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VITAMIN B

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Vitamin B Adverse Events Reported to the FDA Over Time

How are Vitamin B adverse event reports trending over time?

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

Most Common Vitamin B Adverse Events Reported to the FDA

What are the most common Vitamin B adverse events reported to the FDA?

Nausea
24 (1.87%)
Dizziness
19 (1.48%)
Vomiting
17 (1.32%)
Fatigue
14 (1.09%)
Feeling Abnormal
14 (1.09%)
Foetal Alcohol Syndrome
14 (1.09%)
Anxiety
13 (1.01%)
Dyspnoea
13 (1.01%)
Insomnia
13 (1.01%)
Tremor
13 (1.01%)
Convulsion
12 (.93%)
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Drug Ineffective
12 (.93%)
Rash
12 (.93%)
Drug Interaction
11 (.86%)
Headache
11 (.86%)
Pyrexia
11 (.86%)
Toxic Epidermal Necrolysis
10 (.78%)
Asthenia
9 (.7%)
Confusional State
9 (.7%)
Disorientation
9 (.7%)
Drug Exposure During Pregnancy
9 (.7%)
Hypoaesthesia
9 (.7%)
Pain
9 (.7%)
Somnolence
9 (.7%)
Abdominal Pain
8 (.62%)
Arthralgia
8 (.62%)
Aspartate Aminotransferase Increase...
8 (.62%)
Chest Pain
8 (.62%)
Diarrhoea
8 (.62%)
Myalgia
8 (.62%)
Pneumonia
8 (.62%)
Alanine Aminotransferase Increased
7 (.55%)
Blood Glucose Increased
7 (.55%)
Death
7 (.55%)
Decreased Appetite
7 (.55%)
Maternal Drugs Affecting Foetus
7 (.55%)
Pruritus
7 (.55%)
Stevens-johnson Syndrome
7 (.55%)
Thrombocytopenia
7 (.55%)
Weight Increased
7 (.55%)
Depression
6 (.47%)
Drug Rash With Eosinophilia And Sys...
6 (.47%)
Dyskinesia
6 (.47%)
Dyspepsia
6 (.47%)
Fall
6 (.47%)
Hepatitis
6 (.47%)
Jaundice
6 (.47%)
Liver Injury
6 (.47%)
Loss Of Consciousness
6 (.47%)
Muscular Weakness
6 (.47%)
Myocardial Infarction
6 (.47%)
Oedema
6 (.47%)
Paralysis
6 (.47%)
Abdominal Discomfort
5 (.39%)
Abortion Spontaneous
5 (.39%)
Acute Hepatic Failure
5 (.39%)
Amnesia
5 (.39%)
Apathy
5 (.39%)
Aphasia
5 (.39%)
Ascites
5 (.39%)
Blindness Transient
5 (.39%)
Blood Bilirubin Increased
5 (.39%)
Constipation
5 (.39%)
Coordination Abnormal
5 (.39%)
Coronary Artery Occlusion
5 (.39%)
Drug Hypersensitivity
5 (.39%)
Drug Withdrawal Syndrome
5 (.39%)
Dysphagia
5 (.39%)
Erythema
5 (.39%)
Flushing
5 (.39%)
Haematemesis
5 (.39%)
Haematoma
5 (.39%)
Hypertension
5 (.39%)
Injection Site Haemorrhage
5 (.39%)
Leukopenia
5 (.39%)
Malaise
5 (.39%)
Muscle Rigidity
5 (.39%)
Musculoskeletal Pain
5 (.39%)
Neutropenia
5 (.39%)
Nightmare
5 (.39%)
Pain In Extremity
5 (.39%)
Palpitations
5 (.39%)
Paraesthesia
5 (.39%)
Rales
5 (.39%)
Speech Disorder
5 (.39%)
Visual Impairment
5 (.39%)
Weight Decreased
5 (.39%)
Withdrawal Syndrome
5 (.39%)
Anaemia
4 (.31%)
Back Pain
4 (.31%)
Balance Disorder
4 (.31%)
Blood Lactate Dehydrogenase Increas...
4 (.31%)
Cleft Palate
4 (.31%)
Cystitis
4 (.31%)
Dehydration
4 (.31%)
Disturbance In Attention
4 (.31%)
Dry Mouth
4 (.31%)
Dysmorphism
4 (.31%)
Gastroenteritis
4 (.31%)
Heart Rate Increased
4 (.31%)
Heart Rate Irregular
4 (.31%)

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This graph shows the top adverse events submitted to the FDA for Vitamin B, 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 Vitamin B 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 Vitamin B

What are the most common Vitamin B adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Vitamin B, 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 Vitamin B 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 Vitamin B According to Those Reporting Adverse Events

Why are people taking Vitamin B, according to those reporting adverse events to the FDA?

Product Used For Unknown Indication
2016
Drug Use For Unknown Indication
1235
Vitamin Supplementation
1039
Prophylaxis
952
Supplementation Therapy
570
Vitamin B12 Deficiency
309
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Anaemia
212
Premedication
183
Medical Diet
166
Routine Health Maintenance
117
Crohns Disease
100
Pernicious Anaemia
96
Nutritional Support
63
Neuropathy Peripheral
60
Hypovitaminosis
60
Vitamin B12 Decreased
43
Vitamin B Complex Deficiency
41
Fatigue
40
Asthenia
38
Anaemia Prophylaxis
23
Anaemia Vitamin B12 Deficiency
21
Ill-defined Disorder
19
Malabsorption
17
Alcohol Withdrawal Syndrome
17
Adverse Drug Reaction
17
Rheumatoid Arthritis
15
Alcoholism
14
Polyneuropathy
13
Multiple Sclerosis
12
Bipolar Disorder
12
Gastric Bypass
11
Energy Increased
11
Vitamin B6 Deficiency
9
Hepatic Cirrhosis
9
Asthma
8
Pain
8
Memory Impairment
8
Iron Deficiency
8
Migraine
8
Alcohol Abuse
7
Vitamin B12
7
Nervous System Disorder
7
Glossitis
7
Intervertebral Disc Protrusion
7
Osteoporosis
7
General Physical Condition
7
Alcohol Problem
6
Cystic Fibrosis
6
Diabetic Neuropathy
6
Metabolic Disorder
6
Blood Count Abnormal
5

Drug Labels

LabelLabelerEffective
Vitamin B ComplexMylan Institutional LLC31-MAR-12

Vitamin B Case Reports

What Vitamin B 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 Vitamin B. 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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