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 Stop use and ask doctor if • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present
The safety outcomes for acetaminophen (PO) include:
- Severe liver damage if more than 6 caplets are taken in 24 hours, or if taken with other drugs containing acetaminophen, or with 3 or more alcoholic drinks every day 1
- Severe skin reactions, including skin reddening, blisters, and rash 1
- Signs of a serious condition, such as pain getting worse or lasting more than 10 days, fever getting worse or lasting more than 3 days, new symptoms, redness, or swelling 1
From the Research
The safety outcomes for the article are generally favorable, with a low risk of serious gastrointestinal events associated with the use of acetylsalicylic acid, acetaminophen, and ibuprofen in patients with osteoarthritis and rheumatoid arthritis, as reported in the study published in The Journal of Rheumatology 2. The study found that the frequency of serious gastrointestinal complications was low, especially when these medications were used at lower doses or intermittently.
- The rates of gastrointestinal events were similar across the three medications, with no significant differences in gastrointestinal toxicity among them at over-the-counter doses.
- The study also noted that the rate of gastrointestinal events was highly dependent on concurrent therapy, increasing 2 to 6-fold in patients taking other analgesics or corticosteroids.
- The use of these medications without other analgesics or corticosteroids resulted in a very low rate of serious gastrointestinal events, roughly equivalent to background rates.
- The study's findings suggest that the use of acetylsalicylic acid, acetaminophen, and ibuprofen in patients with osteoarthritis and rheumatoid arthritis is relatively safe, with a low risk of serious gastrointestinal events, especially when used at lower doses or without concurrent therapy, as supported by the study published in The Journal of Rheumatology 2. However, it is essential to consider the potential for adverse events and monitor patients accordingly, as highlighted in the study on reporting clinical trial safety results in ClinicalTrials.gov 3. Additionally, the relationship between staff engagement and patient safety outcomes, as explored in the systematic review and meta-analysis published in the Journal of Patient Safety 4, may also impact the safety outcomes for patients using these medications. Overall, the safety outcomes for the article are favorable, with a low risk of serious gastrointestinal events, and support the use of these medications in patients with osteoarthritis and rheumatoid arthritis, as long as they are used judiciously and with appropriate monitoring.