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Nalfon

Last reviewed on RxList: 5/19/2016
Nalfon Side Effects Center

Last reviewed on RxList 12/29/2016

Nalfon (fenoprofen calcium) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by arthritis. Common side effects of Nalfon include:

  • upset stomach,
  • gas,
  • constipation,
  • diarrhea,
  • nausea,
  • vomiting,
  • heartburn,
  • stomach pain,
  • bloating,
  • headache,
  • drowsiness,
  • dizziness,
  • nervousness,
  • fatigue,
  • skin itching or rash,
  • dry mouth,
  • increased sweating,
  • runny nose,
  • blurred vision, or
  • ringing in your ears.

Tell your doctor if you have unlikely but serious side effects of Nalfon including:

  • stomach pain,
  • swelling of the hands or feet,
  • sudden or unexplained weight gain,
  • vision changes,
  • hearing changes,
  • mental/mood changes,
  • fast or pounding heartbeat,
  • persistent or severe headache,
  • fainting,
  • difficult or painful swallowing, or
  • unusual tiredness.

For the treatment of mild to moderate pain, the recommended dosage of Nalfon is 200 mg taken orally every 4 to 6 hours, as needed. For the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis the recommended dose is 400 to 600 mg taken orally, 3 or 4 times a day. Nalfon may interact with antidepressants, cyclosporine, lithium, diuretics (water pills), aspirin or salicylates, blood thinners, steroids, seizure medications, sulfa drugs, oral diabetes medications, or other NSAIDs. Tell your doctor all medications and supplements you use. Nalfon is not recommended for use during pregnancy due to possible harm to a fetus and interference with normal labor/delivery; consult your doctor. This drug passes into breast milk. Consult your doctor before breastfeeding.

Our Nalfon (fenoprofen calcium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Nalfon Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nalfon (Fenoprofen Calcium)

Nalfon Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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.

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, and 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.

Read the entire FDA prescribing information for Nalfon (Fenoprofen Calcium)

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