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On September 22, 2025, the Food and Drug Administration (FDA), issued a safety warning indicating that taking acetaminophen while pregnant may be associated with the development of neurological conditions such as Autism Spectrum Disorder (ASD) or Attention Hyperactivity Deficit Disorder (ADHD) in children. Although no evidence to date has been able to show that acetaminophen in pregnancy causes these disorders, some studies have shown an association. Talk to your doctor about the risks and benefits or using acetaminophen during pregnancy.
Taking too much acetaminophen can cause liver damage, sometimes serious enough to require liver transplantation or cause death. You might accidentally take too much acetaminophen if you do not follow the directions on the prescription or package label carefully, or if you take more than one product that contains acetaminophen.
To be sure that you take acetaminophen safely, you should
People who take nonsteroidal anti-inflammatory drugs (NSAIDs), other than aspirin, such as naproxen may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. These problems may develop at any time during treatment, but the risk may be higher for people who take NSAIDs for a long time or at higher doses. Do not take an NSAID such as naproxen if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, or a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.
If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not take naproxen right before or right after the surgery.
NSAIDs such as naproxen may cause ulcers, bleeding, or holes in the esophagus (tube between the mouth and stomach), stomach, or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time or at higher doses, are older in age, have poor health, who smoke, or who drink large amounts of alcohol while taking naproxen. Be sure to tell your doctor or pharmacist about what prescription and nonprescription medications, herbals, and vitamins you take, or plan to take, during your treatment with acetaminophen and naproxen. Certain medications may increase the risk of bleeding occuring. Tell your doctor if you have or have ever had ulcers, bleeding in your stomach or intestines, other bleeding disorders, or liver disease. If you experience any of the following symptoms, stop taking naproxen and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.
WHY is this medicine prescribed?
Acetaminophen and naproxen is used for the temporary relief of minor aches and pains. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body. Naproxen is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation
HOW should this medicine be used?
Acetaminophen and naproxen comes as a tablet to take by mouth. Take it with a full glass of water every 12 hours as needed. Acetaminophen and naproxen may be taken with food to prevent an upset stomach.
Take acetaminophen and naproxen exactly as directed. Do not take more or less of it or take it more often than recommended.
Are there OTHER USES for this medication?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking acetaminophen and naproxen,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
This medication is usually taken as needed. If your doctor has told you to take acetaminophen and naproxen regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Acetaminophen and naproxen may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms {or those listed in the IMPORTANT WARNING section}, stop taking acetaminophen and naproxen and call your doctor immediately or get emergency medical treatment:
Acetaminophen and naproxen may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.
What OTHER INFORMATION should I know?
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking acetaminophen and naproxen.
Ask your pharmacist any questions you have about acetaminophen and naproxen.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS® Patient Medication Information™ Copyright, 2026. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: September 15, 2026.