HYDROXYCHLOROQUINE SULFATE

Hydroxychloroquine Sulfate Adverse Events Reported to the FDA Over Time

How are Hydroxychloroquine Sulfate adverse event reports trending over time?

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

Most Common Hydroxychloroquine Sulfate Adverse Events Reported to the FDA

What are the most common Hydroxychloroquine Sulfate adverse events reported to the FDA?

Nausea	114 (1.21%)
Dyspnoea	103 (1.09%)
Diarrhoea	101 (1.07%)
Drug Exposure During Pregnancy	79 (.84%)
Pyrexia	76 (.8%)
Abdominal Pain	75 (.79%)
Rash	75 (.79%)
Vomiting	75 (.79%)
Completed Suicide	74 (.78%)
Drug Ineffective	73 (.77%)
Asthenia	66 (.7%)
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Hypotension	64 (.68%)
Thrombocytopenia	60 (.63%)
Fatigue	59 (.62%)
Pain	59 (.62%)
Headache	58 (.61%)
Condition Aggravated	57 (.6%)
Drug Interaction	57 (.6%)
Cardiac Arrest	53 (.56%)
Pneumonia	52 (.55%)
Pruritus	52 (.55%)
Renal Failure Acute	50 (.53%)
Systemic Lupus Erythematosus	50 (.53%)
Malaise	45 (.48%)
Arthralgia	44 (.47%)
Haematemesis	42 (.44%)
Contusion	40 (.42%)
Vision Blurred	39 (.41%)
Weight Decreased	39 (.41%)
Loss Of Consciousness	38 (.4%)
Muscular Weakness	38 (.4%)
Dizziness	37 (.39%)
Death	36 (.38%)
Dysphagia	36 (.38%)
Hypoglycaemia	36 (.38%)
Rheumatoid Arthritis	36 (.38%)
Cardiomyopathy	35 (.37%)
Chest Pain	35 (.37%)
Oedema Peripheral	35 (.37%)
Pancytopenia	35 (.37%)
Respiratory Failure	35 (.37%)
Hypokalaemia	34 (.36%)
Anaemia	33 (.35%)
Blindness	33 (.35%)
Cataract	33 (.35%)
Hypersensitivity	33 (.35%)
Progressive Multifocal Leukoencepha...	33 (.35%)
Confusional State	32 (.34%)
Myopathy	32 (.34%)
Alopecia	31 (.33%)
Cardiac Failure	31 (.33%)
Electrocardiogram Qt Prolonged	30 (.32%)
Platelet Count Decreased	30 (.32%)
Cleft Lip And Palate	29 (.31%)
Torsade De Pointes	29 (.31%)
Urticaria	29 (.31%)
Gait Disturbance	28 (.3%)
Galactorrhoea	28 (.3%)
Convulsion	27 (.29%)
Fall	27 (.29%)
Sepsis	27 (.29%)
Tachycardia	27 (.29%)
Eye Disorder	26 (.28%)
Full Blood Count Abnormal	26 (.28%)
Macular Degeneration	26 (.28%)
Multi-organ Failure	26 (.28%)
Overdose	26 (.28%)
Cough	25 (.26%)
Feeling Abnormal	25 (.26%)
Hypertension	25 (.26%)
Leukopenia	25 (.26%)
Maternal Drugs Affecting Foetus	25 (.26%)
Abortion Induced	24 (.25%)
Blood Creatinine Increased	24 (.25%)
Disorientation	24 (.25%)
Dysgeusia	24 (.25%)
Dyspnoea Exertional	24 (.25%)
Pleural Effusion	24 (.25%)
Retinal Detachment	24 (.25%)
Decreased Appetite	23 (.24%)
Ventricular Tachycardia	23 (.24%)
Visual Acuity Reduced	23 (.24%)
Alanine Aminotransferase Increased	22 (.23%)
Burning Sensation	22 (.23%)
Chest Discomfort	22 (.23%)
Dehydration	22 (.23%)
Depression	22 (.23%)
Myelodysplastic Syndrome	22 (.23%)
Paraesthesia	22 (.23%)
Rash Generalised	22 (.23%)
Teratogenicity	22 (.23%)
Toxic Epidermal Necrolysis	22 (.23%)
Angioedema	21 (.22%)
Electrocardiogram Qrs Complex Prolo...	21 (.22%)
Hypoxia	21 (.22%)
Myalgia	21 (.22%)
Rash Pruritic	21 (.22%)
Skin Lesion	21 (.22%)
Stevens-johnson Syndrome	21 (.22%)
Tremor	21 (.22%)
Abdominal Pain Upper	20 (.21%)

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

What are the most common Hydroxychloroquine Sulfate adverse events reported to the FDA?

Epidermal And Dermal Conditions	594 (6.28%)
Gastrointestinal Signs	383 (4.05%)
Respiratory	373 (3.95%)
Neurological	344 (3.64%)
Infections - Pathogen Unspecified	279 (2.95%)
Cardiac Arrhythmias	262 (2.77%)
Therapeutic And Nontherapeutic Effe...	197 (2.08%)
Hepatic And Hepatobiliary	185 (1.96%)
Muscle	170 (1.8%)
Hematology Investigations	151 (1.6%)
Cardiac And Vascular Investigations	147 (1.55%)
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Vision	147 (1.55%)
Chemical Injury And Poisoning	142 (1.5%)
Bacterial Infectious	138 (1.46%)
Joint	137 (1.45%)
Gastrointestinal Motility And Defec...	128 (1.35%)
Renal Disorders	108 (1.14%)
Injuries	106 (1.12%)
Myocardial	104 (1.1%)
Hepatobiliary	100 (1.06%)
Electrolyte And Fluid Balance Condi...	95 (1%)
Viral Infectious	95 (1%)
Decreased And Nonspecific Blood Pre...	93 (.98%)
Body Temperature Conditions	91 (.96%)
Platelet	89 (.94%)
Suicidal And Self-injurious Behavio...	86 (.91%)
Medication Errors	85 (.9%)
White Blood Cell	83 (.88%)
Anemias Nonhemolytic And Marrow Dep...	81 (.86%)
Physical Examination Topics	76 (.8%)
Ocular Structural Change, Deposit A...	75 (.79%)
Skin Appendage Conditions	74 (.78%)
Musculoskeletal And Connective Tiss...	73 (.77%)
Gastrointestinal Hemorrhages	71 (.75%)
Lower Respiratory Tract Disorders	70 (.74%)
Allergic Conditions	68 (.72%)
Heart Failures	68 (.72%)
Eye	62 (.66%)
Headaches	60 (.63%)
Appetite And General Nutritional	59 (.62%)
Cardiac Disorder Signs	59 (.62%)
Deliria	59 (.62%)
Oral Soft Tissue Conditions	58 (.61%)
Connective Tissue Disorders	57 (.6%)
Fungal Infectious	57 (.6%)
Musculoskeletal And Connective Tiss...	57 (.6%)
Glucose Metabolism Disorders	56 (.59%)
Angiedema And Urticaria	53 (.56%)
Enzyme	53 (.56%)
Leukemias	53 (.56%)
Renal And Urinary Tract Investigati...	49 (.52%)
Movement Disorders	47 (.5%)
Urinary Tract Signs	46 (.49%)
Anterior Eye Structural Change, Dep...	44 (.47%)
Gastrointestinal Conditions	42 (.44%)
Skin Vascular Abnormalities	41 (.43%)
Coronary Artery	39 (.41%)
Anxiety Disorders	38 (.4%)
Fatal Outcomes	38 (.4%)
Administration Site Reactions	37 (.39%)
Bone And Joint Injuries	37 (.39%)
Pleural	37 (.39%)
Tissue	37 (.39%)
Obstetric And Gynecological Therape...	36 (.38%)
Peripheral Neuropathies	36 (.38%)
Gastrointestinal Tract Disorders Co...	35 (.37%)
Congenital And Hereditary	34 (.36%)
Acid-base	33 (.35%)
Product Quality Issues	33 (.35%)
Seizures	33 (.35%)
Breast	32 (.34%)
Bronchial Disorders	32 (.34%)
Central Nervous System Vascular	31 (.33%)
Skin And Subcutaneous Tissue	30 (.32%)
Abortions And Stillbirth	29 (.31%)
Metabolic, Nutritional And Blood Ga...	28 (.3%)
Procedural And Device Related Injur...	28 (.3%)
Vascular Hypertensive	28 (.3%)
Ear And Labyrinthine Disorders Cong...	27 (.29%)
Respiratory And Mediastinal Neoplas...	27 (.29%)
Exocrine Pancreas Conditions	26 (.28%)
Depressed Mood Disorders	25 (.26%)
Eye Disorders Congenital	25 (.26%)
Hearing	25 (.26%)
Mood Disorders	25 (.26%)
Neonatal And Perinatal Conditions	25 (.26%)
Neuromuscular	25 (.26%)
Cardiac Valve	24 (.25%)
Spleen, Lymphatic And Reticulendoth...	24 (.25%)
Disturbances In Thinking	23 (.24%)
Lifestyle Issues	23 (.24%)
Mental Impairment	23 (.24%)
Cardiac And Vascular Disorders Cong...	22 (.23%)
Coagulopathies And Bleeding Diathes...	22 (.23%)
Immunology And Allergy	22 (.23%)
Microbiology And Serology	22 (.23%)
Pulmonary Vascular	22 (.23%)
Investigations, Imaging And Histopa...	21 (.22%)
Ocular Infections, Irritations And ...	21 (.22%)
Pericardial	21 (.22%)
Skin Neoplasms Malignant And Unspec...	21 (.22%)

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