Thiamine

Mechanism-of-action class: Enzyme Interactions.

• Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe.

• A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication.contraindicated

“Wet” beriberi with myocardial failure must be treated as an emergency cardiac condition, and thiamine must be administered slowly by the IV route in this situation (see WARNINGS ). In the treatment of beriberi, 10 to 20 mg of thiamine hydrochloride are given IM three times daily for as long as two weeks. (See WARNINGS regarding repeated injections of thiamine.) An oral therapeutic multivitamin preparation containing 5 to 10 mg thiamine, administered daily for one month, is recommended to achieve body tissue saturation. Infantile beriberi that is mild may respond to oral therapy, but if collapse occurs, doses of 25 mg may cautiously be given IV. Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed. Patients with neuritis of pregnancy in whom vomiting is severe enough to preclude adequate oral therapy should receive 5 to 10 mg of thiamine hydrochloride IM daily. In the treatment of Wernicke-Korsakoff syndrome, thiamine hydrochloride has been administered IV in an initial dose of 100 mg, followed by IM doses of 50 to 100 mg daily until the patient is consuming a regular, balanced diet. (See WARNINGS regarding repeated injections of thiamine.) Patients with marginal thiamine status to whom dextrose is being administered should receive 100 mg thiamine hydrochloride in each of the first few liters of IV fluid to avoid precipitating heart failure. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Serious hypersensitivity/anaphylactic reactions can occur, especially after repeated administration. Deaths have resulted from IV or IM administration of thiamine (see ADVERSE REACTIONS ). Routine testing for hypersensitivity, in many cases, may not detect hypersensitivity. Nevertheless, a skin test should be performed on patients who are suspected of drug allergies or previous reactions to thiamine, and any positive responders should not receive thiamine by injection. If hypersensitivity to thiamine is suspected (based on history of drug allergy or occurrence of adverse reactions after thiamine administration), administer one-hundredth of the dose intradermally and observe for 30 minutes. If no reaction occurs, full dose can be given; the patient should be observed for at least 30 minutes after injection. Be prepared to treat anaphylactic reactions regardless of the precautions taken.

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. An occasional individual may develop a hypersensitivity or life-threatening anaphylactic reaction to thiamine, especially after repeated injections. 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 ).

Usage in Pregnancy Studies in pregnant women have not shown that thiamine hydrochloride increases the risk of fetal abnormalities if administered during pregnancy. If the drug is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm however, thiamine hydrochloride should be used during pregnancy only if clearly needed.

Parenteral doses of 100 to 500 mg singly have been administered without toxic effects. However, dosages exceeding 30 mg three times a day are not utilized effectively. When the body tissues are saturated with thiamine, it is excreted in the urine as pyrimidine. As the intake of thiamine is further increased, it appears unchanged in the urine.

• Jun 20, 1972ANDAANDA080556Fresenius Kabi Usa
• Feb 26, 1974ANDAANDA080571Dr Reddys
• Jun 24, 1975ANDAANDA080575West-ward Pharms Int
• Feb 21, 2001NDANDA021265Sandoz Canada Inc
• Jun 25, 2012ANDAANDA091623Mylan Institutional
• Dec 1, 2017ANDAANDA206106Sagent Pharms Inc
• Apr 20, 2022ANDAANDA208703Eugia Pharma
• Mar 6, 2023ANDAANDA215692Caplin

1. 1Fatigue3,9969.4%
2. 2Nausea3,0637.2%
3. 3Diarrhoea2,9657.0%
4. 4Headache2,6126.1%
5. 5Pain2,4935.8%
6. 6Drug Ineffective2,4335.7%
7. 7Dyspnoea2,2675.3%
8. 8Off Label Use2,2115.2%
9. 9Dizziness2,1905.1%
10. 10Asthenia1,8584.4%
11. 11Arthralgia1,8544.3%
12. 12Fall1,8084.2%
13. 13Vomiting1,6523.9%
14. 14Malaise1,5603.7%
15. 15Rash1,4933.5%

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

• Development of PDMS Films Containing Thiamine Bromide and Sodium Iodide: Part 1-Matrix Characterisation and In Vitro Release.
  Molecules (Basel, Switzerland) · 2026 · Farmazyan Z, Avagyan N, Topuzyan V, et al.
  PMID 42197141DOI 10.3390/molecules31101588
• Alpha-Lipoic Acid and Benfotiamine in Diabetic Peripheral Neuropathy: A Critical Review of Mechanistic Rationale and Clinical Evidence Within a Nutritional Therapeutic Framework.
  Nutrients · 2026 · Ciubotaru A, Grosu C, Alexa D, et al.
  PMID 42196997DOI 10.3390/nu18101538
• Electroenzymatic Oxidative Desymmetrization by Engineered Thiamine-Dependent Enzymes for the Enantioselective Synthesis of Axially Chiral Biaryls.
  Journal of the American Chemical Society · 2026 · Shi F, Ren Y, Wu J, et al.
  PMID 42144905DOI 10.1021/jacs.6c01275
• Degradation study of thiamine hydrochloride and analysis of expired ampoules using a novel, validated HPLC-UV method.
  Journal of pharmaceutical and biomedical analysis · 2026 · Klapper S, Holzgrabe U
  PMID 42105595DOI 10.1016/j.jpba.2026.117542
• Association of vitamin B1/B6/B12 supplementation with sphingosine-1-phosphate signaling and its receptors in multiple sclerosis patients: relevance to LISPR1 and APOA1-AS.
  Bioscience reports · 2026 · Mehana NA, Ghaiad HR, Nooh MM, et al.
  PMID 42063363DOI 10.1042/BSR20260065
• A prospective, randomized, double-blind, placebo-controlled, multicenter study of thiamin plus folic acid in the treatment of cognitive impairment in patients undergoing maintenance hemodialysis.
  Renal failure · 2026 · Xie K, Jiang Y, Chen T, et al.
  PMID 42059045DOI 10.1080/0886022X.2026.2658981
• Relationship between dietary thiamine, riboflavin, and niacin intake and hypertension subtypes: A cross-sectional study from the 1999-2023.
  PloS one · 2026 · Ma S, Jin Q, Yu K, et al.
  PMID 42030351DOI 10.1371/journal.pone.0335834
• Repurposing extracellular phosphatases to enhance thiamine biosynthesis and refine a genetic tool in Schizosaccharomyces pombe.
  FEMS microbiology letters · 2026 · Huang X, Bai H, Sun L, et al.
  PMID 41990136DOI 10.1093/femsle/fnag044

The 10 most recently updated of 257 ClinicalTrials.gov registrations naming Thiamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Immune-Mitochondrial Correction in Military Recruits
  Not yet recruiting · Interventional · 200 enrolled · MIPO Clinic
  NCT07622147updated 2026-06-02
• The Effect of Vitamin D on in Vitro Fertilization Outcome
  Completed · Observational · 688 enrolled · The First Affiliated Hospital of Zhengzhou University
  NCT02361827updated 2026-05-27
• Vitamin B Complex for Inferior Alveolar Nerve Paresthesia Recovery
  Not yet recruiting · Phase 4 · Interventional · 50 enrolled · University of Sao Paulo
  NCT07592897updated 2026-05-20
• Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being
  Recruiting · Interventional · 20 enrolled · King's College London
  NCT07599930updated 2026-05-20
• Clinical Trial On The Effect Of Artisterol On Risk Factors In Individuals With Suboptimal Cholesterol Levels
  Recruiting · Interventional · 106 enrolled · Zentiva, k.s.
  NCT07405814updated 2026-05-12
• Efficacy of Early Intravenous High-dose Vitamin C in Post-cardiac Arrest Shock.
  Recruiting · Phase 2 · Interventional · 234 enrolled · Centre Hospitalier de Bethune
  NCT05817851updated 2026-05-08
• Prealbumin and IGF-1 Levels in Pediatric Chronic Cholestasis With Severe Malnutrition After Nutrition Therapy
  Recruiting · Interventional · 15 enrolled · Indonesia University
  NCT07569003updated 2026-05-06
• The Critical Link Between Gut Microbiome Dysfunction, Cravings and Relapse: RECLAIM-GUT TRIAL
  Active not recruiting · Interventional · 20 enrolled · University of Roehampton
  NCT07350538updated 2026-05-04
• Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
  Recruiting · Phase 2 · Interventional · 60 enrolled · AB Biotics, SA
  NCT07193927updated 2026-04-30
• Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.
  Enrolling by invitation · Interventional · 10 enrolled · Shanghai Zhongshan Hospital
  NCT06649825updated 2026-04-24

Frequently asked questions

How does Thiamine work?

Mechanism-of-action class: Enzyme Interactions.

What is Thiamine used for?

According to FDA labeling, Thiamine carries indications including: Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Thiamine?

Thiamine is classified as Vitamin B1, plain, Enzyme Interactions, Cellular Activity Alteration.

What are the brand names for Thiamine?

Thiamine is marketed under brand names including Concept OB, Dialyvite 800, Dialyvite 800 with Iron, Dialyvite 800 with Zinc, Eldertonic, Ellis Tonic, Hemocyte Plus, Infuvite.

What are the contraindications for Thiamine?

Thiamine labeling lists contraindications including: A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication.. Always consult the full prescribing information and a clinician.