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Suprofen ophthalmic Side Effects

Applies to suprofen ophthalmic: ophthalmic solution.

Warning

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

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 and talk to your doctor about any side effects that you experience.

For Healthcare Professionals

Applies to suprofen ophthalmic: ophthalmic solution.

General

In general, suprofen is well tolerated. Much of the available side effect data is from studies utilizing orally administered suprofen.[Ref]

Ocular

Ocular side effects associated with suprofen ophthalmic 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.[Ref]

Hypersensitivity

Hypersensitivity reactions to suprofen have rarely been reported. Contact dermatitis has been associated with topically administered suprofen.[Ref]

Gastrointestinal

The relative incidence of gastrointestinal bleeding associated with orally administered suprofen is significantly less compared to aspirin.[Ref]

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.[Ref]

Nervous system

Nervous system side effects have been associated with orally administered suprofen, and include headache, drowsiness, dizziness, and somnolence.[Ref]

Renal

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.[Ref]

Renal side effects including new or worsened renal dysfunction has not been associated with the use of suprofen ophthalmic 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.[Ref]

Cardiovascular

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.[Ref]

Hematologic

Hematologic side effects including rare cases of hematologic abnormalities (hemolytic anemia, mild leukopenia) have been associated with orally administered suprofen.[Ref]

References

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2. Burgio GR, Nespoli L, Michos N, Sarchi C. Open study of the clinical effect of suprofen syrup in children. Arzneimittelforschung. 1986;36:968-71.

3. Giovannini M, Longhi R, Besana R, Michos N, Sarchi C. Clinical experience and results of treatment with suprofen in pediatrics. 5th communication: a single-blind study on antipyretic effect and tolerability of suprofen syrup versus metamizole drops in pediatric patients. Arzneimittelforschung. 1986;36:959-64.

4. Weydert A, Gugler E, Michos N, Hobel W, Martinek G. Clinical effect of rectal application of suprofen in children. An open controlled study. Arzneimittelforschung. 1985;35:1735-8.

5. Bodner E, Michos N. Clinically controlled comparative study of suprofen, pentazocine, and placebo. Experience with intramuscular single doses. SO- Arzneimittelforschung 1985;35(4):755-9. Arzneimittelforschung. 1985;35:755-9.

6. Yeadon A, Raina M, Gardner MC, Milak DM, Smith KE. Suprofen. An overview of long-term safety. Pharmacology. 1983;27 Suppl 1:87-94.

7. Willkens RF. Long-term clinical evaluation of suprofen and aspirin in patients with osteoarthritis. Pharmacology. 1983;27 Suppl 1:48-54.

8. Todd PA, Heel RC. Suprofen. A review of its pharmacodynamic and pharmacokinetic properties, and analgesic efficacy. Drugs. 1985;30:514-38.

9. Product Information. Profenal (suprofen ophthalmic). Alcon Laboratories Inc. 2022.

10. Kurumaji Y, Ohshiro Y, Miyamoto C, Keong CH, Katoh T, Nishioka K. Allergic photocontact dermatitis due to suprofen. Photopatch testing and cross-reaction study. Contact Dermatitis. 1991;25:218-23.

11. Schuermans Y. Comparison of suprofen and ibuprofen in the treatment of pain secondary to osteoarthritis. Pharmacology. 1983;27 Suppl 1:41-7.

12. von Szeged AV, Michos N. Controlled single-blind clinical study of suprofen syrup versus metamizole syrup. Arzneimittelforschung. 1986;36:1110-2.

13. Probst G, Michos N. Open clinical study with suprofen drops in the treatment of postoperative and posttraumatic pain. Arzneimittelforschung. 1986;36:1107-9.

14. Honig WJ, Michos N. Clinically controlled comparative study of intravenous single doses of suprofen versus indoprofen. Arzneimittelforschung. 1986;36:1104-7.

15. Weippl G, Baerlocher K, Michos N. Open study of the clinical effect of suprofen drops in children. Arzneimittelforschung. 1986;36:965-7.

16. Focan C, Hendrickx P, Meunier-Carpentier F, Servais J, Michos N, Stocker H. Antipyretic effect and tolerability of suprofen suppositories. Controlled clinical double-blind study with placebo. Arzneimittelforschung. 1985;35:1739-41.

17. Weippl G, Michos N, Sundal EJ, Stocker H. Clinical experience and results of treatment with suprofen in pediatrics. 3rd communication: Antipyretic effect and tolerability of repeat doses of suprofen and paracetamol syrup in hospitalized children/A single-blind study. Arzneimittelforschung. 1985;35:1728-31.

18. Weippl G, Michos N, Bolla K, Stocker H. Clinical experience and results of treatment with suprofen in pediatrics. 1st communication: Suprofen dosage for children/An open and a double-blind study with suprofen syrup. Arzneimittelforschung. 1985;35:1720-3.

19. Fellmann N, Stocker H, Reuteler H. Double-blind study of suprofen vs naproxen in the treatment of osteoarthritic pain. Eur J Rheumatol Inflamm. 1983;6:216-21.

20. Denis FR, de Beer JM. Clinical evaluation of suprofen in the treatment of elderly patients with pain of diverse etiology. Pharmacology. 1983;27 Suppl 1:81-6.

21. Honig WJ. Clinical comparison of the analgesic efficacy of suprofen, diflunisal and placebo in the treatment of pain after meniscectomy. Pharmacology. 1983;27 Suppl 1:74-80.

22. Silberman HM. Multiple-dose comparison of suprofen, aspirin, and placebo in the treatment of musculoskeletal pain. Pharmacology. 1983;27 Suppl 1:65-73.

23. Salzman RT, Brobyn RD. Long-term comparison of suprofen and propoxyphene in patients with osteoarthritis. Pharmacology. 1983;27 Suppl 1:55-64.

24. Sunshine A, Marrero I, Olson NZ, Laska EM, McCormick N. Oral analgesic efficacy of suprofen compared to aspirin, aspirin plus codeine, and placebo in patients with postoperative dental pain. Pharmacology. 1983;27 Suppl 1:31-40.

25. Arnold JD, Berger AE. Comparison of fecal blood loss after use of aspirin and suprofen. Pharmacology. 1983;27 Suppl 1:14-22.

26. Weippl G, Michos N, Sundal EJ, Stocker H. Clinical experiences and results of treatment with suprofen in pediatrics. 2nd communication: use of suprofen suppositories as an antipyretic in children with fever due to acute infections. Arzneimittelforschung. 1985;35:1724-7.

27. Cooper SA, Wagenberg B, Eskow R, Zissu J. Double-blind evaluation of suprofen and aspirin in the treatment of periodontal pain. Pharmacology. 1983;27 Suppl 1:23-30.

28. Snyder S, Teehan BP. Suprofen and renal failure. Ann Intern Med. 1987;106:776.

29. Hart D, Ward M, Lifschitz MD. Suprofen-related nephrotoxicity. A distinct clinical syndrome. Ann Intern Med. 1987;106:235-8.

30. Davis NS, Spital A, Kamm DE. Suprofen and acute renal failure. Ann Intern Med. 1986;105:976-7.

31. Abreo K, LaBarre J. Suprofen, acute renal failure, and hematuria. Ann Intern Med. 1986;105:799.

32. Strom BL, West SL, Sim E, Carson JL. The epidemiology of the acute flank pain syndrome from suprofen. Clin Pharmacol Ther. 1989;46:693-9.

33. Rossi AC, Bosco L, Faich GA, Tanner A, Temple R. The importance of adverse reaction reporting by physicians. Suprofen and the flank pain syndrome. JAMA. 1988;259:1203-4.

34. Wolfe SM. Suprofen-induced transient flank pain and renal failure. N Engl J Med. 1987;316:1025-6.

35. Talmud J, Davey J. Suprofen, flank pain and renal involvement: a case report. S Afr Med J. 1987;72:225-6.

36. Nies AS. Renal effects of nonsteroidal anti-inflammatory drugs. Agents Actions Suppl. 1988;24:95-106.

37. Henann NE, Morales JR. Suprofen-induced acute renal failure revisited. Drug Intell Clin Pharm. 1987;21:69.

38. Henann NE, Morales JR. Suprofen-induced acute renal failure. Drug Intell Clin Pharm. 1986;20:860-2.

39. Malandrino S, Angelini M, Baldini L, Barenghi L, Borsa M, Carrabba M, Ceriotti F, Tonon GC. Effects of suprofen on renal function in patients with rheumatoid arthritis. Int J Clin Pharmacol Res. 1987;7:259-63.

40. Abraham PA, Halstenson CE, Opsahl JA, Matzke GR, Keane WF. Suprofen-induced uricosuria. A potential mechanism for acute nephropathy and flank pain. Am J Nephrol. 1988;8:90-5.

41. Wolfe SM, Bennett WM. Suprofen-induced transient flank pain and renal failure. N Engl J Med. 1987;316:1025.

42. Ellis CL, Anisko JJ. Suprofen-induced transient flank pain and renal failure. N Engl J Med. 1987;316:1025-6.

43. Temple R. Suprofen-induced transient flank pain and renal failure. N Engl J Med. 1987;316:1026.

44. van Dijk BA, Rico PB, Hoitsma A, Kunst VA. Immune hemolytic anemia associated with tolmetin and suprofen. Transfusion. 1989;29:638-41.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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