SPL MEDGUIDE

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Rx only

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.

This chance increases:

• with longer use of NSAID medicines

  NSAID medicines should never be used right before or after a 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:

  • in people who have heart disease
    • can happen without warning symptoms

      The chance of a person getting an ulcer or bleeding increases with:

      • may cause death
        • taking medicines calledcorticosteroidsandanticoagulants
        • longer use
          • smoking
            • drinking alcohol
              • older age

                NSAID medicines should only be used:

                • having poor health
                  • exactly as prescribed
                    • at the lowest dose possible for your treatment

                      What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

                      
                      NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

                      • for the shortest time needed
                        • different types of arthritis

                          Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
                          
                          Do not take an NSAID medicine:

                          • menstrual cramps and other types of short-term pain
                            • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine

                              Tell your healthcare provider:

                              • for pain right before or after heart bypass surgery
                                • 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 by pregnant women late in their pregnancy.

                                      What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

                                      
                                      Serious Side effects include:Other side effects include:heart attackstomach painstrokeconstipationhigh blood pressurediarrheaheart failure from body swelling (fluid retention)gasheartburnkidney problems including kidney failurenauseableeding and ulcers in the stomach and intestinevomitinglow red blood cells (anemia)dizzinesslife-threatening skin reactionslife-threatening allergic reactionsliver problems including liver failureasthma attacks in people who have asthma

                                      Get emergency help right away if you have any of the following symptoms:

                                      • if you are breastfeeding. Talk to your doctor.
                                        • shortness of breath or trouble breathing
                                          • chest pain
                                            • weakness in one part or side of your body
                                              • slurred speech

                                                Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

                                                • swelling of the face or throat
                                                  • nausea
                                                    • more tired or weaker than usual
                                                      • itching
                                                        • your skin or eyes look yellow
                                                          • stomach pain
                                                            • flu-like symptoms
                                                              • vomit blood
                                                                • there is blood in your bowel movement or it is black and sticky like tar
                                                                  • unusual weight gain
                                                                    • skin rash or blisters with fever

                                                                      These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

                                                                      Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

                                                                      • swelling of the arms and legs, hands and feet
                                                                        • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

                                                                          
                                                                          NSAID medicines that need a prescription

                                                                          *

                                                                          • Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.
                                                                          • Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.Generic NameTradenameCelecoxibCelebrexDiclofenacCataflam, Voltaren, Arthrotec (combined with misoprostol)DiflunisalDolobidEtodolacLodine, Lodine XLFenoprofenNalfon, Nalfon 200FlurbiprofenAnsaidIbuprofenMotrin, Tab-Profen, Vicoprofen

                                                                            *

                                                                            (combined with hydrocodone), Combunox (combined with oxycodone)IndomethacinIndocin, Indocin SR, Indo-Lemmon, IndomethaganKetoprofenOruvailKetorolacToradolMefenamic AcidPonstelMeloxicamMobicNabumetoneRelafenNaproxenNaprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (copackaged with lansoprazole)OxaprozinDayproPiroxicamFeldeneSulindacClinorilTolmetinTolectin, Tolectin DS, Tolectin 600

                                                                            Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

                                                                            
                                                                            This Medication Guide has been approved by the U.S. Food and Drug Administration.