Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Gynaecomastia may develop in association with the use of spironolactone. Development appears to be related to both dosage level and duration of therapy and is normally reversible when the drug is discontinued. In rare instances some breast enlargement may persist.

The following adverse events have been reported in association with spironolactone therapy: 

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                                                                                      Frequency
Not Known
Uncommo          Rare
Very       Common                                                   (cannot be System                                         n        ≥ 1/10,000   Very Rare Common      ≥ 1/100 to                                                estimated Organ Class                                  ≥ 1/1,000        to       < 1/10,000 ≥ 1/10       < 1/10                                                  from the to < 1/100    < 1/1,000 available data)
Neoplasms                                    Benign benign,                                      breast malignant                                   neoplasm and                                          (male) unspecified
(including cysts and polyps)
Blood and                                                                           Agranulocytos lymphatic                                                                                is, system                                                                               Leukopenia, disorders                                                                           Thrombocytop enia
Metabolism      Hyperkala                   Electrolyte and nutrition     emia                      imbalance disorders
Psychiatric                 Confusion                                                   Libido disorders                    al state                                                  disorder Nervous                     Dizziness system disorders
Gastrointesti                   Nausea                                              Gastrointestina nal disorders                                                                         l disorder Hepatobiliar                                 Hepatic y disorders                                 function abnormal
Skin and                        Pruritus,   Urticaria                                    Toxic subcutaneous                     Rash                                                 epidermal tissue                                                                                necrolysis disorders                                                                               (TEN), Stevens-
Johnson syndrome,
Drug reaction with eosinophilia and systemic symptoms
(DRESS),
Alopecia,
Hypertrichosis
, Pemphigoid
Musculoskel                     Muscle etal and                        spasms connective tissue disorders
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                                                                                            Frequency
Not Known
Uncommo          Rare
Very           Common                                                (cannot be System                                           n        ≥ 1/10,000   Very Rare Common          ≥ 1/100 to                                             estimated Organ Class                                    ≥ 1/1,000        to       < 1/10,000 ≥ 1/10           < 1/10                                               from the to < 1/100    < 1/1,000 available data)
Renal and                              Acute urinary                               kidney disorders                              injury
Reproductive                         Gynaecom     Menstrual system and                              astia,    disorder,
breast                                Breast        Breast disorders                               pain         pain
(male)a     (female)b
General                               Malaise disorders and administratio n site conditions
Abbreviations: CDS = Core Data Sheet; F = female; LLT = lower level term; M = male; PT = preferred term; WHO-ART = World Health Organization Adverse Drug Reaction Terminology.
a
The term Breast pain is mapped from CDS and the frequency is derived from WHO-ART term Breast pain (M); however, Breast pain male is the LLT.
b
Breast pain is the PT from CDS, and the frequency is derived from WHO-ART term Breast pain (F).

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/