Created by FindLaw's team of legal writers and editors | Last reviewed December 14, 2016
What is Acetaminophen?
Acetaminophen is a medicine used to relieve pain and reduce fever. Although acetaminophen does not relieve the redness, stiffness, or swelling caused by rheumatoid arthritis, it may relieve the pain caused by mild forms of arthritis. Acetaminophen is available without a prescription. However, your healthcare professional may provide special instructions on proper acetaminophen dosage for your particular medical condition.
Acetaminophen can be taken orally in the form of capsules, granules, liquids, powders, suspension (drops or liquid), and chewable and non-chewable tablets.
Store-Brand Acetaminophen Recalled by Perrigo Company
On November 9, 2006, the U.S. Food and Drug Administration(FDA) alerted the public to a voluntary recall by Perrigo Company (Allegan, Michigan) of 383 lots of acetaminophen 500 mg caplets manufactured and distributed under various store-brands. Small metal fragments have been found in a small number of these caplets, affecting approximately 11 million bottles with varying quantities of acetaminophen 500 mg caplets.
As of the time of the recall, no illnesses, injuries, or consumer complaints had been reported. Although the FDA believes that the probability of serious adverse health effects is remote, consumers should contact their healthcare professional if they suspect they have been harmed by the affected acetaminophen tablets. The FDA is investigating the presence of the metal particles in the caplets.
For more information about this recall, visit the following pages:
- FDA News Release on the Acetaminophen Recall
- Acetaminophen Recall Product and Batch Information (FDA)
- Acetaminophen Recall Customer List (FDA)
Acetaminophen and Liver Risk
In recent years, studies have shown that taking acetaminophen in large amounts can lead to serious liver damage. The FDA has warned consumers that over-the-counter pain relievers should be taken with care, in order to avoid the serious liver problems that can occur with misuse.
Signs of liver disease include abnormally yellow skin and eyes (jaundice), dark urine, light-colored stools, nausea, vomiting, and loss of appetite. Because the signs can besimilar to flu symptoms, they may go unnoticed if consumers believe they are related to their initial illness. Serious cases of liver disease may lead to mental confusion, coma, and death. From the FDA: Use Caution with Pain Relievers
On December 19, 2006, the FDA proposed to amend the labeling regulations on over-the-counter pain relievers, to include important safety information about the potential for stomach bleeding and liver damage. For products containing acetaminophen, the FDA proposed new warnings highlighting the risk of liver toxicity -- particularly when using acetaminophen in high doses, when taken with other acetaminophen products, or when taken with moderate amounts of alcohol. The FDA also proposed that the ingredient acetaminophen be prominently identified on the product display panel on the immediate container, and on the outer carton (if applicable). Click here to read more from the FDA.
What Should I Know Before Using Acetaminophen?
If you are taking acetaminophen without a prescription, carefully read and follow any precautions on the label. Consider the following when taking acetaminophen:
- Although studies have not been done on pregnant women, acetaminophen has not been reported to cause birth defects or other problems.
- Although acetaminophen passes into breast milk in small amounts, it has not been reported to cause problems in nursing babies.
- Acetaminophen use by children has not been shown to cause different side effects or problems than those found in adults. However, some children's acetaminophen products also contain aspartame, which may pose a danger for children with phenylketonuria.
- Acetaminophen may interfere with medical test results. Before undergoing any tests, tell the person in charge if you have taken acetaminophen in the last three or four days.
Acetaminophen Side Effects
Acetaminophen may cause side effects. Some side effects can be serious. If you experience any of the following symptoms, contact your healthcare professional immediately:
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
Food and Drug Interactions with Acetaminophen
Tell your healthcare professional about any prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you take or plan to take.
If you plan to take more than the occasional one or two doses of acetaminophen, do not drink alcoholic beverages. Doing so may increase the chance of liver damage, especially if you drink large amounts of alcoholic beverages regularly,if you take more acetaminophen than recommended on the package label, or if you take it regularly for a long period of time.
Taking certain other medicines together with acetaminophen may increase the chance of unwanted effects. Do not take any of the following medicines together with acetaminophen for more than a few days unless your director has directed you to do so and is following your progress:
- Diclofenac (e.g., Voltaren)
- Diflunisal(e.g., Dolobid)
- Tenoxicam(e.g., Apo-Tenoxicam)
- Tiaprofenicacid (e.g., Surgam)
Acetaminophen - Getting Legal Help
While all medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."
If you or a loved one have experienced any dangerous symptoms or unusual medical conditions while using acetaminophen, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by acetaminophen use.
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