May 31, 2016
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Feldene

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Feldene




Side Effects
Interactions

SIDE EFFECTS

In patients taking FELDENE or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1–10% of patients are:

Cardiovascular System: Edema.

Digestive System: Anorexia, abdominal pain, constipation, diarrhea, dyspepsia, elevated liver enzymes, flatulence, gross bleeding/perforation, heartburn, nausea, ulcers (gastric/duodenal), vomiting.

Hemic and Lymphatic System: Anemia, increased bleeding time.

Nervous System: Dizziness, headache.

Skin and Appendages: Pruritus, rash.

Special Senses: Tinnitus.

Urogenital System: Abnormal renal function.

Additional adverse experiences reported occasionally include:

Body As a Whole: Fever, infection, sepsis.

Cardiovascular System: Congestive heart failure, hypertension, tachycardia, syncope.

Digestive System: Dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, stomatitis.

Hemic and Lymphatic System: Ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia.

Metabolic and Nutritional: Weight changes, fluid retention.

Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo.

Respiratory System: Asthma, dyspnea.

Skin and Appendages: Alopecia, bruising, desquamation, erythema, photosensitivity, sweat.

Special Senses: Blurred vision.

Urogenital System: Cystitis, dysuria, hematuria, hyperkalemia, interstitial nephritis, nephritic syndrome, oliguria/polyuria, proteinuria, renal failure, glomerulonephritis.

Other adverse reactions which occur rarely are:

Body As a Whole: Anaphylactic reactions, appetite changes, death, flu-like syndrome, pain (colic), serum sickness.

Cardiovascular System: Arrhythmia, exacerbation of angina, hypotension, myocardial infarction, palpitations, vasculitis.

Digestive System: Eructation, liver failure, pancreatitis.

Hemic and Lymphatic System: Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia.

Hypersensitivity: Positive ANA.

Metabolic and Nutritional: Hyperglycemia, hypoglycemia.

Nervous System: Akathisia, convulsions, coma, hallucinations, meningitis, mood alterations.

Respiratory: Respiratory depression, pneumonia.

Skin and Appendages: Angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens-Johnson Syndrome, urticaria, vesiculobullous reaction.

Special Senses: Conjunctivitis, hearing impairment, swollen eyes.

Reproductive system and breast disorders: Female fertility decreased.

Read the Feldene (piroxicam) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Highly Protein Bound Drugs

FELDENE is highly protein bound and, therefore, might be expected to displace other protein bound drugs. Physicians should closely monitor patients for a change in dosage requirements when administering FELDENE to patients on other highly protein bound drugs.

Aspirin

When FELDENE is administered with aspirin, its protein binding is reduced, although the clearance of free FELDENE is not altered. Plasma levels of piroxicam are depressed to approximately 80% of their normal values when FELDENE is administered (20 mg/day) in conjunction with aspirin (3900 mg/day). The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of piroxicam and aspirin is not generally recommended because of the potential for increased adverse effects.

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

ACE-Inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACEinhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.

Diuretics

Clinical studies, as well as postmarketing observations, have shown that FELDENE can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS: Renal Effects), as well as to assure diuretic efficacy.

Lithium

NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

Warfarin

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

Read the Feldene Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/4/2016

Side Effects
Interactions

Feldene - User Reviews

Feldene User Reviews

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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