Thiamine Hydrochloride side effects: what 12,372 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Thiamine Hydrochloride (Thiamine Hydrochloride)
Who reports
12,372 reports · 90% serious · 1,943 with death outcome · 44% female
Used for
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 hydrochl.
What it is
DESCRIPTION Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,103 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Gastric ileus | 18 | 911.6 513.5–1,618.5ROR 912.9 · χ² 10,013 / p <1e-300 | 362.4 EB05 242.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Electrocardiogram t wave alternans | 12 | 646.9 332.3–1,259.4ROR 647.6 · χ² 5,123 / p <1e-300 | 267.8 EB05 163.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Encephalitis toxic | 17 | 451.0 264.0–770.3ROR 451.6 · χ² 5,661 / p <1e-300 | 254.0 EB05 168.0 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | not reported in cached trials |
| Presbyacusis | 49 | 317.4 234.0–430.6ROR 318.7 · χ² 12,724 / p <1e-300 | 241.8 EB05 190.1 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 100% (drug 44%) | not reported in cached trials |
| Failure to anastomose | 13 | 224.0 125.6–399.5ROR 224.2 · χ² 2,352 / p <1e-300 | 153.6 EB05 95.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Vaginal flatulence | 33 | 205.0 142.9–294.2ROR 205.6 · χ² 5,788 / p <1e-300 | 165.4 EB05 123.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 100% (drug 44%) · 100% clinician | not reported in cached trials |
| Nonalcoholic fatty liver disease | 19 | 179.4 111.8–287.9ROR 179.7 · χ² 2,885 / p <1e-300 | 139.7 EB05 94.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Decreased gait velocity | 15 | 168.2 99.0–286.0ROR 168.5 · χ² 2,116 / p <1e-300 | 128.4 EB05 82.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Neglect of personal appearance | 21 | 159.5 102.0–249.5ROR 159.8 · χ² 2,877 / p <1e-300 | 128.9 EB05 88.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Capillaritis | 23 | 158.8 103.6–243.5ROR 159.1 · χ² 3,152 / p <1e-300 | 129.7 EB05 91.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Vitamin b1 deficiency | 34 | 149.1 105.1–211.7ROR 149.6 · χ² 4,458 / p <1e-300 | 127.4 EB05 95.3 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications | serious n=33 · 100% clinician | not reported in cached trials |
| Pleural thickening | 51 | 137.0 103.1–182.2ROR 137.6 · χ² 6,240 / p <1e-300 | 121.1 EB05 95.7 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 100% (drug 44%) | not reported in cached trials |
| Starvation ketoacidosis | 11 | 104.5 56.8–192.0ROR 104.5 · χ² 966 / p 3e-212 | 84.4 EB05 50.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Blood magnesium increased | 51 | 101.3 76.4–134.4ROR 101.8 · χ² 4,684 / p <1e-300 | 92.4 EB05 73.0 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=51 · ♀ 100% (drug 44%) | not reported in cached trials |
| Gait spastic | 19 | 98.0 61.7–155.6ROR 98.2 · χ² 1,633 / p <1e-300 | 85.0 EB05 57.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Rheumatic fever | 233 | 95.5 83.8–108.8ROR 97.3 · χ² 20,518 / p <1e-300 | 89.7 EB05 80.5 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=233 · ♀ 100% (drug 44%) · 96% clinician | not reported in cached trials |
| Alcoholic liver disease | 18 | 94.3 58.7–151.6ROR 94.4 · χ² 1,486 / p <1e-300 | 81.8 EB05 54.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Total lung capacity abnormal | 20 | 93.9 59.9–147.3ROR 94.0 · χ² 1,653 / p <1e-300 | 82.2 EB05 56.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Pleural fibrosis | 51 | 88.2 66.6–116.9ROR 88.6 · χ² 4,096 / p <1e-300 | 81.4 EB05 64.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 100% (drug 44%) | not reported in cached trials |
| Onychomadesis | 196 | 83.9 72.8–96.7ROR 85.2 · χ² 15,209 / p <1e-300 | 79.3 EB05 70.4 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=195 · ♀ 100% (drug 44%) · 96% clinician | not reported in cached trials |
| Alcohol withdrawal syndrome | 39 | 78.8 57.2–108.6ROR 79.1 · χ² 2,788 / p <1e-300 | 72.7 EB05 55.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=38 | not reported in cached trials |
| Pulmonary vasculitis | 23 | 77.0 50.7–117.0ROR 77.2 · χ² 1,578 / p <1e-300 | 69.6 EB05 48.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Facet joint syndrome | 137 | 77.0 64.9–91.3ROR 77.8 · χ² 9,748 / p <1e-300 | 72.9 EB05 63.2 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=137 · ♀ 100% (drug 44%) · 95% clinician | not reported in cached trials |
| Sarcopenia | 18 | 76.0 47.4–121.8ROR 76.1 · χ² 1,203 / p 7e-264 | 67.7 EB05 45.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Needle fatigue | 19 | 73.3 46.3–116.1ROR 73.4 · χ² 1,230 / p 8e-270 | 65.9 EB05 44.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Onychomycosis | 178 | 71.8 61.8–83.3ROR 72.8 · χ² 11,845 / p <1e-300 | 68.4 EB05 60.3 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=178 · ♀ 100% (drug 44%) · 97% clinician | not reported in cached trials |
| Mite allergy | 25 | 69.1 46.3–103.0ROR 69.2 · χ² 1,546 / p <1e-300 | 63.3 EB05 45.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 44%) | not reported in cached trials |
| C-reactive protein abnormal | 249 | 68.5 60.4–77.7ROR 69.9 · χ² 15,850 / p <1e-300 | 65.5 EB05 59.0 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=249 · ♀ 100% (drug 44%) · 98% clinician | not reported in cached trials |
| Spirometry abnormal | 22 | 65.9 43.0–100.9ROR 66.0 · χ² 1,291 / p 5e-283 | 60.3 EB05 42.0 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=22 | not reported in cached trials |
| Peripheral venous disease | 140 | 61.5 52.0–72.8ROR 62.2 · χ² 7,985 / p <1e-300 | 58.9 EB05 51.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=140 · ♀ 100% (drug 44%) · 95% clinician | not reported in cached trials |
| Delirium tremens | 14 | 60.1 35.3–102.5ROR 60.2 · χ² 730 / p 5e-161 | 54.1 EB05 34.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Antineutrophil cytoplasmic antibody positive | 24 | 57.7 38.4–86.7ROR 57.8 · χ² 1,239 / p 1e-271 | 53.6 EB05 37.9 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=24 | not reported in cached trials |
| Cirrhosis alcoholic | 15 | 57.2 34.2–95.7ROR 57.3 · χ² 748 / p 6e-165 | 51.9 EB05 33.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Dislocation of vertebra | 72 | 56.7 44.8–71.6ROR 57.0 · χ² 3,754 / p <1e-300 | 54.1 EB05 44.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=72 · ♀ 100% (drug 44%) · 96% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 61 | 52.8 41.0–68.2ROR 53.1 · χ² 2,958 / p <1e-300 | 50.5 EB05 40.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 100% (drug 44%) · 100% clinician | not reported in cached trials |
| Mycotic allergy | 25 | 51.8 34.8–77.1ROR 51.9 · χ² 1,159 / p 3e-254 | 48.5 EB05 34.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 44%) | not reported in cached trials |
| Gastroschisis | 14 | 50.8 29.8–86.4ROR 50.8 · χ² 615 / p 4e-136 | 46.4 EB05 29.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Respiratory tract infection bacterial | 14 | 48.7 28.7–82.9ROR 48.8 · χ² 591 / p 9e-131 | 44.7 EB05 28.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Epidermal necrosis | 26 | 46.1 31.2–68.0ROR 46.2 · χ² 1,072 / p 2e-235 | 43.5 EB05 31.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 44%) · 100% clinician | not reported in cached trials |
| Dust allergy | 25 | 45.1 30.3–67.0ROR 45.2 · χ² 1,007 / p 3e-221 | 42.6 EB05 30.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 44%) | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Thiamine as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT03509350 — Vitamin C, Thiamine, and Steroids in Sepsis (N=501, PHASE3; 2 AE terms posted; arms: Treatment Protocol; Control Protocol)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 972 | 1.9 1.8–2.0ROR 2.0 · χ² 430 / p 8e-96 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.1 | not reported in cached trials |
| Nausea | 831 | 1.8 1.7–1.9ROR 1.8 · χ² 297 / p 6e-67 | 1.8 EB05 1.7 · IC025 +0.7 | Likely indication confounding term in indications; also in warnings | serious PRR 2.0 · ♀ 74% (drug 44%) | not reported in cached trials |
| Drug ineffective (drug did not work) | 817 | 1.1 1.0–1.1ROR 1.1 · χ² 2 / p 0.071 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.8 · ♀ 73% (drug 44%) | not reported in cached trials |
| Dyspnoea (shortness of breath) | 791 | 2.4 2.2–2.5ROR 2.5 · χ² 643 / p 4e-142 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | not reported in cached trials |
| Diarrhoea (diarrhea) | 728 | 1.9 1.8–2.1ROR 2.0 · χ² 329 / p 7e-74 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.9 · ♀ 66% (drug 44%) | not reported in cached trials |
| Pain | 711 | 2.0 1.8–2.1ROR 2.0 · χ² 343 / p 8e-77 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.9 · ♀ 67% (drug 44%) | not reported in cached trials |
| Fatigue (tiredness) | 683 | 1.5 1.4–1.6ROR 1.5 · χ² 114 / p 7e-27 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.6 · ♀ 68% (drug 44%) | not reported in cached trials |
| Confusional state (confusion) | 653 | 6.9 6.4–7.4ROR 7.2 · χ² 3,274 / p <1e-300 | 6.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | not reported in cached trials |
| Vomiting | 595 | 2.2 2.0–2.3ROR 2.2 · χ² 374 / p 1e-83 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 1.9 · ♀ 70% (drug 44%) | not reported in cached trials |
| Malaise (feeling unwell) | 572 | 2.2 2.0–2.4ROR 2.3 · χ² 384 / p 9e-86 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | not reported in cached trials |
| Dizziness | 567 | 1.9 1.8–2.1ROR 2.0 · χ² 259 / p 1e-58 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.0 | not reported in cached trials |
| Condition aggravated | 549 | 3.1 2.8–3.3ROR 3.2 · χ² 781 / p 3e-172 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | not reported in cached trials |
| Headache | 537 | 1.5 1.3–1.6ROR 1.5 · χ² 78 / p 5e-19 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.7 · ♀ 69% (drug 44%) | not reported in cached trials |
| Fall | 534 | 2.7 2.5–3.0ROR 2.8 · χ² 590 / p 1e-130 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 504 | 5.6 5.2–6.1ROR 5.8 · χ² 1,919 / p <1e-300 | 5.6 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 91% clinician | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Presbyacusis — n=49, PRR 317.4
- Vaginal flatulence — n=33, PRR 205.0
- Neglect of personal appearance — n=21, PRR 159.5
- Capillaritis — n=23, PRR 158.8
- Pleural thickening — n=51, PRR 137.0
- Rheumatic fever — n=233, PRR 95.5
- Total lung capacity abnormal — n=20, PRR 93.9
- Pleural fibrosis — n=51, PRR 88.2
- Onychomadesis — n=196, PRR 83.9
- Alcohol withdrawal syndrome — n=39, PRR 78.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Thiamine?
In FDA FAERS, the most frequently co-reported reaction terms for Thiamine are nausea, dyspnoea, diarrhoea, pain, fatigue, confusional state. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Thiamine have an FDA boxed warning?
No. The FDA label retrieved for Thiamine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Thiamine causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 2e957a35-83b3-47f5-ad09-216b22cc30be, effective 20251120; matched on
openfda.generic_name.exact:"THIAMINE HYDROCHLORIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,143 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
THIAMINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.