Side effects of Yosprala

Yosprala is a prescription medicine used in people who have had heart problems or strokes caused by blood clots, to help reduce their risk of further heart problems or strokes, and who are at risk of developing stomach ulcers with aspirin.1

Yosprala can cause serious side effects, including:

  • Kidney problems (acute interstitial nephritis) may happen at any time during treatment with Yosprala. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
  • Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor if you have watery stools or stomach pain that does not go away. You may or may not have a fever.
  • Bone fractures (hip, wrist, or spine) in people who take multiple daily doses of proton pump inhibitor (PPI) medicines and for a long period of time (a year or longer).
  • Certain types of lupus erythematosus may happen or get worse in people who already have lupus and who take PPI medicines, including Yosprala. Call your doctor right away if you have joint pain or a rash on your cheeks or arms that gets worse in the sun.

Talk to your doctor about your risk of these serious side effects.


What are other possible side effects of Yosprala?1

Yosprala can cause serious side effects, including:

  • See What is the most important information I should know about Yosprala?
  • Stomach and intestine problems. Stop taking Yosprala and call your doctor right away if you have any of the following signs or symptoms: black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds, or severe nausea, vomiting, or stomach pain.
  • Kidney failure. Long-lasting (chronic) kidney failure can happen with regular use of aspirin, a medicine in Yosprala. This is more likely to happen in people who already have kidney problems before treatment with Yosprala. Tell your doctor if you have signs or symptoms of kidney failure, including: changes in urination, swelling, skin rash or itching, or your breath smells like ammonia.
  • Liver problems. Long-term use of Yosprala at certain doses may cause liver problems. Tell your doctor if you have signs or symptoms of liver problems, including: yellowing of your skin or your eyes, stomach-area (abdominal) pain and swelling, itchy skin, and dark (tea-colored) urine.
  • Low vitamin B-12 levels in your body can happen in people who have taken a PPI medicine, such as omeprazole, for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including: shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness.
  • Low magnesium levels in your body can happen in people who have taken Yosprala for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including: seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.

The most common side effects of Yosprala include: indigestion or heartburn and stomach-area pain, nausea, diarrhea, growths (polyps) in your stomach, and chest pain behind the breastbone, for example, with eating.

These are not all the possible side effects of Yosprala. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

References: 1. Yosprala Prescribing Information. Charleston, WV: Innovida Pharmaceutique Corporation; 2018.

Yosprala® is a registered trademark of Genus Lifesciences, Inc. and is used under license. All other product/brand names are trademarks of their respective owners. Manufactured for: Innovida Pharmaceutique Corporation.