From the Guidelines
Tylenol (acetaminophen) can cause significant liver damage when taken in excessive doses, and individuals with existing liver disease, chronic alcohol users, or those taking other medications containing acetaminophen should be cautious and may need reduced dosing. The most significant concern with Tylenol is liver damage, which can occur with excessive doses (more than 4,000 mg per day for adults) or when taken with alcohol 1. Common side effects of acetaminophen include:
- Nausea
- Stomach pain
- Loss of appetite
- Headache These side effects typically resolve on their own. More serious side effects, though rare, include:
- Allergic reactions (rash, itching, swelling)
- Unusual tiredness
- Yellowing of the skin or eyes (jaundice) which require immediate medical attention. According to the most recent guidelines, the daily dose of acetaminophen should be limited to 3 g or less per day to minimize the risk of liver damage 1. It is essential to follow the recommended dosage on the package or as prescribed by your healthcare provider and be aware of acetaminophen in combination medications to avoid accidental overdose. The FDA recommends limiting daily acetaminophen intake to a maximum of 4 g and imposes a limit of 325 mg of acetaminophen per tablet, capsule, or other dosage unit in prescription products to reduce the risk of severe liver injury from acetaminophen overdosing 1.
From the FDA Drug Label
WARNINGS Liver warning: This product contains acetaminophen. Severe Liver damage may occur if you take • more than 6 caplets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks everyday while using this product Allergy alert: acetaminophen may cause severe skin reactions Symptoms may include: • skin reddening • blisters • rash The side effects of acetaminophen (Tylenol) include:
- Severe Liver damage if taken in excess or with other drugs containing acetaminophen or with excessive alcohol consumption
- Severe skin reactions, with symptoms such as:
- Skin reddening
- Blisters
- Rash 2
From the Research
Side Effects of Acetaminophen (Tylenol)
- The most significant side effect of acetaminophen is hepatotoxicity, which can occur if doses in excess of the therapeutic amount are ingested inappropriately 3.
- Acetaminophen is generally well tolerated at recommended doses (≤4 g/day) in healthy adults, but inappropriate use may increase the risks of both overdosing and inadequate analgesia 4.
- Hepatotoxicity is rare among adults who use paracetamol as directed, including people with cirrhotic liver disease 4.
- Putative epidemiologic associations of paracetamol use with kidney or cardiovascular disease, hypertension, gastrointestinal disorders, and asthma largely reflect confounding biases and are of doubtful relevance to short-term use (<14 days) 4.
- The mechanism for acetaminophen liver damage is quite clear, producing hepatic injury as a result of a large single overdose, usually suicidal in intent 5.
- Patients with acetaminophen blood levels higher than 300 mg/dL at four hours after intake are most likely to develop hepatic damage; when N-acetylcysteine is used within the first ten hours after ingestion of an overdose, the recovery rate is reported to be virtually 100% 5.
- Prospective studies indicated that repeated use of a true therapeutic acetaminophen dosage may slightly increase the level of serum aminotransferase activity, but hepatic failure or death was not reported 6.
- Retrospective reports indicated a higher rate of increased serum aminotransferase levels, and several reported associated liver injury and death, which may be inadvertent overdoses, rather than true therapeutic dosages 6.
- Accidental or intentional overdose of acetaminophen can lead to hepatotoxicity, making prompt recognition of acetaminophen toxicity essential to prevent morbidity and mortality 7.
Common Side Effects
Special Considerations
- Older adults: no evidence supports routine dose reduction, but dosing should be individualized in consultation with their physician 4.
- Patients with liver, kidney, or cardiovascular disease: paracetamol is a suitable first-line analgesic for mild to moderate acute pain, but dosing should be individualized in consultation with their physician 4.
- Patients with gastrointestinal disorders, asthma: paracetamol is a suitable first-line analgesic for mild to moderate acute pain, but dosing should be individualized in consultation with their physician 4.