FOLIC ACID

Folic Acid Adverse Events Reported to the FDA Over Time

How are Folic Acid adverse event reports trending over time?

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

Most Common Folic Acid Adverse Events Reported to the FDA

What are the most common Folic Acid adverse events reported to the FDA?

Drug Exposure During Pregnancy	147 (2.47%)
Pyrexia	84 (1.41%)
Malaise	80 (1.34%)
Constipation	76 (1.28%)
Urinary Tract Infection	75 (1.26%)
White Blood Cell Count Increased	71 (1.19%)
Premature Baby	67 (1.13%)
Cardiac Murmur	65 (1.09%)
Staphylococcal Infection	65 (1.09%)
Sinus Tachycardia	63 (1.06%)
Diabetes Mellitus	61 (1.03%)
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Hiatus Hernia	60 (1.01%)
Maternal Drugs Affecting Foetus	60 (1.01%)
Abdominal Tenderness	59 (.99%)
Iron Deficiency Anaemia	59 (.99%)
Skin Disorder	59 (.99%)
Mean Cell Volume Decreased	57 (.96%)
Neutrophil Count Increased	56 (.94%)
Body Mass Index Decreased	55 (.92%)
Monocyte Count Increased	53 (.89%)
Hypertension	47 (.79%)
Renal Failure	44 (.74%)
Diarrhoea	43 (.72%)
White Blood Cell Disorder	43 (.72%)
Physical Assault	41 (.69%)
Convulsion	40 (.67%)
Therapeutic Agent Toxicity	40 (.67%)
Hypotension	39 (.66%)
Drug Ineffective	38 (.64%)
Caesarean Section	37 (.62%)
Drug Interaction	35 (.59%)
Vomiting	34 (.57%)
Dyspnoea	30 (.5%)
Metabolic Acidosis	30 (.5%)
Condition Aggravated	28 (.47%)
Galactorrhoea	28 (.47%)
Fall	26 (.44%)
Confusional State	25 (.42%)
Nausea	25 (.42%)
Anaemia	23 (.39%)
Hypokalaemia	23 (.39%)
Pneumonia	23 (.39%)
Pregnancy	23 (.39%)
Death	22 (.37%)
Depressed Level Of Consciousness	22 (.37%)
Dizziness	21 (.35%)
Renal Impairment	20 (.34%)
Encephalopathy	19 (.32%)
Haemoglobin Decreased	19 (.32%)
Respiratory Failure	19 (.32%)
Ventricular Septal Defect	19 (.32%)
Abnormal Dreams	18 (.3%)
Asthenia	18 (.3%)
Pulmonary Hypertension	18 (.3%)
Tumour Lysis Syndrome	18 (.3%)
Completed Suicide	17 (.29%)
Pruritus	17 (.29%)
Rash	17 (.29%)
Septic Shock	17 (.29%)
Thrombocytopenia	17 (.29%)
Abortion Spontaneous	16 (.27%)
Hip Dysplasia	16 (.27%)
Renal Failure Acute	16 (.27%)
Agitation	15 (.25%)
Dehydration	15 (.25%)
Intentional Overdose	15 (.25%)
Myoclonus	15 (.25%)
Overdose	15 (.25%)
Pain	15 (.25%)
Urine Output Decreased	15 (.25%)
Aspartate Aminotransferase Increase...	14 (.24%)
Blood Creatinine Increased	14 (.24%)
Blood Potassium Decreased	14 (.24%)
Haemodynamic Instability	14 (.24%)
Stevens-johnson Syndrome	14 (.24%)
Treatment Noncompliance	14 (.24%)
Gamma-glutamyltransferase Increased	13 (.22%)
General Physical Health Deteriorati...	13 (.22%)
Limb Malformation	13 (.22%)
Multi-organ Failure	13 (.22%)
Arnold-chiari Malformation	12 (.2%)
Headache	12 (.2%)
Hydronephrosis	12 (.2%)
Microtia	12 (.2%)
Nuclear Magnetic Resonance Imaging ...	12 (.2%)
Pancytopenia	12 (.2%)
Pelvic Deformity	12 (.2%)
Abdominal Pain	11 (.18%)
Alanine Aminotransferase Increased	11 (.18%)
Disorientation	11 (.18%)
Erythema	11 (.18%)
Fatigue	11 (.18%)
Gastrointestinal Disorder	11 (.18%)
Glasgow Coma Scale Abnormal	11 (.18%)
Grand Mal Convulsion	11 (.18%)
Haemolytic Anaemia	11 (.18%)
Haemorrhage	11 (.18%)
Hypersensitivity	11 (.18%)
Intra-uterine Death	11 (.18%)
Jaundice	11 (.18%)
Nephropathy Toxic	11 (.18%)

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This graph shows the top adverse events submitted to the FDA for Folic Acid, 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 Folic Acid 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 Folic Acid

What are the most common Folic Acid adverse events reported to the FDA?

Hematology Investigations	312 (5.24%)
Chemical Injury And Poisoning	256 (4.3%)
Infections - Pathogen Unspecified	229 (3.85%)
Epidermal And Dermal Conditions	201 (3.38%)
Gastrointestinal Signs	184 (3.09%)
Neurological	159 (2.67%)
Gastrointestinal Motility And Defec...	129 (2.17%)
Bacterial Infectious	116 (1.95%)
Anemias Nonhemolytic And Marrow Dep...	114 (1.92%)
Cardiac Arrhythmias	110 (1.85%)
Respiratory	107 (1.8%)
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Renal Disorders	105 (1.77%)
Hepatic And Hepatobiliary	99 (1.66%)
Cardiac And Vascular Investigations	91 (1.53%)
Neonatal And Perinatal Conditions	89 (1.5%)
Body Temperature Conditions	87 (1.46%)
Cardiac And Vascular Disorders Cong...	86 (1.45%)
Therapeutic And Nontherapeutic Effe...	85 (1.43%)
White Blood Cell	85 (1.43%)
Seizures	79 (1.33%)
Musculoskeletal And Connective Tiss...	77 (1.29%)
Physical Examination Topics	73 (1.23%)
Electrolyte And Fluid Balance Condi...	72 (1.21%)
Glucose Metabolism Disorders	69 (1.16%)
Medication Errors	68 (1.14%)
Decreased And Nonspecific Blood Pre...	67 (1.13%)
Abdominal Hernias And Other Abdomin...	63 (1.06%)
Obstetric And Gynecological Therape...	55 (.92%)
Hepatobiliary	54 (.91%)
Vascular Hypertensive	47 (.79%)
Renal And Urinary Tract Investigati...	45 (.76%)
Injuries	44 (.74%)
Metabolic, Nutritional And Blood Ga...	42 (.71%)
Legal Issues	41 (.69%)
Water, Electrolyte And Mineral	41 (.69%)
Lower Respiratory Tract Disorders	39 (.66%)
Joint	38 (.64%)
Deliria	37 (.62%)
Abortions And Stillbirth	36 (.61%)
Musculoskeletal And Connective Tiss...	36 (.61%)
Lifestyle Issues	35 (.59%)
Neurological Disorders Congenital	35 (.59%)
Pregnancy, Labour, Delivery And Pos...	35 (.59%)
Procedural And Device Related Injur...	35 (.59%)
Gastrointestinal Tract Disorders Co...	33 (.55%)
Acid-base	32 (.54%)
Breast	31 (.52%)
Cardiac Disorder Signs	30 (.5%)
Neurological, Special Senses And Ps...	29 (.49%)
Vascular	29 (.49%)
Urinary Tract Signs	28 (.47%)
Enzyme	27 (.45%)
Anxiety Disorders	26 (.44%)
Appetite And General Nutritional	26 (.44%)
Central Nervous System Vascular	26 (.44%)
Fatal Outcomes	26 (.44%)
Sleep Disorders	26 (.44%)
Suicidal And Self-injurious Behavio...	26 (.44%)
Toxicology And Therapeutic Drug Mon...	26 (.44%)
Allergic Conditions	25 (.42%)
Viral Infectious	25 (.42%)
Pulmonary Vascular	24 (.4%)
Encephalopathies	23 (.39%)
Gastrointestinal Inflammatory Condi...	23 (.39%)
Platelet	23 (.39%)
Congenital And Hereditary	22 (.37%)
Peripheral Neuropathies	21 (.35%)
Psychiatric	21 (.35%)
Bone Disorders	20 (.34%)
Fungal Infectious	20 (.34%)
Heart Failures	20 (.34%)
Movement Disorders	20 (.34%)
Musculoskeletal And Connective Tiss...	20 (.34%)
Ear And Labyrinthine Disorders Cong...	19 (.32%)
Mental Impairment	19 (.32%)
Bone And Joint Injuries	18 (.3%)
Hemolyses And Related Conditions	18 (.3%)
Muscle	18 (.3%)
Exocrine Pancreas Conditions	17 (.29%)
Eye Disorders Congenital	17 (.29%)
Fetal Complications	17 (.29%)
Gastrointestinal Conditions	17 (.29%)
Eye	16 (.27%)
Maternal Complications Of Labour An...	16 (.27%)
Oral Soft Tissue Conditions	16 (.27%)
Peritoneal And Retroperitoneal Cond...	16 (.27%)
Renal And Urinary Tract Disorders C...	16 (.27%)
Upper Respiratory Tract Disorders	16 (.27%)
Urolithiases	16 (.27%)
Headaches	15 (.25%)
Pleural	15 (.25%)
Tissue	15 (.25%)
Coagulopathies And Bleeding Diathes...	14 (.24%)
Coronary Artery	14 (.24%)
Neonatal Respiratory	14 (.24%)
Vision	14 (.24%)
Embolism And Thrombosis	13 (.22%)
Gastrointestinal Stenosis And Obstr...	13 (.22%)
Skin Appendage Conditions	13 (.22%)
Vascular Hemorrhagic	13 (.22%)
Gastrointestinal Hemorrhages	12 (.2%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Folic Acid, 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 Folic Acid 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.