Last reviewed 2026-04-20 · How we verify

IOTHALAMATE SODIUM

Iothalamate Sodium is a marketed drug with a key composition patent expiring in 2028. The drug's primary strength lies in its established market presence and long-term use. The primary risk is the potential increase in competition following the patent expiry in 2028.

At a glance

Approved indications

No approved indications tracked.

Common side effects

• Nausea
• Vomiting
• Facial flush
• Body warmth sensation
• Headache
• Urticaria
• Erythema
• Pruritus
• Maculopapular rash
• Dry mouth
• Sweating
• Coughing

Serious adverse events

• Death
• Anaphylaxis
• Bronchospasm
• Laryngospasm
• Pulmonary edema
• Cardiac arrest
• Cardiac arrhythmia
• Hypotensive shock
• Stevens-Johnson syndrome
• Toxic epidermal necrolysis

Key clinical trials

• Best Noninvasive Predictor of Renal Function in Assessing Adult Sickle Nephropathy
• Assessment of Renal Function in Cirrhotic Patients
• Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate (NA)
• Pharmacokinetics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Tacrolimus Toxicity (PHASE2, PHASE3)
• Measurement of Renal Functional Reserve (NA)
• Comparative Renal Function of Young (18-45 Years) and Ageing (55 Years and Above) Kidney Donors
• Live Kidney Donor Study -Renal Function Study
• Evaluation of New Test Method to Measure Kidney Function

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• IOTHALAMATE SODIUM CI brief — competitive landscape report
• IOTHALAMATE SODIUM updates RSS · CI watch RSS