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Does Tylenol Cause Steven Johnson Syndrome?

4 min read

Stevens-Johnson syndrome (SJS) is a rare disorder, affecting 1 to 2 people per million each year [1.5.1, 1.7.4]. While uncommon, research and FDA warnings have explored the question: Does Tylenol cause Steven Johnson Syndrome? This article examines the evidence.

Quick Summary

Acetaminophen, the active ingredient in Tylenol, is associated with a rare risk of causing Stevens-Johnson syndrome (SJS). The FDA requires warning labels about this severe skin reaction.

Key Points

  • FDA Warning: The FDA has confirmed a rare link between acetaminophen (Tylenol) and Stevens-Johnson Syndrome (SJS) and requires a warning on labels [1.6.2].

  • Rare but Serious: SJS is a medical emergency, but the risk from acetaminophen is considered rare [1.2.1, 1.2.2].

  • Initial Symptoms: SJS often starts with flu-like symptoms (fever, sore throat) before a painful, blistering rash appears [1.5.1].

  • Seek Immediate Care: If you develop a rash or blisters while taking acetaminophen, stop the drug and seek immediate medical attention [1.2.1].

  • Other Drug Causes: SJS is more commonly caused by other drugs, including certain antibiotics, anticonvulsants, and allopurinol [1.4.1, 1.4.2].

  • No Cross-Sensitivity: Having an SJS reaction to acetaminophen does not necessarily mean you will react to NSAIDs like ibuprofen or naproxen [1.2.1, 1.6.3].

  • Long-Term Sequelae: Survivors of SJS can face long-term complications affecting their skin, eyes, and mental health [1.9.1, 1.9.5].

In This Article

What is Stevens-Johnson Syndrome (SJS)?

Stevens-Johnson syndrome (SJS) is a rare but serious and potentially fatal medical emergency that affects the skin and mucous membranes [1.5.1, 1.5.3]. It is considered a hypersensitivity reaction, most often triggered by medications [1.4.1, 1.5.1]. The condition typically begins with flu-like symptoms, such as fever, sore throat, and fatigue, which are then followed by a painful, spreading rash that blisters [1.5.1, 1.5.6]. The top layer of the affected skin dies and sheds [1.5.2].

When skin detachment covers less than 10% of the body's surface, it is classified as SJS [1.5.1, 1.8.3]. If it covers more than 30%, it is known as toxic epidermal necrolysis (TEN) [1.5.1, 1.8.3]. The range between 10% and 30% is considered SJS/TEN overlap [1.5.2]. Treatment requires hospitalization, often in a burn unit or intensive care unit, to manage symptoms, prevent infection, and support healing [1.5.1, 1.5.3].

Early Signs and Symptoms of SJS

  • Fever and body aches [1.5.2]
  • Sore throat and cough [1.5.1]
  • Burning eyes [1.5.1]
  • A red or purplish rash that spreads and blisters [1.5.2]
  • Sores on mucous membranes, including the mouth, eyes, and genitals [1.3.3, 1.5.2]

The Link Between Tylenol (Acetaminophen) and SJS

Tylenol is the brand name for acetaminophen, one of the most widely used over-the-counter medications for pain and fever in the United States [1.2.1]. The U.S. Food and Drug Administration (FDA) has confirmed a link between acetaminophen and rare cases of SJS, TEN, and a related condition called acute generalized exanthematous pustulosis (AGEP) [1.6.2].

In 2013, the FDA issued a Drug Safety Communication warning that acetaminophen can, in rare instances, cause these severe skin reactions [1.6.2]. This warning was based on a review of medical literature and the FDA's Adverse Event Reporting System (FAERS), which found dozens of cases linked to the drug, including some resulting in hospitalization and death [1.3.5, 1.6.2]. As a result, the FDA mandated that a warning about this risk be added to the labels of both prescription and over-the-counter acetaminophen products [1.6.2, 1.6.6].

It's important to note that this reaction is rare and can occur at any time, even if someone has used acetaminophen in the past without issue [1.2.1]. There is no way to predict who might be at higher risk [1.2.1]. A key challenge in confirming causality is "protopathic bias," where acetaminophen is taken for the early flu-like symptoms of SJS, making it difficult to distinguish it as the cause versus a treatment for the initial symptoms [1.3.1, 1.6.2]. However, some studies that controlled for this bias still found a significant association [1.2.2, 1.3.1].

Other Medications That Cause SJS

While acetaminophen is a known trigger, it is not the most common one. SJS is more frequently associated with other classes of drugs [1.4.2, 1.5.1]. Anyone who develops a rash while taking a new medication should seek medical attention immediately [1.2.1].

Common high-risk medications include:

  • Anti-gout medications: Allopurinol is a frequently cited cause [1.4.1, 1.4.2].
  • Anticonvulsants: Medications for seizures like carbamazepine, lamotrigine, and phenytoin are strongly linked to SJS [1.4.2, 1.4.5].
  • Antibiotics: Sulfa antibiotics (sulfonamides), penicillins, and cephalosporins are known triggers [1.4.2, 1.4.4].
  • NSAIDs: Nonsteroidal anti-inflammatory drugs like ibuprofen (Advil, Motrin) and naproxen (Aleve) also carry a risk of causing SJS [1.4.1].

Comparison of Severe Skin Reactions

It can be challenging to distinguish SJS from other skin reactions. Here is a comparison of key features.

Feature Stevens-Johnson Syndrome (SJS) Toxic Epidermal Necrolysis (TEN) Erythema Multiforme (EM)
Primary Cause Usually medications [1.5.1] Usually medications [1.5.1] Mostly infections (e.g., Herpes Simplex Virus) [1.8.1, 1.8.2]
Skin Detachment <10% of Body Surface Area [1.5.2, 1.8.3] >30% of Body Surface Area [1.5.2, 1.8.3] Typically none, or less than 10% [1.8.2]
Lesion Type Flat, atypical targets or purpuric macules that may blister [1.8.2] Widespread blisters and sheet-like peeling of skin [1.5.2] Typical "target" lesions, often raised [1.8.2, 1.8.4]
Mucosal Involvement Almost always present (mouth, eyes, genitals) [1.8.3] Almost always present and often severe [1.5.2] Can be present (EM major) or absent (EM minor) [1.8.4, 1.8.5]
Systemic Symptoms Prodrome of fever, malaise is common [1.8.3] Severe, systemic illness is characteristic [1.5.2] Mild or no systemic symptoms [1.8.3]

Long-Term Effects and Recovery

Recovery from SJS can take weeks to months and may result in long-term complications [1.5.1]. The mortality rate for SJS is around 5-10% [1.5.1]. Survivors often face lasting physical and psychological sequelae.

Common long-term problems include:

  • Cutaneous Issues: Scarring, changes in skin pigmentation, chronic dry or itchy skin, and abnormal nail or hair growth [1.9.1, 1.9.5].
  • Ocular Problems: Severe dry eye is the most common long-term complication [1.9.2]. Other issues include light sensitivity (photophobia), corneal scarring, and in some cases, impaired vision or blindness [1.9.1].
  • Oral and Mucosal Damage: Chronic oral pain, dry mouth, and dental problems are common [1.9.1]. Genitourinary scarring can also occur [1.9.4].
  • Psychological Impact: Survivors report high rates of depression, anxiety, and post-traumatic stress disorder (PTSD). Many express a fear of taking new medications [1.9.1, 1.9.3].

Conclusion

In conclusion, while Tylenol (acetaminophen) is a widely used and generally safe medication, it is associated with a rare but serious risk of causing Stevens-Johnson syndrome [1.2.2, 1.6.2]. The FDA has mandated warning labels to reflect this risk [1.6.6]. The reaction is unpredictable and not dose-dependent. Given the severity of SJS, any individual who develops a rash or blistering, especially when starting a new medication, should immediately stop taking the drug and seek emergency medical care [1.2.1]. Awareness of the signs and prompt action are crucial for improving outcomes.

For more information on drug safety, you can visit the FDA's Drug Safety and Availability page.

Frequently Asked Questions

Yes, a serious skin reaction like SJS can occur at any time while taking acetaminophen, even if you have taken it many times before without any issues [1.2.1].

The earliest symptoms of SJS often mimic the flu, including fever, body aches, sore throat, cough, and burning eyes [1.5.1, 1.5.2]. A painful rash typically follows within a few days [1.5.1].

No. While Tylenol (acetaminophen) is a known cause, SJS is more commonly triggered by other medications like anti-gout drug allopurinol, certain antibiotics (especially sulfa drugs), and anticonvulsants [1.4.1, 1.4.2, 1.5.1].

You should stop taking the medication immediately and seek medical attention right away. A healthcare professional needs to evaluate the rash to determine if it is a serious reaction like SJS [1.2.1, 1.6.2].

SJS and TEN are considered part of the same disease spectrum, differing by severity. SJS involves skin detachment on less than 10% of the body, while TEN involves more than 30%. The range in between is called SJS/TEN overlap [1.5.1, 1.5.2].

While other pain relievers like ibuprofen also carry a risk of SJS, there does not appear to be cross-sensitivity. This means having a reaction to acetaminophen does not necessarily put you at higher risk for a reaction to drugs like ibuprofen or naproxen, but you should discuss alternatives with your doctor [1.2.1, 1.6.3].

For over-the-counter drugs, check the "Active Ingredient" section of the Drug Facts label. For prescription drugs, the label may list acetaminophen or abbreviations like "APAP" or "acet." If you are unsure, ask your pharmacist [1.2.1, 1.6.2].

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.