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Sulfinpyrazone Side Effects

For the Consumer

Applies to sulfinpyrazone: oral capsule, oral tablet

As well as its needed effects, sulfinpyrazone may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking sulfinpyrazone, check with your doctor immediately:

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

Severity: Moderate

If any of the following side effects occur while taking sulfinpyrazone, check with your doctor or nurse as soon as possible:

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

Minor Side Effects

Some sulfinpyrazone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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. 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

6. 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

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. 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

9. 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

10. 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

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

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