Fenoprofen Side Effects

Brand Names: Nalfon

Please note - some side effects for Fenoprofen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Fenoprofen - for the consumer

Fenoprofen

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 Fenoprofen:

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

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.

Fenoprofen Capsules

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 Fenoprofen Capsules:

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

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.

For the professional

Fenoprofen

During clinical studies for rheumatoid arthritis or osteoarthritis, complaints were compiled from a checklist of potential adverse reactions, from which the following data emerged. These encompass observations in 3,391 patients, including 188 observed for at least 52 weeks. During short-term studies for analgesia, the incidence of adverse reactions was markedly lower than that seen in longer-term studies.

INCIDENCE GREATER THAN 1%

Digestive System: During clinical trials with Fenoprofen calcium, the most common adverse reactions were gastrointestinal in nature and occurred in about 14% of patients. In descending order of frequency, these reactions included dyspepsia,1 constipation,1 nausea,1 vomiting,1 abdominal pain, anorexia, occult blood in the stool, diarrhea, flatulence, and dry mouth.

The drug was discontinued because of adverse gastrointestinal reactions in less than 2% of patients.

Nervous System: The most frequent adverse neurologic reactions were headache and somnolence, which occurred in about 15% of patients. Dizziness,1 tremor, confusion, and insomnia were noted less frequently.

Fenoprofen was discontinued in less than 0.5% of patients because of these side effects.

Skin and Appendages: Pruritus,1 rash, increased sweating, and urticaria.

Fenoprofen was discontinued in about 1% of patients because of an adverse effect related to the skin.

Special Senses: Tinnitus, blurred vision, and decreased hearing.

Fenoprofen was discontinued in about 0.5% of patients because of adverse effects related to the special senses.

Cardiovascular: Palpitations1 and tachycardia.

Fenoprofen was discontinued in about 0.5% of patients because of adverse cardiovascular reactions.

Miscellaneous: Nervousness,1 asthenia,1 dyspnea, fatigue, and malaise.

1

Reactions in 3% to 9% of patients treated with Fenoprofen. (Those reactions occurring in less than 3% of the patients are unmarked.)

INCIDENCE LESS THAN 1%

The following adverse reactions, occurring in less than 1% of patients, were reported in controlled clinical trials and through voluntary reports since Fenoprofen was initially marketed. The probability of a causal relationship exists between Fenoprofen and these adverse reactions:

Digestive System: Gastritis, peptic ulcer with/without perforation, and/or gastrointestinal hemorrhage. Increases in alkaline phosphatase, LDH, and SGOT, jaundice, and cholestatic hepatitis were observed.

Genitourinary Tract: Dysuria, cystitis, hematuria, oliguria, azotemia, anuria, interstitial nephritis, nephrosis, and papillary necrosis.

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

Miscellaneous: Peripheral edema and anaphylaxis.

INCIDENCE LESS THAN 1%

Other reactions have been reported but occurred in circumstances in which a causal relationship could not be established. However, with these rarely reported reactions, the possibility of such a relationship cannot be excluded. Therefore, these observations are listed to alert the physician.

Skin and Appendages: Stevens-Johnson syndrome, angioneurotic edema, exfoliative dermatitis, and alopecia.

Digestive System: Aphthous ulcerations of the buccal mucosa, metallic taste, and pancreatitis.

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

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

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

Miscellaneous: Personality change, lymphadenopathy, mastodynia, and fever.

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