FDA SIDE EFFECTS UPDATE: Children’s Zyrtec Linked to Withdrawal Itching, Finasteride Tied to Suicidal Thoughts, and More

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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 Alli (orlistat), Children's Zyrtec Allergy (cetirizine hydrochloride), Proscar (finasteride), and Sandimmune (cyclosporine) </p>
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<h3 class="wp-block-accordion-heading"><button type="button" class="wp-block-accordion-heading__toggle"><span class="wp-block-accordion-heading__toggle-title">How to Read This Report</span><span class="wp-block-accordion-heading__toggle-icon" aria-hidden="true">+</span></button></h3>
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<p>This report is prepared using the most recent information posted in the <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm">SrLC database</a>. 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.</p>
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<p>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>
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<h3 class="wp-block-heading">Alli (orlistat) capsules</h3>
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<p><strong>Initial FDA Approval</strong>: 2007<br><strong>Side Effect Update Date</strong>: March 24, 2026<br><strong>Medication Description</strong>: Weight-loss treatment to be used along with a reduced-calorie, low-fat diet and exercise<br><strong>Updated Side Effects/Safety Information</strong>: A new warning about the risk of kidney injury, especially for people who have or have had kidney problems. Patients are advised to ask their doctor before taking this medication if they have ever had kidney disease. Patients should seek medical help if they experience symptoms of kidney injury, which include back/groin pain, painful or bloody urine, swelling in the legs/feet, or less urine than usual.<br><strong>Essential Extras</strong>: The higher dose <a href="https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6240792b-9224-2d10-e053-2a91aa0a2c3e">prescription version</a> of orlistat, Xenical (orlistat 120 mg) approved in 1999 for weight loss, already includes a warning about the risks of kidney disease. Alli was approved as an over-the-counter, lower-dose orlistat version (60 mg) in 2007.</p>
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<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=220">Alli Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021887Orig1s013lbl.pdf">Revised Drug Label</a></p>
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<h3 class="wp-block-heading">Children's Zyrtec Allergy (cetirizine hydrochloride) oral solution, chewable tablets, or orally disintegrating tablets</h3>
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<p><strong>Initial FDA Approval:</strong> 2001 (became available Over-the-Counter in 2007)<br><strong>Side Effect Update Date</strong>: March 24, 2026<br><strong>Medication Description</strong>: Treats symptoms like sneezing, runny nose, itchy and watery eyes, and itching of the nose or throat due to hay fever or other upper respiratory allergies in children.<br><strong>Updated Side Effects/Safety Information</strong>: A new warning about the rare risk of severe itching after stopping cetirizine, especially after long-term daily use.<br><strong>Essential Extras</strong>: The FDA issued a <a href="https://www.fda.gov/safety/medical-product-safety-information/cetirizine-or-levocetirizine-drug-safety-communication-fda-warns-about-risk-severe-itching-after">Drug Safety Communication</a> in May 2025 warning about  extreme itching withdrawal effects associated with long-term use of prescription and over-the-counter allergy medicines cetirizine (Zyrtec) and levocetirizine (Xyzal). Children’s Xyzal Allergy 24 HR (levocetirizine dihydrochloride) oral solution recently received <a href="https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/209090Orig1s007ltr.pdf">FDA approval</a> for adding the itching effect to the “Drug Facts” section of the product label.</p>
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<p><strong>FDA Safety Announcement:</strong>  <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=3271">Children’s Zyrtec Allergy Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021621Orig1s018lbl.pdf">Revised Drug Label</a></p>
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<h3 class="wp-block-heading">Proscar (finasteride) tablets</h3>
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<p><strong>Initial FDA Approval</strong>: 1992<br><strong>Side Effect Update Date</strong>: March 18 2026<br><strong>Medication Description</strong>: Treats benign prostatic hyperplasia, a noncancerous enlarged prostate. It works by lowering levels of a hormone called dihydrotestosterone, which can help shrink the prostate and improve urine flow.<br><strong>Updated Side Effects/Safety Information</strong>: Warns that suicidal ideation, or thoughts of self-harm or suicide, is a reported risk. Patients taking Proscar should tell their healthcare provider right away if they notice new or worsening depression, mood changes, or suicidal thoughts.<br><strong>Essential Extras</strong>: Finasteride is also the active ingredient in Propecia tablets, a prescription hair loss treatment for men, which was approved by the FDA in 1997. Propecia added a warning about the risk of suicidal ideation in 2022. For years, the <a href="https://www.pfsfoundation.org/news/first-ever-suicidality-adrs-added-to-us-propecia-product-label-per-fda-mandate/">Post-Finasteride Syndrome Foundation</a> has petitioned the FDA to stop selling finasteride (Propecia) or include stronger warnings about how the drug affects the sexual, mental, and physical health of men. Drug maker Merck was accused of <a href="https://www.yahoo.com/news/exclusive-merck-anti-baldness-drug-201026672.html">wrongly not including</a> a warning about suicidal ideation risk in its 2011 label update for Propecia.</p>
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<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2444">Proscar Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020180s050lbl.pdf">Revised Label</a></p>
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<h3 class="wp-block-heading">Sandimmune (cyclosporine) capsules or oral solution</h3>
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<p><strong>Initial FDA Approval</strong>: 1983<br><strong>Side Effect Update Date</strong>: March 6, 2026<br><strong>Medication Description</strong>: Prevents organ rejection after kidney, liver, or heart transplants. As an immunosuppressant, it works by weakening the immune system to stop it from attacking the new organ.<br><strong>Updated Side Effects/Safety Information</strong>: The label strengthens warnings not to switch Sandimmune capsules (25 mg or 100 mg) to Neoral capsules (a newer cyclosporine formulation) on a mg-per-mg basis, as this can lead to too much or too little medicine in the body, raising risks of side effects or organ rejection. If a switch is made, it should be done only under the supervision of a healthcare provider, as it may require a change in dosage.</p>
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<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2858">Sandimmune Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/050625s065lbl.pdf">Revised Drug Label</a></p>
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