Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

(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 Nonsteroidal 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 increasing doses of NSAID medicines
• in people who have heart disease
• 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:

• can happen without warning symptoms
• may cause death

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

• increasing doses of NSAID medicines
• smoking
• taking medicines called “corticosteroids” and “anticoagulants”
• drinking alcohol
• older age
• longer use
• having poor health

NSAID medicines should only be used:

• exactly as prescribed
• for the shortest time needed
• at the lowest dose possible for your treatment

What are Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)?

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

• different types of arthritis
• menstrual cramps and other types of short-term pain

Who should not take a Nonsteroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

• 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

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.

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

Serious side effects include:	Other side effects include:
• heart attack • stroke • high blood pressure • heart failure from body swelling (fluid retention) • kidney problems including kidney failure • bleeding and ulcers in the stomach and intestine • low red blood cells (anemia) • life-threatening skin reactions • life-threatening allergic reactions • liver problems including liver failure • asthma attacks in people who have asthma	• stomach pain • constipation • diarrhea • gas • heartburn • nausea • vomiting • dizziness

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

• shortness of breath or trouble breathing
• slurred speech
• chest pain
• swelling of the face or throat
• weakness in one part or side of your body

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

• 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
• swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. 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.

Other information about Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

• 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.
• Some of these NSAID medicines are sold in lower doses without a prescription (over-thecounter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines requiring a prescription

Generic Name	Tradename
Celecoxib	Celebrex
Diclofenac	Zorvolex, Cataflam, Cambia, Voltaren, Voltaren gel, Arthrotec (combined with misoprostol), Flector, Zipsor, Pennsaid
Diflunisal	Dolobid
Etodolac	Lodine, Lodine XL
Fenoprofen	Nalfon, Nalfon 200
Flurbiprofen	Ansaid
Ibuprofen	Motrin, Tab-Profen,*Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone), Duexis (combined with famotidine)
Indomethacin	Tivorbex, Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen	Oruvail, Nexcede
Ketorolac	Toradol, Sprix
Mefenamic Acid	Ponstel
Meloxicam	Mobic
Nabumetone	Relafen
Naproxen	Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (copackaged with lansoprazole), Treximet (combined with sumatriptan succinate) and Vimovo (combined with esomeprazole magnesium)
Oxaprozin	Daypro
Piroxicam	Feldene
Sulindac	Clinoril
Tolmetin	Tolectin, Tolectin DS, Tolectin 600

* 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.

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

*All trademarks are property of their respective owners.

Manufactured by:

Amneal Pharmaceuticals Pvt. Ltd.

Ahmedabad, INDIA 382220

Repackaged and Distributed by:

Apotheca Inc.

Phoenix,AZ 85006