METHYLDOPA

Methyldopa Adverse Events Reported to the FDA Over Time

How are Methyldopa adverse event reports trending over time?

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

Most Common Methyldopa Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	69 (5.12%)
Caesarean Section	50 (3.71%)
Premature Baby	43 (3.19%)
Hypertension	35 (2.6%)
Somnolence	23 (1.71%)
Maternal Drugs Affecting Foetus	22 (1.63%)
Blood Pressure Increased	20 (1.48%)
Premature Labour	19 (1.41%)
Hypotension	17 (1.26%)
Suicide Attempt	16 (1.19%)
Small For Dates Baby	15 (1.11%)
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Ventricular Hypertrophy	15 (1.11%)
Proteinuria	13 (.97%)
Atrial Fibrillation	12 (.89%)
Cerebral Haematoma	12 (.89%)
Dysarthria	12 (.89%)
Glucose Urine Present	11 (.82%)
Hemianopia Homonymous	11 (.82%)
Nausea	11 (.82%)
Dehydration	10 (.74%)
Foetal Growth Retardation	10 (.74%)
Abortion Spontaneous	9 (.67%)
Blood Creatinine Increased	9 (.67%)
Multiple Drug Overdose Intentional	9 (.67%)
Alanine Aminotransferase Increased	8 (.59%)
Blood Pressure Inadequately Control...	8 (.59%)
Cardiogenic Shock	8 (.59%)
Coma	8 (.59%)
Condition Aggravated	8 (.59%)
Haemorrhagic Stroke	8 (.59%)
Headache	8 (.59%)
Polyuria	8 (.59%)
Pre-eclampsia	8 (.59%)
Aspartate Aminotransferase Increase...	7 (.52%)
Dizziness	7 (.52%)
Heart Rate Increased	7 (.52%)
Hypokalaemia	7 (.52%)
Intentional Overdose	7 (.52%)
Talipes	7 (.52%)
Vomiting	7 (.52%)
Apgar Score Low	6 (.45%)
Asthenia	6 (.45%)
Diarrhoea	6 (.45%)
Drug Ineffective	6 (.45%)
Drug Toxicity	6 (.45%)
Hemiparesis	6 (.45%)
Hypoglycaemia	6 (.45%)
Hypoperfusion	6 (.45%)
Malaise	6 (.45%)
Neonatal Disorder	6 (.45%)
Neonatal Respiratory Distress Syndr...	6 (.45%)
Renal Disorder	6 (.45%)
Renal Impairment	6 (.45%)
Sinus Tachycardia	6 (.45%)
Anaemia	5 (.37%)
Blood Alkaline Phosphatase Increase...	5 (.37%)
Blood Pressure Decreased	5 (.37%)
Cholecystitis	5 (.37%)
Fatigue	5 (.37%)
Foetal Distress Syndrome	5 (.37%)
Foetal Heart Rate Deceleration	5 (.37%)
Jaundice	5 (.37%)
Oedema Peripheral	5 (.37%)
Orthostatic Hypotension	5 (.37%)
Overdose	5 (.37%)
Pregnancy	5 (.37%)
Shock	5 (.37%)
Syncope	5 (.37%)
Vaginal Haemorrhage	5 (.37%)
Visual Impairment	5 (.37%)
Weight Decrease Neonatal	5 (.37%)
Abdominal Pain	4 (.3%)
Blood Bilirubin Increased	4 (.3%)
Delivery	4 (.3%)
Drug Interaction	4 (.3%)
Drug Screen False Positive	4 (.3%)
Dyspnoea	4 (.3%)
Failed Induction Of Labour	4 (.3%)
Gestational Diabetes	4 (.3%)
Glomerulosclerosis	4 (.3%)
Hypoglycaemia Neonatal	4 (.3%)
Hypotonia Neonatal	4 (.3%)
Pneumothorax	4 (.3%)
Postpartum Haemorrhage	4 (.3%)
Renal Failure	4 (.3%)
Renal Failure Acute	4 (.3%)
Uterine Hypotonus	4 (.3%)
Abortion Induced	3 (.22%)
Anaemia Haemolytic Autoimmune	3 (.22%)
Beta 2 Microglobulin Increased	3 (.22%)
Bradycardia Neonatal	3 (.22%)
Cerebral Haemorrhage	3 (.22%)
Cerebral Infarction	3 (.22%)
Congenital Anomaly	3 (.22%)
Delayed Fontanelle Closure	3 (.22%)
Depression	3 (.22%)
Drug Exposure Via Breast Milk	3 (.22%)
External Auditory Canal Atresia	3 (.22%)
Fall	3 (.22%)
Hepatic Necrosis	3 (.22%)
Hepatitis Acute	3 (.22%)

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

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

Chemical Injury And Poisoning	97 (7.2%)
Neonatal And Perinatal Conditions	73 (5.42%)
Neurological	67 (4.97%)
Obstetric And Gynecological Therape...	54 (4.01%)
Decreased And Nonspecific Blood Pre...	44 (3.27%)
Cardiac Arrhythmias	41 (3.04%)
Vascular Hypertensive	40 (2.97%)
Cardiac And Vascular Investigations	39 (2.9%)
Renal Disorders	38 (2.82%)
Central Nervous System Vascular	35 (2.6%)
Medication Errors	30 (2.23%)
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Maternal Complications Of Labour An...	29 (2.15%)
Gastrointestinal Signs	28 (2.08%)
Renal And Urinary Tract Investigati...	28 (2.08%)
Urinary Tract Signs	27 (2%)
Electrolyte And Fluid Balance Condi...	25 (1.86%)
Fetal Complications	24 (1.78%)
Hepatobiliary	24 (1.78%)
Myocardial	23 (1.71%)
Hepatic And Hepatobiliary	21 (1.56%)
Musculoskeletal And Connective Tiss...	19 (1.41%)
Infections - Pathogen Unspecified	17 (1.26%)
Therapeutic And Nontherapeutic Effe...	17 (1.26%)
Suicidal And Self-injurious Behavio...	16 (1.19%)
Glucose Metabolism Disorders	15 (1.11%)
Neonatal Respiratory	15 (1.11%)
Epidermal And Dermal Conditions	14 (1.04%)
Maternal Complications Of Pregnancy	14 (1.04%)
Pregnancy, Labour, Delivery And Pos...	13 (.97%)
Hematology Investigations	12 (.89%)
Nephropathies	12 (.89%)
Physical Examination Topics	12 (.89%)
Abortions And Stillbirth	11 (.82%)
Metabolic, Nutritional And Blood Ga...	11 (.82%)
Movement Disorders	11 (.82%)
Neurological Disorders Of The Eye	11 (.82%)
Renal And Urinary Tract Disorders C...	11 (.82%)
Cardiac And Vascular Disorders Cong...	9 (.67%)
Muscle	9 (.67%)
Headaches	8 (.59%)
Heart Failures	8 (.59%)
Protein And Chemistry Analyses	8 (.59%)
Anemias Nonhemolytic And Marrow Dep...	7 (.52%)
Injuries	7 (.52%)
Respiratory	7 (.52%)
Gastrointestinal Motility And Defec...	6 (.45%)
Musculoskeletal And Connective Tiss...	6 (.45%)
Vascular	6 (.45%)
Vision	6 (.45%)
Water, Electrolyte And Mineral	6 (.45%)
Congenital And Hereditary	5 (.37%)
Enzyme	5 (.37%)
Gallbladder	5 (.37%)
Toxicology And Therapeutic Drug Mon...	5 (.37%)
Vulvovaginal Disorders	5 (.37%)
Bacterial Infectious	4 (.3%)
Breast	4 (.3%)
Cardiac Disorder Signs	4 (.3%)
Endocrine Investigations	4 (.3%)
Fetal And Neonatal	4 (.3%)
Hearing	4 (.3%)
Hemolyses And Related Conditions	4 (.3%)
Musculoskeletal And Connective Tiss...	4 (.3%)
Placental, Amniotic And Cavity Diso...	4 (.3%)
Pleural	4 (.3%)
Postpartum And Puerperal	4 (.3%)
Procedural And Device Related Injur...	4 (.3%)
Seizures	4 (.3%)
Allergic Conditions	3 (.22%)
Depressed Mood Disorders	3 (.22%)
Ear And Labyrinthine Disorders Cong...	3 (.22%)
Hematological And Lymphoid Tissue T...	3 (.22%)
Lifestyle Issues	3 (.22%)
Lower Respiratory Tract Disorders	3 (.22%)
Neuromuscular	3 (.22%)
Psychiatric	3 (.22%)
Skin Appendage Conditions	3 (.22%)
Thyroid Gland	3 (.22%)
Uterine, Pelvic And Broad Ligament	3 (.22%)
Appetite And General Nutritional	2 (.15%)
Body Temperature Conditions	2 (.15%)
Cardiac Valve	2 (.15%)
Changes In Physical Activity	2 (.15%)
Connective Tissue Disorders	2 (.15%)
Deliria	2 (.15%)
Disturbances In Thinking	2 (.15%)
Endocrine Neoplasms Malignant And U...	2 (.15%)
Fatal Outcomes	2 (.15%)
Hypothalamus And Pituitary Gland	2 (.15%)
Immune	2 (.15%)
Infections And Infestations Congeni...	2 (.15%)
Lipid Analyses	2 (.15%)
Microbiology And Serology	2 (.15%)
Nervous System Neoplasms Benign	2 (.15%)
Neurological Disorders Congenital	2 (.15%)
Psychiatric And Behavioural Symptom...	2 (.15%)
Respiratory Disorders Congenital	2 (.15%)
Salivary Gland Conditions	2 (.15%)
Sleep Disorders	2 (.15%)
Structural Brain	2 (.15%)
Acid-base	1 (.07%)

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