Important Safety Info | PROTONIX® (pantoprazole sodium) | Safety Info


  • Do not take PROTONIX if you are:
    • allergic to pantoprazole sodium or any of the other ingredients of PROTONIX or other proton pump inhibitors (PPIs).
    • are taking a medicine that contains rilpivirine (Edurant®, Complera®, Odefsey®) used to treat HIV-1 (Human Immunodeficiency Virus).
  • Relief of your symptoms while on PROTONIX does not exclude the possibility that serious stomach conditions may be present. Talk with your doctor.
  • A very serious allergic reaction to this drug is rare. Get medical help right away if you notice any symptoms of a serious allergic reaction, including throat tightness, fever, rash, difficult breathing, weight loss, feeling tired, and weakness as this may be a serious allergic reaction.
  • Some people who take proton pump inhibitor (PPI) medicines, including PROTONIX, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with PROTONIX. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
  • PROTONIX may increase the risk of getting severe diarrhea due to an intestinal infection caused by Clostridium difficile. Call your doctor right away if you have diarrhea, cramps, and fever that does not go away. Patients should use the lowest dose and shortest duration of PPI appropriate to the condition being treated.
  • PPI therapy, like PROTONIX, may be associated with an increased risk of bone fractures of the hip, wrist or spine. The risk of fracture increases in patients who are taking multiple daily doses and are on PPI therapy for a year or longer.
  • Some people who take PPIs, including PROTONIX, develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have joint pain or rash on your cheeks or arms that gets worse in the sun.
  • PROTONIX reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on PROTONIX for a long time (more than 3 years).
  • Low magnesium levels can happen in some patients who take PPIs, like PROTONIX, for at least 3 months. Tell your doctor right away if you have any of these symptoms of low magnesium: seizures, dizziness, irregular heartbeat, muscle spasms or cramps.
  • The most common side effects for PROTONIX include:
    • headache, diarrhea, nausea, abdominal pain, vomiting, gas, dizziness, and joint pain in adults
    • upper respiratory infections, headache, fever, diarrhea, vomiting, rash, and abdominal pain in children
  • Before taking PROTONIX, tell your doctor if you are pregnant or plan to become pregnant. PROTONIX may harm your unborn baby.
  • Before taking PROTONIX, tell your doctor about all of the medicines you take, especially if you take atazanavir, nelfinavir, warfarin, a product that contains iron, ketoconazole methotrexate, or mycophenolate mofetil. If you are taking PROTONIX with warfarin, you may need to have certain laboratory tests monitored as potential serious risks may occur.
  • Use of PROTONIX along with high doses of methotrexate may increase blood levels of methotrexate, possibly leading to methotrexate toxicity.
  • PROTONIX is a prescription drug for the short-term treatment in the healing and relief of symptoms of acid-related damage to the esophagus. This condition is known as erosive esophagitis or erosive gastroesophageal reflux disease (GERD) and is caused by back up of stomach acid into the esophagus.
  • PROTONIX can be used for adults and children 5 years of age and older for treatment up to 8 weeks. Adults can receive an additional 8 weeks of treatment if needed. Safety of treatment beyond 8 weeks has not been established in children. PROTONIX can be used to maintain healing of erosive GERD in adults. Studies did not go beyond 12 months.
  • PROTONIX is used in adults for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

Please see Full Prescribing Information, including Medication Guide.


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