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What the label lists and what reports show

Thiamine side effects

Thiamine's FDA label lists its adverse reactions in its own words. FAERS holds 12,374 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 dyspnoea (791 reports).

  • Generic listed

Check it at the source: the thiamine FDA label on DailyMed (effective July 22, 2026, Sagent Pharmaceuticals); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

An occasional individual may develop a hypersensitivity or life-threatening anaphylactic reaction to thiamine, especially after repeated injection. Collapse and death have been reported. A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat, angioneurotic edema, cyanosis, pulmonary edema, and hemorrhage into the gastrointestinal tract have also been reported. Some tenderness and induration may follow IM use (see WARNINGS ). To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: FDA drug label, Sagent Pharmaceuticals, effective July 22, 2026 (SPL set 5982cf83-01d6-4acb-8373-339079b8a76e), via openFDA; the full label on DailyMed

What do FAERS reports show?

12,374 reports list thiamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,943 are coded as a death and 6,753 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 18 reactions below, none is 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

  • Off Label Use (a use or a product term, not a reaction)972
  • Nausea (a use or a product term, not a reaction)831
  • Drug Ineffective (a use or a product term, not a reaction)817
  • Dyspnoea791
  • Diarrhoea728
  • Pain711
  • Fatigue683
  • Confusional State653
  • Vomiting (a use or a product term, not a reaction)595
  • Malaise572
  • Dizziness567
  • Condition Aggravated (a use or a product term, not a reaction)549
  • Headache537
  • Fall534
  • Acute Kidney Injury504
  • Asthenia487
  • Rash468
  • Pneumonia465
  • Arthralgia430
  • Death (an outcome recorded in the report)400
  • Pyrexia399
  • Drug Hypersensitivity395
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)388
  • Hypotension384
  • Pain In Extremity370

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

What next?

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