FDA SIDE EFFECTS UPDATE: Blood Pressure Drug Linked to Life-Threatening Swelling, Black Box Updates for Gastroparesis Meds

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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 a safety update concerning Altace (ramipril), Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride), along with updates for three gastroparesis medications: Gimoti, Reglan tablets, and Reglan injection.</p>
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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">Altace (ramipril) capsules</h3>
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<p><strong>Initial FDA Approval</strong>: 1991<br><strong>Side Effect Update Date</strong>: May 7, 2026<br><strong>Medication Description</strong>: Ramipril is an angiotensin-converting enzyme (ACE) inhibitor used to treat high blood pressure. It is also prescribed to improve survival after a heart attack in people with heart failure and to help reduce the risk of heart attack, stroke, and cardiovascular death in certain high-risk adults. Ramipril works by relaxing and widening blood vessels, making it easier for blood to flow and reducing the heart's workload.<br><strong>Updated Side Effects/Safety Information</strong>: Updated safety information warns that angioedema, a potentially life-threatening swelling of the face, lips, tongue, or throat, can occur at any time during ramipril treatment, including months or years after therapy begins. While the risk is greatest after the first dose, patients who experience symptoms of angioedema should discontinue the medication immediately and contact their healthcare provider.<br><strong>Essential Extras</strong>: Brand-name Altace and ramipril tablet formulations have been discontinued; this side-effect update applies to all associated generic capsules. <a href="https://dermnetnz.org/topics/ace-inhibitor-induced-angioedema">ACE inhibitor-induced angioedema</a> is a known adverse effect for all ACE inhibitor blood pressure medications.<br><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1038">Altace FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019901s072lbl.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">Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets</h3>
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<p><strong>Initial FDA Approval</strong>: 2022<br><strong>Side Effect Update Date</strong>: April 30, 2026<br><strong>Description</strong>: Treats major depression in adults; Auvelity was approved to treat agitation associated with dementia due to <a href="https://medlineplus.gov/alzheimersdisease.html">Alzheimer’s disease</a> in April 2026. Patients with Alzheimer's experiencing agitation may be restless or verbally or physically aggressive.<br><strong>Updated Side Effects/Safety Information</strong>: Clinical trial results were added to support Auvelity’s expanded approval to treat agitation associated with dementia due to Alzheimer’s disease. There’s a new warning that low blood sodium levels (<a href="https://medlineplus.gov/ency/article/000394.htm">hyponatremia</a>) may happen, especially in the elderly. Symptoms of hyponatremia include headache, difficulty concentrating, memory changes, confusion, weakness, and balance problems. Symptoms of sudden or severe cases may include: hallucinations (seeing or hearing things that are not real), fainting, seizures, and coma. Use of Auvelity with a serotonergic antidepressant (SSRI such as sertraline or Zoloft) may increase the risk. </p>
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<p>Additional side effects reported in postmarketing experience include feeling abnormal, tinnitus, and tremor.</p>
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<p><strong>Essential Extras:</strong> Auvelity is the first FDA-approved treatment for agitation associated with dementia due to Alzheimer’s disease that is not an antipsychotic, unlike Rexulti (<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205422s017lbl.pdf">brexpiprazole</a>). <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-non-antipsychotic-drug-treat-agitation-associated-dementia">FDA Press Release</a><br><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2957">Auvelity FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215430s009s018lbl.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">Gimoti (metoclopramide hydrochloride) nasal spray</h3>
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<p><strong>Initial FDA Approval</strong>: 1979 (active ingredient); 2020 (this product)<br><strong>Side Effect Update Date</strong>: February 9, 2026<br><strong>Description</strong>: Treats diabetic <a href="https://medlineplus.gov/ency/article/000297.htm">gastroparesis</a> (a delay in the movement of stomach contents in adults with diabetes)<br><strong>Updated Side Effects/Safety Information</strong>: The FDA expanded Gimoti's boxed warning about tardive dyskinesia (TD), a potentially irreversible movement disorder that can cause involuntary movements of the face, tongue, trunk, or limbs. The updated warning states that people with a history of TD should not use Gimoti. Because the risk increases with longer exposure to metoclopramide, the drug's active ingredient, patients should use the medication for the shortest duration possible and generally no longer than 12 weeks. If longer treatment is necessary, clinicians should monitor for signs and symptoms of TD. </p>
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<p>The FDA also noted that metoclopramide can mask early symptoms of TD, potentially delaying diagnosis, and updated the patient counseling information accordingly.</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=2391">Gimoti FDA Safety Label Change</a> and Revised Drug Label<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">Reglan (metoclopramide hydrochloride) tablets</h3>
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<p><strong>Initial FDA Approval</strong>: 1979 (active ingredient); 2011 (this product)<br><strong>Side Effect Update Date</strong>: February 9, 2026<br><strong>Description</strong>: Treats diabetic gastroparesis (a delay in the movement of stomach contents) in adults; short-term (4 to 12 weeks) treatment of gastroesophageal reflux (GERD) in adult patients who don’t respond to conventional therapies.<br><strong>Updated Side Effects/Safety Information</strong>: The FDA expanded Reglan's boxed warning about tardive dyskinesia (TD), a potentially irreversible movement disorder that can cause involuntary movements of the face, tongue, trunk, or limbs. The updated warning states that people with a history of TD should not take Reglan. Because the risk increases with longer-term use of metoclopramide, the drug's active ingredient, patients are advised to use the medication for the shortest duration possible and generally no longer than 12 weeks. </p>
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<p>The FDA also noted that metoclopramide can suppress signs of TD, potentially delaying diagnosis. In some cases, symptoms may improve or resolve after the medication is discontinued. Patient counseling information was also revised.</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=1246">Reglan FDA Safety Label Change</a> and Revised Drug Label<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">Reglan (metoclopramide hydrochloride) injection for intravenous (IV) or intramuscular (IM) administration</h3>
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<p><strong>Initial FDA Approval</strong>: 1979<br><strong>Side Effect Update Date</strong>: February 9, 2026<br><strong>Description</strong>: Used to treat diabetic gastroparesis, a condition in which the stomach empties more slowly than normal. It is also used to prevent or treat nausea and vomiting associated with chemotherapy, surgery, and certain medical procedures, and may be used during diagnostic examinations of the stomach and small intestine. Reglan injection is administered by a healthcare professional as an intravenous (IV) or intramuscular (IM) injection.<br><strong>Updated Side Effects/Safety Information</strong>: For adults receiving Reglan injection for diabetic gastroparesis, the FDA expanded the boxed warning about tardive dyskinesia (TD), a potentially irreversible movement disorder that can cause involuntary movements of the face, tongue, trunk, or limbs. The updated warning states that metoclopramide injection should not be used in people with a history of TD or in those taking antipsychotics or monoamine oxidase inhibitors (MAOIs), which can also increase the risk of TD. Because the risk rises with longer-term use, treatment should generally be limited to 12 weeks. If longer use is unavoidable, patients should be routinely monitored for signs and symptoms of TD, and treatment for TD should be considered if symptoms persist.</p>
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<p>The FDA updated the warning to note that, in addition to tardive dyskinesia (TD), metoclopramide can cause Parkinsonian symptoms, including slowed movement (bradykinesia), tremor, and reduced facial expression. These symptoms typically occur within the first six months of treatment but may also develop after longer-term use. </p>
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<p>The updated warning also highlights the risk of a hypertensive crisis (a sudden, severe increase in blood pressure) in people with undiagnosed <a href="https://my.clevelandclinic.org/health/diseases/16717-adrenal-disorders">pheochromocytoma</a>, a rare adrenal gland tumor. Patients who experience a rapid rise in blood pressure should discontinue the medication and seek medical attention.</p>
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<p><strong>Essential Extras</strong>: The brand-name Reglan injection is no longer marketed, but these updated warnings apply to all generic injectable metoclopramide products.<br><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=3249">Reglan Injection FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/017862s64lbl.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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