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SODIUM BICARBONATE

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Sodium Bicarbonate Adverse Events Reported to the FDA Over Time

How are Sodium Bicarbonate adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Sodium Bicarbonate, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Sodium Bicarbonate is flagged as the suspect drug causing the adverse event.

Most Common Sodium Bicarbonate Adverse Events Reported to the FDA

What are the most common Sodium Bicarbonate adverse events reported to the FDA?

Off Label Use
26 (2.02%)
Toxic Epidermal Necrolysis
23 (1.78%)
Medication Error
22 (1.71%)
Drug Toxicity
19 (1.47%)
Loss Of Consciousness
16 (1.24%)
Dyspnoea
15 (1.16%)
Injection Site Pain
15 (1.16%)
Blood Pressure Decreased
14 (1.09%)
Nausea
14 (1.09%)
Vomiting
14 (1.09%)
Completed Suicide
12 (.93%)
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Cardiac Arrest
11 (.85%)
Injection Site Erythema
11 (.85%)
Pyrexia
11 (.85%)
Erythema
10 (.78%)
Hypokalaemia
10 (.78%)
Renal Failure
10 (.78%)
Drug Exposure During Pregnancy
9 (.7%)
Drug Ineffective
9 (.7%)
Metabolic Acidosis
9 (.7%)
Oedema Peripheral
9 (.7%)
Pain
9 (.7%)
Pneumonia
9 (.7%)
Product Quality Issue
9 (.7%)
Rhabdomyolysis
9 (.7%)
Asthenia
8 (.62%)
Death
8 (.62%)
Hypersensitivity
8 (.62%)
Respiratory Failure
8 (.62%)
Abdominal Pain Upper
7 (.54%)
Apparent Death
7 (.54%)
Blister
7 (.54%)
Dizziness
7 (.54%)
Granuloma
7 (.54%)
Injection Site Oedema
7 (.54%)
Respiratory Arrest
7 (.54%)
Sneezing
7 (.54%)
Stevens-johnson Syndrome
7 (.54%)
Acidosis Hyperchloraemic
6 (.47%)
Blood Creatinine Increased
6 (.47%)
Blood Pressure Increased
6 (.47%)
Chills
6 (.47%)
Condition Aggravated
6 (.47%)
Contusion
6 (.47%)
Diarrhoea
6 (.47%)
Drug Dependence
6 (.47%)
Fall
6 (.47%)
Feeling Abnormal
6 (.47%)
Hypotension
6 (.47%)
Injection Site Swelling
6 (.47%)
Necrosis
6 (.47%)
Pruritus
6 (.47%)
Wrong Technique In Drug Usage Proce...
6 (.47%)
Abortion Spontaneous
5 (.39%)
Acute Generalised Exanthematous Pus...
5 (.39%)
Cardio-respiratory Arrest
5 (.39%)
Decreased Appetite
5 (.39%)
Extravasation
5 (.39%)
Haemodialysis
5 (.39%)
Hallucination, Auditory
5 (.39%)
Headache
5 (.39%)
Hyperhidrosis
5 (.39%)
Injection Site Rash
5 (.39%)
Joint Swelling
5 (.39%)
Laceration
5 (.39%)
Memory Impairment
5 (.39%)
Overdose
5 (.39%)
Rash
5 (.39%)
Ventricular Tachycardia
5 (.39%)
Visual Acuity Reduced
5 (.39%)
Abdominal Pain
4 (.31%)
Cardiac Disorder
4 (.31%)
Chest Pain
4 (.31%)
Circumstance Or Information Capable...
4 (.31%)
Convulsion
4 (.31%)
Cough
4 (.31%)
Depression
4 (.31%)
Drug Interaction
4 (.31%)
Ecchymosis
4 (.31%)
Fatigue
4 (.31%)
Haemorrhage Subcutaneous
4 (.31%)
Hypernatraemia
4 (.31%)
Hyperuricaemia
4 (.31%)
Hypocalcaemia
4 (.31%)
Hypophosphataemia
4 (.31%)
Inflammation
4 (.31%)
Infusion Related Reaction
4 (.31%)
Injection Site Paraesthesia
4 (.31%)
Insomnia
4 (.31%)
Malaise
4 (.31%)
Mental Disorder
4 (.31%)
Metabolic Alkalosis
4 (.31%)
Myocardial Infarction
4 (.31%)
Product Substitution Issue
4 (.31%)
Pulmonary Fibrosis
4 (.31%)
Renal Failure Acute
4 (.31%)
Respiratory Distress
4 (.31%)
Scar
4 (.31%)
Skin Lesion
4 (.31%)
Unevaluable Event
4 (.31%)
Urinary Tract Infection
4 (.31%)

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This graph shows the top adverse events submitted to the FDA for Sodium Bicarbonate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Sodium Bicarbonate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Sodium Bicarbonate

What are the most common Sodium Bicarbonate adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Sodium Bicarbonate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Sodium Bicarbonate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Sodium Bicarbonate According to Those Reporting Adverse Events

Why are people taking Sodium Bicarbonate, according to those reporting adverse events to the FDA?

Product Used For Unknown Indication
370
Drug Use For Unknown Indication
333
Prophylaxis
98
Metabolic Acidosis
88
Acidosis
76
Constipation
46
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Renal Failure Chronic
40
Gastrooesophageal Reflux Disease
27
Renal Disorder
25
Stomatitis
19
Renal Failure
17
Dental Disorder Prophylaxis
13
Local Anaesthesia
12
Ph Urine
12
Premedication
12
Ill-defined Disorder
12
Dyspepsia
11
Dehydration
10
Mucosal Inflammation
10
Cystitis Interstitial
10
Nephrolithiasis
9
Hyperkalaemia
9
Cerumen Impaction
9
Fluid Replacement
8
Gastritis
8
Supplementation Therapy
8
Oesophagitis
7
Blood Bicarbonate Decreased
7
Urinary Tract Disorder
6
Nephropathy
6
Tumour Lysis Syndrome
6
Preoperative Care
6
Diarrhoea
6
Sepsis
6
Ph Urine Abnormal
6
Drug Therapy
6
Drug Toxicity
6
Nerve Block
5
Antacid Therapy
5
Adverse Event
5
Cardiopulmonary Bypass
5
Acid Base Balance
5
Electrolyte Imbalance
5
Vitamin Supplementation
4
Prophylaxis Against Diarrhoea
4
Haemorrhage
4
Renal Tubular Acidosis
4
Rash
4
Hyperchlorhydria
4
Arteriogram Coronary
4
Gastrointestinal Disorder
4

Drug Labels

LabelLabelerEffective
Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride And Sodium BicarbonateNovel Laboratories, Inc.28-MAY-09
NulytelyBraintree Laboratories, Inc.15-OCT-09
NulytelyPhysicians Total Care, Inc.15-OCT-09
Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium ChlorideAffordable Pharmaceuticals, LLC23-OCT-09
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate And Potassium ChloridePaddock Laboratories, Inc.01-MAR-10
Sodium BicarbonateMcKesson Packaging Services Business Unit of McKesson Corporation03-MAY-10
Halflytely And Bisacodyl Bowel Prep With Flavor PacksBraintree Laboratories, Inc.27-JUL-10
Sodium BicarbonateGeneral Injectables & Vaccines, Inc27-AUG-10
Sodium BicarbonateGeneral Injectables & Vaccines, Inc27-AUG-10
Sodium BicarbonateAmphastar Pharmaceuticals, Inc.20-SEP-10
Sodium BicarbonateRugby Laboratories, Inc.23-NOV-10
Sodium BicarbonateRugby Laboratories, Inc.05-DEC-10
Sodium BicarbonateGeneral Injectables & Vaccines, Inc.10-MAR-11
Sodium BicarbonateMirror Pharmaceuticals LLC04-APR-11
Sodium BicarbonateGeneral Injectables & Vaccines, Inc20-APR-11
Sodium BicarbonateGeneral Injectables & Vaccines, Inc23-APR-11
Sodium BicarbonateGeneral Injectables & Vaccines, Inc23-APR-11
De La Cruz Sodium Bicarbonate AntacidDLC Laboratories, Inc.25-MAY-11
Omeprazole And Sodium BicarbonatePar Pharmaceutical Inc.17-APR-12
ZegeridPhysicians Total Care, Inc.01-MAY-12
Sodium BicarbonateOnpharma, Inc.07-JUN-12
Sodium BicarbonateHospira, Inc.07-JUN-12
Sodium Bicarbonate Rising Pharmaceuticals, Inc.26-JUN-12
Sodium BicarbonateHospira, Inc.13-AUG-12
Sodium BicarbonateCardinal Health23-AUG-12
Sodium BicarbonateAPP Pharmaceuticals, LLC27-AUG-12
Sodium BicarbonateAPP Pharmaceuticals, LLC31-AUG-12
Neut Sodium BicarbonateHospira, Inc.24-OCT-12
Omeprazole/sodium BicarbonatePrasco, Laboratories01-NOV-12
ZegeridSantarus, Inc.14-NOV-12
Sodium Bicarbonate International Medication Systems, Limited 10-JAN-13
SuclearBraintree Laboratories, Inc.31-JAN-13
Peg-3350, Sodium Chloride, Sodium Bicarbonate And Potassium ChlorideAffordable Pharmaceuticals, LLC08-FEB-13
Sodium BicarbonateSagent Pharmaceuticals13-FEB-13

Sodium Bicarbonate Case Reports

What Sodium Bicarbonate safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Sodium Bicarbonate. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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