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Does Feldene (piroxicam) cause side effects?
NSAIDs are non-narcotic relievers of mild to moderate pain of many causes, including injury, menstrual cramps, arthritis, and other musculoskeletal conditions. NSAIDs work by reducing levels of prostaglandins, chemicals responsible for pain, fever, and inflammation.
Feldene blocks the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower concentrations of prostaglandins. As a result, inflammation, pain and fever are reduced.
Common side effects of Feldene include
- abdominal pain,
- fluid retention,
- ringing in the ears, and
- sensitivity to sunlight.
Serious side effects of Feldene include
- increased bleeding after an injury,
- stomach and intestinal bleeding and ulcers (signs include black tarry stools, weakness, and dizziness upon standing),
- impaired kidney function,
- allergic reactions (more common in patients with asthma),
- fluid retention,
- blood clots,
- heart attacks,
- high blood pressure (hypertension), and
- heart failure.
- Feldene may reduce the blood pressure lowering effects of blood pressure medications.
- Combining NSAIDs such as Feldene with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors in patients who are elderly, volume-depleted (including those on diuretic therapy), or with poor kidney function may result in reduced kidney function, including kidney failure.
- When Feldene is used in combination with methotrexate or aminoglycoside antibiotics the blood levels of methotrexate or aminoglycoside may increase, which may lead to more methotrexate- or aminoglycoside- related side effects.
- Individuals taking oral blood thinners or anticoagulants, for example, warfarin, should avoid Feldene because Feldene also thins the blood, and excessive blood thinning may lead to bleeding.
- Alcohol consumption may increase the risk of developing stomach ulcers when taking Feldene or other NSAIDs.
Safety of Feldene during pregnancy has not been established. Use of Feldene in late pregnancy may cause premature closing of the ductus arteriosus in the fetus. Feldene is excreted into human breast milk. Use by breastfeeding mothers is not recommended.
What are the important side effects of Feldene (piroxicam)?
The most common side effects of piroxicam are:
- abdominal pain,
- fluid retention,
- ringing in the ears, and
NSAIDs reduce the ability of blood to clot and therefore increase bleeding after an injury.
Piroxicam also may cause stomach and intestinal bleeding and ulcers. Sometimes, stomach ulceration and intestinal bleeding can occur without any abdominal pain. Black tarry stools, weakness, and dizziness upon standing may be the only signs of the bleeding. People who are allergic to other NSAIDs should not use piroxicam.
NSAIDs reduce the flow of blood to the kidneys and impair function of the kidneys. The impairment is most likely to occur in patients with preexisting impairment of kidney function or congestive heart failure, and use of NSAIDs in these patients should be done cautiously.
Individuals with asthma are more likely to experience allergic reactions to prioxicam and other NSAIDs. Fluid retention, blood clots, heart attacks, hypertension, and heart failure have also been associated with the use of NSAIDs.
Feldene (piroxicam) side effects list for healthcare professionals
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events
- GI Bleeding, Ulceration and Perforation
- Heart Failure and Edema
- Renal Toxicity and Hyperkalemia
- Anaphylactic Reactions
- Serious Skin Reactions
- Hematologic Toxicity
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In patients taking Feldene or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1–10% of patients are:
Cardiovascular System: Edema
Skin and Appendages: Pruritus, rash
Special Senses: Tinnitus
Additional adverse experiences reported occasionally include:
Cardiovascular System: Palpitations
Digestive System: Stomatitis
Nervous System: Drowsiness
Special Senses: Blurred vision
The following adverse reactions have been identified during post approval use of Feldene. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Digestive System: Dyspepsia, elevated liver enzymes, gross bleeding/perforation, heartburn, ulcers (gastric/duodenal), dry mouth, esophagitis, gastritis, glossitis, hematemesis, hepatitis, jaundice, melena, rectal bleeding, eructation, liver failure, pancreatitis
Hemic and Lymphatic System: Anemia, increased bleeding time, ecchymosis, eosinophilia, epistaxis, leukopenia, purpura, petechial rash, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
Hypersensitivity: Positive ANA
Nervous System: Anxiety, asthenia, confusion, depression, dream abnormalities, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, akathisia, convulsions, coma, hallucinations, meningitis, mood alterations
Skin and Appendages: Alopecia, bruising, desquamation, erythema, photosensitivity, sweat, angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, onycholysis, Stevens Johnson Syndrome, urticaria, vesiculobullous reaction
Reproductive system and breast disorders: Female fertility decreased
What drugs interact with Feldene (piroxicam)?
See Table 1 for clinically significant drug interactions with piroxicam.
Table 1: Clinically Significant Drug Interactions with Piroxicam
|Drugs That Interfere with Hemostasis|
|Intervention:||Monitor patients with concomitant use of Feldene with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors
(SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding.
|Clinical Impact:||Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone.|
|Intervention:||Concomitant use of Feldene and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. Feldene is not a substitute for low dose aspirin for cardiovascular protection.|
|ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers|
|Clinical Impact:||Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of Feldene with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.|
|Clinical Impact:||The concomitant use of piroxicam with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.|
|Intervention:||During concomitant use of Feldene and digoxin, monitor serum digoxin levels.|
|Clinical Impact:||NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of Feldene and lithium, monitor patients for signs of lithium toxicity.|
|Clinical Impact:||Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).|
|Intervention:||During concomitant use of Feldene and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of Feldene and cyclosporine may increase cyclosporine's nephrotoxicity.|
|Intervention:||During concomitant use of Feldene and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of piroxicam with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy.|
|Intervention:||The concomitant use of piroxicam with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of Feldene and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention:||During concomitant use of Feldene and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.|
|Highly Protein Bound Drugs|
|Clinical Impact:||Feldene is highly protein bound and, therefore, might be expected to displace other protein bound drugs.|
|Intervention:||Physicians should closely monitor patients for a change in dosage requirements when administering Feldene to patients on other highly protein bound drugs.|
|Clinical Impact:||Concomitant use of corticosteroids with Feldene may increase the risk of GI ulceration or bleeding.|
|Intervention:||Monitor patients with concomitant use of Feldene with corticosteroids for signs of bleeding.|
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Report Problems to the Food and Drug Administration
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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.