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Sodium Bicarbonate side effects: what 23,109 FDA adverse event reports show

Sodium Bicarbonate · 1,246 reaction terms · 107,232 drug–reaction co-reports · data 2026-09-14
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Drug class

Not stated in label

Label matched

Sodium Bicarbonate (Sodium Bicarbonate)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

23,109 reports · 86% serious · 4,266 with death outcome · 47% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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. Solutions are offered in concentrations of 4.2% and 8.4%.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 1Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 5Not in label — unassessed 28
What the badges mean

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). 1,206 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Vascular anastomotic haemorrhage2410,729.1
2,535.8–45,395.9ROR 10,740.2 · calibrated p 2e-16 ✓
497.1 EB05 351.6 · IC025 +4.9
3/3 methods agree
Not in label — unassessedserious n=24 · ♀ 0% (drug 47%)not reported in cached trials
Foetal biophysical profile score abnormal191,415.6
687.3–2,915.9ROR 1,416.8 · calibrated p 1e-15 ✓
353.2 EB05 239.0 · IC025 +4.4
3/3 methods agree
Lab value / disease markerserious n=19not reported in cached trials
Central nervous system mass44819.6
544.5–1,233.6ROR 821.1 · calibrated p 3e-15 ✓
360.8 EB05 279.9 · IC025 +5.7
3/3 methods agree
Not in label — unassessedserious n=44 · ♀ 0% (drug 47%)not reported in cached trials
Vaginal flatulence131684.9
545.7–859.7ROR 688.8 · calibrated p 4e-15 ✓
367.4 EB05 317.5 · IC025 +7.0
3/3 methods agree
Not in label — unassessedserious n=131 · ♀ 100% (drug 47%)not reported in cached trials
Wall motion score index abnormal45628.7
429.4–920.3ROR 629.9 · calibrated p 4e-14 ✓
319.3 EB05 248.4 · IC025 +5.7
3/3 methods agree
Lab value / disease markerserious n=45 · ♀ 0% (drug 47%)not reported in cached trials
Airway remodelling44498.0
344.5–719.8ROR 498.9 · calibrated p 3e-13 ✓
281.1 EB05 218.0 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious n=44 · ♀ 0% (drug 47%)not reported in cached trials
Vena cava injury26374.9
237.2–592.6ROR 375.4 · calibrated p 1e-11 ✓
221.5 EB05 158.9 · IC025 +4.8
3/3 methods agree
Not in label — unassessedserious n=26 · ♀ 0% (drug 47%)not reported in cached trials
Antacid therapy34357.6
240.3–532.2ROR 358.2 · calibrated p 1e-11 ✓
223.7 EB05 167.4 · IC025 +5.2
3/3 methods agree
Reporting / coding artifactserious n=34 · ♀ 0% (drug 47%) · 100% cliniciannot reported in cached trials
Perineal cyst19339.8
200.4–576.1ROR 340.0 · calibrated p 6e-11 ✓
197.7 EB05 133.8 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious n=19not reported in cached trials
Sleep disorder therapy49324.5
234.1–449.9ROR 325.2 · calibrated p 1e-11 ✓
218.2 EB05 171.5 · IC025 +5.7
3/3 methods agree
Reporting / coding artifactserious n=49 · ♀ 0% (drug 47%) · 100% clinicianNCT01467466: 1/1,292 (0.1%) on Bicarbonate; 1/1,300 (0.1%) control (serious AE)
Appendicolith71208.8
161.3–270.3ROR 209.5 · calibrated p 5e-10 ✓
162.1 EB05 132.9 · IC025 +5.9
3/3 methods agree
Not in label — unassessedserious n=71 · ♀ 0% (drug 47%) · 94% cliniciannot reported in cached trials
Sensitisation134192.6
159.9–232.0ROR 193.7 · calibrated p 7e-10 ✓
155.2 EB05 134.4 · IC025 +6.4
3/3 methods agree
Not in label — unassessedserious n=134 · ♀ 100% (drug 47%)not reported in cached trials
Renal cyst haemorrhage38189.8
133.8–269.3ROR 190.1 · calibrated p 2e-9 ✓
145.4 EB05 110.6 · IC025 +5.2
3/3 methods agree
Not in label — unassessedserious n=38 · ♀ 0% (drug 47%)not reported in cached trials
Ejection fraction101189.7
153.1–235.1ROR 190.5 · calibrated p 9e-10 ✓
152.2 EB05 128.9 · IC025 +6.1
3/3 methods agree
Not in label — unassessedserious n=101 · ♀ 100% (drug 47%)NCT01467466: 1/1,291 (0.1%) on Bicarbonate (serious AE)
Atopy44170.3
123.4–235.0ROR 170.6 · calibrated p 4e-9 ✓
134.9 EB05 104.7 · IC025 +5.3
3/3 methods agree
Not in label — unassessedserious n=44 · ♀ 0% (drug 47%)not reported in cached trials
Analgesic therapy46160.0
117.0–219.0ROR 160.3 · calibrated p 6e-9 ✓
128.7 EB05 100.4 · IC025 +5.3
3/3 methods agree
Reporting / coding artifactserious n=46 · ♀ 0% (drug 47%) · 100% cliniciannot reported in cached trials
Drug therapy40129.6
93.0–180.5ROR 129.8 · calibrated p 3e-8 ✓
107.6 EB05 82.4 · IC025 +5.0
3/3 methods agree
Reporting / coding artifactserious n=40 · ♀ 0% (drug 47%) · 100% clinicianNCT01467466: 1/1,294 (0.1%) on Bicarbonate; 3/1,300 (0.2%) control (serious AE)
Anticoagulant therapy33122.4
85.1–176.1ROR 122.6 · calibrated p 6e-8 ✓
101.6 EB05 75.7 · IC025 +4.8
3/3 methods agree
Reporting / coding artifactserious n=33 · ♀ 0% (drug 47%) · 100% cliniciannot reported in cached trials
Iron binding capacity total decreased26121.7
80.8–183.3ROR 121.8 · calibrated p 8e-8 ✓
99.6 EB05 71.4 · IC025 +4.5
3/3 methods agree
Lab value / disease markerserious n=26not reported in cached trials
Abdominal wall haemorrhage2388.6
57.8–136.0ROR 88.7 · calibrated p 8e-7 ✓
75.8 EB05 53.2 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=23 · ♀ 0% (drug 47%)not reported in cached trials
Congenital hiatus hernia1984.9
53.1–135.9ROR 85.0 · calibrated p 1e-6 ✓
72.2 EB05 48.9 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=19not reported in cached trials
Polycystic ovaries13283.2
69.6–99.4ROR 83.6 · calibrated p 5e-7 ✓
75.4 EB05 65.2 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious n=132 · ♀ 100% (drug 47%)not reported in cached trials
Female genital tract fistula14180.9
68.1–96.1ROR 81.4 · calibrated p 6e-7 ✓
73.6 EB05 63.9 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious n=141 · ♀ 100% (drug 47%)not reported in cached trials
Nonreassuring foetal heart rate pattern1879.3
49.0–128.4ROR 79.3 · calibrated p 2e-6 ✓
67.9 EB05 45.4 · IC025 +3.8
3/3 methods agree
Not in label — unassessedserious n=18not reported in cached trials
Delayed graft function5678.0
59.4–102.4ROR 78.2 · calibrated p 1e-6 ✓
70.2 EB05 56.1 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=56 · ♀ 0% (drug 47%)not reported in cached trials
Intraductal papillary mucinous neoplasm2377.6
50.7–118.8ROR 77.7 · calibrated p 2e-6 ✓
67.6 EB05 47.5 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious n=23 · ♀ 0% (drug 47%)not reported in cached trials
Sars-cov-2 antibody test positive2176.0
48.7–118.7ROR 76.1 · calibrated p 3e-6 ✓
66.1 EB05 45.6 · IC025 +4.0
3/3 methods agree
Lab value / disease markerserious n=21not reported in cached trials
Hyperparathyroidism secondary19274.4
64.3–86.2ROR 75.0 · calibrated p 1e-6 ✓
68.3 EB05 60.6 · IC025 +5.6
3/3 methods agree
Not in label — unassessedserious n=190not reported in cached trials
Carbuncle2172.8
46.7–113.5ROR 72.8 · calibrated p 3e-6 ✓
63.7 EB05 43.9 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious n=21 · ♀ 100% (drug 47%) · 100% cliniciannot reported in cached trials
Bacteroides infection1971.7
44.9–114.4ROR 71.7 · calibrated p 4e-6 ✓
62.5 EB05 42.3 · IC025 +3.9
3/3 methods agree
Not in label — unassessedserious n=19not reported in cached trials
Vascular compression2269.0
44.7–106.5ROR 69.1 · calibrated p 4e-6 ✓
60.9 EB05 42.4 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious n=22 · ♀ 0% (drug 47%)not reported in cached trials
Eosinophilic myocarditis4458.1
42.8–78.8ROR 58.2 · calibrated p 8e-6 ✓
53.4 EB05 41.4 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious n=44 · ♀ 0% (drug 47%)not reported in cached trials
Ejection fraction abnormal7458.1
45.9–73.5ROR 58.3 · calibrated p 7e-6 ✓
53.9 EB05 44.3 · IC025 +4.9
3/3 methods agree
Lab value / disease markerserious n=74 · ♀ 100% (drug 47%)NCT01467466: 1/1,291 (0.1%) on Bicarbonate (serious AE)
Nephrogenic anaemia27356.2
49.8–63.5ROR 56.9 · calibrated p 6e-6 ✓
52.8 EB05 47.7 · IC025 +5.4
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=273not reported in cached trials
Cardiac septal defect4255.8
40.9–76.2ROR 55.9 · calibrated p 1e-5 ✓
51.4 EB05 39.6 · IC025 +4.5
3/3 methods agree
Not in label — unassessedserious n=42 · ♀ 0% (drug 47%)not reported in cached trials
Chronic kidney disease-mineral and bone disorder6154.5
42.1–70.5ROR 54.6 · calibrated p 1e-5 ✓
50.6 EB05 40.8 · IC025 +4.8
3/3 methods agree
Not in label — unassessedserious n=61not reported in cached trials
Radiculopathy14452.4
44.3–61.9ROR 52.7 · calibrated p 1e-5 ✓
49.2 EB05 42.8 · IC025 +5.1
3/3 methods agree
Not in label — unassessedserious n=144 · ♀ 100% (drug 47%)not reported in cached trials
Chronic sinusitis20151.4
44.6–59.2ROR 51.8 · calibrated p 1e-5 ✓
48.4 EB05 43.1 · IC025 +5.2
3/3 methods agree
Not in label — unassessedserious n=201 · ♀ 79% (drug 47%)not reported in cached trials
Hyperphosphataemia11049.6
41.0–60.1ROR 49.9 · calibrated p 2e-5 ✓
46.7 EB05 39.8 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=107 · ♀ 24% (drug 47%)not reported in cached trials
Metabolic alkalosis7746.0
36.6–57.8ROR 46.1 · calibrated p 3e-5 ✓
43.4 EB05 35.8 · IC025 +4.7
3/3 methods agree
Labeled adverse reaction
exact term
serious n=77 · ♀ 76% (drug 47%) · 100% cliniciannot reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Bicarbonate 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 (4 of 40 signal terms matched).

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.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Acute kidney injury (sudden kidney damage)1,69610.2
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 — unassessedserious PRR 6.8 · 90% clinicianNCT01467466: 58/1,291 (4.5%) on Bicarbonate; 41/1,300 (3.2%) control (serious AE)
Off label use (used outside approved label)1,6581.7
1.7–1.8ROR 1.8 · calibrated p 0.825
1.7 EB05 1.7 · IC025 +0.7Reporting / coding artifactserious PRR 1.9not reported in cached trials
Drug ineffective (drug did not work)1,6231.1
1.1–1.2ROR 1.1 · calibrated p 0.391
1.1 EB05 1.1 · IC025 +0.1Reporting / coding artifactserious PRR 1.9not reported in cached trials
Diarrhoea (diarrhea)1,4442.0
1.9–2.1ROR 2.1 · calibrated p 0.998
2.0 EB05 1.9 · IC025 +0.9Likely indication confounding
term in indications
serious PRR 1.9NCT01467466: 2/1,291 (0.2%) on Bicarbonate; 1/1,300 (0.1%) control (serious AE)
Nausea1,1821.4
1.3–1.4ROR 1.4 · calibrated p 0.561
1.4 EB05 1.3 · IC025 +0.3Not in label — unassessedserious PRR 1.4NCT01467466: 1/1,300 (0.1%) control (serious AE)
Anaemia (low red blood cells)1,1105.3
5.0–5.6ROR 5.5 · calibrated p 0.186
5.3 EB05 5.0 · IC025 +2.3
3/3 methods agree
Not in label — unassessedserious PRR 3.8NCT01467466: 15/1,291 (1.2%) on Bicarbonate; 14/1,300 (1.1%) control (serious AE)
Death1,0631.1
1.1–1.2ROR 1.1 · calibrated p 0.390
1.1 EB05 1.1 · IC025 +0.1Outcome field, not a reactionserious PRR 0.8NCT01467466: 1/1,291 (0.1%) on Bicarbonate; 2/1,300 (0.2%) control (serious AE)
Dyspnoea (shortness of breath)1,0291.7
1.6–1.8ROR 1.7 · calibrated p 0.758
1.6 EB05 1.6 · IC025 +0.6Not in label — unassessedserious PRR 1.4NCT01467466: 3/1,291 (0.2%) on Bicarbonate; 4/1,294 (0.3%) control (serious AE)
Pain9781.4
1.4–1.5ROR 1.5 · calibrated p 0.617
1.4 EB05 1.4 · IC025 +0.4Not in label — unassessedserious PRR 1.4NCT01467466: 1/1,291 (0.1%) on Bicarbonate (serious AE)
Pyrexia (fever)9682.5
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 — unassessedserious PRR 2.1NCT01467466: 1/1,291 (0.1%) on Bicarbonate; 2/1,294 (0.2%) control (serious AE)
Pneumonia (lung infection)9652.7
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 — unassessedserious PRR 1.9NCT01467466: 1/1,300 (0.1%) control (serious AE)
Fatigue (tiredness)9441.1
1.0–1.2ROR 1.1 · calibrated p 0.377
1.1 EB05 1.0 · IC025 +0.0Not in label — unassessedserious PRR 1.0not reported in cached trials
Vomiting9371.8
1.7–1.9ROR 1.8 · calibrated p 0.859
1.8 EB05 1.7 · IC025 +0.7Labeled adverse reaction
exact term
serious PRR 1.6NCT01467466: 3/1,291 (0.2%) on Bicarbonate; 2/1,294 (0.2%) control (serious AE)
Chronic kidney disease86810.4
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 — unassessedserious PRR 7.0NCT01467466: 3/1,291 (0.2%) on Bicarbonate; 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.

✓ 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 Bicarbonate?

In FDA FAERS, the most frequently co-reported reaction terms for Bicarbonate 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 Bicarbonate have an FDA boxed warning?

No. The FDA label retrieved for Bicarbonate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Bicarbonate 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

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.