ZORVOLEX is a nonsteroidal anti-inflammatory drug (NSAID) indicated for management of mild to moderate acute pain and osteoarthritis (OA) pain.
All prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), like ZORVOLEX, may increase the chances of a heart attack or stroke that can lead to death. These chances increase with higher doses of NSAID medicines; and, generally, with longer periods of 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 grafting (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 prolonged 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 are taking 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, diarrhea, gas, leg or foot pain, abdominal pain, stuffy or runny nose, abnormal blood tests, high blood pressure, 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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You must present your card to the pharmacist along with your prescription to participate in this program. Card valid at participating pharmacies only. If you have any questions regarding your eligibility or benefits, or if you wish to discontinue your participation, call the ZORVOLEX co-pay card program at 1-877-264-2440 (8:00 AM-8:00 PM ET, Monday-Friday). When you use this card, you are certifying that you are 18 years of age or older; you understand the program rules, regulations, and terms and conditions; and you hereby agree to comply with all program requirements. You are not eligible if this prescription is covered by any state or federally funded programs, including but not limited to any state pharmaceutical assistance program, Medicare (Part D or otherwise), Medicaid, Medigap, VA or DOD, or TriCare; if you are Medicare eligible and enrolled in an employer-sponsored health plan or prescription benefit program for retirees; or if your 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. Your acceptance of this offer must be consistent with the terms of any drug benefit provided by your health insurer. You agree to report the use of this card to your insurer if required.
Expiration date: 06/30/2015.