Find Information About:

Drugs & Supplements

Get information and reviews on prescription drugs, over-the-counter medications, vitamins, and supplements. Search by name or medical condition.

Pill Identifier

Pill Identifier

Having trouble identifying your pills?

Enter the shape, color, or imprint of your prescription or OTC drug. Our pill identification tool will display pictures that you can compare to your pill.

Get Started
My Medicine

My Medicine

Save your medicine, check interactions, sign up for FDA alerts, create family profiles and more.

Get Started

WebMD Health Experts and Community

Talk to health experts and other people like you in WebMD's Communities. It's a safe forum where you can create or participate in support groups and discussions about health topics that interest you.

  • Second Opinion

    Second Opinion

    Read expert perspectives on popular health topics.

  • Community


    Connect with people like you, and get expert guidance on living a healthy life.

Got a health question? Get answers provided by leading organizations, doctors, and experts.

Get Answers

Sign up to receive WebMD's award-winning content delivered to your inbox.

Sign Up

Pain Management Health Center

Font Size

FDA Issues New Warnings for Painkillers

Products Containing Acetaminophen, NSAIDs Must Warn of Liver Damage, Stomach Bleeding

Acetaminophen Risks

Holman says consumers with liver disease are at increased risk of damage when using acetaminophen, and therefore, containers should also instruct people to ask a doctor before using the product.

"The new regulations also require a new warning for consumers taking the blood thinning drug warfarin to ask a doctor or pharmacist before using acetaminophen," he says. "Warfarin is a prescription drug, and the prescription labeling includes a warning that acetaminophen can interfere with the blood thinning action of warfarin."

He says the FDA is aware of cases in which patients had excessive bleeding when using warfarin and acetaminophen and that people taking both should consult a doctor.

Products introduced within one year from July 28, 2009, must include the statement, "see new warnings information," on front labels.


As for NSAIDs, the new regulations require front labels to instruct users to see new warnings that products contain the ingredient.

"Every over-the-counter product containing an NSAID will have to include a bolded stomach bleeding warning at the beginning of the warnings section in the drug facts panel," Holman says.

This warning must read: "This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinning or steroid drug, take other drugs containing prescription or nonprescription NSAIDs, have three or more alcoholic drinks every day using this product, take more or for a longer time than directed."

Warnings for Patients

The new regulations also require a separate warning instructing consumers to ask their doctors if the stomach bleeding warning applies to them, he says.

The rules also warn patients to stop use of medications if they experience signs of stomach bleeding, which including vomiting blood, feeling faint, having bloody or black stools, or stomach pains that do not get better.

The rules are intended "to reduce the incidence and seriousness of liver damage caused by acetaminophen and stomach bleeding caused by NSAIDs."

Shanthi Sitaraman, MD, a professor of digestive diseases at Emory University School of Medicine in Atlanta, tells WebMD the FDA's action is long overdue.

"Of two major causes of GI bleeding, NSAIDs is No. 1," she says. And NSAIDs can worsen stomach bleeding from other causes, she says.

Today on WebMD

pain in brain and nerves
Top causes and how to find relief.
knee exercise
8 exercises for less knee pain.
acupuncture needles in woman's back
How it helps arthritis, migraines, and dental pain.
chronic pain
Get personalized tips to reduce discomfort.
illustration of nerves in hand
lumbar spine
Woman opening window
Man holding handful of pills
Woman shopping for vegetables
Sore feet with high heel shoes
acupuncture needles in woman's back
man with a migraine