ZORVOLEX™ is a nonsteroidal anti-inflammatory drug (NSAID) indicated for treatment of mild to moderate acute pain in adults.
All prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), like ZORVOLEX™, may increase the chance of heart attack or stroke that can lead to death. This chance increases with higher doses of NSAID medicines; with longer use of NSAID medicines; or in people who have heart disease.
ZORVOLEX™ should not be used right before or after a certain heart surgery called a “coronary artery bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding can happen without warning symptoms and may cause death. The chance of a person having bleeding or getting an ulcer increases with higher doses or longer use of NSAID medicines, taking other medicines called “corticosteroids” and “anticoagulants,“ smoking, drinking alcohol, older age, or having poor health.
Tell your healthcare provider about all of your medical conditions, if you are pregnant or breastfeeding, and about all of the medicines you take because NSAIDs and some other medicines can interact with each other and cause serious side effects.
ZORVOLEX™ should not be taken in late pregnancy.
Do not take ZORVOLEX™ if you had an asthma attack, hives, or other allergic reaction with aspirin, or any other NSAID medicine.
Life threatening allergic reactions can occur with ZORVOLEX™. Get help right away if you’ve had swelling of the face or throat or trouble breathing.
Other serious side effects of NSAIDs include: high blood pressure, heart failure causing swelling (fluid retention), kidney problems including kidney failure, low red blood cells, life-threatening skin reactions, and liver problems including liver failure. The most common side effects reported in studies using ZORVOLEX™ were swelling, nausea, headache, dizziness, vomiting, constipation, itching, gas, leg or foot pain, and heartburn.
ZORVOLEX™ should be used exactly as prescribed, at the lowest dose possible, and for the shortest time needed for your treatment.
These are not all the side effects reported with ZORVOLEX™. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Patients must present their card to the pharmacist along with their prescription to participate in this program. Card valid at participating pharmacies only. If patients have any questions regarding their eligibility or benefits, or if they wish to discontinue their participation, they can call the ZORVOLEX™ co-pay card program at 1-877-264-2440 (8:00 AM-8:00 PM EST, Monday-Friday). When patients use this card, they are certifying that they are 18 years of age or older; they understand the program rules, regulations, and terms and conditions; and they agree to comply with all program requirements. Patients are not eligible if their prescription is covered by any state or federally funded program, including but not limited to any state pharmaceutical assistance program, Medicare (Part D or otherwise), Medicaid, Medigap, VA or DOD, or TriCare; if patients are Medicare eligible and enrolled in an employer-sponsored health plan or prescription benefit program for retirees; or if their insurance plan is paying the entire cost of this prescription. Void outside the US and its territories or where prohibited by law, taxed, or restricted. This card is not health insurance. Patients’ acceptance of this offer must be consistent with the terms of any drug benefit provided by their health insurer. Patients agree to report the use of this card to their insurer if required.