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What the label lists and what reports show

Diatrizoate side effects

Diatrizoate's FDA label lists its adverse reactions in its own words. FAERS holds 520 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (95 reports).

  • Generic listed

Check it at the source: the diatrizoate FDA label on DailyMed (effective January 1, 2021, Liebel-Flarsheim Company LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most adverse reactions to enteral diagnostic radiopaque agents are mild and transitory. Nausea, vomiting and/or diarrhea, urticaria with erythema, hypoxia, acute dyspnea, tachyarrhythmia, and anaphylaxis have occurred following ingestion of the contrast medium, particularly when high concentrations or large volumes of solution are administered. Severe changes in serum osmolarity and electrolyte concentrations may produce shock-like states ( see WARNINGS ). It should be kept in mind that serious or anaphylactoid reactions that may occur with intravascular administration of radiopaque contrast agents are theoretically possible following administration by other routes.

Source: FDA drug label, Liebel-Flarsheim Company LLC, effective January 1, 2021 (SPL set b348b1cf-6250-4ab6-b2bf-3bff86628c53), via openFDA; the full label on DailyMed

What do FAERS reports show?

520 reports list diatrizoate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 141 are coded as a death and 262 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Nausea (named in the label)95
  • Off Label Use (a use or a product term, not a reaction)93
  • Drug Ineffective (a use or a product term, not a reaction)87
  • Dyspnoea (named in the label)83
  • Rash (named in the label)79
  • Pain76
  • Confusional State68
  • Drug Hypersensitivity67
  • Type 2 Diabetes Mellitus65
  • Pericarditis64
  • Product Use Issue (a use or a product term, not a reaction)64
  • Psoriatic Arthropathy64
  • Treatment Failure (a use or a product term, not a reaction)64
  • Pemphigus63
  • Systemic Lupus Erythematosus63
  • Therapeutic Product Effect Decreased (a use or a product term, not a reaction)63
  • Wound63
  • C-Reactive Protein Increased62
  • Injection Site Reaction62
  • Rheumatic Fever62
  • Rheumatoid Arthritis62
  • Sleep Disorder62
  • Infusion Related Reaction61
  • Onychomycosis61
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)61

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Diatrizoate: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions