HYDROCORTISONE

Hydrocortisone Adverse Events Reported to the FDA Over Time

How are Hydrocortisone adverse event reports trending over time?

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

Most Common Hydrocortisone Adverse Events Reported to the FDA

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

Pyrexia	152 (1.21%)
Drug Ineffective	120 (.96%)
Hypotension	92 (.73%)
Vomiting	87 (.69%)
Dyspnoea	86 (.69%)
Malaise	84 (.67%)
Sepsis	84 (.67%)
Hypertension	82 (.65%)
Nausea	82 (.65%)
Condition Aggravated	81 (.65%)
Medication Error	78 (.62%)
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Eye Irritation	77 (.61%)
Acute Respiratory Distress Syndrome	71 (.57%)
Diarrhoea	71 (.57%)
Loss Of Consciousness	69 (.55%)
Blood Glucose Increased	68 (.54%)
Septic Shock	68 (.54%)
Anaemia	66 (.53%)
Multi-organ Failure	65 (.52%)
Hypersensitivity	64 (.51%)
Hyponatraemia	64 (.51%)
Hyperglycaemia	63 (.5%)
Respiratory Failure	62 (.49%)
Headache	61 (.49%)
Pneumonia	61 (.49%)
Rash	60 (.48%)
Abdominal Pain	59 (.47%)
Pain	59 (.47%)
Toxic Epidermal Necrolysis	59 (.47%)
Convulsion	58 (.46%)
Adrenocortical Insufficiency Acute	56 (.45%)
Shock	56 (.45%)
Renal Failure Acute	53 (.42%)
Asthenia	52 (.41%)
Febrile Neutropenia	51 (.41%)
Pleural Effusion	51 (.41%)
Pruritus	51 (.41%)
Renal Failure	51 (.41%)
Hypoglycaemia	48 (.38%)
Hypokalaemia	48 (.38%)
Anaphylactic Shock	47 (.37%)
Drug Exposure During Pregnancy	46 (.37%)
Thrombocytopenia	46 (.37%)
Oedema Peripheral	45 (.36%)
Food Poisoning	43 (.34%)
Neutropenia	42 (.33%)
Tachycardia	42 (.33%)
Arthralgia	41 (.33%)
Cardiac Arrest	41 (.33%)
Erythema	41 (.33%)
Incorrect Route Of Drug Administrat...	41 (.33%)
Rhabdomyolysis	41 (.33%)
Adrenal Insufficiency	40 (.32%)
Aspartate Aminotransferase Increase...	39 (.31%)
Infusion Related Reaction	39 (.31%)
Wrong Drug Administered	39 (.31%)
Infection	38 (.3%)
Pulmonary Embolism	38 (.3%)
Respiratory Distress	38 (.3%)
Urticaria	38 (.3%)
Alanine Aminotransferase Increased	37 (.29%)
Drug Dispensing Error	37 (.29%)
Reversible Posterior Leukoencephalo...	37 (.29%)
Blood Pressure Decreased	36 (.29%)
Drug Toxicity	36 (.29%)
Gastrointestinal Haemorrhage	36 (.29%)
Platelet Count Decreased	36 (.29%)
Vision Blurred	35 (.28%)
Weight Increased	35 (.28%)
Drug Interaction	34 (.27%)
Off Label Use	34 (.27%)
Death	33 (.26%)
Dehydration	33 (.26%)
Haemorrhage Intracranial	33 (.26%)
Cough	32 (.26%)
Dizziness	32 (.26%)
Hyperkalaemia	32 (.26%)
Fatigue	31 (.25%)
Haemoglobin Decreased	31 (.25%)
Pain In Extremity	31 (.25%)
Renal Impairment	31 (.25%)
Blood Pressure Increased	30 (.24%)
Osteonecrosis	30 (.24%)
Back Pain	29 (.23%)
Drug Hypersensitivity	29 (.23%)
Fungal Infection	29 (.23%)
Leukopenia	29 (.23%)
Pulmonary Oedema	29 (.23%)
White Blood Cell Count Decreased	29 (.23%)
Asthma	28 (.22%)
Blood Culture Positive	28 (.22%)
Confusional State	28 (.22%)
Disseminated Intravascular Coagulat...	28 (.22%)
General Physical Health Deteriorati...	28 (.22%)
Agitation	27 (.22%)
Anaphylactic Reaction	27 (.22%)
Deep Vein Thrombosis	27 (.22%)
Foetal Distress Syndrome	27 (.22%)
Pancytopenia	27 (.22%)
Paraesthesia	27 (.22%)
Rectal Haemorrhage	27 (.22%)

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

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

Infections - Pathogen Unspecified	607 (4.84%)
Epidermal And Dermal Conditions	482 (3.84%)
Neurological	437 (3.48%)
Respiratory	405 (3.23%)
Bacterial Infectious	326 (2.6%)
Gastrointestinal Signs	314 (2.5%)
Medication Errors	270 (2.15%)
Cardiac Arrhythmias	263 (2.1%)
Electrolyte And Fluid Balance Condi...	219 (1.75%)
Therapeutic And Nontherapeutic Effe...	217 (1.73%)
Hematology Investigations	211 (1.68%)
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Allergic Conditions	188 (1.5%)
Renal Disorders	182 (1.45%)
Hepatic And Hepatobiliary	181 (1.44%)
White Blood Cell	179 (1.43%)
Decreased And Nonspecific Blood Pre...	178 (1.42%)
Hepatobiliary	170 (1.35%)
Body Temperature Conditions	166 (1.32%)
Cardiac And Vascular Investigations	166 (1.32%)
Fungal Infectious	165 (1.31%)
Lower Respiratory Tract Disorders	158 (1.26%)
Adrenal Gland	146 (1.16%)
Administration Site Reactions	135 (1.08%)
Glucose Metabolism Disorders	135 (1.08%)
Anemias Nonhemolytic And Marrow Dep...	132 (1.05%)
Ocular Infections, Irritations And ...	132 (1.05%)
Injuries	130 (1.04%)
Metabolic, Nutritional And Blood Ga...	129 (1.03%)
Gastrointestinal Hemorrhages	124 (.99%)
Muscle	120 (.96%)
Viral Infectious	108 (.86%)
Chemical Injury And Poisoning	107 (.85%)
Musculoskeletal And Connective Tiss...	107 (.85%)
Gastrointestinal Motility And Defec...	99 (.79%)
Seizures	98 (.78%)
Vascular Hypertensive	93 (.74%)
Procedural And Device Related Injur...	92 (.73%)
Central Nervous System Vascular	90 (.72%)
Encephalopathies	85 (.68%)
Vision	84 (.67%)
Movement Disorders	82 (.65%)
Gastrointestinal Conditions	81 (.65%)
Joint	81 (.65%)
Physical Examination Topics	80 (.64%)
Gastrointestinal Inflammatory Condi...	79 (.63%)
Headaches	68 (.54%)
Pleural	67 (.53%)
Bone Disorders	64 (.51%)
Bronchial Disorders	63 (.5%)
Anxiety Disorders	59 (.47%)
Myocardial	59 (.47%)
Urinary Tract Signs	59 (.47%)
Platelet	58 (.46%)
Vascular	57 (.45%)
Appetite And General Nutritional	56 (.45%)
Aural	56 (.45%)
Embolism And Thrombosis	56 (.45%)
Oral Soft Tissue Conditions	56 (.45%)
Skin Appendage Conditions	56 (.45%)
Deliria	55 (.44%)
Therapeutic Procedures And Supporti...	55 (.44%)
Heart Failures	54 (.43%)
Acid-base	53 (.42%)
Microbiology And Serology	52 (.41%)
Angiedema And Urticaria	51 (.41%)
Coagulopathies And Bleeding Diathes...	51 (.41%)
Upper Respiratory Tract Disorders	50 (.4%)
Enzyme	49 (.39%)
Gastrointestinal Ulceration And Per...	47 (.37%)
Miscellaneous And Site Unspecified ...	47 (.37%)
Spinal Cord And Nerve Root	47 (.37%)
Water, Electrolyte And Mineral	47 (.37%)
Renal And Urinary Tract Investigati...	46 (.37%)
Eye	45 (.36%)
Pulmonary Vascular	45 (.36%)
Endocrine Investigations	43 (.34%)
Hematological And Lymphoid Tissue T...	43 (.34%)
Hypothalamus And Pituitary Gland	43 (.34%)
Peritoneal And Retroperitoneal Cond...	42 (.33%)
Product Quality Issues	42 (.33%)
Fatal Outcomes	41 (.33%)
Tendon, Ligament And Cartilage	41 (.33%)
Vascular Hemorrhagic	40 (.32%)
Anterior Eye Structural Change, Dep...	37 (.29%)
Peripheral Neuropathies	36 (.29%)
Bone, Calcium, Magnesium And Phosph...	35 (.28%)
Lifestyle Issues	35 (.28%)
Fetal Complications	34 (.27%)
Immune	34 (.27%)
Immunodeficiency Syndromes	34 (.27%)
Spleen, Lymphatic And Reticulendoth...	33 (.26%)
Bone And Joint Injuries	31 (.25%)
Hearing	31 (.25%)
Anal And Rectal Conditions	30 (.24%)
Gastrointestinal Stenosis And Obstr...	30 (.24%)
Lipid Analyses	30 (.24%)
Neurological, Special Senses And Ps...	30 (.24%)
Psychiatric	29 (.23%)
Central Nervous System Infections A...	27 (.22%)
Disturbances In Thinking	27 (.22%)
Hematopoietic Neoplasms	27 (.22%)

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