Fenoprofen

Fenoprofen is a prescription medication used to treat pain and inflammation caused by arthritis.

• Fenoprofen is available under the following different brand names: Nalfon.

Common side effects of Fenoprofen 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
• ringing in the ears

Serious side effects of Fenoprofen include:

• changes in the 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 the feet or ankles, feeling tired; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed, cold hands and feet
• 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

Rare side effects of Fenoprofen include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 200 mg
• 400 mg

Tablets

• 600 mg

Pain

Adult and geriatric dosage

• 200 mg orally every 4-6 hours; not to exceed 3200 mg/day

Rheumatoid arthritis

Adult and geriatric dosage

• 300-600 mg orally every 6-8 hours
• Maximum recommended dose is 3200 mg/day

Osteoarthritis

Adult and geriatric dosage

• 300-600 mg orally every 6-8hours
• Maximum recommended dose is 3200 mg/day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Fenoprofen has severe interactions with no other drugs
• Fenoprofen has serious interactions with the following drugs:
  • aminolevulinic acid oral
  • aminolevulinic acid topical
  • apixaban
  • benazepril
  • captopril
  • enalapril
  • fosinopril
  • ketorolac
  • ketorolac intranasal
  • lisinopril
  • methotrexate
  • methyl aminolevulinate
  • moexipril
  • pemetrexed
  • perindopril
  • quinapril
  • ramipril
  • tacrolimus
  • trandolapril
• Fenoprofen has moderate interactions with at least 235 other drugs
• Fenoprofen has minor interactions with at least 74 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Absolute: Acetylsalicylic acid allergy
• Relative: bleeding disorders, duodenal/gastric/peptic ulcer, renal impairment, stomatitis, systemic lupus erythematosus, ulcerative colitis, upper gastrointestinal disease, late pregnancy (may cause premature closure of ductus arteriosus)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fenoprofen?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fenoprofen?”

Cautions

• Use caution in asthma (bronchial), cardiac disease, congestive heart failure, hepatic impairment, hypertension
• Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, angiotensin converting enzyme inhibitors, or angiotensin receptor blockers
• Drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Drug Reactions reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
• Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
• Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
• Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately
• Heart Failure (HF) risk
  • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
• NSAIDS should be avoided or withdrawn whenever possible
• AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134

Pregnancy and Lactation

• Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
• In animal reproduction studies, embryo-fetal lethality and skeletal abnormalities were noted in offspring of pregnant rabbits following oral administration of Fenoprofen during organogenesis at 0.6 times the maximum human daily dose of 3200 mg/day
• However, there were no major malformations noted following oral administration of fenoprofen calcium to pregnant rats and rabbits during organogenesis at exposures up to 0.3 and 0.6 times the maximum human daily dose of 3200 mg/day
• Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization
• In animal studies, administration of prostaglandin synthesis inhibitors such as fenoprofen, resulted in increased pre-and post-implantation loss
• Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses
• Fetal toxicity
  • NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment
  • Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment
  • If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to the lowest effective dose and shortest duration possible; if treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue therapy, and follow up according to clinical practice
  • Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases risk of premature closure of the fetal ductus arteriosus
  • Because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy
• Labor or Delivery
  • There are no studies on the effects of NALFON during labor or delivery; in animal studies, NSAIDS, including fenoprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth
• Reproductive potential
  • Females
    • Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs may delay or prevent the rupture of ovarian follicles, which has been associated with reversible infertility in some women
    • Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation
    • Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation; consider withdrawal of NSAIDs, in women who have difficulties conceiving or who are undergoing investigation of infertility
• Lactation
  • Information not available