Valdecoxib Side Effects

It is possible that some side effects of valdecoxib may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to valdecoxib: oral tablet

As well as its needed effects, valdecoxib may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking valdecoxib, check with your doctor immediately:

Less common
  • Bloating or swelling of face, arms, hands, lower legs, feet
  • blood in urine
  • bloody, black, or sticky stools
  • blurred vision
  • chills
  • decreased or painful urination
  • dizziness
  • fever
  • muscle aches and pains
  • nausea
  • nervousness
  • pale skin
  • pounding in the ears
  • rapid weight gain
  • severe stomach pain
  • tingling of the hands or feet
  • trouble breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • yellow eyes or skin
Incidence not known
  • Blistering, peeling, loosening of skin
  • constipation
  • cracks in the skin
  • darkened urine
  • difficulty swallowing
  • fast heartbeat
  • hives
  • indigestion
  • itching
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • joint or muscle pain
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • loss of appetite
  • loss of heat from the body
  • nausea
  • pains in stomach, side, or abdomen, possibly radiating to the back
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • red, swollen skin
  • scaly skin
  • shortness of breath
  • skin rash
  • sores, ulcers, or white spots in mouth or on lips
  • tightness in chest
  • vomiting
  • wheezing
  • yellow eyes or skin
Symptoms of overdose

If any of the following symptoms of overdose occur while taking valdecoxib, get emergency help immediately:

  • Bloody or black tarry stools
  • continuing thirst
  • dizziness
  • drowsiness
  • headache, severe or continuing
  • nausea and/or vomiting
  • shortness of breath
  • stomach pain
  • sudden decrease in the amount of urine
  • swelling of face, fingers, and/or lower legs
  • tightness in chest and/or wheezing
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • weight gain

Some valdecoxib side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Acid or sour stomach
  • belching
  • cough
  • diarrhea
  • ear congestion
  • headache
  • heartburn
  • indigestion
  • sore throat
Less common
  • Abdominal fullness
  • accidental injury
  • back pain
  • bloating in the abdomen
  • excess gas
  • rash
  • stuffy or runny nose

For Healthcare Professionals

Applies to valdecoxib: oral tablet

Cardiovascular

An increase in cardiovascular thromboembolic events (i.e., myocardial infarction, stroke, deep vein thrombosis (leg), and pulmonary embolism) have been reported in post CABG patients (n=1500) treated with valdecoxib compared to placebo. The risk of the intravenous form is higher (2%) than the oral form (1%) immediately following CABG surgery.

Studies to evaluate valdecoxib's long-term cardiovascular safety profile in patients with arthritis are being planned by the makers of the drug.

Cardiovascular side effects reported in less than 2% of patients have included aggravated hypertension, aneurysm, angina pectoris, arrhythmia, cardiomyopathy, congestive heart failure, coronary artery disorder, heart murmur, and hypotension. A greater frequency of cardiovascular events has been reported in patients given valdecoxib following a coronary artery bypass grafting surgery than in those given standard pain treatment.

Nervous system

Nervous side effects have included headache and dizziness. Other side effects reported have included cerebrovascular disorder, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, tremor, twitching, convulsions, and vertigo.

Dermatologic

In a recent letter to healthcare professionals sent by the manufacturer of valdecoxib, the following postmarketing dermatologic adverse effects have been reported: erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Data obtained from postmarketing adverse event reporting suggest that the skin reactions have occurred primarily within the first two weeks of valdecoxib therapy.

Toxic epidermal necrolysis has been reported in a 55-year-old woman, with a documented sulfa allergy, after taking valdecoxib for 8 days.

Dermatologic side effects have included serious, potentially fatal skin reactions, including Stevens-Johnson Syndrome and toxic epidermal necrolysis. These reactions are most likely to occur in the first two weeks of treatment, but can occur any time during therapy. In a few cases these reactions have resulted in death. The reported rate of these serious skin reactions appears to be greater for valdecoxib than other COX-2 agents.

Acne, alopecia, dermatitis, fungal dermatitis, eczema, photosensitivity allergic reaction, pruritus, erythematous rash, maculopapular rash, psoriaform rash, dry skin, skin hypertrophy, skin ulceration, increased sweating, and urticaria have been reported in less than 2% of patients.

Endocrine

Endocrine side effects reported in less than 2% of patients have included goiter.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, dyspepsia, flatulence, and nausea. Other side effects reported have included abnormal stools, constipation, diverticulosis, dry mouth, duodenal ulcer, duodenitis, eructation, esophagitis, fecal incontinence, gastric ulcer, gastritis, gastroenteritis, gastroesophageal reflux, hematemesis, hematochezia, melena, tenesmus, and vomiting.

Pancreatitis has been reported during the postmarketing period. It is not possible to estimate the frequency or to establish causality.

Hepatic

Hepatic side effects have included cholelithiasis, hepatitis, abnormal hepatic function, increased ALT, and increased AST.

Metabolic

Metabolic side effects have included increases in alkaline phosphatase, BUN, CPK, and creatinine, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperlipemia, hyperuricemia, hypocalcemia, hypokalemia, increased LDH, increased thirst, increases and decreases in weight, and xerophthalmia.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, accidental fracture, myalgia, neck stiffness, osteoporosis, synovitis, and tendonitis.

Respiratory

Respiratory side effects have included sinusitis and upper respiratory tract infection. Other side effects have included abnormal breath sounds, bronchitis, bronchospasm, coughing, dyspnea, emphysema, laryngitis, pneumonia, pharyngitis, pleurisy, and rhinitis.

Psychiatric

Psychiatric side effects have included anorexia, anxiety, increased appetite, confusion, depression, insomnia, nervousness, morbid dreaming, and somnolence.

Hematologic

Hematologic side effects have included anemia, ecchymosis, eosinophilia, epistaxis, hematoma, leukopenia, leukocytosis, lymphadenopathy, lymphangitis, lymphopenia, and thrombocytopenia.

Ocular

Ocular side effects have included blurred vision, cataract, conjunctival hemorrhage, conjunctivitis, eye pain, keratitis, and abnormal vision.

Genitourinary

Genitourinary side effects have included albuminuria, cystitis, dysuria, hematuria, micturition frequency increased, pyuria, urinary incontinence, and urinary tract infection. Female patients have reported amenorrhea, dysmenorrhea, leukorrhea, mastitis, menstrual disorder, menorrhagia, menstrual bloating, and vaginal hemorrhage. Male patients have reported impotence and prostatic disorder.

Hypersensitivity

Hypersensitivity side effects have included aggravated allergies and allergic reaction.

General

General side effects have included asthenia, chest pain, chills, cysts, generalized edema, face edema, fatigue, fever, hot flushes, halitosis, malaise, pain, periorbital swelling, and peripheral pain.

In a recent letter to healthcare professionals sent by the manufacturer of valdecoxib, postmarketing general adverse effects have included anaphylactic reactions and angioedema (hypersensitivity reactions).

Other

Resistance mechanism disorder side effects reported in less than 2% of patients have included herpes simplex, herpes zoster, fungal infection, soft tissue infection, viral infection, moniliasis, genital moniliasis, and otitis media.

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