FDA SIDE EFFECTS UPDATE: Tetracycline Antibiotics and Serious Skin Reactions, New Rinvoq Warnings for GCA

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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 Doryx, Minocin, Nuzyra, Oracea, Pylera, Tygacil, and Rinvoq.</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 <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm" target="_blank" rel="noreferrer noopener">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.<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" id="h-side-effect-update-for-prescription-tetracycline-antibiotics">Side Effect Update for Prescription Tetracycline Antibiotics</h2>
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<p>Antibiotics are <a href="https://www.ncbi.nlm.nih.gov/books/NBK535443/" target="_blank" rel="noreferrer noopener">drugs that fight a variety of infections caused by bacteria</a>. There are seven main categories, or “classes,” of antibiotics, including tetracycline antibiotics. Drugs in the tetracycline class now carry updated safety labels warning of a serious skin reaction known as fixed drug eruptions (FDE), a form of hypersensitivity that causes rashes or blistering, typically recurring in the same spot each time the drug is taken.</p>
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<p>With an FDE reaction, skin rashes or blistering worsen each subsequent time the drug is used. A very severe variant of FDE is “generalized bullous fixed drug eruption” (GBFDE), which can be life-threatening. If severe skin reactions occur, patients are advised to discontinue the medicine immediately and seek medical help.</p>
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<p>These label changes were made in response to an FDA letter (<a href="https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/050786Orig1s029ltr.pdf" target="_blank" rel="noreferrer noopener">here</a> is one example) sent in December 2024 notifying drug sponsors that the required safety information should be added to the drug labels.</p>
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<p>Two of the tetracycline antibiotics in this update (Doryx and Oracia) also have new warnings about psychiatric adverse events.</p>
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<h3 class="wp-block-heading" id="h-doryx-mpc-active-ingredient-doxycycline-hyclate-delayed-release-tablets">Doryx MPC (active ingredient: doxycycline hyclate) delayed-release tablets</h3>
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<p><strong>Initial FDA Approval</strong>: 1967; this formulation was approved in 2005</p>
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<p><strong>Side Effect Update</strong> Date: March 31, 2025</p>
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<p><strong>Medication Description</strong>: Treats a variety of bacterial infections, including respiratory tract infections, sexually transmitted infections, “rickettsial infections” like Rocky Mountain spotted fever and tick-related fevers, anthrax, severe acne, and more.</p>
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<p><strong>Updated Side Effects/Safety Information</strong>: A new warning of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. The warning also includes risks related to psychiatric reactions, including depression, anxiety, suicidal ideation, insomnia, abnormal dreams, and hallucinations.</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=2197" target="_blank" rel="noreferrer noopener">Doryx MPC FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050795s037lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</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" id="h-minocin-active-ingredient-minocycline-hydrochloride-capsules-and-solution-for-injection">Minocin (active ingredient: minocycline hydrochloride) capsules and solution for injection</h3>
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<p><strong>Initial FDA Approval:</strong> 1972 (for injection); capsule formulation approved in 1990.</p>
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<p><strong>Side Effect Update Date</strong>: March 31, 2025</p>
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<p><strong>Medication Description</strong>: Treats a variety of bacterial infections, including infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others.</p>
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<p><strong>Updated Side Effects/Safety Information</strong>: A new warning of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</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=1753" target="_blank" rel="noreferrer noopener">Minocin FDA Safety Label Change</a> and <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6dd5b14b-ebfc-49a2-ac63-429f9a8b974f" target="_blank" rel="noreferrer noopener">Revised Drug Label</a> (capsules) and <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e415c323-8219-464b-9e3e-72c5a796cdaa" target="_blank" rel="noreferrer noopener">Revised Drug Label</a> (injection)</p>
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<h3 class="wp-block-heading" id="h-nuzyra-active-ingredient-omadacycline-tosylate-for-intravenous-injection-tablets">Nuzyra (active ingredient: omadacycline tosylate) for intravenous injection; tablets</h3>
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<p><strong>Initial FDA Approval:</strong> 2018</p>
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<p><strong>Side Effect Update Date:</strong> March 31, 2025</p>
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<p><strong>Medication Description</strong>: Treats community-acquired bacterial pneumonia and bacterial skin infections.</p>
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<p><strong>Updated Side Effects/Safety Information:</strong> A new warning of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</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=3103" target="_blank" rel="noreferrer noopener">Nuzyra FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209816s017,209817s017lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
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<h3 class="wp-block-heading" id="h-oracea-active-ingredient-doxycycline-capsule">Oracea (active ingredient: doxycycline) capsule</h3>
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<p><strong>Initial FDA Approval</strong>: 1967; this formulation was approved in 2006.</p>
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<p><strong>Side Effect Update Date</strong>: April 2, 2025</p>
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<p><strong>Medication Description</strong>: Treats inflammatory lesions (papules and pustules) of the skin condition <a href="https://medlineplus.gov/rosacea.html" target="_blank" rel="noreferrer noopener">rosacea</a> in adult patients.</p>
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<p><strong>Updated Side Effects/Safety Information</strong>: A new warning of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. The warning also includes risks related to psychiatric reactions, including depression, anxiety, suicidal ideation, insomnia, abnormal dreams, and hallucinations.</p>
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<p><strong>Essential Extras</strong>: The label states that this formulation of doxycycline has not been evaluated in the treatment or prevention of bacterial infections; it is only for the treatment of inflammatory lesions associated with rosacea.</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=2567" target="_blank" rel="noreferrer noopener">Oracea FDA Safety Label Change</a>  and <a href="https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=aa15c93a-ff4c-447a-8a21-96da506d8997" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
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<h3 class="wp-block-heading" id="h-pylera-active-ingredients-bismuth-subcitrate-potassium-metronidazole-tetracycline">Pylera (active ingredients: bismuth subcitrate potassium; metronidazole; tetracycline)</h3>
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<p><strong>Initial FDA Approval</strong>: 2006</p>
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<p><strong>Side Effect Update Date:</strong> March 31, 2025</p>
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<p><strong>Medication Description</strong>: Treats Helicobacter pylori infection (H. pylori) and duodenal ulcer disease associated with H. pylori. Should be used as a combination therapy with omeprazole (a stomach acid-reducing <a href="https://medlineplus.gov/ency/patientinstructions/000381.htm" target="_blank" rel="noreferrer noopener">proton pump inhibitor</a>).</p>
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<p><strong>Updated Side Effects/Safety Information</strong>: A new warning of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</p>
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<p><strong>Essential Extras</strong>: H.pylori is the <a href="https://medlineplus.gov/ency/article/007715.htm" target="_blank" rel="noreferrer noopener">leading cause</a> of peptic ulcers.</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=807" target="_blank" rel="noreferrer noopener"> Pylera FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050786s029lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a></p>
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<h3 class="wp-block-heading" id="h-tygacil-active-ingredient-tigecycline-and-tigecycline-generic-for-intravenous-injection">Tygacil (active ingredient: tigecycline) and Tigecycline (generic) for intravenous injection</h3>
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<p><strong>Initial FDA Approva</strong>l: 2005</p>
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<p><strong>Side Effect Update Date</strong>: March 31, 2025</p>
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<p><strong>Medication Description</strong>: Treats complicated skin infections, serious abdominal infections, and community-acquired pneumonia.</p>
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<p><strong>Updated Side Effects/Safety Information</strong>: A new warning of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</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=257" target="_blank" rel="noreferrer noopener">Tygacil FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021821s056lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a><a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2344" target="_blank" rel="noreferrer noopener"> Tigecycline FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208744s006lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a></p>
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<h3 class="wp-block-heading" id="h-rinvoq-active-ingredient-upadacitinib-extended-release-tablets">Rinvoq (active ingredient: upadacitinib) extended-release tablets</h3>
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<p><strong>Initial FDA Approval</strong>: 2019</p>
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<p><strong>Side Effect Update Date</strong>: April 25, 2025</p>
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<p><strong>Medication Description</strong>: Treats rheumatoid arthritis, ulcerative colitis, eczema, and most recently received expanded approval to treat giant cell arteritis (GCA) in adults.</p>
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<p><strong>Updated Side Effects/Safety Information</strong>: New warnings for adverse reactions that may occur when taking Rinvoq for giant cell arteritis (GCA). These include upper respiratory tract infections, headache, fatigue, swelling (edema), cough, anemia, rash, herpes zoster (shingles), and nausea.</p>
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<p><strong>Essential Extras</strong>: Read more about <a href="https://medlineplus.gov/giantcellarteritis.html" target="_blank" rel="noreferrer noopener">giant cell arteritis</a> (GCA) at Medline Plus and in Rinvoq’s<a href="https://www.rinvoq.com/giant-cell-arteritis" target="_blank" rel="noreferrer noopener"> press release</a> about the new approval.</p>
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<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211675Orig1s025ltr.pdf" target="_blank" rel="noreferrer noopener">FDA Supplemental Approval Letter</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211675s025lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
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