Nalfon Side Effects

Generic name: fenoprofen

Note: This document contains side effect information about fenoprofen. Some of the dosage forms listed on this page may not apply to the brand name Nalfon.

Some side effects of Nalfon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fenoprofen: oral capsule, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking fenoprofen (the active ingredient contained in Nalfon) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking fenoprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

• black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• confusion, tremors or shaking;

• urinating less than usual or not at all;

• pain, burning, or bleeding when you urinate;

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects of fenoprofen may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;

• dizziness, headache, nervousness;

• skin itching or rash;

• dry mouth;

• increased sweating, runny nose;

• blurred vision; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to fenoprofen: compounding powder, oral capsule, oral tablet

Gastrointestinal

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Fenoprofen (the active ingredient contained in Nalfon) should be used with caution in these patients.

Gastrointestinal side effects have been reported frequently. These have included dyspepsia (up to 10%), nausea, vomiting, abdominal pain, and constipation. More serious gastrointestinal side effects include peptic ulcer with or without perforation, gastrointestinal hemorrhage, and pancreatitis.

Hepatic

Hepatic side effects have included elevations in liver function tests, which may occur in up to 15% of patients. In addition, jaundice and cholestatic hepatitis have been reported.

Elevations in liver function tests to three times normal values occur in less than 1% of patients.

Cautious use of fenoprofen with frequent monitoring of the liver function tests is recommended in patients with liver disease,

Renal

Renal side effects have included increased serum creatinine and blood urea nitrogen, oliguria, hematuria, cystitis, interstitial nephritis, nephrotic syndrome, and renal papillary necrosis.

Idiosyncratic nephropathy is seen more frequently with fenoprofen than with other nonsteroidal anti-inflammatory agents, and may occur days to months after initiation of therapy.

Fenoprofen may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for nonsteroidal anti-inflammatory drug-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk for end-stage renal disease.

Patients with reduced renal function may be at increased risk for renal side effects.

Hypersensitivity

Hypersensitivity side effects have been reported rarely. These have included eosinophilia. rash, angioedema, bronchospasm, and anaphylaxis. Fenoprofen-associated nephritis may be due to a hypersensitivity. In addition, rare cases of pulmonary hypersensitivity and severe dermatologic reactions have been reported.

Hematologic

Hematological side effects have included platelet dysfunction, thrombocytopenia, agranulocytosis, pure red cell aplasia, hemolytic anemia, and aplastic anemia.

Nervous system

Nervous system side effects have been rare. These have included dizziness, headache, nervousness, asthenia, and fatigue.

Dermatologic

Dermatologic side effects have included increased sweating, pruritus, and rash. In addition, rare cases of exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported.

Other

Lab values which may be altered by fenoprofen (the active ingredient contained in Nalfon) include elevated free and total triiodothyronine (T3) due to interference with the T3 assay.

Cardiovascular

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and antagonize the blood-pressure lowering effect of antihypertensive mediations in patients already being treated with antihypertensive drugs.

Cardiovascular side effects have included edema and palpitations. In addition, blood pressure may be elevated by fenoprofen, which may have clinical relevance in patients with comorbid illnesses.

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