Sulfadiazine Side Effects

It is possible that some side effects of sulfadiazine 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 sulfadiazine: oral tablet

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

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

Rare
  • Anxiety
  • blurred vision
  • changes in menstrual periods
  • chills
  • cold sweats
  • coma
  • confusion
  • cool, pale skin
  • decreased sexual ability in males
  • depression
  • dizziness
  • dry, puffy skin
  • fast heartbeat
  • feeling cold
  • headache
  • increased hunger
  • nausea
  • nervousness
  • nightmares
  • seizures
  • shakiness
  • slurred speech
  • swelling of front part of the neck
  • unusual tiredness or weakness
  • weight gain
Incidence not known
  • Abdominal or stomach pain
  • back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • bleeding under the skin
  • blindness or vision changes
  • blistering, peeling, or loosening of the skin
  • bloating
  • blood in the urine or stools
  • bluish-colored lips, fingernails, or palms
  • burning of the face or mouth
  • burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
  • chest pain
  • cloudy urine
  • clumsiness or unsteadiness
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cough or hoarseness
  • cracks in the skin
  • darkened urine
  • decrease in the amount of urine
  • diarrhea
  • difficulty with breathing
  • difficulty with moving
  • dizziness or lightheadedness
  • feeling of discomfort
  • fever with or without chills
  • general body swelling
  • general feeling of tiredness or weakness
  • headache
  • hearing loss
  • indigestion
  • itching
  • joint or muscle pain
  • light-colored stools
  • loss of appetite and weight
  • loss of heat from the body
  • lower back or side pain
  • muscle pain or stiffness
  • nosebleeds
  • not able to pass urine
  • pain or burning while urinating
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red or purple spots on the skin
  • rapid heart rate
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • red, swollen skin
  • redness of the white part of the eyes
  • scaly skin
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shakiness and unsteady walk
  • shortness of breath
  • sore throat
  • soreness of the muscles
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden decrease in amount of urine
  • swelling around the eyes
  • swelling of the face, hands, legs, and feet
  • swelling or inflammation of the mouth
  • swollen lymph glands
  • swollen or painful glands
  • tightness in the chest
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • upper right abdominal pain
  • vision changes
  • vomiting
  • weakness in the hands or feet
  • wheezing
  • yellow eyes or skin

Some sulfadiazine 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:

Incidence not known
  • Feeling of constant movement of self or surroundings
  • hives or welts
  • sensation of spinning
  • sleeplessness
  • trouble with sleeping
  • unable to sleep

For Healthcare Professionals

Applies to sulfadiazine: compounding powder, oral tablet

Hypersensitivity

Hypersensitivity side effects have included urticarial rash (most common), allergic myocarditis, anaphylactoid reactions, anaphylaxis, arthralgia, conjunctival and scleral injection, drug fever and chills, epidermal necrolysis, erythema multiforme, exfoliative dermatitis, generalized skin eruptions, periorbital edema, photosensitization, serum sickness, Stevens-Johnson syndrome, and urticaria.[Ref]

The use of sulfonamide antibiotics, including sulfadiazine, is associated with large increases in the risk of Stevens-Johnson syndrome and toxic epidermal necrolysis, although these phenomena are rare as a whole.[Ref]

Hematologic

Hematologic side effects have included agranulocytosis (0.1%), aplastic anemia, hemolytic anemia (0.05%), hypoprothrombinemia, leukopenia, methemoglobinemia, and purpura.[Ref]

Hemolytic anemia occurs less often with sulfadiazine than with other sulfonamides. Aplastic anemia may be more likely in patients with poor bone marrow reserves.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal pain, diarrhea, anorexia, pancreatitis, and stomatitis.[Ref]

Hepatic

Hepatic side effects are rare but can be serious. Isolated cases of hepatitis and jaundice due to cholestasis have been associated with sulfadiazine. Elevated liver function tests (with a negative hepatitis panel) have been reported in at least one case associated with psychosis.[Ref]

Psychiatric

Psychosis associated with sulfadiazine and pyrimethamine therapy in patients with AIDS and CNS toxoplasmosis has been described in two separate case reports. In each case, tremulousness and disorientation developed within three days to two weeks after starting therapy, despite partial resolution of the size of the intracranial T gondii lesions. No other obvious cause for mental status changes was found. The delirium resolved upon discontinuation of therapy in each case, and was reproducible upon rechallenge. In one case, the patient had elevated liver function tests (hepatitis panel was negative), which were reversible upon discontinuation of therapy.[Ref]

Psychiatric side effects have rarely included frank psychosis in patients with AIDS and CNS toxoplasmosis. Tremulousness, disorientation, and delirium have been reported.[Ref]

Nervous system

Nervous system side effects have included ataxia, convulsions, hallucinations, headache, insomnia, mental depression, peripheral neuritis, tinnitus, and vertigo.[Ref]

Renal

Renal side effects have included crystalluria, lupus erythematosus, periarteritis nodosa, toxic nephrosis with oliguria and anuria, and acute renal failure secondary to crystalluria or tubulointerstitial nephritis.[Ref]

Genitourinary

In one case, analysis of the stone fragments showed a composition of 100% acetylated 2-sulfanilamidopyrimidine, a metabolite of sulfadiazine.[Ref]

Genitourinary side effects have included urolithiasis.[Ref]

Metabolic

Metabolic side effects have included hypoglycemia.[Ref]

Endocrine

Endocrine side effects associated with sulfonamides have rarely included diuresis, goiter production, and sialadenitis.[Ref]

References

1. Tenant-Flowers M, Boyle M, Carey D, et al "Sulphadiazine desenitization in patients with AIDS and cerebral toxoplasmosis." AIDS 5 (1991): 311-5

2. Finland M, Strauss E, Peterson O "Sulfadiazine." JAMA 251 (1984): 1467-74

3. Robson M, Levi J, Dolberg L, Rosenfeld J "Acute tubulo-interstitial nephritis following sulfadiazine therapy." Isr J Med Sci 6 (1970): 561-6

4. Finland M, Strauss E, Peterson O "Sulfadiazine." JAMA 116 (1941): 2641-7

5. Goadsby P, Donaghy A, Lloyd A, Wakefield D "Acquired immunodeficiency syndrome (AIDS) and sulfadiazine-associated acute renal failure." Ann Intern Med 107 (1987): 783-4

6. Pisanty S, Brayer L "Erythema multiforme-like eruption due to sulfadiazine." J Dent Med 20 (1965): 154-7

7. Roujeau JC, Kelly JP, Naldi L, et al. "Medication use and the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis." N Engl J Med 333 (1995): 1600-7

8. Carbone L, Bendixen B, Appel G "Sulfadiazine-associated obstructive nephropathy occurring in a patient with the acquired immunodeficiency syndrome." Am J Kidney Dis 12 (1988): 72-5

9. "Product Information. Sulfadiazine (sulfadiazine)." Eon Labs Manufacturing Inc, Laurelton, NY.

10. Carrion-Carion C, Morales-Suarez-Varela MM, Llopis-Gonzalez A "Fatal Stevens-Johnson syndrome in an AIDS patient treated with sulfadiazine." Ann Pharmacother 33 (1999): 379

11. Kounis GN, Kouni SA, Chiladakis JA, Kounis NG "Comment: Mesalamine-Associated Hypersensitivity Myocarditis in Ulcerative Colitis and the Kounis Syndrome (February)." Ann Pharmacother 43 (2009): 393-4

12. Iaccheri B, Fiore T, Papadaki T, et al. "Adverse drug reactions to treatments for ocular toxoplasmosis: A retrospective chart review." Clin Ther 30 (2008): 2069-74

13. Puckett J, Cooper M, Stuart J, Wu WC, Sterchi JM "Pyrimethamine, sulfadiazine, and villous atrophy of the jejunum." Ann Intern Med 96 (1982): 380

14. Reboli AC, Mandler HD "Encephalopathy and psychoses associated with sulfadiazine in two patients with AIDS and CNS toxoplasmosis." Clin Infect Dis 15 (1992): 556-7

15. Young C "Acute encephalopathy associated with sulfadiazine in a patient with AIDS-related complex." J Infect Dis 160 (1989): 163-4

16. Dusseault BN, Croce KJ, Pais VM Jr "Radiographic characteristics of sulfadiazine urolithiasis." Urology 73 (2009): 928.e5-6

17. Crespo M, Quereda C, Pascual J, Rivera M, Clemente L, Cano T "Patterns of sulfadiazine acute nephrotoxicity." Clin Nephrol 54 (2000): 68-72

18. Schuler AK, Talor Z "The case: 69 year old man with sand in the urine. N-acetylsulfadiazine crystals." Kidney Int 72 (2007): 769-70

19. Perazella MA "Drug-induced renal failure: update on new medications and unique mechanisms of nephrotoxicity." Am J Med Sci 325 (2003): 349-62

20. Marques LPJ, Madeira EPQ, Santos OR "Renal alterations induced by sulfadiazine therapy in an AIDS patients." Clin Nephrol 42 (1994): 68-9

21. Anibarro B, Fontela JL "Sulfadiazine-induced sialadenitis." Ann Pharmacother 31 (1997): 59-60

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