Thiamine combination (4 ingredients) side effects: what 30,106 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Thiamine Hydrochloride, Riboflavin 5 Phosphate Sodium, Dexpanthenol And Niacinamide (Vitamin B Complex)
Who reports
30,106 reports · 58% serious · 2,005 with death outcome · 67% female
Used for
In disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist.
What it is
DESCRIPTION Vitamin B-Complex 100 Injection is a sterile solution for intramuscular or slow intravenous injection comprised of vitamins which may be categorized as belonging to the vitamin B complex group.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,128 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 |
|---|---|---|---|---|---|---|
| Gait spastic | 34 | 75.5 53.0–107.5ROR 75.5 · calibrated p 2e-6 ✓ | 65.7 EB05 49.2 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 0% (drug 67%) | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 44 | 49.1 36.1–66.6ROR 49.1 · calibrated p 2e-5 ✓ | 45.0 EB05 34.9 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=44 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Needle fatigue | 30 | 48.8 33.7–70.6ROR 48.8 · calibrated p 3e-5 ✓ | 44.4 EB05 32.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 0% (drug 67%) · 100% clinician | not reported in cached trials |
| Seronegative arthritis | 50 | 32.4 24.4–43.0ROR 32.5 · calibrated p 2e-4 ✓ | 30.7 EB05 24.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=50 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Lupus vulgaris | 53 | 32.4 24.6–42.7ROR 32.5 · calibrated p 2e-4 ✓ | 30.7 EB05 24.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=53 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Relapsing-remitting multiple sclerosis | 35 | 29.4 21.0–41.2ROR 29.4 · calibrated p 4e-4 ✓ | 27.8 EB05 20.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=33 · ♀ 0% (drug 67%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 31 | 24.6 17.2–35.2ROR 24.6 · calibrated p 0.001 ✓ | 23.5 EB05 17.3 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=31 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Dislocation of vertebra | 75 | 24.3 19.3–30.5ROR 24.3 · calibrated p 9e-4 ✓ | 23.3 EB05 19.2 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=75 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 67 | 23.9 18.7–30.5ROR 23.9 · calibrated p 1e-3 ✓ | 23.0 EB05 18.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=67 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 58 | 21.2 16.3–27.5ROR 21.2 · calibrated p 0.002 ✓ | 20.5 EB05 16.4 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=58 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Retinitis | 45 | 19.3 14.3–25.9ROR 19.3 · calibrated p 0.003 ✓ | 18.6 EB05 14.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=45 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| X-ray abnormal | 46 | 18.4 13.7–24.6ROR 18.4 · calibrated p 0.003 ✓ | 17.8 EB05 13.8 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=46 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Light chain analysis increased | 26 | 18.1 12.2–26.7ROR 18.1 · calibrated p 0.004 ✓ | 17.3 EB05 12.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 | not reported in cached trials |
| Facet joint syndrome | 76 | 17.2 13.7–21.6ROR 17.2 · calibrated p 0.004 ✓ | 16.7 EB05 13.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=76 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Peripheral venous disease | 86 | 15.3 12.4–18.9ROR 15.3 · calibrated p 0.007 ✓ | 14.9 EB05 12.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=86 · ♀ 100% (drug 67%) | not reported in cached trials |
| Infusion site discharge | 36 | 14.9 10.7–20.8ROR 15.0 · calibrated p 0.009 ✓ | 14.4 EB05 10.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 100% (drug 67%) · 100% consumer | not reported in cached trials |
| Swollen joint count increased | 63 | 14.3 11.2–18.4ROR 14.4 · calibrated p 0.009 ✓ | 13.9 EB05 11.2 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=63 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Monoparesis | 36 | 14.0 10.1–19.5ROR 14.0 · calibrated p 0.011 ✓ | 13.5 EB05 10.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=36 · ♀ 0% (drug 67%) · 100% clinician | not reported in cached trials |
| Hypertonic bladder | 53 | 13.0 9.9–17.1ROR 13.1 · calibrated p 0.014 ✓ | 12.6 EB05 9.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=46 · ♀ 39% (drug 67%) | not reported in cached trials |
| Rheumatoid factor positive | 103 | 12.6 10.4–15.3ROR 12.7 · calibrated p 0.014 ✓ | 12.3 EB05 10.4 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=103 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Bone erosion | 63 | 12.6 9.8–16.1ROR 12.6 · calibrated p 0.015 ✓ | 12.2 EB05 9.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=63 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Cataplexy | 25 | 12.4 8.3–18.4ROR 12.4 · calibrated p 0.019 ✓ | 11.5 EB05 7.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 · ♀ 100% (drug 67%) | not reported in cached trials |
| Blood pressure systolic abnormal | 42 | 11.9 8.8–16.2ROR 11.9 · calibrated p 0.020 ✓ | 11.4 EB05 8.6 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=40 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Pre-existing condition improved | 105 | 11.8 9.7–14.3ROR 11.8 · calibrated p 0.019 ✓ | 11.4 EB05 9.7 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=59 | not reported in cached trials |
| Spondylitis | 58 | 11.3 8.7–14.6ROR 11.3 · calibrated p 0.023 ✓ | 10.8 EB05 8.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=55 · ♀ 100% (drug 67%) | not reported in cached trials |
| Eyelid pain | 28 | 10.2 7.0–14.8ROR 10.2 · calibrated p 0.036 ✓ | 9.3 EB05 6.6 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | 100% consumer | not reported in cached trials |
| Rheumatic fever | 63 | 10.2 7.9–13.0ROR 10.2 · calibrated p 0.033 ✓ | 9.7 EB05 7.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=63 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| C-reactive protein abnormal | 88 | 9.7 7.8–11.9ROR 9.7 · calibrated p 0.038 ✓ | 9.3 EB05 7.8 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=88 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Infusion site haemorrhage | 42 | 9.1 6.7–12.4ROR 9.1 · calibrated p 0.048 ✓ | 8.5 EB05 6.5 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=31 · 71% consumer | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 91 | 9.0 7.3–11.1ROR 9.0 · calibrated p 0.047 ✓ | 8.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 8.8 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Gastrointestinal ulcer | 28 | 8.9 6.1–12.9ROR 8.9 · calibrated p 0.056 | 8.0 EB05 5.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · 100% clinician | not reported in cached trials |
| Essential hypertension | 32 | 8.7 6.1–12.3ROR 8.7 · calibrated p 0.058 | 7.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 | not reported in cached trials |
| Vitamin b12 decreased | 35 | 8.6 6.1–11.9ROR 8.6 · calibrated p 0.060 | 7.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious n=26 | not reported in cached trials |
| Seasonal allergy | 166 | 8.3 7.1–9.6ROR 8.3 · calibrated p 0.061 | 8.1 EB05 7.1 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=91 | not reported in cached trials |
| Spinal fusion surgery | 47 | 8.2 6.2–11.0ROR 8.2 · calibrated p 0.066 | 7.7 EB05 6.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=47 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Blood pressure diastolic abnormal | 30 | 8.2 5.7–11.8ROR 8.2 · calibrated p 0.070 | 7.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious n=28 · 100% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 84 | 8.0 6.5–10.0ROR 8.1 · calibrated p 0.068 | 7.7 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.9 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Lip dry | 102 | 8.0 6.6–9.7ROR 8.0 · calibrated p 0.068 | 7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=90 · ♀ 100% (drug 67%) | not reported in cached trials |
| Skin abrasion | 52 | 7.8 5.9–10.3ROR 7.8 · calibrated p 0.076 | 7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 | not reported in cached trials |
| Muscle injury | 89 | 7.6 6.2–9.4ROR 7.6 · calibrated p 0.080 | 7.3 EB05 6.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 · ♀ 100% (drug 67%) · 100% clinician | 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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 3,386 | 3.0 2.9–3.1ROR 3.3 · calibrated p 0.536 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | not reported in cached trials |
| Nausea | 2,257 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.984 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | not reported in cached trials |
| Diarrhoea (diarrhea) | 2,225 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.802 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Headache | 2,129 | 2.4 2.3–2.5ROR 2.5 · calibrated p 0.824 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | not reported in cached trials |
| Pain | 1,792 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.995 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | not reported in cached trials |
| Dizziness | 1,678 | 2.4 2.2–2.5ROR 2.4 · calibrated p 0.843 | 2.3 EB05 2.3 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,677 | 0.9 0.8–0.9ROR 0.9 · calibrated p 0.231 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.3 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,534 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.910 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | not reported in cached trials |
| Arthralgia (joint pain) | 1,468 | 2.5 2.4–2.6ROR 2.5 · calibrated p 0.794 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | not reported in cached trials |
| Asthenia (weakness) | 1,392 | 2.6 2.5–2.7ROR 2.7 · calibrated p 0.748 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | not reported in cached trials |
| Off label use (used outside approved label) | 1,313 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.343 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Fall | 1,290 | 2.7 2.6–2.9ROR 2.8 · calibrated p 0.701 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | not reported in cached trials |
| Weight decreased (weight loss) | 1,105 | 2.8 2.6–2.9ROR 2.8 · calibrated p 0.684 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | not reported in cached trials |
| Pain in extremity | 1,082 | 2.6 2.4–2.7ROR 2.6 · calibrated p 0.766 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | not reported in cached trials |
| Insomnia (trouble sleeping) | 1,080 | 2.8 2.7–3.0ROR 2.9 · calibrated p 0.662 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | not reported in cached trials |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Oxycodone Hydrochloride ↔ Drug Dependence.
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 fatigue, nausea, diarrhoea, headache, pain, dizziness. 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 282ccec8-9bcd-4571-9b91-bbb96ef2620d, effective 20210915; matched on
openfda.generic_name.exact:"THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE") - 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, 1,168 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 2026-10-14. 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.