Sparsentan Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 13, 2024.

Applies to sparsentan: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. Blood and urine tests may be needed to check for unwanted effects. Your doctor will do tests before starting treatment, every month for 12 months, and then every 3 months during treatment with this medicine.

Do not use this medicine together with aliskiren (Tekturna®) or other blood pressure medicine (eg, angiotensin receptor blocker, endothelin receptor blocker).

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor will do tests before starting, during treatment, and 1 month after stopping this medicine to make sure you are not pregnant. Use an effective form of birth control before starting, during treatment, and for 1 month after your final dose to keep from getting pregnant. Ask your doctor which form of birth control is right for you. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious liver problems. Check with your doctor right away if you have dark urine, fatigue, loss of appetite, nausea or vomiting, severe stomach pain, or yellow eyes or skin.

Check with your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness. These may be symptoms of hypotension (low blood pressure).

This medicine may cause serious kidney problems. Check with your doctor right away if you have agitation, coma, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

Check with your doctor right away if you have confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, stomach pain, trouble breathing, or weakness or heaviness of the legs. These may be symptoms of hyperkalemia (high potassium in the blood).

This medicine may cause fluid retention (too much water in the body). Check with your doctor right away if you have decrease in amount of urine, noisy, rattling, or trouble breathing, swelling of the face, hands, feet, or lower legs, or weight gain.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

For healthcare professionals

Applies to sparsentan: oral tablet.

General adverse events

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

• Very common (10% or more): Decreased hemoglobin (11%)
• Common (1% to 10%): Anemia^[Ref]

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]

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

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

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]

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]

See also:

Further information

Sparsentan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer