Applies to finerenone: oral tablet.

Serious side effects of Finerenone

Along with its needed effects, finerenone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking finerenone:

More common

• Confusion
• irregular heartbeat
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• stomach pain
• trouble breathing
• weakness or heaviness of the legs

Less common

• Blurred vision
• coma
• decreased urine output
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast heartbeat
• headache
• increase thirst
• muscle pain or cramps
• seizures
• sweating
• swelling of the face, ankles, or hands
• unusual tiredness or weakness

For Healthcare Professionals

Applies to finerenone: oral tablet.

General

The most frequently reported adverse reaction was hyperkalemia.^[Ref]

Cardiovascular

Common (1% to 10%): Hypotension (includes blood pressure decreased, diastolic blood pressure decreased, diastolic hypotension, hypotension)

Frequency not reported: Systolic blood pressured decreased, diastolic blood pressure decreased^[Ref]

In patients treated with this drug, the mean systolic and diastolic blood pressure decreased by 2 to 4 mmHg and 1 to 2 mmHg, respectively, at month 1 and remained stable thereafter. Most hypotension events were mild or moderate and resolved; events associated with hypotension (e.g., dizziness, syncope, fall) were not more frequent in patients treated with this drug compared to placebo.^[Ref]

Dermatologic

Common (1% to 10%): Pruritus^[Ref]

Hematologic

Common (1% to 10%): Anemia

Uncommon (0.1% to 1%): Hemoglobin decreased

Frequency not reported: Hematocrit decreased^[Ref]

Metabolic

Very common (10% or more): Serum potassium increased (up to 21.7%), hyperkalemia (includes blood potassium increased, hyperkalemia; up to 18.3%)

Common (1% to 10%): Hyponatremia (includes blood sodium decreased, hyponatremia)^[Ref]

In a study, hyperkalemia events were reported in 18.3% of patients treated with this drug; most hyperkalemia events were mild to moderate in patients treated with this drug. Serious hyperkalemia events were report more often for this drug than placebo; serum potassium levels greater than 5.5 mmol/L and greater than 6 mmol/L were reported in 21.7% and 4.5% of patients treated with this drug and in 9.8% and 1.4% of those treated with placebo, respectively.

An increase from baseline in mean serum potassium in the first month of therapy was about 0.2 mmol/L in patients treated with this drug.^[Ref]

Nervous system

Frequency not reported: Dizziness, syncope^[Ref]

Other

Frequency not reported: Fall^[Ref]

Renal

This drug caused an initial small decrease in eGFR (mean 2 mL/min/1.73 m2); it occurred within the first 4 weeks of therapy and then stabilized. In a study including patients with chronic kidney disease associated with type 2 diabetes, this decrease was reversible after therapy was stopped.^[Ref]

Common (1% to 10%): Estimated glomerular filtration rate (eGFR) decreased/GFR decreased^[Ref]