Call 911 or your physician immediately if you believe you are having an allergic reaction to Celebrex. It is important that you receive medical attention as quickly as possible in the case of a serious complication.

Allergic Reaction

You should not take Celebrex if you have a known allergy to sulfonamides. In the case of a serious allergic reaction, anaphylactic shock may occur. Symptoms include:

• Trouble breathing
• Swelling of the face and throat
• Hives (Itchy red patches on the skin)

If you have any of these symptoms, stop using Celebrex and seek medical attention immediately.

Overdose

In case of accidental overdose, seek medical attention and contact a poison control center immediately. Symptoms of an overdose may include:

• Nausea
• Stomach pain
• Drowsiness
• Black or bloody stool
• Vomiting blood
• Shortness of breath
• Fainting
• Coma

If you think you or someone you know has overdosed on Celebrex, call 911 or your local poison control center immediately.

Cardiovascular Events (Heart Attack, Stroke)

Celebrex has been associated with the increased risk of severe cardiovascular complications, including heart attack and stroke, especially when taken in large doses and for prolonged periods. Heart attacks and strokes can occur without warning, but here are some symptoms that may indicate an approaching cardiovascular event:

• Chest pain
• Shortness of breath
• Weakness
• Slurred speech

If you have any of these symptoms, call 911 or your emergency physician immediately.

Ulceration and Bleeding

Celebrex has been associated with an increased risk of gastrointestinal complications, including perforations (bleeding ulcers) in the stomach and intestinal lining, which can lead to death. Severe ulceration and fatal internal bleeding may occur without warning, but here are some symptoms of gastrointestinal complications which may require immediate medical attention:

• Epigastric pain (upper abdomen)
• Dyspepsia (severe indigestion)
• Melena (bloody/tarry feces)
• Hematemesis (vomiting blood)
• Vomit that looks like coffee grounds

If you have any of these symptoms, seek medical attention immediately.

Skin Rash/Reaction

In rare cases, Celebrex may cause a severe skin reaction similar to that of a sulfa allergy. Symptoms include:

• Blistering of the skin
• Itching
• Fever

If you develop any of these symptoms while using Celebrex, stop taking the drug and seek medical attention.

Hepatotoxicity (Chemical-driven Liver Damage)

Celebrex may cause a condition called hepatotoxicity, in which ingestion of chemicals, usually medications, causes damage to the liver. The liver plays the role in the body of cleansing chemicals from the bloodstream; it is thereby at increased risk for damage by toxins contained in these chemicals. The symptoms of hepatotoxicity include:

• Nausea
• Fatigue
• Lethargy
• Pruritus (uncontrollable itching)
• Jaundice (yellowing of skin and/or eyes)
• Pain in right upper quadrant
• Flu-like symptoms

If you have any of these symptoms, stop taking Celebrex and seek medical attention.

Reporting Serious Side Effects to the FDA

If you experience or witness a serious side effect or complication of Celebrex, the FDA urges you to report the event through its “MedWatch” service. Your report helps the FDA to gather more complete information regarding the safety of this drug, which could save other patients from suffering the same complications.

Definition of Side Effects

The side effects of a drug include all of its physical effects besides its main intended effect. Typically, drug manufacturers are aware of a drug’s possible side effects, and are required to disclose that information before the drug can be approved by the FDA. Side effects are different from risk factors, in that risk factors are typically more rare and more serious than side effects, and they often don’t come to light until a drug has already hit the market.

Minor Side Effects, Which May Subside During Treatment

The most common side effects of Celebrex are stomach pain or nausea, which may be prevented by taking the medication with food, milk, or a full glass of water. Other minor side effects include:

• Burping
• Hunger
• Weight Changes
• Sweating
• Drowsiness
• Loss of energy
• Muscle pain
• Itching
• Dermatitis
• Sun sensitivity
• Constipation
• Dry mouth
• Yeast infection, systemic or vaginal
• Ringing in the ears
• Dry skin
• Painful menstruation
• Disease of the fingernails and/or toenails

Severe Side Effects of Celebrex:

The following side effects are rare but serious, and require medical diagnosis and attention.

• Allergic reaction (hives, swelling)
• Breast tumors
• Diabetes
• High cholesterol
• Water retention
• Drop in potassium levels
• Rupture in stomach or intestinal wall
• Anemia
• Increased platelet count
• Migraines
• Hearing loss
• Hemorrhoids
• Blood hemorrhaging under the skin
• Bronchitis
• Abscess
• Fever
• Numbness or tingling
• Bladder control problems
• Joint inflammation
• Abnormal liver function
• Herpes Simplex infection
• Vaginal infection or inflammation