Nalfon

Last reviewed on RxList: 5/10/2021
Nalfon Side Effects Center

What Is Nalfon?

Nalfon (fenoprofen calcium) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by arthritis.

What Are Side Effects of Nalfon?

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.

Dosage for Nalfon

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.

What Drugs, Substances, or Supplements Interact with Nalfon?

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 During Pregnancy or Breastfeeding

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.

Additional Information

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.

SLIDESHOW

Slideshow: Exercises for Knee Osteoarthritis and Joint Pain See Slideshow
Nalfon Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, runny or stuffy nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, swelling in your legs, feeling short of breath.

Stop using fenoprofen and call your doctor at once if you have:

  • changes in your vision;
  • any skin rash, no matter how mild;
  • shortness of breath (even with mild exertion);
  • swelling or rapid weight gain;
  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired; or
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed, cold hands and feet.

Common side effects may include:

  • nausea, vomiting, stomach pain, indigestion;
  • diarrhea, constipation;
  • headache, dizziness, drowsiness, tiredness;
  • feeling nervous;
  • itching, sweating; 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)

QUESTION

What joints are most often affected by osteoarthritis? See Answer
Nalfon Professional Information

SIDE EFFECTS

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

  • Cardiovascular Thrombotic Events [ see WARNINGS AND PRECAUTIONS]
  • GI Bleeding, Ulceration and Perforation [ see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [ see WARNINGS AND PRECAUTIONS]
  • Hypertension [ see WARNINGS AND PRECAUTIONS]
  • Heart Failure and Edema [ see WARNINGS AND PRECAUTIONS]
  • Renal Toxicity and Hyperkalemia [ see WARNINGS AND PRECAUTIONS]
  • Anaphylactic Reactions [ see WARNINGS AND PRECAUTIONS]
  • Serious Skin Reactions [ see WARNINGS AND PRECAUTIONS]
  • Hematologic Toxicity [ see WARNINGS AND PRECAUTIONS]

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.

DRUG INTERACTIONS

See Table 1 for clinically significant drug interactions with fenoprophen.

Table 1: Clinically Significant Drug Interactions with Fenoprofen

Drugs That Interfere with Hemostasis
Clinical Impact:
  • Fenoprofen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of fenoprofen and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
  • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Intervention: Monitor patients with concomitant use of NALFON 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 [ see WARNINGS AND PRECAUTIONS].
Aspirin
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 [ see WARNINGS AND PRECAUTIONS].
Intervention: Concomitant use of NALFON and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [ see WARNINGS AND PRECAUTIONS]. NALFON is not a substitute for low dose aspirin for cardiovascular protection.
ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers
Clinical Impact:
  • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
Intervention:
  • During concomitant use of NALFON and ACE-inhibitors, ARBs, or betablockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
  • During concomitant use of NALFON, ACE-inhibitors, or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [ see WARNINGS AND PRECAUTIONS].
  • When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
Diuretics
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 NALFON with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS].
Digoxin
Clinical Impact: The concomitant use of fenoprofen with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.
Intervention: During concomitant use of NALFON and digoxin, monitor serum digoxin levels.
Lithium
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 NALFON and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
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 NALFON and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine
Clinical Impact: Concomitant use of NALFON and cyclosporine may increase cyclosporine’s nephrotoxicity.
Intervention: During concomitant use of NALFON and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates
Clinical Impact: Concomitant use of fenoprofen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [ see WARNINGS AND PRECAUTIONS].
Intervention: The concomitant use of fenoprofen with other NSAIDs or salicylates is not recommended.
Pemetrexed
Clinical Impact: Concomitant use of NALFON and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention: During concomitant use of NALFON 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.
Phenobarbital
Clinical Impact: Chronic administration of phenobarbital, a known enzyme inducer, may be associated with a decrease in the plasma half-life of fenoprofen.
Intervention: When phenobarbital is added to or withdrawn from treatment, dosage adjustment of NALFON may be required.
Hydantoins, sulfonamides, or sulfonylureas
Clinical Impact: In vitro studies have shown that fenoprofen, because of its affinity for albumin, may displace from their binding sites other drugs that are also albumin bound, and this may lead to drug interactions. Theoretically, fenoprofen could likewise be displaced.
Intervention: Patients receiving hydantoins, sulfonamides, or sulfonylureas should be observed for increased activity of these drugs and, therefore, signs of toxicity from these drugs.

Drug/Laboratory Test Interactions

Amerlex-M kit assay values of total and free triiodothyronine in patients receiving Nalfon have been reported as falsely elevated on the basis of a chemical cross-reaction that directly interferes with the assay. Thyroid-stimulating hormone, total thyroxine, and thyrotropin-releasing hormone response are not affected. Thus, results of the Amerlex- M kit assay should be interpreted with caution in these patients.

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

© Nalfon Patient Information is supplied by Cerner Multum, Inc. and Nalfon Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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