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                                           Hyperlipidaemias                           Hyponatraemia; and                                                  and lipid                                  Hypomagnesaemia nutrition                                            increases                                  (see section 4.4); disorders                                            (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                                  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            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 /