FDA SIDE EFFECTS UPDATE: New Warnings for Stelara, Tepezza, and Other Autoimmune Drugs

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<p>Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications. In this installment, we’re highlighting safety updates concerning drugs used to treat autoimmune conditions like rheumatoid arthritis, plaque psoriasis, and thyroid eye disease: Actemra, Gazvya, Kineret, Rystiggo, Stelara, and Tepezza.</p>
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<div class="wp-block-myplugin-custom-alignment-block alignright"><h2>How to Read This Report</h2><p>This report is prepared using the most recent information posted in the SrLC database. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.<br><br>Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.</p></div>
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<h2 class="wp-block-heading">Updated Side Effect Warnings for Autoimmune Disease Medications</h2>
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<p><a href="https://www.ncbi.nlm.nih.gov/books/NBK605884/">Autoimmune conditions</a> develop when the immune system wrongly targets healthy tissue, leading to inflammation that often affects the joints or connective tissues. These conditions may be temporary or chronic, with symptoms that can progress over years.</p>
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<p>Many autoimmune conditions are commonly treated with <a href="https://rheumatology.org/patient-blog/understanding-rheumatic-disease-treatments-conventional-dmards-vs-biologic-medications">biologic</a> (or <a href="https://www.als.net/news/understanding-the-different-types-of-therapeutics/#:~:text=Large%20Molecule%20Drugs/Biologics%20and%20Peptides%20Drugs">“large molecule</a>”) medications. These drugs are made from complex proteins or other cell-derived components that can’t be taken orally because they would be broken down during digestion. Instead, biologics are given by injection under the skin or by intravenous infusion. These drugs work by targeting specific parts of the immune system involved in driving inflammation.</p>
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<h3 class="wp-block-heading">Actemra (tocilizumab) for intravenous infusion or subcutaneous injection</h3>
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<p><strong>Initial FDA Approval</strong>: 2010<br><strong>Side Effect Update Date</strong>: December 10, 2025<br><strong>Medication Description</strong>:  A biologic medication that treats moderate to severe <a href="https://medlineplus.gov/rheumatoidarthritis.html">rheumatoid arthritis</a>, giant cell arteritis, systemic sclerosis-associated interstitial lung disease, juvenile idiopathic arthritis, and other inflammatory diseases. Actemra works by blocking an inflammatory protein to help reduce joint pain, swelling, and other inflammation-related symptoms. The subcutaneous formulation may be administered weekly by a health care professional or self-injected by the patient or caregiver who has been instructed on the proper injection technique.<br><strong>Updated Side Effects/Safety Information</strong>: A new warning about the rare risk of <a href="https://www.merriam-webster.com/medical/hypofibrinogenemia">hypofibrinogenemia</a>, or low levels of the protein fibrinogen in the blood. Fibrinogen helps blood to clot.<br><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=440">Actemra FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125276s147lbl.pdf">Revised Drug Label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
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<h3 class="wp-block-heading">Gazvya (obinutuzumab) injection, for intravenous use</h3>
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<p><strong>Initial FDA Approval</strong>: 2013<br><strong>Side Effect Update Date:</strong> December 17, 2025<br><strong>Medication Description:</strong> A biologic medication that treats non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, two types of blood cancers. Gazvya also recently received expanded approval to treat a lupus-related kidney condition called <a href="https://www.niddk.nih.gov/health-information/kidney-disease/lupus-nephritis">lupus nephritis</a> (LN).<br><strong>Updated Side Effects/Safety Information</strong>: New clinical trial results and new dosing information related to the approval of Gazvya for lupus nephritis have been added. In clinical trials for LN, the most frequently reported adverse reactions were upper respiratory tract infections, urinary tract infections, bronchitis, pneumonia, infusion-related reactions, and neutropenia (low level of white blood cells).<br><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1366">Gazvya FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125486s040lbl.pdf">Revised Drug Label<br></a>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
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<h3 class="wp-block-heading">Kineret (anakinra) subcutaneous injection</h3>
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<p><strong>Initial FDA Approval</strong>: 2001<br><strong>Side Effect Update Date</strong>: October 27, 2025<br><strong>Medication Description</strong>: A biologic medication that treats moderate to severe rheumatoid arthritis (RA) in adults who have already tried at least one disease-modifying antirheumatic drug (<a href="https://rheumatology.org/patient-blog/understanding-rheumatic-disease-treatments-conventional-dmards-vs-biologic-medications">DMARD</a>). Kineret also treats pediatric patients with Neonatal-Onset Multisystem Inflammatory Disease (<a href="https://medlineplus.gov/download/genetics/condition/neonatal-onset-multisystem-inflammatory-disease.pdf">NOMID</a>) or with Deficiency of Interleukin-1 Receptor Antagonist (DIRA). NOMID and DIRA are rare genetic disorders that usually begin in early infancy and cause ongoing inflammation, tissue damage, and periodic fevers, most often affecting the nervous system, skin, and joints. Kineret is administered daily by subcutaneous injection by the patient or caregiver.<br><strong>Updated Side Effects/Safety Information</strong>: A new warning about the risk of injection site amyloid deposits (amyloidosis). This has occurred after patients receive high doses of Kineret injected subcutaneously into the same area of skin over long periods of time. Patients are advised to rotate the injection site and to avoid injecting into an area that is already swollen or red.<br><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=256">Kineret FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/103950s5197lbl.pdf">Revised Drug Label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
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<h3 class="wp-block-heading">Rystiggo (rozanolixizumab-noli) injection, for subcutaneous infusion</h3>
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<p><strong>Initial FDA Approval</strong>: 2023<br><strong>Side Effect Update Date</strong>: December 9, 2025<br><strong>Medication Description</strong>: A biologic medication that treats <a href="https://medlineplus.gov/myastheniagravis.html">myasthenia gravis</a>, an autoimmune disorder of the nervous system that causes muscle weakness. Rystiggo is administered by a healthcare provider once weekly for six weeks.<br><strong>Updated Side Effects/Safety Information</strong>: A new warning that herpes zoster (shingles) infections have been reported in patients taking Rystiggo. A new addition has also been added about a registry that monitors pregnancy outcomes in patients with Myasthenia Gravis who have been exposed to RYSTIGGO during pregnancy or breastfeeding.<br><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=3224">Rystiggo FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761286s007lbl.pdf">Revised Drug Label<br></a>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
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<h3 class="wp-block-heading">Stelara (ustekinumab) injection for subcutaneous or intravenous use</h3>
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<p><strong>Initial FDA Approval</strong>: 2009<br><strong>Side Effect Update Date</strong>: November 3, 2025<br><strong>Medication Description</strong>: A biologic medication that treats plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Stelara works by blocking inflammatory proteins. It is administered by a healthcare provider every 8 or 12 weeks, depending on the condition being treated.<br><strong>Updated Side Effects/Safety Information</strong>: A new warning that serious hypersensitivity reactions, including anaphylaxis, rash, and swelling, shortness of breath, and chest tightening have been reported with Stelara, including a fatal case that occurred during infusion of the first dose. If hypersensitivity reactions occur, medication should be discontinued immediately and appropriate medical treatment administered.<br><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1304">Stelara FDA Safety Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125261s171,761044s019lbl.pdf">Revised Drug Label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
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<h3 class="wp-block-heading">Tepezza (teprotumumab-trbw) injection for subcutaneous or intravenous use</h3>
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<p><strong>Initial FDA Approval</strong>: 2020<br><strong>Side Effect Update Date</strong>: November 24, 2025<br><strong>Medication Description</strong>: A biologic medication that treats <a href="https://gdatf.org/fast-facts/thyroid-eye-disease/">Thyroid Eye Disease</a> (TED), a condition associated with <a href="https://medlineplus.gov/ency/article/000358.htm">Graves’ disease</a>. Graves’ disease causes the thyroid gland to produce too much thyroid hormone, resulting in hyperthyroidism. TED is an autoimmune attack on the connective tissue cells surrounding the eyes. Tepezza is administered by a health care provider every three weeks for a total of eight infusions.<br><br><strong>Updated Side Effects/Safety Information</strong>: Adverse reaction data have been updated for two post-approval clinical trials. The following adverse reactions occurred in at least 5% of the clinical trial participants treated with Tepezza: muscle spasms (29%), hearing impairment (19%), hyperglycemia (18%) diarrhea (16%), fatigue (13%), headache (13%), alopecia (10%), dry skin (10%), dysgeusia (9%), ear discomfort (9%), and nail disorder (6%).<br><br>There’s also an updated warning about the risk of worsening or new-onset Inflammatory Bowel Disease (IBD). Patients experiencing abdominal pain with diarrhea, with or without blood or rectal bleeding, should immediately seek medical advice.<br><br><strong>Essential Extras</strong>: The corrected adverse reactions data in the <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2544">Safety Label Change announcement</a> represent an increase for each of the reaction types reported for the post-approval clinical trials. For example, the “muscle spasm” reaction rose from 20% (reported in September 2025)  to 29% of participants (in the November update), and the “hearing impairment” reaction rose from 13% to 19% of participants. Tepezza has faced increased scrutiny because of its association with tinnitus and hearing loss, which is sometimes permanent. A warning about the risk of permanent hearing loss was added to Tepezza’s label in <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2544">July 2023</a>.</p>
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