Over-the-counter (OTC) antacids are routinely used to combat heartburn, indigestion, upset and sour stomach complaints, but the FDA has issued a Drug Safety Communication warning consumers against using OTC antacids that also contain aspirin because of the risk of serious bleeding.

The FDA changed drug safety labeling on all OTC products containing non-steroidal anti-inflammatories (NSAIDs) in 2009 to warn about the increased risk of serious bleeding in the stomach or GI tract. Since 2009, the FDA has received 8 Adverse Event reports of serious bleeding with hospitalization caused by combination antacid/aspirin products. These combination medicines include widely used products such as Alka-Seltzer Original and Bromo Seltzer, as well as other brand name products and generics containing both antacids and aspirin.

Other factors increase the risk of serious bleeding with use of these combination products including:

  • 60 years or older
  • Pre-existing history of stomach ulcers or bleeding problems
  • Use of blood thinners or steroids
  • Use of NSAIDs including aspiring
  • Consuming 3 or more alcoholic beverages a day

Taking more than the recommended dosage, or for a longer period of time than recommended also increases the risk of serious bleeding.

Recommended action

To avoid the risk of serious bleeding complications, the FDA recommends taking an antacid that does not contain aspirin or NSAIDs. The FDA also recommends reading all product labels and Drug Facts on OTC antacids before use to ensure the product is aspirin or NSAIDs-free.

The FDA will assemble an expert advisory panel in 2017 to further evaluate the bleeding risk, and advise whether further regulatory action or warning label changes are needed.

If you or a loved one suffers any adverse or side effects when using a combination antacid/aspirin product, the FDA asks that you report any complications to your healthcare provider, and complete a MedWatch Safety Information and Adverse Event Report to document your complaints as part of their continuing effort to evaluate the safety and effectiveness of combination antacid/aspirin products. Reports can be found at www.fda.gov/MedWatch/report or you can call 1-800-332-1088 to request a reporting form.