Home > Drug Updates & Recalls > FDA Side Effect Updates > FDA SIDE EFFECTS UPDATE: Baqsimi and Serious Hypersensitivity Reactions, Plus More

FDA SIDE EFFECTS UPDATE: Baqsimi and Serious Hypersensitivity Reactions, Plus More

Safety updates sourced directly from the FDA's Drug Safety Database, presented in clear and accessible language

Katie Rowley

May 7, 2025

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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 concerning Baqsimi, Belsomra, Furoscix, Imfinzi, Pluvicto, Trodelvy, and Tymlos.

As of this article’s publication, updates to the FDA’s Drug Safety Database appear to be stalled. This is one of the last updates we were able to collect. To learn more about the reasons behind the delay, see our article: Medication Safety Updates from the FDA Delayed

How to Read This Report

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.

Baqsimi (active ingredient: glucagon) single-use intranasal powder

Initial FDA Approval: 1960; this formulation was approved in 2019.

Side Effect Update Date: March 17, 2025

Medication Description: Treats very low blood sugar (hypoglycemia) in adults and children with diabetes.

Updated Side Effects/Safety Information: Includes clinical trial data supporting expanded approval for pediatric patients as young as one year old, lowering the previous age limit from four years. There is also an added warning for serious hypersensitivity reactions, such as hives, difficulty swallowing, dizziness, cough, rapid heartbeat, and facial swelling. Nosebleeds and cough have been added to the list of common side effects.

FDA Safety Announcement: Baqsimi FDA Safety Label Change and Revised Drug Label

Belsomra (active ingredient: suvorexant) tablets

Initial FDA Approval: 2014

Side Effect Update Date: March 10, 2025

Medication Description: Treats insomnia in adults.

Updated Side Effects/Safety Information: New data from a small lactation study shows that the active ingredient, suvorexant, appears in low concentrations in breast milk, with a relative infant dose of less than 1% of the maternal dose. Patients are advised to consult their doctors to determine the best feeding approach while using Belsomra.

FDA Safety Announcement: Belsomra FDA Safety Label Change and Revised Drug Label (PDF)

Furoscix (active ingredient: furosemide) subcutaneous injection

Initial FDA Approval: 1968; this formulation was approved in 2022.

Side Effect Update Date: March 6, 2025

Medication Description: A diuretic that treats edema (water retention) in adult patients with chronic heart failure; also recently approved to treat edema in adult patients with chronic kidney disease.

Updated Side Effects/Safety Information: This update supports the recent approval for use in patients with kidney disease, noting that those with severely impaired kidney function may need additional diuretic therapy. It also adds a warning for patients with liver conditions such as cirrhosis and ascites, as sudden shifts in fluid and electrolyte balance could trigger hepatic encephalopathy and coma. Careful monitoring of electrolytes is recommended for these individuals.

FDA Safety Announcement: Furoscix FDA Safety Label Change and Revised Drug Label

Imfinzi (active ingredient: durvalumab) intravenous infusion

Initial FDA Approval: 2017

Side Effect Update Date: March 28, 2025

Medication Description: Treats different kinds of cancer, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), liver cancer, endometrial cancer, and most recently, muscle invasive bladder cancer (MIBC).

Updated Side Effects/Safety Information: This update supports a recent approval for muscle invasive bladder cancer (MIBC), a type of cancer that has spread into the muscle layer of the bladder but not to other parts of the body. The most common side effects when used for MIBC include low red blood cells (anemia), low white blood cells, constipation, increased level of creatinine in the blood, decreased level of magnesium in the blood, decreased appetite, nausea, and more. See revised label for additional clinical trial results.

FDA Safety Announcement: Imfinzi FDA Safety Label Change and Revised Drug Label

Pluvicto (active ingredient: lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use

Initial FDA Approval: 2022

Side Effect Update Date: March 28, 2025

Medication Description: A “radioligand” therapy that treats advanced prostate cancer by delivering radiation directly to the tumor. Patients are screened for treatment eligibility using a companion imaging test.

Updated Side Effects/Safety Information: New clinical trial results support its expanded approval to treat additional metastatic castration-resistant prostate cancer (mCRPC) patients. Pluvicto may now be used by adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor blockers such as Xtandi (enzalutamide) or Erleada (apalutamide), who are eligible to delay taxane-based chemotherapy (paclitaxel, docetaxel and cabazitaxel). Previously, patients were required to have been treated with the taxane-based chemotherapy before taking Pluvicto.

The revised label provides additional warnings about the risk of myelosuppression (decrease in bone marrow’s production of blood cells) and renal toxicity (kidney injury). Patients are advised to remain well hydrated and to urinate frequently. Healthcare providers should perform kidney function laboratory tests and monitor complete blood counts. Extensive changes to clinical trials data; read revised label for complete details.

Essential Extras: FDA issued a press release about the expanded approval of Pluvicto. Novartis expects that with the expanded approval, the number of people eligible for the treatment will triple.

FDA Safety Announcement: Pluvicto FDA Safety Label Change and Revised Drug Label

Trodelvy (active ingredient: sacituzumab govitecan-hziy) for injection, for intravenous use

Initial FDA Approval: 2020

Side Effect Update Date: March 26, 2025

Medication Description: Treats advanced breast cancer.

Updated Side Effects/Safety Information: New updates to the boxed warning about the risk of severe, life-threatening, or fatal neutropenia (low white blood cell count). Patients at an increased risk of febrile neutropenia (neutropenia with fever) are advised to receive a prophylactic (preventative treatment) starting at the first cycle of treatment. The Patient Information section has been updated to add that your heathcare provider may decide to decrease your dose, delay treatment, or permanently stop your treatment with Trodelvy if your white blood cell count is too low, or if your nausea, vomiting or diarrhea is severe and cannot be controlled with medications.

FDA Safety Announcement: Trodelvy FDA Safety Label Change and Revised Drug Label

Tymlos (active ingredient: abaloparatide) injection, for subcutaneous use

Initial FDA Approval: 2017

Side Effect Update Date: March 28,2025

Medication Description: Treats osteoporosis.

Updated Side Effects/Safety Information: New reports that some patients have experienced increased blood pressure.

FDA Safety Announcement: Tymlos FDA Safety Label Change and Revised Drug Label

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                    <!-- wp:paragraph -->
<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 Baqsimi, Belsomra, Furoscix, Imfinzi, Pluvicto, Trodelvy, and Tymlos.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><em>As of this article’s publication, updates to the FDA’s Drug Safety Database appear to be stalled. This is one of the last updates we were able to collect. To learn more about the reasons behind the delay, see our article: <a href="https://medshadow.org/mission-critical-update-medication-safety-updates-from-the-fda-delayed/" target="_blank" rel="noreferrer noopener">Medication Safety Updates from the FDA Delayed</a></em></p>
<!-- /wp:paragraph -->

<!-- wp:myplugin/custom-alignment-block {"align":"right"} -->
<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.<br></p></div>
<!-- /wp:myplugin/custom-alignment-block -->

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<h3 class="wp-block-heading" id="h-baqsimi-active-ingredient-glucagon-single-use-intranasal-powder">Baqsimi (active ingredient: glucagon) single-use intranasal powder</h3>
<!-- /wp:heading -->

<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1960; this formulation was approved in 2019.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: March 17, 2025</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats very low blood sugar (hypoglycemia) in adults and children with diabetes.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Includes clinical trial data supporting expanded approval for pediatric patients as young as one year old, lowering the previous age limit from four years. There is also an added warning for serious hypersensitivity reactions, such as hives, difficulty swallowing, dizziness, cough, rapid heartbeat, and facial swelling. Nosebleeds and cough have been added to the list of common side effects.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2349" target="_blank" rel="noreferrer noopener">Baqsimi FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210134s004lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a></p>
<!-- /wp:paragraph -->

<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading" id="h-belsomra-active-ingredient-suvorexant-tablets">Belsomra (active ingredient: suvorexant) tablets</h3>
<!-- /wp:heading -->

<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2014</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Side Effect Update Date:</strong> March 10, 2025</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats insomnia in adults.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: New data from a small lactation study shows that the active ingredient, suvorexant, appears in low concentrations in breast milk, with a relative infant dose of less than 1% of the maternal dose. Patients are advised to consult their doctors to determine the best feeding approach while using Belsomra.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=258" target="_blank" rel="noreferrer noopener">Belsomra FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204569s010lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label (PDF)</a></p>
<!-- /wp:paragraph -->

<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading" id="h-furoscix-active-ingredient-furosemide-subcutaneous-injection">Furoscix (active ingredient: furosemide) subcutaneous injection</h3>
<!-- /wp:heading -->

<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1968; this formulation was approved in 2022.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: March 6, 2025</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: A diuretic that treats edema (water retention) in adult patients with chronic heart failure; also recently approved to treat edema in adult patients with chronic kidney disease.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: This update supports the recent approval for use in patients with kidney disease, noting that those with severely impaired kidney function may need additional diuretic therapy. It also adds a warning for patients with liver conditions such as cirrhosis and ascites, as sudden shifts in fluid and electrolyte balance could trigger hepatic encephalopathy and coma. Careful monitoring of electrolytes is recommended for these individuals.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>:<a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=3004" target="_blank" rel="noreferrer noopener"> Furoscix FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209988s003lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a></p>
<!-- /wp:paragraph -->

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<h3 class="wp-block-heading" id="h-imfinzi-active-ingredient-durvalumab-intravenous-infusion">Imfinzi (active ingredient: durvalumab) intravenous infusion</h3>
<!-- /wp:heading -->

<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2017</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: March 28, 2025</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats different kinds of cancer, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), liver cancer, endometrial cancer, and most recently, muscle invasive bladder cancer (MIBC).</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: This update supports a recent approval for muscle invasive bladder cancer (MIBC), a type of cancer that has spread into the muscle layer of the bladder but not to other parts of the body. The most common side effects when used for MIBC include low red blood cells (anemia), low white blood cells, constipation, increased level of creatinine in the blood, decreased level of magnesium in the blood, decreased appetite, nausea, and more. See revised label for additional clinical trial results.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement:</strong> <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1457" target="_blank" rel="noreferrer noopener">Imfinzi FDA Safety Label Change</a>  and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761069s050lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
<!-- /wp:paragraph -->

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<h3 class="wp-block-heading" id="h-pluvicto-active-ingredient-lutetium-lu-177-vipivotide-tetraxetan-injection-for-intravenous-use">Pluvicto (active ingredient: lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use</h3>
<!-- /wp:heading -->

<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2022</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: March 28, 2025</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: A “<a href="https://www.novartis.com/research-and-development/technology-platforms/radioligand-therapy" target="_blank" rel="noreferrer noopener">radioligand</a>” therapy that treats advanced prostate cancer by delivering radiation directly to the tumor. Patients are screened for treatment eligibility using a companion imaging test.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: New clinical trial results support its expanded approval to treat additional metastatic castration-resistant prostate cancer (mCRPC) patients. Pluvicto may now be used by adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with <a href="https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet" target="_blank" rel="noreferrer noopener">androgen receptor blockers</a> such as Xtandi (enzalutamide) or Erleada (apalutamide), who are eligible to delay <a href="https://my.clevelandclinic.org/health/drugs/24914-taxane" target="_blank" rel="noreferrer noopener">taxane-based</a> chemotherapy (paclitaxel, docetaxel and cabazitaxel). Previously, patients were required to have been treated with the taxane-based chemotherapy before taking Pluvicto.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p>The revised label provides additional warnings about the risk of <a href="https://www.merriam-webster.com/medical/myelosuppression" target="_blank" rel="noreferrer noopener">myelosuppression</a> (decrease in bone marrow’s production of blood cells) and renal toxicity (kidney injury). Patients are advised to remain well hydrated and to urinate frequently. Healthcare providers should perform kidney function laboratory tests and monitor complete blood counts. Extensive changes to clinical trials data; read revised label for complete details.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Essential Extras</strong>: FDA issued a <a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication" target="_blank" rel="noreferrer noopener">press release</a> about the expanded approval of Pluvicto. <a href="https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer" target="_blank" rel="noreferrer noopener">Novartis expects</a> that with the expanded approval, the number of people eligible for the treatment will triple.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=3097" target="_blank" rel="noreferrer noopener">Pluvicto FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215833s021s024lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
<!-- /wp:paragraph -->

<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading" id="h-trodelvy-active-ingredient-sacituzumab-govitecan-hziy-for-injection-for-intravenous-use">Trodelvy (active ingredient: sacituzumab govitecan-hziy) for injection, for intravenous use</h3>
<!-- /wp:heading -->

<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2020</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: March 26, 2025</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats advanced breast cancer.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: New updates to the boxed warning about the risk of severe, life-threatening, or fatal <a href="https://www.merriam-webster.com/dictionary/neutropenia#medicalDictionary" target="_blank" rel="noreferrer noopener">neutropenia</a> (low white blood cell count). Patients at an increased risk of febrile neutropenia (neutropenia with fever) are advised to receive a prophylactic (preventative treatment) starting at the first cycle of treatment. The Patient Information section has been updated to add that your heathcare provider may decide to decrease your dose, delay treatment, or permanently stop your treatment with Trodelvy if your white blood cell count is too low, or if your nausea, vomiting or diarrhea is severe and cannot be controlled with medications.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2442" target="_blank" rel="noreferrer noopener">Trodelvy FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761115s059lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
<!-- /wp:paragraph -->

<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading" id="h-tymlos-active-ingredient-abaloparatide-injection-for-subcutaneous-use">Tymlos (active ingredient: abaloparatide) injection, for subcutaneous use</h3>
<!-- /wp:heading -->

<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2017</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: March 28,2025</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats osteoporosis.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: New reports that some patients have experienced increased blood pressure.</p>
<!-- /wp:paragraph -->

<!-- wp:paragraph -->
<p><strong>FDA Safety Announcemen</strong>t: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2347" target="_blank" rel="noreferrer noopener">Tymlos FDA Safety Label Change</a>  and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208743s017lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
<!-- /wp:paragraph -->