Sparsentan Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 5, 2023.

Applies to sparsentan: oral tablet.

Serious side effects of Sparsentan

Along with its needed effects, sparsentan 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 sparsentan:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• chills
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• irregular heartbeat
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pale skin
• rapid weight gain
• sweating
• tingling of the hands or feet
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness or heaviness of the legs

Less common

• Agitation
• coma
• decreased urine output
• depression
• headache
• hostility
• irritability
• lethargy
• muscle twitching
• stupor
• swelling of the face, ankles, or hands

Incidence not known

• Dark urine
• loss of appetite
• stomach pain, severe
• yellow eyes or skin

For Healthcare Professionals

Applies to sparsentan: oral tablet.

General

The most common adverse reactions occurring in 5% of patients or more included peripheral edema, hypotension (including orthostatic hypotension), dizziness, hyperkalemia, and anemia.^[Ref]

Cardiovascular

Very common (10% or more): Peripheral edema (14%), hypotension (14%)^[Ref]

Hematologic

-Decreases in hemoglobin greater than 2 g/dL compared to baseline and below the lower limit of normal occurred more commonly with this drug; hemodilution may be a contributing factor.

-No treatment discontinuations occurred due to anemia or hemoglobinemia.^[Ref]

Very common (10% or more): Decreased hemoglobin (11%)

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

Hepatic

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

-Transaminase elevations occurred in 2.5% of patients and were reported as adverse events when greater than 3 times the upper limit of normal (3 x ULN).

-No cases of liver failure or elevations in bilirubin (greater than 2 x ULN) were observed with this drug.^[Ref]

Metabolic

-Patients who have advanced kidney disease, or take concomitant potassium-increasing drugs, or use potassium-containing salts are at higher risk for developing hyperkalemia.^[Ref]

Very common (10% or more): Hyperkalemia (13%)^[Ref]

Nervous system

Very common (10% or more): Dizziness (13%)^[Ref]

Renal

Common (1% to 10%): Acute kidney injury

Frequency not reported: Decreased estimated glomerular filtration rate^[Ref]

-Patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, volume depletion, or those whose kidney function may depend in part on the activity of the renin-angiotensin system may be at higher risk of developing acute kidney injury.

-Small decreases in estimated glomerular filtration rate occurred during the first 4 weeks of initiating therapy with this drug, and then stabilized.^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer