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Sulfinpyrazone Side Effects

For the Consumer

Applies to sulfinpyrazone: oral capsule, oral tablet

Along with its needed effects, sulfinpyrazone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sulfinpyrazone:

Rare
  • Shortness of breath, troubled breathing, tightness in chest, and/or wheezing
  • sores, ulcers, or white spots on lips or in mouth
  • sore throat and fever with or without chills
  • swollen and/or painful glands
  • unusual bleeding or bruising
Symptoms of overdose
  • Clumsiness or unsteadiness
  • convulsions (seizures)
  • diarrhea
  • nausea or vomiting (severe or continuing)
  • stomach pain (severe or continuing)
  • difficulty in breathing

Check with your doctor as soon as possible if any of the following side effects occur while taking sulfinpyrazone:

More common
  • Lower back and/or side pain
  • painful urination (possibly with blood)
Less common
  • Skin rash
Rare
  • Bloody or black, tarry stools
  • fever
  • increased blood pressure
  • pinpoint red spots on skin
  • sudden decrease in amount of urine
  • swelling of face, fingers, feet, and/or lower legs
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • weight gain

Some side effects of sulfinpyrazone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Joint pain, redness, and/or swelling
  • nausea or vomiting
  • stomach pain

For Healthcare Professionals

Applies to sulfinpyrazone: oral capsule, oral tablet

Gastrointestinal

Gastrointestinal symptoms have been the most frequently reported side effects. Peptic ulcer disease may be exacerbated or reactivated.[Ref]

Hematologic

Hematologic side effects including anemia, leukopenia, agranulocytosis, thrombocytopenia, and aplastic anemia have occurred. Two cases of leukemia following chronic sulfinpyrazone therapy have been reported. Concomitant drug therapy was also reported and a causal relationship with sulfinpyrazone has not been established.[Ref]

Dermatologic

Dermatologic side effects have been limited to rash.[Ref]

Renal

Renal failure has been reported. Suggested mechanisms have included hypersensitivity induced interstitial nephritis, tubular-interstitial damage due to precipitation of urinary uric acid crystals, and inhibition of renal prostaglandin synthesis. Urolithiasis and renal colic may occur following initiation of therapy. Adequate fluid intake and urinary alkalinization are recommended.[Ref]

Musculoskeletal

Mobilization of urates during initiation of therapy has resulted in musculoskeletal symptoms of acute gouty arthritis.[Ref]

References

1. "Product Information. Anturane (sulfinpyrazone)." Novartis Pharmaceuticals, East Hanover, NJ.

2. Mattingly D, Bradley M, Selley PJ "Hazards of sulphinpyrazone." Br Med J 2 (1978): 1786-7

3. Braun J "Abnormalities of urinary sediment and renal failure following sulfinpyrazone therapy." Arch Intern Med 136 (1976): 1060-1

4. Walls M, Goral S, Stone W "Acute renal failure due to sulfinpyrazone." Am J Med Sci 315 (1998): 319-21

5. Howard T, Hoy RH, Warren S, Georgiev M, Selinger H "Acute renal dysfunction due to sulfinpyrazone therapy in post- myocardial infarction cardiomegaly: reversible hypersensitiv interstitial nephritis." Am Heart J 102 (1981): 294-5

6. Keidar S, Kohan R, Levy J, Grenadier E, Palant A, Ben Ari J "Non oliguric acute renal failure after treatment with sulfinpyrazone." Clin Nephrol 17 (1982): 266-7

7. Keidar S, Kohan R, Levy J, et al "Non oliguric acute renal failure after treatment with sulfinpyrazone." Clin Nephrol 17 (1982): 266-7

8. Lenfant F, Lahet JJ, Volot F, Schafer I, Freysz M, Rochette L "Effects of bupivacaine on human erythrocytes submitted to stress and evidence for an interaction between bupivacaine and flumazenil." Br J Clin Pharmacol 48 (1999): 826-8

9. Boelaert J, Lijnen P, Robbens E, Rocher A, Daneels R, Schurgers M, Amery A "Impairment of renal function due to sulphinpyrazone after coronary artery bypass surgery: a prospective double-blind study." J Cardiovasc Pharmacol 8 (1986): 386-91

10. Lijnen P, Boelaert J, van Eeghem P, Daneels R, Schurgers M, de Jaegere P, van der Stichele E, Vincke J, Fagard R, Verschueren LJ, Amery A "Decrease in renal function due to sulphinpyrazone treatment early after myocardial infarction." Clin Nephrol 19 (1983): 143-6

Some side effects of sulfinpyrazone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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