Profenal Side Effects
Generic name: suprofen ophthalmic
Note: This document contains side effect information about suprofen ophthalmic. Some of the dosage forms listed on this page may not apply to the brand name Profenal.
Some side effects of Profenal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to suprofen ophthalmic: ophthalmic solution
Serious side effects are not expected with this medication.
Some eye burning, stinging, irritation, itching, redness, or sensitivity to light may occur. Continue to use suprofen ophthalmic (the active ingredient contained in Profenal) and talk to your doctor about any side effects that you experience.
For Healthcare Professionals
Applies to suprofen ophthalmic: ophthalmic solution
In general, suprofen is well tolerated. Much of the available side effect data is from studies utilizing orally administered suprofen.
Ocular side effects associated with suprofen ophthalmic (the active ingredient contained in Profenal) solution have included local discomfort and irritation upon application, itching, redness, iritis, chemosis, photophobia, or punctate epithelial staining in less than 0.5% of patients.
Hypersensitivity reactions to suprofen have rarely been reported. Contact dermatitis has been associated with topically administered suprofen.
Gastrointestinal side effects associated with orally administered suprofen have included mild gastrointestinal disturbances. Nausea, diarrhea, constipation, gastralgia or dyspepsia occur in up to 7% of patients.
The relative incidence of gastrointestinal bleeding associated with orally administered suprofen is significantly less compared to aspirin.
Nervous system side effects have been associated with orally administered suprofen, and include headache, drowsiness, dizziness, and somnolence.
Renal side effects including new or worsened renal dysfunction has not been associated with the use of suprofen ophthalmic (the active ingredient contained in Profenal) solution, but is the main reason why the use of orally administered suprofen has been limited in the US. The manufacturer concluded that the mechanism was most likely intratubular precipitation of uric acid with tubular obstruction (suprofen increases renal excretion of uric acid). Rarely, interstitial nephritis and mild reversible renal failure have been associated with intravenously or orally administered suprofen.
During a five-year period in Europe, when approximately 3 to 5 million people used the drug as an orally administered antiinflammatory agent, only 3 reports of flank pain associated with suprofen were reported to the manufacturer. In the US, however, 163 cases of acute flank pain syndrome were reported from approximately 700,000 persons using the drug. Unlike renal complications from other NSAIDs, the syndrome of flank pain and mild acute renal failure tends to appear suddenly after smaller (600 mg) single doses.
Especially in "salt-retaining" states (congestive heart failure, liver cirrhosis, nephrosis, preexisting renal insufficiency, dehydration, or decreased effective circulating blood volume), suprofen, like other NSAIDs, can reduce renal blood flow and glomerular filtration rate, reduce sodium excretion, inhibit prostaglandin-dependent renin secretion (which can cause hyperkalemia), enhance the antidiuretic effects of vasopressin, and reduce the antihypertensive efficacy of some drugs.
An allergic mechanism has been suspected in some cases of interstitial nephritis due to the presence of acute renal failure, eosinophilia, positive gallium scanning, and the chronological relationship to the use of suprofen.
Cardiovascular side effects including rare cases of elevated blood pressure have been reported after the use of orally administered suprofen. A cause-and-effect relationship with suprofen has not been shown.
Hematologic side effects including rare cases of hematologic abnormalities (hemolytic anemia, mild leukopenia) have been associated with orally administered suprofen.
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