HYDRALAZINE

Hydralazine Adverse Events Reported to the FDA Over Time

How are Hydralazine adverse event reports trending over time?

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

Most Common Hydralazine Adverse Events Reported to the FDA

What are the most common Hydralazine adverse events reported to the FDA?

Completed Suicide	74 (2.01%)
Drug Exposure During Pregnancy	72 (1.95%)
Blood Pressure Increased	70 (1.9%)
Hypertension	57 (1.54%)
Hypotension	55 (1.49%)
Premature Baby	50 (1.36%)
Caesarean Section	49 (1.33%)
Dizziness	47 (1.27%)
Headache	41 (1.11%)
Oedema Peripheral	40 (1.08%)
Drug Ineffective	38 (1.03%)
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Dyspnoea	38 (1.03%)
Vasculitis Necrotising	32 (.87%)
Medication Error	31 (.84%)
Death	27 (.73%)
Atrial Fibrillation	26 (.7%)
Bradycardia	26 (.7%)
Premature Labour	26 (.7%)
Proteinuria	26 (.7%)
Pyrexia	26 (.7%)
Renal Vasculitis	26 (.7%)
Anaemia	25 (.68%)
Asthenia	25 (.68%)
Dysarthria	25 (.68%)
Nausea	24 (.65%)
Renal Failure Acute	24 (.65%)
Syncope	23 (.62%)
Fatigue	22 (.6%)
Feeling Abnormal	22 (.6%)
Lupus-like Syndrome	21 (.57%)
Somnolence	21 (.57%)
Blood Pressure Inadequately Control...	20 (.54%)
Tachycardia	20 (.54%)
Heart Rate Increased	19 (.51%)
Pain In Extremity	19 (.51%)
Rash	19 (.51%)
Tremor	19 (.51%)
Acute Febrile Neutrophilic Dermatos...	18 (.49%)
Aspartate Aminotransferase Increase...	18 (.49%)
Alanine Aminotransferase Increased	17 (.46%)
Cerebral Haematoma	17 (.46%)
Chest Pain	17 (.46%)
Depressed Level Of Consciousness	17 (.46%)
Gait Disturbance	17 (.46%)
Renal Impairment	17 (.46%)
Ventricular Hypertrophy	17 (.46%)
Weight Increased	17 (.46%)
Confusional State	16 (.43%)
Cough	16 (.43%)
Glucose Urine Present	16 (.43%)
Hemianopia Homonymous	16 (.43%)
Blood Lactate Dehydrogenase Increas...	15 (.41%)
Diarrhoea	15 (.41%)
Drug Dispensing Error	15 (.41%)
Pulmonary Oedema	15 (.41%)
Systemic Lupus Erythematosus	15 (.41%)
Blood Pressure Decreased	14 (.38%)
Pleural Effusion	14 (.38%)
Anxiety	13 (.35%)
Blood Creatinine Increased	13 (.35%)
Cerebrovascular Accident	13 (.35%)
Gastrointestinal Tract Mucosal Pigm...	13 (.35%)
Haemoglobin Decreased	13 (.35%)
Malaise	13 (.35%)
Overdose	13 (.35%)
Pneumonia	13 (.35%)
Toxic Epidermal Necrolysis	13 (.35%)
Vomiting	13 (.35%)
Angioedema	12 (.33%)
Blood Bilirubin Increased	12 (.33%)
Cardiac Failure Congestive	12 (.33%)
Jaundice	12 (.33%)
Small For Dates Baby	12 (.33%)
Anti-neutrophil Cytoplasmic Antibod...	11 (.3%)
Arthralgia	11 (.3%)
Erythema	11 (.3%)
Haemorrhagic Stroke	11 (.3%)
Blood Alkaline Phosphatase Increase...	10 (.27%)
Cardiomegaly	10 (.27%)
Condition Aggravated	10 (.27%)
Dehydration	10 (.27%)
Incorrect Dose Administered	10 (.27%)
Liver Disorder	10 (.27%)
Mental Status Changes	10 (.27%)
Nervousness	10 (.27%)
Normal Newborn	10 (.27%)
Oedema	10 (.27%)
Palpitations	10 (.27%)
Poisoning	10 (.27%)
Pre-eclampsia	10 (.27%)
Prothrombin Time Shortened	10 (.27%)
Blood Glucose Increased	9 (.24%)
Blood Urea Increased	9 (.24%)
Drug Interaction	9 (.24%)
Flushing	9 (.24%)
Hemiparesis	9 (.24%)
Presyncope	9 (.24%)
Respiratory Disorder	9 (.24%)
Rhabdomyolysis	9 (.24%)
Thrombocytopenia	9 (.24%)
Vision Blurred	9 (.24%)

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

What are the most common Hydralazine adverse events reported to the FDA?

Neurological	201 (5.45%)
Cardiac And Vascular Investigations	155 (4.2%)
Cardiac Arrhythmias	141 (3.82%)
Respiratory	118 (3.2%)
Medication Errors	112 (3.04%)
Epidermal And Dermal Conditions	109 (2.95%)
Chemical Injury And Poisoning	99 (2.68%)
Decreased And Nonspecific Blood Pre...	87 (2.36%)
Renal Disorders	87 (2.36%)
Suicidal And Self-injurious Behavio...	75 (2.03%)
Gastrointestinal Signs	70 (1.9%)
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Therapeutic And Nontherapeutic Effe...	69 (1.87%)
Hematology Investigations	67 (1.82%)
Vascular Hypertensive	66 (1.79%)
Hepatobiliary	64 (1.73%)
Neonatal And Perinatal Conditions	62 (1.68%)
Central Nervous System Vascular	59 (1.6%)
Hepatic And Hepatobiliary	55 (1.49%)
Renal And Urinary Tract Investigati...	54 (1.46%)
Obstetric And Gynecological Therape...	51 (1.38%)
Infections - Pathogen Unspecified	50 (1.36%)
Urinary Tract Signs	50 (1.36%)
Lower Respiratory Tract Disorders	49 (1.33%)
Headaches	45 (1.22%)
Myocardial	42 (1.14%)
Vascular Inflammations	42 (1.14%)
Connective Tissue Disorders	39 (1.06%)
Musculoskeletal And Connective Tiss...	38 (1.03%)
Physical Examination Topics	36 (.98%)
Anemias Nonhemolytic And Marrow Dep...	34 (.92%)
Movement Disorders	34 (.92%)
Anxiety Disorders	33 (.89%)
Enzyme	31 (.84%)
Muscle	31 (.84%)
Maternal Complications Of Labour An...	30 (.81%)
Fatal Outcomes	27 (.73%)
Gastrointestinal Motility And Defec...	27 (.73%)
Body Temperature Conditions	26 (.7%)
Metabolic, Nutritional And Blood Ga...	25 (.68%)
Deliria	24 (.65%)
Maternal Complications Of Pregnancy	24 (.65%)
Electrolyte And Fluid Balance Condi...	22 (.6%)
Fetal Complications	22 (.6%)
Nephropathies	21 (.57%)
Pleural	21 (.57%)
Cardiac Disorder Signs	20 (.54%)
Joint	20 (.54%)
Heart Failures	19 (.51%)
Injuries	19 (.51%)
Psychiatric	19 (.51%)
Glucose Metabolism Disorders	18 (.49%)
Immunology And Allergy	18 (.49%)
Vision	18 (.49%)
Angiedema And Urticaria	17 (.46%)
Coronary Artery	17 (.46%)
Gastrointestinal Conditions	17 (.46%)
Water, Electrolyte And Mineral	17 (.46%)
Neurological Disorders Of The Eye	16 (.43%)
Vascular	16 (.43%)
Bacterial Infectious	14 (.38%)
Pregnancy, Labour, Delivery And Pos...	14 (.38%)
Allergic Conditions	13 (.35%)
Gastrointestinal Hemorrhages	13 (.35%)
Product Quality Issues	13 (.35%)
Skin Appendage Conditions	12 (.33%)
Immune	11 (.3%)
Placental, Amniotic And Cavity Diso...	11 (.3%)
Platelet	11 (.3%)
Procedural And Device Related Injur...	11 (.3%)
Therapeutic Procedures And Supporti...	11 (.3%)
Appetite And General Nutritional	10 (.27%)
Arteriosclerosis, Stenosis, Vascula...	10 (.27%)
Skin Vascular Abnormalities	10 (.27%)
Lifestyle Issues	9 (.24%)
Neonatal Respiratory	9 (.24%)
Pericardial	9 (.24%)
Seizures	9 (.24%)
Vascular Hemorrhagic	9 (.24%)
Viral Infectious	9 (.24%)
Aural	8 (.22%)
Bronchial Disorders	8 (.22%)
Encephalopathies	8 (.22%)
Eye	8 (.22%)
Hematological And Lymphoid Tissue T...	8 (.22%)
Mental Impairment	8 (.22%)
Oral Soft Tissue Conditions	8 (.22%)
Coagulopathies And Bleeding Diathes...	7 (.19%)
Embolism And Thrombosis	7 (.19%)
Endocrine Neoplasms Malignant And U...	7 (.19%)
Mood Disorders	7 (.19%)
Pulmonary Vascular	7 (.19%)
Renal And Urinary Tract Disorders C...	7 (.19%)
Upper Respiratory Tract Disorders	7 (.19%)
Autoimmune	6 (.16%)
Bone And Joint Injuries	6 (.16%)
Disturbances In Thinking	6 (.16%)
Inner Ear And Viiith Cranial Nerve	6 (.16%)
Sleep Disorders	6 (.16%)
Thoracic Disorders	6 (.16%)
Bone Disorders	5 (.14%)
Gastrointestinal Stenosis And Obstr...	5 (.14%)

Share/Embed Graph Export Data

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