Azithromycin Lawsuit Claims Side Effects of the Antibiotic Resulted in SJS/TEN Symptoms

In addition to incidents of hypersensitivity, azithromycin has also been linked to overuse, which has contributed to the rise of antibiotic-resistant bacteria.

Lupin Pharmaceuticals faces an azithromycin lawsuit brought by a Tennessee couple, indicating that the drug maker failed to adequately warn about side effects associated with the antibiotic, which allegedly caused the husband to suffer an allergic reaction that put his life in danger.

The complaint (PDF) was filed by Craig and Michelle Patty in the U.S. District Court for the Eastern District of Tennessee on February 6, naming Lupin as the defendant. The lawsuit blames the company for Craig Patty’s dangerous skin reactions to the antibiotic, including the development of Stevens-Johnson Syndrome.

Commonly known by the names Zithromax or Zpack, azithromycin is a popular antibiotic that belongs to a class of medications known as macrolides, which are frequently prescribed to treat common bacterial infections like respiratory infections, skin and soft tissue infections and sexually transmitted diseases. Other brand names for the popular medication include Biaxin, Dificid and Erythromycin.

In August 2025, a case study by University of Maryland researchers highlighted the potential side effects of the antibiotic, outlining at least 12 incidents where the drug was linked to Stevens-Johnson syndrome (SJS), which is a serious and potentially life-threatening skin reaction that has been linked to several different classes of medications. It can produce painful blisters and rashes when burns develop from the inside out, causing the skin to separate from the body.

If the skin lesions affect more than 30% of the body, SJS is then referred to as toxic epidermal necrolysis (TEN), which typically requires treatment in a hospital intensive care unit or burn unit, often leading to disfiguring injuries, blindness or death. Almost nine out of 10 cases of SJS are caused by a medication reaction, and more than 200 drugs are known to potentially trigger the dangerous skin condition.

The SJS/TEN lawsuit alleges that Craig Patty was prescribed 250 milligram tablets of generic azithromycin manufactured by Lupin in February 2024, and soon after experienced a severe hypersensitivity reaction that resulted in permanent injuries.

As a result of azithromycin use, the lawsuit indicates Patty now suffers from SJS or TEN, and will require continuing medical treatment.

The lawsuit highlights continuing concerns over azithromycin side effects, which have also been linked to increased risk of heart problems and cardiovascular death.

“As a direct result of this reaction, Plaintiff Craig Patty sustained permanent injuries and ongoing medical complications.”

— Craig Patty et al v. Lupin Pharmaceuticals Inc.

The Pattys present claims of negligence, defective and unreasonably dangerous product, manufacturing defect, and seeks damages for past and future medical expenses, physical pain and suffering, permanent injury and impairment, emotional distress, loss of enjoyment of life and economic losses. Michelle Patty also filed claims of loss of services, companionship and consortium of her husband.

Antibiotic Use and Superbugs

Beyond the risk of rare but devastating hypersensitivity reactions like SJS and TEN, azithromycin and other widely prescribed antibiotics have also drawn scrutiny for their role in fueling antibiotic resistance.

Public health researchers warn that antibiotic resistance is now one of the most serious global health threats. Drug resistant infections are more difficult to treat, often require stronger or intravenous antibiotics, and can lead to longer hospital stays, higher medical costs and increased mortality. Some studies estimate that antibiotic resistant bacteria are involved in up to one third of hospital acquired infections.

Health experts have emphasized that resistance trends are driven by multiple factors, including overprescribing of antibiotics in outpatient settings, incomplete treatment courses, agricultural antibiotic use and infection control challenges in hospitals. Increased use of disinfectants and other medications in intensive care environments have also been identified for their potential role in altering microbial ecosystems.

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