Enbrel Kidney Side Effects Continue To Be Reported After FDA Glomerulonephritis Warning

Recent FDA data and medical research found that side effects of Enbrel may expose users to previously underrecognized risks of kidney inflammation and renal failure.

Following a decision by federal regulators last year to update Enbrel’s warning label to add information about the risk of glomerulonephritis, which is a serious inflammatory condition that damages the tiny filtering units in the kidneys, new injury reports continue to pour into the FDA’s adverse event database, suggesting that concerns over the biologic’s potential renal side effects are far from resolved.

Enbrel was originally developed by Immunex Corporation and later acquired by Amgen Inc., which gained U.S. Food and Drug Administration (FDA) approval in 1998 for the treatment of rheumatoid arthritis. Over time, its approved uses expanded to include psoriatic arthritis, ankylosing spondylitis, plaque psoriasis and juvenile idiopathic arthritis, making it a cornerstone therapy for patients with chronic autoimmune disorders.

The medication belongs to a class of biologics known as tumor necrosis factor (TNF) inhibitors, which block the activity of TNF-alpha, a protein that fuels the damaging inflammation behind many autoimmune diseases. By suppressing this immune signal, Enbrel helps prevent joint destruction, relieve pain, and restore mobility for individuals whose conditions often resist conventional treatment.

Over the past two decades, Enbrel has become one of the most commercially successful biologic drugs in the world. Global sales surpassed $4.5 billion in 2023, with analysts projecting the market to exceed $22 billion by 2029. Given per-patient costs that can reach tens of thousands of dollars annually, those numbers suggest hundreds of thousands of people in the U.S. and worldwide have been prescribed Enbrel to manage debilitating inflammatory diseases.

However, despite its success and broad clinical use, the FDA has now confirmed, and continues to receive adverse event reports of Enbrel kidney side effects, which can cause kidney inflammation and glomerulonephritis, a potentially serious condition that can lead to long-term renal damage or failure.

Enbrel Kidney Side Effect Reports

As of this year, the FDA’s Adverse Event Reporting System (FAERS) indicates that kidney-related injuries continue to be reported among Enbrel users, despite prior safety actions and label changes.

The database lists nearly 1,900 serious adverse events involving the drug, including more than 1,000 classified as renal and urinary disorders. Among those, the most frequently reported kidney-related injuries include:

• Renal Failure: 1,310 cases
• Kidney Infection: 1,090 cases
• Acute Kidney Injury: 487 reports
• Chronic Kidney Disease: 227 reports
• Glomerulonephritis: 132 reports
• Prerenal Failure: 50 cases

Within the 132 Enbrel glomerulonephritis reports, the FDA data identifies several specific subtypes of the condition:

• Glomerulonephritis, Rapidly Progressive: 35 cases
• Glomerulonephritis, Membranous: 20 cases
• Glomerulonephritis, Proliferative: 15 cases
• Glomerulonephritis, Membranoproliferative: 6 cases
• Glomerulonephritis, Minimal Lesion: 5 cases
• Glomerulonephritis, Chronic: 4 cases
• Glomerulonephritis, Acute: 3 cases
• Fibrillary Glomerulonephritis: 1 case

A significant portion of these incidents resulted in hospitalization or other serious medical outcomes, with some reports involving life-threatening complications.

The number of kidney injury reports grew steadily through the 2010s, peaking in 2014 with nearly 250 documented cases. While the total volume of reports has declined somewhat in recent years, adverse event filings involving renal disorders remain consistent through 2025, underscoring ongoing safety concerns even after the FDA updated Enbrel’s warning label in 2024.

Researchers and safety experts caution that while FAERS data does not prove causation, the persistence of kidney-related reports long after regulatory action suggests that renal complications may continue to be underrecognized or underreported in real-world use of the drug.

Enbrel Kidney Side Effects Warning Label Update

As the number of adverse events reported to the FDA and medical research linking Enbrel to renal injuries continued to grow, the agency approved an Enbrel glomerulonephritis warning label update on July 17, 2024, to include new information about the risk in the Postmarketing Experience section of Enbrel’s prescribing information.

Glomerulonephritis is a form of kidney inflammation that occurs when the immune system attacks the tiny filtering units of the kidneys, called glomeruli. This inflammation disrupts the kidneys’ ability to clear waste and excess fluid from the blood, leading to swelling, high blood pressure, foamy or discolored urine, fatigue, and, in severe cases, kidney failure. If left untreated, the condition can cause permanent scarring and long-term loss of renal function.

The addition marked the first time the FDA formally acknowledged an immune-mediated kidney disorder as a potential side effect of Enbrel. According to the agency’s approval letter, the change was based on post-marketing reports involving patients who developed glomerulonephritis while taking the drug, some of whom experienced partial recovery after discontinuation.

Although the agency stopped short of issuing a boxed warning, which would be the strongest label update the FDA can require a drug maker to place on their product, the update reflects a significant shift in regulatory understanding, acknowledging that the same immune suppression that makes Enbrel effective in treating autoimmune disease can, in rare cases, provoke a damaging autoimmune reaction against the kidneys themselves.

Study Outlines Enbrel Kidney Function Decline

The timing of the label change closely followed publication of a study in JAMA Network Open, which examined more than 10,000 U.S. veterans diagnosed with inflammatory bowel disease after using Enbrel and other TNF inhibitors.

Researchers found that patients who initiated TNF-blocker therapy, including Enbrel, faced a 34% higher risk of experiencing a significant decline in kidney function compared to those who did not use the drugs.

The authors of the study urged clinicians to monitor kidney function closely in patients starting or continuing TNF inhibitor therapy, warning that “distinct pathophysiologic contributions” of these drugs may increase susceptibility to renal impairment.

Enbrel Kidney Injury Lawsuits Under Investigation

Following the FDA’s warning label update and the continuing flow of adverse event reports, product liability lawyers are now evaluating the potential for Enbrel kidney injury lawsuits on behalf of individuals who developed renal problems after using the medication.

Enbrel lawsuit investigations allege that Amgen failed to adequately warn patients and healthcare providers about the risk of kidney inflammation and glomerulonephritis associated with Enbrel, despite mounting evidence from both clinical studies and post-marketing data.

Law firms nationwide are offering free case evaluations for individuals who suffered kidney failure, glomerulonephritis or other renal complications while taking the drug. Enbrel lawyers indicate that compensation could become available for medical costs, long-term treatment, and other losses associated with the injuries.