Nalfon Side Effects

Generic Name: fenoprofen

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

Side Effects of Nalfon - for the Consumer

Nalfon

All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nalfon:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Nalfon:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; decreased hearing; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Nalfon Side Effects - for the Professional

Nalfon

During clinical studies for rheumatoid arthritis, osteoarthritis, or mild to moderate pain and studies of pharmacokinetics, complaints were compiled from a checklist of potential adverse reactions, and the following data emerged. These encompass observations in 6,786 patients, including 188 observed for at least 52 weeks. For comparison, data are also presented from complaints received from the 266 patients who received placebo in these same trials. During short-term studies for analgesia, the incidence of adverse reactions was markedly lower than that seen in longer-term studies.

Adverse drug reactions reported in ≥1% of patients during clinical trials

Digestive System—During clinical trials with Nalfon, the most common adverse reactions were gastrointestinal in nature and occurred in 20.8% of patients receiving Nalfon as compared to 16.9% of patients receiving placebo. In descending order of frequency, these reactions included dyspepsia (10.3% Nalfon vs. 2.3% placebo), nausea (7.7% vs. 7.1%), constipation (7% vs. 1.5%), vomiting (2.6% vs. 1.9%), abdominal pain (2% vs. 1.1%), and diarrhea (1.8% vs. 4.1%). The drug was discontinued because of adverse gastrointestinal reactions in less than 2% of patients during premarketing studies.

Nervous System —The most frequent adverse neurologic reactions were headache (8.7% vs. 7.5%) and somnolence (8.5% vs. 6.4%). Dizziness (6.5% vs. 5.6%), tremor (2.2% vs. 0.4%), and confusion (1.4% vs. none) were noted less frequently. Nalfon was discontinued in less than 0.5% of patients because of these side effects during premarketing studies.

Skin and Appendages—Increased sweating (4.6% vs. 0.4%), pruritus (4.2% vs. 0.8%), and rash (3.7% vs. 0.4%) were reported. Nalfon was discontinued in about 1% of patients because of an adverse effect related to the skin during premarketing studies.

Special Senses—Tinnitus (4.5% vs. 0.4%), blurred vision (2.2% vs. none), and decreased hearing (1.6% vs. none) were reported. Nalfon was discontinued in less than 0.5% of patients because of adverse effects related to the special senses during premarketing studies.

Cardiovascular—Palpitations (2.5% vs. 0.4%). Nalfon was discontinued in about 0.5% of patients because of adverse cardiovascular reactions during premarketing studies.

Miscellaneous—Nervousness (5.7% vs. 1.5%), asthenia (5.4% vs. 0.4%), peripheral edema (5.0% vs. 0.4%), dyspnea (2.8% vs. none), fatigue (1.7% vs. 1.5%), upper respiratory infection (1.5% vs. 5.6%), and nasopharyngitis (1.2% vs. none).

Adverse drug reactions reported in <1% of patients during clinical trials

Digestive System—Gastritis, peptic ulcer with/without perforation, gastrointestinal hemorrhage, anorexia, flatulence, dry mouth, and blood in the stool. Increases in alkaline phosphatase, LDH, SGOT, jaundice, cholestatic hepatitis, aphthous ulcerations of the buccal mucosa, metallic taste, and pancreatitis.

Cardiovascular—Atrial fibrillation, pulmonary edema, electrocardiographic changes, and supraventricular tachycardia.

Genitourinary Tract—Renal failure, dysuria, cystitis, hematuria, oliguria, azotemia, anuria, interstitial nephritis, nephrosis, and papillary necrosis.

Hypersensitivity—Angioedema (angioneurotic edema).

Hematologic—Purpura, bruising, hemorrhage, thrombocytopenia, hemolytic anemia, aplastic anemia, agranulocytosis, and pancytopenia.

Nervous System—Depression, disorientation, seizures, and trigeminal neuralgia.

Special Senses—Burning tongue, diplopia, and optic neuritis.

Skin and Appendages—Exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, and alopecia.

Miscellaneous—Anaphylaxis, urticaria, malaise, insomnia, tachycardia, personality change, lymphadenopathy, mastodynia, and fever.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Fenoprofen 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 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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