(tran                                            Hepatocellular saminases, γ-                                             failure
GT)
Frequency          Common        Uncommon         Rare                Very rare              Not known System
Organ Class
Skin and sub-                       Rash /           Urticaria;                                 Stevens-Johnson cutaneous tissue                    exanthema /      Angioedema                                 syndrome; Lyell disorders                           eruption;                                                   syndrome (TEN); Pruritus                                                    Drug reaction with eosinophilia and systemic symptoms
(DRESS);
Erythema multiforme;
Photosensitivity;
Subacute cutaneous lupus erythematosus
(see section 4.4)



Musculoskeletal                     Fracture of the Arthralgia;                                 Muscle spasm (2) and connective                      hip, wrist or   Myalgia tissue 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     Injection     Asthenia,        Body and administration    site          fatigue and      temperature site conditions       thrombo-      malaise          increased;
phlebitis                      Oedema 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 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 /