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: Rare                Frequency Not
Very       Common Uncommon
System Organ                                                ≥ 1/10,000 Very Rare   Known   (cannot Common       ≥ 1/100 to ≥ 1/1,000 to                        be estimated  from Class                                                       to     < 1/10,000 ≥ 1/10       < 1/10       < 1/100                             the available < 1/1,000 data)
Neoplasms                                      Benign breast benign,                                        neoplasm malignant and                                  (male) unspecified
(including cysts and polyps)
Blood and                                                                                 Agranulocytosis, lymphatic                                                                                 Leukopenia, system disorders                                                                          Thrombocytopenia 

Metabolism and Hyperkalaemia                     Electrolyte nutrition                                        imbalance disorders
Psychiatric                        Confusional                                            Libido disorder disorders                          state

Nervous system                     Dizziness disorders

Gastrointestinal                   Nausea                                                 Gastrointestinal disorders                                                                                 disorder 
Rare                Frequency Not
Very         Common Uncommon
System Organ                                               ≥ 1/10,000 Very Rare   Known   (cannot Common         ≥ 1/100 to ≥ 1/1,000 to                       be estimated  from Class                                                      to     < 1/10,000 ≥ 1/10         < 1/10       < 1/100                            the available < 1/1,000 data)
Hepatobiliary                                  Hepatic disorders                                      function abnormal

Skin and                           Pruritus,      Urticaria                              Toxic epidermal subcutaneous                       Rash                                                  necrolysis (TEN), tissue disorders                                                                         Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms
(DRESS),
Alopecia,
Hypertrichosis,
Pemphigoid

Musculoskeletal                    Muscle and connective                     spasms tissue disorders

Renal and                          Acute kidney urinary disorders                  injury
Reproductive                       Gynaecomastia, Menstrual system and                         Breast pain disorder,
breast disorders                   (male)a     Breast pain
(female)b

General                            Malaise disorders and administration 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.