Adverse reactions : תופעות לוואי

4.8 Undesirable effects

In two studies EPHESUS and Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure [EMPHASIS-HF]), the overall incidence of adverse events reported with eplerenone was similar to placebo.


Adverse events reported below are those with suspected relationship to treatment and in excess of placebo or are serious and significantly in excess of placebo, or have been observed during post marketing surveillance. Adverse events are listed by body system and absolute frequency. Frequencies are defined as:
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).

Table 2: ADR Frequency in Eplerenone Placebo Controlled Studies

MedDRA system organ class                     Adverse reaction
Infections and infestations
Uncommon                                      pyelonephritis, infection, pharyngitis Blood and lymphatic system disorders
Uncommon                                      eosinophilia
Endocrine disorders
Uncommon                                      hypothyroidism
Metabolism and nutrition disorders
Common                                        hyperkalaemia (see sections 4.3 and 4.4), hypercholesterolaemia
Uncommon                                      hyponatraemia, dehydration, hypertriglyceridaemia Psychiatric disorders
Common                                        insomnia
Nervous system disorders
Common                                        syncope , dizziness, headache Uncommon                                      hypoaesthesia
Cardiac disorders
Common                                        left ventricular failure, atrial fibrillation tachycardia
Uncommon
Vascular disorders
Common                                        hypotension
Uncommon                                      arterial thrombosis limb, orthostatic hypotension 
2020-0061520, 2020-0061488, 2020-0059237                                                          7/13
Respiratory, thoracic and mediastinal disorders                                       cough
Common
Gastrointestinal disorders
Common                                          diarrhoea, nausea, constipation, vomiting Uncommon                                        flatulence
Skin and subcutaneous tissue disorders
Common                                          rash, pruritus
Uncommon                                        angioedema, hyperhidrosis 
Musculoskeletal and connective tissue disorders
Common                                          muscle spasms, back pain Uncommon                                        musculoskeletal pain
Renal and urinary disorders
Common                                          renal impairment (see sections 4.4 and 4.5) Hepatobiliary disorders
Uncommon                                        cholecystitis
Reproductive system and breast disorders
Uncommon                                        gynaecomastia
General disorders and administration site conditions
Common                                          asthenia malaise
Uncommon
Investigations
Common                                           blood urea increased, blood creatinine increased Uncommon                                         epidermal growth factor receptor decreased, blood glucose increased
In EPHESUS, there were numerically more cases of stroke in the very elderly group (> 75 years old).
There was however no statistical significant difference between the occurrence of stroke in the eplerenone (30) vs placebo (22) groups. In EMPHASIS-HF, the number of cases of stroke in the very elderly (≥ 75 years old) was 9 in the eplerenone group and 8 in the placebo group.

Reporting of suspected adverse reactions

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/