Sulfadiazine

Mechanism-of-action class: Para-Aminobenzoic Acid Inhibitors.

• Sulfadiazine Tablets are indicated in the following conditions: Chancroid Trachoma Inclusion conjunctivitis Nocardiosis Urinary tract infections (primarily pyelonephritis, pyelitis and cystitis) in the absence of obstructive uropathy or foreign bodies, when these infections are caused by susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Staphylococcus aureus, Proteus mirabilis and P. vulgaris .ICD-10: H10.9, N39.0

• Sulfadiazine is contraindicated in the following circumstances: Hypersensitivity to sulfonamides. In infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis).contraindicated

SYSTEMIC SULFONAMIDES ARE CONTRAINDICATED IN INFANTS UNDER 2 MONTHS OF AGE except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis. Usual Dosage for Infants over 2 Months of Age and Children Initially, one-half the 24-hour dose. Maintenance, 150 mg/kg or 4 g/m 2 , divided into 4 to 6 doses, every 24 hours, with a maximum of 6 g every 24 hours. Rheumatic fever prophylaxis, under 30 kg (66 pounds), 500 mg every 24 hours; over 30 kg (66 pounds), 1 g every 24 hours. Usual Adult Dosage Initially, 2 g to 4 g. Maintenance, 2 g to 4 g, divided into 3 to 6 doses, every 24 hours.

The sulfonamides should not be used for the treatment of group A betahemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever and glomerulonephritis. Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood dyscrasias. The presence of such clinical signs as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders. The frequency of renal complications is considerably lower in patients receiving the more soluble sulfonamides.

Blood Dyscrasias Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia and methemoglobinemia. Allergic Reactions Erythema multiforme (Stevens-Johnson syndrome), generalized skin eruptions, epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital edema, conjunctival and scleral injection, photosensitization, arthralgia, allergic myocarditis, drug fever and chills. Gastrointestinal Reactions Nausea, emesis, abdominal pains, hepatitis, diarrhea, anorexia, pancreatitis and stomatitis. C.N.S. Reactions Headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo and insomnia. Renal Crystalluria, stone formation, toxic nephrosis with oliguria and anuria; periarteritis nodosa and lupus erythematosus phenomenon have been noted. Miscellaneous Reactions The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Goiter production, diuresis and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents.

• Nov 26, 1973NDANDA017381King Pharms Llc
• Jul 5, 1978ANDAANDA080084Chartwell Molecular
• Feb 25, 1982NDANDA018578Dr Reddys
• Dec 23, 1985NDANDA018810Thepharmanetwork Llc
• Jul 29, 1994ANDAANDA040091Epic Pharma Llc

1. 1Off Label Use2727.0%
2. 2Dyspnoea2516.5%
3. 3Pain2476.4%
4. 4Drug Hypersensitivity2466.4%
5. 5Nausea2396.2%
6. 6Drug Ineffective2255.8%
7. 7Condition Aggravated2215.7%
8. 8Anxiety2135.5%
9. 9Vomiting2075.4%
10. 10Fatigue2055.3%
11. 11Pain In Extremity1975.1%
12. 12Death1945.0%
13. 13Product Use In Unapproved Indication1744.5%
14. 14Acute Kidney Injury1714.4%
15. 15Diarrhoea1704.4%

Recent PubMed references pinned to Sulfadiazine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Effect of collagenase ointment versus silver sulfadiazine ointment on the healing of deep second-degree burns: a prospective randomised study.
  Journal of wound care · 2026 · Tong L, Shi X, Hu X, et al.
  PMID 42262984DOI 10.12968/jowc.2023.0130
• Comparative pharmacokinetics of trimethoprim-sulfadiazine and trimethoprim-sulfamethoxazole in dogs.
  BMC veterinary research · 2026 · Ekstrand C, Löwgren M, Erkas M, et al.
  PMID 42243796DOI 10.1186/s12917-026-05604-7
• Removal of sulfadiazine antibiotic using carbon-based adsorbents: A comprehensive review on influencing factors, adsorption models and mechanisms.
  Journal of environmental sciences (China) · 2026 · Chau NT
  PMID 42217870DOI 10.1016/j.jes.2025.09.040
• Synthesis, characterization, and anticancer potency of sulfadiazine salicylaldehyde-based Schiff bases.
  Scientific reports · 2026 · Nasr E, Moustafa AH, El-Sayed ASA, et al.
  PMID 42129257DOI 10.1038/s41598-026-51752-z
• Mechanistic insights into activation of periodate by sludge biogas residue biochar loaded with manganese for efficient sulfadiazine degradation in aqueous solutions.
  Journal of environmental management · 2026 · Xu H, Chen X, Zhu J, et al.
  PMID 42114403DOI 10.1016/j.jenvman.2026.129860
• A photoelectrochemical aptasensor based on chlorine-doped double perovskite Cs(2)AgBiBr(6) for highly sensitive detection of sulfadiazine.
  Bioelectrochemistry (Amsterdam, Netherlands) · 2026 · Guo S, Peng W, Sun X, et al.
  PMID 42096746DOI 10.1016/j.bioelechem.2026.109313
• PE microplastics and sulfadiazine drive cross-domain microbial restructuring and antibiotic resistance gene dynamics in biofilms.
  Journal of hazardous materials · 2026 · Ma S, Zhao B, Liu H, et al.
  PMID 42085794DOI 10.1016/j.jhazmat.2026.142269
• Comparison between foam dressings impregnated with ionic silver and silver sulfadiazine cream 1% in treating deep burns.
  Journal of wound care · 2026 · Almeida JB, Coltro PS, Nunes AA, et al.
  PMID 42060508DOI 10.12968/jowc.2024.0071

The 10 most recently updated of 58 ClinicalTrials.gov registrations naming Sulfadiazine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
  Recruiting · Phase 2 · Interventional · 60 enrolled · Skingenix, Inc.
  NCT01297400updated 2026-03-16
• Contact Activation of Coagulation in Newly Inserted Central Venous Catheters
  Recruiting · Interventional · 88 enrolled · Thomas Kander
  NCT07014722updated 2026-02-18
• Microenvironment in Patients Undergoing Non-traumatic Amputation
  Recruiting · Interventional · 20 enrolled · University of Aarhus
  NCT07384689updated 2026-02-12
• Silver Sulfadiazine With Hyaluronic Acid Versus Silver Sulfadiazine Alone in Partial-Thickness Burns
  Not yet recruiting · Interventional · 30 enrolled · Dr Muhammad Naveed Shahzad
  NCT07367087updated 2026-01-26
• Evaluation of the Effectiveness of a Topical Medical Device in Wound Healing and Symptom Relief in the Postoperative Period of Open Excisional Hemorrhoidectomy (The Emor Study)
  Completed · Phase 4 · Interventional · 114 enrolled · University of Cagliari
  NCT06872151updated 2025-07-02
• Evaluation of a Management Strategy for Second-degree Fibrinous Burns Integrating a Poly-absorbent Dressing
  Completed · Interventional · 7 enrolled · Hospices Civils de Lyon
  NCT05347654updated 2025-06-22
• SWC for Treatment of Superficial Partial-Thickness Burns
  Terminated · Interventional · 2 enrolled · Synedgen, Inc.
  NCT05877638updated 2024-12-03
• Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns
  Terminated · Interventional · 14 enrolled · KeraNetics, LLC
  NCT03564795updated 2024-08-01
• StrataXRT for the Prevention and Treatment of Radiation Dermatitis in Breast Cancer or Head and Neck Cancer Patients
  Withdrawn · Interventional · 0 enrolled · OHSU Knight Cancer Institute
  NCT05073172updated 2024-05-06
• Superficial Partial-Thickness Burn Study
  Terminated · Phase 4 · Interventional · 26 enrolled · J. Peter Rubin, MD
  NCT04601532updated 2024-02-01

CPIC-curated drug–gene pairs for Sulfadiazine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• G6PDCPIC CFDA label: Informative PGx
  G6PD

Frequently asked questions

How does Sulfadiazine work?

Mechanism-of-action class: Para-Aminobenzoic Acid Inhibitors.

What is Sulfadiazine used for?

According to FDA labeling, Sulfadiazine carries indications including: Sulfadiazine Tablets are indicated in the following conditions: Chancroid Trachoma Inclusion conjunctivitis Nocardiosis Urinary tract infections (primarily pyelonephritis, pyelitis and cystitis) in the absence of obstructive uropathy or foreign bodies, when these infections are caused by susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Staphylococcus aureus, Proteus mirabilis and P. vulgaris .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sulfadiazine?

Sulfadiazine is classified as Intermediate-acting sulfonamides, Sulfonamide Antibacterial, Para-Aminobenzoic Acid Inhibitors, Cellular Synthetic Activity Alteration, Decreased Folic Acid Modification.

What are the brand names for Sulfadiazine?

Sulfadiazine is marketed under brand names including Equisul SDT, Rebalance, Uniprim.

What are the contraindications for Sulfadiazine?

Sulfadiazine labeling lists contraindications including: Sulfadiazine is contraindicated in the following circumstances: Hypersensitivity to sulfonamides. In infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis).. Always consult the full prescribing information and a clinician.