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 Transderm Scop, Caprelsa, Depakote, Hyzaar, Lamictal, and Xarelto.
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.
Transderm Scop (active ingredient: scopolamine) transdermal patch
Initial FDA Approval: 1979
Side Effect Update Date: April 25, 2025
Medication Description: Prevents nausea and vomiting associated with motion sickness in adults. Also prevents nausea associated with anesthesia use during surgery. The scopolamine-containing patch is applied behind the ear and delivers the medicine for up to three days.
Updated Side Effects/Safety Information: A new warning that scopolamine can raise core body temperature and reduce sweating. Serious cases of overheating, or hyperthermia, have occurred in adults and pediatric patients, including fatal cases. Patients are advised that if they have a high body temperature or are not sweating in warm conditions, to remove the transdermal patch and contact a doctor. People over the age of 65 and those under the age of 17 may be at greater risk of this heat-related complication.
Essential Extras: Transderm Scop isn’t FDA-approved for pediatric use, but is sometimes prescribed off-label for children.
The FDA issued a Drug Safety Communication about the serious risk of heat-related complications with Transderm Scop (scopolamine transdermal system) on June 18, 2025.
FDA Safety Announcement: Transderm Scop FDA Safety Label Change and Revised Drug Label and Drug Safety Communication
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Caprelsa (active ingredient: vandetanib) tablets
Initial FDA Approval: 2011
Side Effect Update Date: May 15, 2025
Medication Description: Treats advanced medullary thyroid cancer.
Updated Side Effects/Safety Information: A new warning that osteonecrosis, including osteonecrosis of the jaw (ONJ), has occurred during treatment. Exposure to bisphosphonate drugs like alendronate (brand name Fosamax) or denosumab-containing drugs (Prolia brand name) may increase the risk of ONJ. Patients should avoid invasive dental procedures while taking Caprelsa. In osteonecrosis, bone tissue deteriorates more quickly than the body can regenerate it.
FDA Safety Announcement: Caprelsa Safety Label Change, and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Depakote (active ingredient: divalproex sodium) delayed-release tablets
Initial FDA Approval: 1983
Side Effect Update Date: April 25, 2025
Medication Description: Treats epilepsy, bipolar disorders, seizures, and prevents migraine headaches.
Updated Side Effects/Safety Information: A new warning about the risk of facial and upper airway swelling (angioedema) and a serious drug hypersensitivity reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Symptoms of DRESS include fever, rash, facial swelling, enlarged lymph nodes and kidney or liver injury.
FDA Safety Announcement: Depakote FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Hyzaar (active ingredient: hydrochlorothiazide; losartan potassium)
Initial FDA Approval: 1994
Side Effect Update Date: June 20, 2025
Medication Description: Treats high blood pressure. Hyzaar is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic or “water pill.” Diuretics help your body eliminate excess fluid.
Updated Side Effects/Safety Information: A new warning that reported angioedema (swelling) side effects have included swelling of the intestines, or “visceral angioedema.”
Essential Extras: Rare case reports of losartan-induced visceral angioedema have been reported in medical literature.
FDA Safety Announcement: Hyzaar FDA Safety Label Change and Revised Drug Label.
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Lamictal (active ingredient: lamotrigine) tablets, oral suspension, orally disintegrating tablets and extended release tablets
Initial FDA Approval: 1994
Side Effect Update Date: April 25, 2025
Medication Description: Treats epilepsy and bipolar disorder.
Updated Side Effects/Safety Information: A new warning of potential interactions with estrogen-containing drugs, including oral contraceptives and hormone replacement therapy (HRT). Estrogen may reduce the effectiveness of Lamictal. Patients should notify their doctor if they use or plan to use estrogen-containing medications while taking Lamictal.
FDA Safety Announcement: Lamictal Safety Label Change, Lamictal CD Safety Label Change, Lamictal ODT Safety Label Change and Lamictal XR Safety Label Change (extended release tablets) and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Xarelto (active ingredient: rivaroxaban) tablets and oral suspension
Initial FDA Approval: 2011
Side Effect Update Date: June 17, 2025
Medication Description: Treats and prevents deep vein thrombosis or DVT (a type of blood clot usually in the leg) and pulmonary embolism, which is a blood clot in the lung. The medication is also taken to prevent strokes and blood clots in people with atrial fibrillation that is not caused by heart valve disease. Xarelto is approved to treat other cardiovascular conditions; see label for complete list of indications.
Updated Side Effects/Safety Information: A new warning states that the risk of internal bleeding extends to all organs, including the spleen, and also highlights the potential for spleen rupture. Patients are advised to get medical help right away if they experience symptoms of a ruptured spleen: upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder, or diffuse abdominal discomfort.
FDA Safety Announcement: Xarelto Safety Label Change, and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
