Frequently Asked Questions

valdecoxib

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Bextra

Cox-2 inhibitors


What is valdecoxib?

Valdecoxib (Bextra) was withdrawn from the U.S. market in 2005.

Valdecoxib is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Valdecoxib works by reducing substances in the body that cause inflammation, pain, and fever.

Valdecoxib is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Valdecoxib is also used to treat painful menstruation.

Valdecoxib may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about valdecoxib?

Valdecoxib (Bextra) was withdrawn from the U.S. market in 2005.

The manufacturer of valdecoxib (Bextra) has announced the voluntary withdrawal of the drug from the U.S. market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs (valdecoxib is a "COX-2" selective non-steroidal anti-inflammatory drug) and safety concerns of an increased risk of rare but serious skin reactions in patients taking valdecoxib.

Do not take valdecoxib without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as celecoxib (Celebrex), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to valdecoxib.

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Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of the skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

Serious skin reactions have occurred in patients taking valdecoxib. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking valdecoxib and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction.

What should I discuss with my healthcare provider before taking valdecoxib?

The manufacturer of valdecoxib (Bextra) has announced the voluntary withdrawal of the drug from the U.S. market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs (valdecoxib is a "COX-2" selective non-steroidal anti-inflammatory drug) and safety concerns of an increased risk of rare but serious skin reactions in patients taking valdecoxib.

Do not take valdecoxib without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as celecoxib (Celebrex), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to valdecoxib.

Valdecoxib should not be used for the treatment of pain after coronary artery bypass surgery (CABG). The use of valdecoxib in such patients has led to an increased incidence of cardiovascular events, deep surgical infections and wound complications. Talk to your doctor before taking valdecoxib if you are being treated for pain associated with CABG.

Before taking valdecoxib, tell your doctor if you

  • smoke;

  • drink alcohol;

  • have an ulcer or bleeding in the stomach;

  • have liver disease;

  • have kidney disease;

  • have asthma;

  • have congestive heart failure;

  • have fluid retention;

  • have heart disease;

  • have high blood pressure;

  • have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin); or

  • are taking a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others.

You may not be able to take valdecoxib, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above.

Valdecoxib is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Valdecoxib should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take valdecoxib without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether valdecoxib passes into breast milk. Do not take valdecoxib without first talking to your doctor if you are breast-feeding a baby.

If you are over the age of 65 years, you may be more likely to experience side effects from valdecoxib. You may require a lower dosage or special monitoring during your therapy.

How should I take valdecoxib?

Take valdecoxib exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Valdecoxib can be taken with or without food or milk. Follow your doctor's instructions.

Store valdecoxib at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a valdecoxib overdose include drowsiness, nausea, vomiting, and stomach pain.

What should I avoid while taking valdecoxib?

There are no restrictions on food, beverages, or activity while taking valdecoxib unless otherwise directed by your doctor.

Valdecoxib side effects

Serious skin reactions have occurred in patients taking valdecoxib. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking valdecoxib and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction.

Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of the skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

Other, less serious side effects may be more likely to occur. Continue to take valdecoxib and talk to your doctor if you experience

  • diarrhea;

  • nausea or upset stomach; or

  • headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

See also: Side effects (in more detail)

Valdecoxib dosing information

Usual Adult Dose for Osteoarthritis:

Valdecoxib was voluntarily withdrawn from the market in April, 2005 by the manufacturer following an FDA Public Health Advisory announcing that the overall risk versus benefit profile for valdecoxib is unfavorable, based on the following: reports of serious and potentially life-threatening skin reactions, including deaths, in patients taking Bextra. The risk of these reactions have occurred in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trial that FDA believes may be relevant to chronic use, and lack of any demonstrated advantages for Bextra compared with other NSAIDs. The following dosage information applies to when the drug was available in the USA.

Initial dose: 10 mg once daily

Usual Adult Dose for Rheumatoid Arthritis:

Valdecoxib was voluntarily withdrawn from the market in April, 2005 by the manufacturer following an FDA Public Health Advisory announcing that the overall risk versus benefit profile for valdecoxib is unfavorable, based on the following: reports of serious and potentially life-threatening skin reactions, including deaths, in patients taking Bextra. The risk of these reactions have occurred in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trial that FDA believes may be relevant to chronic use, and lack of any demonstrated advantages for Bextra compared with other NSAIDs. The following dosage information applies to when the drug was available in the USA.

Initial dose: 10 mg once daily

Usual Adult Dose for Dysmenorrhea:

Valdecoxib was voluntarily withdrawn from the market in April, 2005 by the manufacturer following an FDA Public Health Advisory announcing that the overall risk versus benefit profile for valdecoxib is unfavorable, based on the following: reports of serious and potentially life-threatening skin reactions, including deaths, in patients taking Bextra. The risk of these reactions have occurred in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trial that FDA believes may be relevant to chronic use, and lack of any demonstrated advantages for Bextra compared with other NSAIDs. The following dosage information applies to when the drug was available in the USA.

Initial dose: 20 mg twice daily

Usual Adult Dose for Pain:

Valdecoxib was voluntarily withdrawn from the market in April, 2005 by the manufacturer following an FDA Public Health Advisory announcing that the overall risk versus benefit profile for valdecoxib is unfavorable, based on the following: reports of serious and potentially life-threatening skin reactions, including deaths, in patients taking Bextra. The risk of these reactions have occurred in patients with and without a prior history of sulfa allergy, and after both short- and long-term use. The lack of adequate data on the cardiovascular safety of long-term use of Bextra, along with the increased risk of adverse CV events in short-term coronary artery bypass surgery (CABG) trial that FDA believes may be relevant to chronic use, and lack of any demonstrated advantages for Bextra compared with other NSAIDs. The following dosage information applies to when the drug was available in the USA.

Study (n=507) - Oral or Bunionectomy Surgery: 20 or 40 mg single oral dose given 60 to 75 minutes before surgery.

What other drugs will affect valdecoxib?

Before taking valdecoxib, tell your doctor if you are taking any of the following drugs:

  • aspirin or another salicylate (form of aspirin) such as salsalate (Disalcid), choline salicylate-magnesium salicylate (Trilisate, Tricosal, others), and magnesium salicylate (Doan's, Bayer Select Backache Formula, others);

  • an over-the-counter cough, cold, allergy, or pain medicine that contains dextromethorphan, aspirin, ibuprofen, naproxen, or ketoprofen;

  • a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (HydroDiuril, others), chlorothiazide (Diuril, others), chlorthalidone (Hygroton, Thalitone), and others;

  • an angiotensin-converting-enzyme inhibitor (ACE inhibitor) such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and others;

  • a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others;

  • an anticoagulant (blood thinner) such as warfarin (Coumadin);

  • diazepam (Valium);

  • phenytoin (Dilantin);

  • glyburide (DiaBeta, others);

  • an oral contraceptive (Micronor, Triphasil, Levlen, others);

  • omeprazole (Prilosec, Zegerid);

  • lithium (Eskalith, Lithobid, others); or

  • fluconazole (Diflucan) or ketoconazole (Nizoral).

You may not be able to take valdecoxib, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with valdecoxib. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products.

Where can I get more information?

  • Your pharmacist has additional information about valdecoxib written for health professionals that you may read.

What does my medication look like?

Valdecoxib (Bextra) was withdrawn from the U.S. market in 2005.

  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.01. Revision Date: 2/22/07 3:04:26 PM.

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Endocrine

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

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.[Ref]

Hepatic

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

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.[Ref]

Musculoskeletal

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

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.[Ref]

Psychiatric

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

Hematologic

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

Ocular

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

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.[Ref]

Hypersensitivity

Hypersensitivity side effects have included aggravated allergies and allergic reaction.[Ref]

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.[Ref]

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).[Ref]

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.[Ref]

References

1. "Product Information. Bextra (valdecoxib)." Pharmacia Corporation, Peapack, NJ.

2. FDA. U.S. Food and Drug Administration "Medwatch - The FDA Safety Information and Adverse Event Reporting Program - Strengthened warnings on Bextra (valdecoxib) Available from: URL: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Bextra." ([2004 Dec 10]):

3. Pfizer News Release "Pfizer provides information to healthcare professionals about its cox-2 medicine Bextra (valdecoxib). Available from: URL: http://www.pfizer.com/are/news_releases/2004pr/mn_2004_1015.html." ([2004 Oct 15]):

4. Glasser DL, Burroughs SH "Valdecoxib-induced toxic epidermal necrolysis in a patient allergic to sulfa drugs." Pharmacotherapy 23 (2003): 551-3

More about valdecoxib

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Interactions
  • Support Group
  • En Espanol
  • 11 Reviews - Add your own review/rating

Consumer resources

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  • Valdecoxib (Advanced Reading)
  • Other brands: Bextra

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Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.