Sodium Bicarbonate, Injection side effects: what 23,109 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Sodium Bicarbonate, Injection (Sodium Bicarbonate)
Who reports
23,109 reports · 86% serious · 4,266 with death outcome · 47% female
Used for
Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis.
What it is
DESCRIPTION Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO 3 ) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer. Solution is offered in concentration of 8.4%.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- 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, 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). 898 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 |
|---|---|---|---|---|---|---|
| End stage renal disease | 522 | 26.4 24.3–28.8ROR 27.0 · calibrated p 5e-4 ✓ | 25.7 EB05 23.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 17.3 | NCT01467466: 1/1,291 (0.1%) on Sodium Bicarbonate, Injection; 1/1,300 (0.1%) control (serious AE) |
| Macular degeneration | 273 | 21.2 18.9–23.9ROR 21.5 · calibrated p 0.001 ✓ | 20.8 EB05 18.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 · ♀ 100% (drug 47%) | not reported in cached trials |
| Metabolic acidosis | 535 | 15.6 14.3–17.0ROR 15.9 · calibrated p 0.005 ✓ | 15.3 EB05 14.3 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.3 · 92% clinician | NCT01467466: 2/1,291 (0.2%) on Sodium Bicarbonate, Injection; 1/1,300 (0.1%) control (serious AE) |
| Ventricular fibrillation | 178 | 14.7 12.7–17.1ROR 14.8 · calibrated p 0.008 ✓ | 14.5 EB05 12.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · 92% clinician | NCT01467466: 3/1,291 (0.2%) on Sodium Bicarbonate, Injection (serious AE) |
| Blood potassium increased | 235 | 13.3 11.7–15.1ROR 13.4 · calibrated p 0.011 ✓ | 13.1 EB05 11.7 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 | NCT01467466: 1/1,300 (0.1%) control (serious AE) |
| Nephropathy | 132 | 12.9 10.9–15.3ROR 13.0 · calibrated p 0.013 ✓ | 12.7 EB05 10.9 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.1 · ♀ 71% (drug 47%) | NCT01467466: 3/1,291 (0.2%) on Sodium Bicarbonate, Injection; 3/1,300 (0.2%) control (serious AE) |
| Blood test abnormal | 194 | 12.7 11.0–14.6ROR 12.8 · calibrated p 0.014 ✓ | 12.5 EB05 11.1 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 12.6 · ♀ 76% (drug 47%) | not reported in cached trials |
| Oral candidiasis (oral thrush) | 174 | 12.3 10.6–14.3ROR 12.4 · calibrated p 0.015 ✓ | 12.1 EB05 10.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 87% (drug 47%) | NCT01467466: 1/1,294 (0.1%) control (serious AE) |
| Vaginal discharge | 131 | 12.0 10.1–14.2ROR 12.0 · calibrated p 0.017 ✓ | 11.7 EB05 10.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=131 · ♀ 100% (drug 47%) | not reported in cached trials |
| Blood urea increased | 213 | 11.6 10.1–13.3ROR 11.7 · calibrated p 0.019 ✓ | 11.4 EB05 10.2 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 8.3 | not reported in cached trials |
| Lymphocyte count decreased | 223 | 11.6 10.1–13.2ROR 11.7 · calibrated p 0.019 ✓ | 11.4 EB05 10.2 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 · 96% clinician | not reported in cached trials |
| Paraesthesia oral | 180 | 11.5 9.9–13.3ROR 11.6 · calibrated p 0.020 ✓ | 11.3 EB05 9.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · ♀ 100% (drug 47%) | not reported in cached trials |
| Cardiogenic shock | 176 | 11.3 9.8–13.1ROR 11.4 · calibrated p 0.021 ✓ | 11.1 EB05 9.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | NCT01467466: 6/1,291 (0.5%) on Sodium Bicarbonate, Injection; 4/1,300 (0.3%) control (serious AE) |
| Hyperkalaemia (high potassium) | 410 | 10.8 9.8–11.9ROR 10.9 · calibrated p 0.024 ✓ | 10.6 EB05 9.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | NCT01467466: 6/1,291 (0.5%) on Sodium Bicarbonate, Injection; 1/1,300 (0.1%) control (serious AE) |
| Renal tubular necrosis | 112 | 10.4 8.7–12.6ROR 10.5 · calibrated p 0.029 ✓ | 10.2 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | NCT01467466: 4/1,300 (0.3%) control (serious AE) |
| Chronic kidney disease | 868 | 10.4 9.7–11.1ROR 10.7 · calibrated p 0.025 ✓ | 10.3 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | NCT01467466: 3/1,291 (0.2%) on Sodium Bicarbonate, Injection; 4/1,300 (0.3%) control (serious AE) |
| Multi-organ failure | 197 | 10.3 8.9–11.8ROR 10.4 · calibrated p 0.029 ✓ | 10.1 EB05 8.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 1,696 | 10.2 9.7–10.7ROR 10.9 · calibrated p 0.024 ✓ | 10.1 EB05 9.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 90% clinician | NCT01467466: 58/1,291 (4.5%) on Sodium Bicarbonate, Injection; 41/1,300 (3.2%) control (serious AE) |
| Renal injury | 324 | 9.9 8.9–11.0ROR 10.0 · calibrated p 0.033 ✓ | 9.7 EB05 8.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | not reported in cached trials |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 162 | 9.8 8.4–11.5ROR 9.9 · calibrated p 0.034 ✓ | 9.6 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 90% clinician | not reported in cached trials |
| Carpal tunnel syndrome | 145 | 9.5 8.0–11.1ROR 9.5 · calibrated p 0.039 ✓ | 9.2 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 100% (drug 47%) | not reported in cached trials |
| Renal failure (kidney failure) | 1,374 | 9.4 8.9–9.9ROR 9.9 · calibrated p 0.033 ✓ | 9.3 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.3 | NCT01467466: 1/1,291 (0.1%) on Sodium Bicarbonate, Injection (serious AE) |
| Neutrophil count increased | 105 | 9.4 7.7–11.3ROR 9.4 · calibrated p 0.042 ✓ | 9.1 EB05 7.7 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 6.7 · 100% clinician | not reported in cached trials |
| Dialysis | 143 | 9.2 7.8–10.8ROR 9.3 · calibrated p 0.043 ✓ | 9.0 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | NCT01467466: 1/1,292 (0.1%) on Sodium Bicarbonate, Injection; 1/1,300 (0.1%) control (serious AE) |
| Blood creatinine increased | 652 | 9.1 8.5–9.8ROR 9.4 · calibrated p 0.041 ✓ | 9.0 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 | NCT01467466: 1/1,291 (0.1%) on Sodium Bicarbonate, Injection; 2/1,300 (0.2%) control (serious AE) |
| Anhedonia | 262 | 9.1 8.0–10.2ROR 9.1 · calibrated p 0.044 ✓ | 8.9 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | not reported in cached trials |
| Full blood count abnormal | 97 | 8.4 6.9–10.3ROR 8.4 · calibrated p 0.059 | 8.1 EB05 6.8 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 7.1 · ♀ 82% (drug 47%) | not reported in cached trials |
| Appendicitis | 85 | 8.4 6.8–10.3ROR 8.4 · calibrated p 0.060 | 8.0 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 14% (drug 47%) · 94% clinician | NCT01467466: 1/1,291 (0.1%) on Sodium Bicarbonate, Injection (serious AE) |
| Hypocalcaemia (low calcium) | 172 | 8.3 7.2–9.7ROR 8.4 · calibrated p 0.059 | 8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 93% clinician | not reported in cached trials |
| Tubulointerstitial nephritis | 167 | 8.2 7.0–9.5ROR 8.2 · calibrated p 0.063 | 8.0 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | not reported in cached trials |
| Sleep disorder due to a general medical condition | 143 | 8.1 6.9–9.5ROR 8.1 · calibrated p 0.065 | 7.9 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · ♀ 100% (drug 47%) | not reported in cached trials |
| Hypokalaemia (low potassium) | 405 | 8.1 7.3–8.9ROR 8.2 · calibrated p 0.062 | 8.0 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 92% clinician | NCT01467466: 3/1,294 (0.2%) on Sodium Bicarbonate, Injection; 1/1,300 (0.1%) control (serious AE) |
| Hyperlipidaemia | 104 | 7.9 6.5–9.6ROR 8.0 · calibrated p 0.070 | 7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | not reported in cached trials |
| Renal impairment | 711 | 7.8 7.2–8.4ROR 8.0 · calibrated p 0.067 | 7.7 EB05 7.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | NCT01467466: 1/1,291 (0.1%) on Sodium Bicarbonate, Injection; 1/1,294 (0.1%) control (serious AE) |
| Fear | 230 | 7.8 6.8–8.8ROR 7.8 · calibrated p 0.072 | 7.6 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | not reported in cached trials |
| Glomerular filtration rate decreased | 101 | 7.6 6.3–9.3ROR 7.6 · calibrated p 0.079 | 7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 | not reported in cached trials |
| Renal disorder | 386 | 7.6 6.8–8.3ROR 7.7 · calibrated p 0.076 | 7.4 EB05 6.8 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.8 | NCT01467466: 1/1,300 (0.1%) control (serious AE) |
| Sleep apnoea syndrome | 155 | 7.4 6.3–8.7ROR 7.4 · calibrated p 0.084 | 7.2 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 94% (drug 47%) | NCT01467466: 1/1,292 (0.1%) on Sodium Bicarbonate, Injection; 1/1,300 (0.1%) control (serious AE) |
| Blood calcium decreased | 91 | 7.4 6.0–9.1ROR 7.4 · calibrated p 0.087 | 7.1 EB05 5.9 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 | not reported in cached trials |
| Ventricular tachycardia | 133 | 7.3 6.2–8.7ROR 7.4 · calibrated p 0.087 | 7.1 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | NCT01467466: 2/1,291 (0.2%) on Sodium Bicarbonate, Injection; 5/1,300 (0.4%) control (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Sodium Bicarbonate, Injection 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 (20 of 40 signal terms matched).
- NCT01467466 — Prevention of Serious Adverse Events Following Angiography (N=5177, PHASE3; 747 AE terms posted; arms: IV isotonic saline & oral placebo; IV isotonic saline & oral N-acetylcystei; IV isotonic bicarbonate & oral placebo; IV isotonic bicarbonate & oral N-acetylc)
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 |
|---|---|---|---|---|---|---|
| Acute kidney injury (sudden kidney damage) | 1,696 | 10.2 9.7–10.7ROR 10.9 · calibrated p 0.024 ✓ | 10.1 EB05 9.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 90% clinician | NCT01467466: 58/1,291 (4.5%) on Sodium Bicarbonate, Injection; 41/1,300 (3.2%) control (serious AE) |
| Off label use (used outside approved label) | 1,658 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.825 | 1.7 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.9 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,623 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.391 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.9 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,445 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.998 | 2.0 EB05 2.0 · IC025 +0.9 | Likely indication confounding term in indications | serious PRR 1.9 | NCT01467466: 2/1,291 (0.2%) on Sodium Bicarbonate, Injection; 1/1,300 (0.1%) control (serious AE) |
| Renal failure (kidney failure) | 1,374 | 9.4 8.9–9.9ROR 9.9 · calibrated p 0.033 ✓ | 9.3 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.3 | NCT01467466: 1/1,291 (0.1%) on Sodium Bicarbonate, Injection (serious AE) |
| Nausea | 1,182 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.561 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.4 | NCT01467466: 1/1,300 (0.1%) control (serious AE) |
| Anaemia (low red blood cells) | 1,111 | 5.3 5.0–5.6ROR 5.5 · calibrated p 0.185 | 5.3 EB05 5.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | NCT01467466: 15/1,291 (1.2%) on Sodium Bicarbonate, Injection; 14/1,300 (1.1%) control (serious AE) |
| Death | 1,061 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.388 | 1.1 EB05 1.1 · IC025 +0.1 | Outcome field, not a reaction | serious PRR 0.7 | NCT01467466: 1/1,291 (0.1%) on Sodium Bicarbonate, Injection; 2/1,300 (0.2%) control (serious AE) |
| Dyspnoea (shortness of breath) | 1,030 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.759 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.4 | NCT01467466: 3/1,291 (0.2%) on Sodium Bicarbonate, Injection; 4/1,294 (0.3%) control (serious AE) |
| Pain | 978 | 1.4 1.4–1.5ROR 1.5 · calibrated p 0.617 | 1.4 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.4 | NCT01467466: 1/1,291 (0.1%) on Sodium Bicarbonate, Injection (serious AE) |
| Pyrexia (fever) | 968 | 2.5 2.4–2.7ROR 2.6 · calibrated p 0.769 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | NCT01467466: 1/1,291 (0.1%) on Sodium Bicarbonate, Injection; 2/1,294 (0.2%) control (serious AE) |
| Pneumonia (lung infection) | 965 | 2.7 2.6–2.9ROR 2.8 · calibrated p 0.700 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | NCT01467466: 1/1,300 (0.1%) control (serious AE) |
| Fatigue (tiredness) | 944 | 1.1 1.0–1.2ROR 1.1 · calibrated p 0.377 | 1.1 EB05 1.0 · IC025 +0.0 | Not in label — unassessed | serious PRR 1.0 | not reported in cached trials |
| Vomiting | 937 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.859 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT01467466: 3/1,291 (0.2%) on Sodium Bicarbonate, Injection; 2/1,294 (0.2%) control (serious AE) |
| Chronic kidney disease | 868 | 10.4 9.7–11.1ROR 10.7 · calibrated p 0.025 ✓ | 10.3 EB05 9.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | NCT01467466: 3/1,291 (0.2%) on Sodium Bicarbonate, Injection; 4/1,300 (0.3%) control (serious AE) |
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.
- End stage renal disease — n=522, PRR 26.4 (also seen in trial arm)
- Macular degeneration — n=273, PRR 21.2
- Ventricular fibrillation — n=178, PRR 14.7 (also seen in trial arm)
- Oral candidiasis — n=174, PRR 12.3 (also seen in trial arm)
- Vaginal discharge — n=131, PRR 12.0
- Paraesthesia oral — n=180, PRR 11.5
- Cardiogenic shock — n=176, PRR 11.3 (also seen in trial arm)
- Hyperkalaemia — n=410, PRR 10.8 (also seen in trial arm)
- Renal tubular necrosis — n=112, PRR 10.4 (also seen in trial arm)
- Chronic kidney disease — n=868, PRR 10.4 (also seen in trial arm)
✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.
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 Sodium Bicarbonate, Injection?
In FDA FAERS, the most frequently co-reported reaction terms for Sodium Bicarbonate, Injection are acute kidney injury, diarrhoea, renal failure, nausea, anaemia, dyspnoea. 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 Sodium Bicarbonate, Injection have an FDA boxed warning?
No. The FDA label retrieved for Sodium Bicarbonate, Injection has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sodium Bicarbonate, Injection 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 3737e5e5-2296-4a3d-b8f1-dfea1eff1927, effective 20260615; matched on
openfda.generic_name.exact:"SODIUM BICARBONATE, INJECTION") - 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, 938 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
BICARBONATE, 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.