Chantix and SJS

Among the serious side effects reported from Chantix (varenicline) use is Stevens-Johnson Syndrome (SJS).

A serious skin condition, Stevens-Johnson Syndrome (SJS) can be life-threatening. Cell death causes the outermost layer of the skin (epidermis) to separate from the dermis (skin beneath the epidermis that consists of connective tissue). The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes.

Although Stevens-Johnson Syndrome may be caused by viral infections or malignancies, severe allergic reaction to medication is the leading cause.

The connection between Chantix and risk of SJS was highlighted in a recent study conducted by the Institute for Safe Medication Practices (ISMP), which used a combination of Food and Drug Administration (FDA) adverse event reports and pharmaceutical industry Standardized Medical Queries (SMQ) to gather its data.

In the 4th quarter of 2007 Chantix accounted for 998 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period.

The results are even more worrisome because FDA adverse event reporting is voluntary for consumers and health professionals, and as a result it is estimated that only 1 to 10 percent of serious adverse events are reported.

Among the series injuries reported were moderate and severe skin reactions. The FDA notes 338 serious events including hives or swelling of the tongue, face, eyes, lips and other areas. An additional 65 reports of severe side effects included blisters, exfoliation of the skin and lips, and Stevens-Johnson Syndrome.

About Stevens-Johnson Syndrome (SJS)

Stevens-Johnson Syndrome patients suffer from inflammation of the skin and mucous membranes. Since mucous membranes are present in many organs throughout the body, such as the eyes, digestive system, lungs and respiratory system, many organs can become significantly affected during the disease process. SJS technically is an immune-complex-mediated hypersensitivity (allergic) condition.

SJS typically involves multiple areas of the body and extensive lesion formation. The lesions can extend to the mucous membranes, thus affecting the lungs, eyes, mouth, stomach, intestines and virtually every major organ.

SJS is a serious disorder with potential for severe morbidity and in some cases, it can be fatal. SJS proper (with less than 10 percent of body surface area involved) has the mortality rate of around 5 percent. Other outcomes include organ damage and blindness.


  • Facial swelling
  • Tongue swelling
  • Hives
  • Skin pain
  • A red or purple skin rash that spreads
  • Blisters on your skin and mucous membranes, especially in your mouth, nose and eyes
  • Shedding (sloughing) of your skin

If you have Stevens-Johnson Syndrome, several days before the rash develops, you may experience fever, sore throat, cough, and burning eyes.


Stevens-Johnson Syndrome requires hospitalization. Treatment focuses on eliminating the underlying cause, if possible, controlling symptoms and minimizing complications. Recovery after Stevens-Johnson Syndrome can take several weeks to several months, depending on the severity of your condition.

If your doctor determines that your case of Stevens-Johnson Syndrome was caused by medication, be sure to avoid that medication and all others related to it that may cause a similar reaction, because recurrences of Stevens-Johnson syndrome can be fatal.