All non-steroidal anti-inflammatory drugs (NSAIDs), like ZORVOLEX, TIVORBEX and VIVLODEX, increase the risk of heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase with increasing doses and longer use of NSAIDs. Avoid taking NSAIDs after a recent heart attack.
Do not take ZORVOLEX, TIVORBEX or VIVLODEX right before or after a heart surgery called a “coronary artery bypass graft (CABG)."
NSAID medicines can cause ulcers, tears, and bleeding in the esophagus, stomach and intestines at any time during treatment. These events can happen without warning symptoms and may cause death. The risk of a person getting an ulcer or bleeding increases with: a past history of ulcers or bleeding in the stomach or intestines, increasing doses or longer use of NSAIDs, taking other medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”, smoking, drinking alcohol, older age, and having poor health, liver disease or bleeding problems.
Tell your healthcare provider about all of your medical conditions, if you are pregnant or breast feeding, 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, TIVORBEX or VIVLODEX should not be taken after 29 weeks of pregnancy or when breastfeeding.
Do not take ZORVOLEX, TIVORBEX or VIVLODEX 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, TIVORBEX or VIVLODEX. Get help right away if you’ve had swelling of the face or throat or trouble breathing.
Other serious side effects of NSAIDs include: new or worse high blood pressure, heart failure, kidney problems including kidney failure, low red blood cells (anemia), life-threatening skin or allergic 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.
The most common side effects reported in studies using TIVORBEX were: nausea, localized swelling or bleeding at the site of surgery, headache, dizziness, vomiting, constipation, itching, diarrhea, heartburn, light‐headedness, rash, stomach pain, drowsiness, excessive sweating, decreased appetite, hot flashes and fainting.
The most common side effects reported in studies using VIVLODEX were diarrhea, nausea, and abdominal discomfort.
ZORVOLEX, TIVORBEX and VIVLODEX 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, TIVORBEX or VIVLODEX. 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.
Please see full Prescribing Information for additional important safety and dosing information for ZORVOLEX, TIVORBEX, or VIVLODEX.