ZIPSOR® (diclofenac potassium) liquid filled capsules is a prescription Non-Steroidal Anti-Inflammatory Drug (NSAID). ZIPSOR is used for relief of mild to moderate pain in adults (18 years of age and older).
IMPORTANT SAFETY INFORMATION
Like all NSAID medicines, ZIPSOR may increase the chance of a heart attack or stroke that can lead to death. This chance increases:
- with longer use of NSAID medicines
- in people who have heart disease
NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”
Tell your doctor if you have had or plan to have this surgery.
Do not take ZIPSOR if:
- if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
- for pain right before or after heart bypass surgery
Serious side effects for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) include, heart attack, stroke, high blood pressure, heart failure from fluid
retention, kidney problems (including kidney failure), bleeding and ulcers in the stomach and intestine, anemia, life-threatening skin reactions,
life-threatening allergic reactions, liver problems including liver failure, asthma attacks in people who have asthma.
Get emergency help right away if you have any of the following symptoms:
- shortness of breath or trouble breathing
- chest pain
- weakness in one part or side of your body
- slurred speech
- swelling of the face or throat
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
- may cause death
NSAID medicines should only be used:
- exactly as prescribed
- at the lowest dose possible for your treatment
- or the shortest time needed
Tell your healthcare provider:
- about all of your medical conditions.
- about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
- if you are pregnant, NSAID medicines should not be used past 30 weeks of pregnancy.
- if you are breastfeeding, talk to your doctor.
The most common side effects (≥ 2%) of ZIPSOR in clinical trials included nausea, headache, abdominal pain, vomiting, dizziness, constipation, drowsiness, and diarrhea. These are not the only possible side effects of ZIPSOR. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report negative side effects to Depomed at 1-866-458-6389.
For additional information, talk to your healthcare provider and read the FDA-approved Medication Guide or the full Prescribing Information
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088,
or call Depomed, Inc., at 1-866-458-6389.
Please see Important Safety Information and full Prescribing Information, including BOXED WARNING.