Profenal Side Effects

Generic Name: suprofen ophthalmic

Note: This page contains side effects data for the generic drug suprofen ophthalmic. It is possible that some of the dosage forms included below may not apply to the brand name Profenal.

It is possible that some side effects of Profenal may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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

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 (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.[Ref]

Hypersensitivity

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

Gastrointestinal

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]

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

Nervous system

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

Renal

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.[Ref]

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]

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

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

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

3. Viara M, Menicanti V, Nebiolo M, Michos N, Sarchi C "Double-blind placebo-controlled study of the efficacy and tolerability of suprofen suppositories in patients with osteoarthritic pain." Arzneimittelforschung 36 (1986): 1113-5

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

5. 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 36 (1986): 959-64

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

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

8. 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 35 (1985): 755-9

9. "Product Information. Profenal (suprofen topical)." Alcon Laboratories Inc, Fort Worth, TX.

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

11. 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 25 (1991): 218-23

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

13. 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 35 (1985): 1728-31

14. 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 35 (1985): 1724-7

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

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 35 (1985): 1739-41

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

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

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

20. 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 35 (1985): 1720-3

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

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

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

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

25. 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 27 Suppl 1 (1983): 31-40

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

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

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

29. Snyder S, Teehan BP "Suprofen and renal failure." Ann Intern Med 106 (1987): 776

30. Abreo K, LaBarre J "Suprofen, acute renal failure, and hematuria." Ann Intern Med 105 (1986): 799

31. Wolfe SM "Suprofen-induced transient flank pain and renal failure." N Engl J Med 316 (1987): 1025-6

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

33. Henann NE, Morales JR "Suprofen-induced acute renal failure revisited." Drug Intell Clin Pharm 21 (1987): 69

34. Temple R "Suprofen-induced transient flank pain and renal failure." N Engl J Med 316 (1987): 1026

35. 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 7 (1987): 259-63

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

37. Nies AS "Renal effects of nonsteroidal anti-inflammatory drugs." Agents Actions Suppl 24 (1988): 95-106

38. 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 8 (1988): 90-5

39. Talmud J, Davey J "Suprofen, flank pain and renal involvement: a case report." S Afr Med J 72 (1987): 225-6

40. Wolfe SM, Bennett WM "Suprofen-induced transient flank pain and renal failure." N Engl J Med 316 (1987): 1025

41. Davis NS, Spital A, Kamm DE "Suprofen and acute renal failure." Ann Intern Med 105 (1986): 976-7

42. Henann NE, Morales JR "Suprofen-induced acute renal failure." Drug Intell Clin Pharm 20 (1986): 860-2

43. 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 259 (1988): 1203-4

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

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