The U.S. Food and Drug Administration (FDA) is asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of acetaminophen in these products to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients.
In addition, a Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (e.g., swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) are being added to the label of all prescription drug products that contain acetaminophen.
These actions will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen.
Acetaminophen is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. It is one of the most commonly-used drugs in the United States. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet).
OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. Additional safety measures relating to OTC acetaminophen products will be taken through separate action, such as a rulemaking as part of the ongoing OTC monograph proceeding for internal analgesic drug products.
Additional Information for Patients
- Acetaminophen-containing prescription products are safe and effective when used as directed, though all medications carry some risks.
- Do not stop taking your prescription pain medicine unless told to do so by your healthcare professional.
- Carefully read all labels for prescription and OTC medicines and ask the pharmacist if your prescription pain medicine contains acetaminophen.
- Do not take more than one product that contains acetaminophen at any given time.
- Do not take more of an acetaminophen-containing medicine than directed.
- Do not drink alcohol when taking medicines that contain acetaminophen.
- Stop taking your medication and seek medical help immediately if you:
- Think you have taken more acetaminophen than directed or
- Experience allergic reactions such as swelling of the face, mouth, and throat, difficulty breathing, itching, or rash.
- Report side effects to FDA's MedWatch program using the information in the "Contact Us" box at the bottom of the page.
Additional Information for Healthcare Professionals
The maximum amount of acetaminophen in a prescription tablet, capsule, or other dosage unit will be limited to 325 mg. However, the total number of tablets or capsules that may be prescribed and the time intervals at which they may be prescribed will not change as a result of the lower amount of acetaminophen. For example, for a product that previously contained 500 mg of acetaminophen with an opioid and was prescribed as 1-2 tablets every 4-6 hours, once reformulated to contain 325 mg of acetaminophen, the dosing instructions can remain unchanged.
- Advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day).
- Severe liver injury, including cases of acute liver failure resulting in liver transplant and death, has been reported with the use of acetaminophen.
- Educate patients about the importance of reading all prescription and OTC labels to ensure they are not taking multiple acetaminophen-containing products.
- Advise patients not to drink alcohol while taking acetaminophen-containing medications.
- Rare cases of anaphylaxis and other hypersensitivity reactions have occurred with the use of acetaminophen.
- Advise patients to seek medical help immediately if they have taken more acetaminophen than directed or experience swelling of the face, mouth, and throat, difficulty breathing, itching, and rash.
- Report adverse events to FDA's MedWatch program using the information in the "Contact Us" box at the bottom of the page.
Data Summary and Discussion
A number of studies have tried to answer the question of how common liver injury is in relation to the use of acetaminophen ...more
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