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Shedding Light on the Risks
& Benefits of Medications
Shedding Light on the Risks
& Benefits of Medications FDA SIDE EFFECTS UPDATE: Brain Infection Warning for Xeljanz, Neurological Risks for Tepezza, Plus More
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Safety updates sourced directly from the FDA's Drug Safety Database, presented in clear and accessible language
October 14, 2026
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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 for Benlysta, Tepezza, Kybella, Olumiant, Ryaltris, Xeljanz, and Xenical. Generic versions of these medications will have the same safety updates.
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.
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.
Benlysta (belimumab) injection, for intravenous or subcutaneous use
Initial FDA Approval: 2011
Side Effect Update Date: August 21, 2026
Medication Description: Treats active cases of lupus, a chronic autoimmune disease, in patients age 5 and older.
Updated Side Effects/Safety Information: A new warning about the risk of a serious skin reaction called Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (SJS/TEN). Patients should stop using Benlysta immediately and tell their healthcare provider if they develop any signs of SJS/TEN, including skin peeling and blistering, a painful rash with reddish, non-elevated, target-like or circular patches on the trunk, often with a central blister. Patients who have ever had an anaphylactic reaction to belimumab should not use Benlysta.
FDA Safety Announcement: FDA Benlysta Safety Label Change, and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Kybella (deoxycholic acid) injection
Initial FDA Approval: 2015
Side Effect Update Date: September 11, 2026
Medication Description: Lipolysis (fat-dissolving) cosmetic treatment used to reduce fat under the chin (“double chin”) in adults. Up to six treatments may be given at least one month apart. A health care professional administers this treatment.
Updated Side Effects/Safety Information: A new warning states that when Kybella is administered outside the submental fat region (specified chin area), neuromuscular reactions can occur, including facial paralysis, paresthesia (tingling or numbing sensation), and blurred or reduced vision when administered near the eyes. The FDA has identified 129 such neuromuscular reactions reported through the FDA Adverse Event Reporting System (FAERS; now known as the FDA Adverse Event Monitoring System) or in the medical literature.
Warnings were also added about reports of injection site nodules (3 cm or smaller) or masses (larger than 3 cm), which may not resolve over time and may require medical intervention. The FDA identified 117 cases of unresolved injection site nodules or masses reported through the FDA Adverse Event Reporting System (FAERS) or in the medical literature. Health care providers should not inject the drug outside of the approved treatment area.
Essential Extras: Because the medication can pose serious health risks if used outside its approved purpose, the FDA issued a public safety communication on September 15, 2026.
FDA Safety Announcement: FDA Kybella Safety Label Change; FDA Drug Safety Communication about Kybella; Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Olumiant (baricitinib) tablets
Initial FDA Approval: 2018
Side Effect Update Date: September 25, 2026
Medication Description: A Janus kinase (JAK) inhibitor that treats rheumatoid arthritis; Olumiant was also recently approved to treat severe alopecia areata (patchy hair loss) in patients aged 12 and older. JAK inhibitors help relieve symptoms of autoimmune conditions by reducing immune activity.
Updated Side Effects/Safety Information: Side effects and dosage instructions were added with Olumiant’s approval to treat severe alopecia areata (patchy hair loss) in patients aged 12 and older. The most common adverse reactions during clinical trials for treating alopecia areata were upper respiratory tract infections, headache, acne, high cholesterol, increased creatine phosphokinase, urinary tract infections, and elevated liver enzymes.
Essential Extras: In June 2026, Olumiant received a safety label update adding a warning about the risk of low blood sugar in patients with diabetes.
FDA Safety Announcement: FDA Olumiant Safety Label Change and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Ryaltris (mometasone furoate; olopatadine hydrochloride) nasal spray
Initial FDA Approval: 2022
Side Effect Update Date: July 7, 2026
Medication Description: A corticosteroid-antihistamine combination nasal spray treatment for relieving symptoms of seasonal allergies in patients 6 years of age and older.
Updated Side Effects/Safety Information: Updated dosage instructions and safety warnings were added in connection with Ryaltris’ recent approval for pediatric patients age 6 and older. A new warning was added about the risk of growth suppression in children. Children’s growth progress should be monitored while taking this drug, a corticosteroid. Because corticosteroid nasal drugs suppress the immune system, patients may be more susceptible to infections, including worsening existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal cases of chickenpox or measles can appear in susceptible patients. Headache was added to the list of most common side effects.
FDA Safety Announcement: FDA Ryaltris Safety Label Change and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Tepezza (teprotumumab-trbw) injection, for intravenous use
Initial FDA Approval: 2020
Side Effect Update Date: September 23, 2026
Medication Description: Treats Thyroid Eye Disease (TED), a condition associated with Graves’ disease. 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. A health care provider administers Tepezza every three weeks for a total of eight infusions.
Updated Side Effects/Safety Information: A new warning states that some people taking Tepezza have experienced encephalopathy, a neurological disorder of the brain. Symptoms may include confusion, disorientation, poor attention span, memory loss, sleepiness, or behavior changes such as agitation, loss of motivation, or depression. In some patients, symptoms improved after discontinuing the drug or treating encephalopathy. Patients should discontinue the drug and seek immediate attention if signs or symptoms of encephalopathy develop.
Essential Extras: A warning about the risk of worsening or new-onset Inflammatory Bowel Disease (IBD) and additional adverse reactions from clinical trials were added in November 2025.
FDA Safety Announcement: Tepezza FDA Safety Label Change and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Xeljanz (tofacitinib) tablets, Xeljanz XR (extended-release) tablets, Xeljanz oral solution
Initial FDA Approval: 2012
Side Effect Update Date: September 16, 2026
Medication Description: A Janus kinase (JAK) inhibitor that treats rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, polyarticular-course juvenile idiopathic arthritis, and ulcerative colitis. JAK inhibitors help relieve autoimmune symptoms by reducing immune activity.
Updated Side Effects/Safety Information: A new warning notes rare cases of Progressive Multifocal Leukoencephalopathy (PML), a brain infection. In some of these cases, within a few weeks of stopping Xeljanz, an additional serious condition developed: immune reconstitution inflammatory syndrome (IRIS). IRIS is a swelling and worsening of symptoms that may occur as the immune system begins to work again.
After starting Xeljanz, patients should call their healthcare provider if they notice neurological symptoms of PML. These include general muscle weakness, vision changes, and changes in thinking, memory, and orientation that can lead to confusion and personality changes.
Essential Extras: In June 2026, Xeljanz received a safety label update adding a warning about the risk of low blood sugar in patients with diabetes. In March 2026, Xeljanz received a safety label update adding an expanded warning about the risk of serious infections and fractures.
FDA Safety Announcement: FDA Xeljanz Safety Label Change, FDA Xeljanz Oral Solution Safety Label Change; FDA Xeljanz XR Safety Label Change and Revised Label (shared label)
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Xenical (orlistat) capsules
Initial FDA Approval: 1999
Side Effect Update Date: September 30, 2026
Medication Description: Prescription treatment to be used in conjunction with a reduced-calorie diet and physical activity for weight loss and for weight reduction maintenance in patients age 12 and older. Taken three times a day with meals, Xenical works by preventing some of the fat in foods eaten from being absorbed in the intestines. The body then removes this unabsorbed fat in the stool.
Updated Side Effects/Safety Information: Removed the warning that Xenical causes birth defects, stating that data gathered from over decades of its use during pregnancy has not identified an increased risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Discontinuing this medication while pregnant is still advised because weight loss offers no benefit to a pregnant patient and may result in an infant small for gestational age. Warns that patients have reported serious hypersensitivity reactions, including severe allergic reactions (anaphylaxis) and skin swelling (angioedema). Other changes to the label were made to improve clarity. For example, a new table was added that specifies clinically significant drug and dietary supplement interactions with Xenical.
Essential Extras: An over-the-counter weight-loss medication containing orlistat, Alli, is half the dose of Xenical but has not yet received a similar safety label change. Alli had a safety label update in March 2026 to warn of the risk of kidney injury.
FDA Safety Announcement: FDA Xenical Safety Label Change and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
- National Library of Medicine. (n.d.). Lupus. Lupus Symptoms | SLE | MedlinePlus.
- Research, C. F. D. E. A. (2026, September 15). FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use. U.S. Food And Drug Administration.
- Graves disease: MedlinePlus Medical Encyclopedia. (n.d.).
- Encephalopathy. (2025, June 2). Cleveland Clinic.
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