DEXAMETHASONE

Dexamethasone Adverse Events Reported to the FDA Over Time

How are Dexamethasone adverse event reports trending over time?

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

Most Common Dexamethasone Adverse Events Reported to the FDA

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

Pneumonia	1145 (1.49%)
Pyrexia	1024 (1.33%)
Neutropenia	984 (1.28%)
Diarrhoea	909 (1.18%)
Thrombocytopenia	865 (1.12%)
Sepsis	760 (.99%)
Dyspnoea	695 (.9%)
Fatigue	695 (.9%)
Anaemia	684 (.89%)
Febrile Neutropenia	678 (.88%)
Nausea	606 (.79%)
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Platelet Count Decreased	605 (.79%)
Death	603 (.78%)
Haemoglobin Decreased	592 (.77%)
Vomiting	591 (.77%)
Hypotension	579 (.75%)
Dehydration	548 (.71%)
Asthenia	541 (.7%)
Disease Progression	519 (.67%)
Renal Failure Acute	498 (.65%)
Multiple Myeloma	494 (.64%)
Infection	487 (.63%)
Deep Vein Thrombosis	474 (.62%)
Pancytopenia	468 (.61%)
Renal Failure	454 (.59%)
Pulmonary Embolism	445 (.58%)
Constipation	440 (.57%)
Neuropathy Peripheral	436 (.57%)
General Physical Health Deteriorati...	425 (.55%)
Confusional State	393 (.51%)
Atrial Fibrillation	389 (.5%)
Hyperglycaemia	388 (.5%)
Abdominal Pain	386 (.5%)
White Blood Cell Count Decreased	373 (.48%)
Pleural Effusion	360 (.47%)
Septic Shock	360 (.47%)
Respiratory Failure	357 (.46%)
Pain	304 (.39%)
Hyponatraemia	300 (.39%)
Rash	298 (.39%)
Dizziness	297 (.39%)
Chest Pain	290 (.38%)
Multi-organ Failure	282 (.37%)
Headache	278 (.36%)
Oedema Peripheral	275 (.36%)
Blood Creatinine Increased	269 (.35%)
Back Pain	268 (.35%)
Leukopenia	257 (.33%)
Hypokalaemia	255 (.33%)
Drug Ineffective	251 (.33%)
Neutrophil Count Decreased	242 (.31%)
Cough	230 (.3%)
Convulsion	228 (.3%)
Haemorrhage	228 (.3%)
Hypoxia	228 (.3%)
Alanine Aminotransferase Increased	226 (.29%)
Malaise	223 (.29%)
Condition Aggravated	222 (.29%)
Tachycardia	221 (.29%)
Hypertension	216 (.28%)
Mucosal Inflammation	214 (.28%)
Decreased Appetite	213 (.28%)
Fall	204 (.26%)
Muscular Weakness	204 (.26%)
Drug Interaction	203 (.26%)
Somnolence	202 (.26%)
Osteonecrosis	201 (.26%)
Cardiac Failure	199 (.26%)
Gastrointestinal Haemorrhage	196 (.25%)
Syncope	194 (.25%)
Aspartate Aminotransferase Increase...	193 (.25%)
Tumour Lysis Syndrome	192 (.25%)
Malignant Neoplasm Progression	191 (.25%)
Pain In Extremity	188 (.24%)
Lung Disorder	185 (.24%)
Arthralgia	183 (.24%)
Chills	181 (.23%)
Herpes Zoster	181 (.23%)
Blood Glucose Increased	180 (.23%)
Staphylococcal Infection	179 (.23%)
Myelodysplastic Syndrome	177 (.23%)
Cardiac Arrest	175 (.23%)
Hypocalcaemia	175 (.23%)
Thrombosis	174 (.23%)
Urinary Tract Infection	174 (.23%)
Drug Toxicity	171 (.22%)
Insomnia	171 (.22%)
Weight Decreased	171 (.22%)
Haematocrit Decreased	167 (.22%)
Cellulitis	164 (.21%)
C-reactive Protein Increased	163 (.21%)
Hypoaesthesia	155 (.2%)
Renal Impairment	150 (.19%)
Pulmonary Oedema	149 (.19%)
Mental Status Changes	147 (.19%)
Acute Respiratory Distress Syndrome	146 (.19%)
Blood Lactate Dehydrogenase Increas...	146 (.19%)
Atelectasis	145 (.19%)
Colitis	144 (.19%)
Agitation	143 (.19%)
International Normalised Ratio Incr...	142 (.18%)

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

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

Infections - Pathogen Unspecified	5313 (6.89%)
Hematology Investigations	2906 (3.77%)
Respiratory	2699 (3.5%)
Neurological	2612 (3.39%)
Gastrointestinal Signs	2234 (2.9%)
White Blood Cell	2170 (2.82%)
Bacterial Infectious	1803 (2.34%)
Cardiac Arrhythmias	1674 (2.17%)
Epidermal And Dermal Conditions	1673 (2.17%)
Electrolyte And Fluid Balance Condi...	1669 (2.17%)
Gastrointestinal Motility And Defec...	1508 (1.96%)
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Renal Disorders	1452 (1.88%)
Anemias Nonhemolytic And Marrow Dep...	1362 (1.77%)
Viral Infectious	1091 (1.42%)
Body Temperature Conditions	1085 (1.41%)
Lower Respiratory Tract Disorders	1078 (1.4%)
Hepatic And Hepatobiliary	1003 (1.3%)
Platelet	944 (1.22%)
Embolism And Thrombosis	885 (1.15%)
Fungal Infectious	875 (1.14%)
Hepatobiliary	855 (1.11%)
Decreased And Nonspecific Blood Pre...	827 (1.07%)
Central Nervous System Vascular	807 (1.05%)
Therapeutic And Nontherapeutic Effe...	742 (.96%)
Musculoskeletal And Connective Tiss...	723 (.94%)
Peripheral Neuropathies	717 (.93%)
Fatal Outcomes	698 (.91%)
Plasma Cell Neoplasms	648 (.84%)
Cardiac And Vascular Investigations	646 (.84%)
Gastrointestinal Hemorrhages	637 (.83%)
Glucose Metabolism Disorders	632 (.82%)
Gastrointestinal Inflammatory Condi...	616 (.8%)
Muscle	604 (.78%)
Deliria	563 (.73%)
Injuries	540 (.7%)
Bone Disorders	536 (.7%)
Appetite And General Nutritional	533 (.69%)
Pulmonary Vascular	532 (.69%)
Renal And Urinary Tract Investigati...	531 (.69%)
Gastrointestinal Ulceration And Per...	503 (.65%)
Water, Electrolyte And Mineral	478 (.62%)
Pleural	457 (.59%)
Movement Disorders	446 (.58%)
Metabolic, Nutritional And Blood Ga...	435 (.56%)
Leukemias	427 (.55%)
Bone, Calcium, Magnesium And Phosph...	419 (.54%)
Coronary Artery	418 (.54%)
Seizures	412 (.53%)
Heart Failures	409 (.53%)
Physical Examination Topics	408 (.53%)
Joint	398 (.52%)
Miscellaneous And Site Unspecified ...	392 (.51%)
Administration Site Reactions	380 (.49%)
Myocardial	373 (.48%)
Enzyme	366 (.47%)
Microbiology And Serology	349 (.45%)
Urinary Tract Signs	346 (.45%)
Vision	332 (.43%)
Anxiety Disorders	311 (.4%)
Vascular Hemorrhagic	307 (.4%)
Bone And Joint Injuries	304 (.39%)
Procedural And Device Related Injur...	303 (.39%)
Protein And Chemistry Analyses	301 (.39%)
Headaches	300 (.39%)
Coagulopathies And Bleeding Diathes...	298 (.39%)
Oral Soft Tissue Conditions	296 (.38%)
Encephalopathies	280 (.36%)
Hematological And Lymphoid Tissue T...	277 (.36%)
Chemical Injury And Poisoning	272 (.35%)
Vascular Hypertensive	260 (.34%)
Skin Appendage Conditions	250 (.32%)
Ocular Infections, Irritations And ...	247 (.32%)
Medication Errors	243 (.32%)
Peritoneal And Retroperitoneal Cond...	238 (.31%)
Sleep Disorders	222 (.29%)
Allergic Conditions	211 (.27%)
Cardiac Disorder Signs	211 (.27%)
Gastrointestinal Stenosis And Obstr...	199 (.26%)
Lifestyle Issues	196 (.25%)
Skin Vascular Abnormalities	194 (.25%)
Psychiatric	193 (.25%)
Mental Impairment	187 (.24%)
Upper Respiratory Tract Disorders	183 (.24%)
Vascular	181 (.23%)
Endocrine Investigations	179 (.23%)
Respiratory And Mediastinal Neoplas...	175 (.23%)
Therapeutic Procedures And Supporti...	175 (.23%)
Bronchial Disorders	174 (.23%)
Tissue	173 (.22%)
Depressed Mood Disorders	164 (.21%)
Anterior Eye Structural Change, Dep...	161 (.21%)
Immune	160 (.21%)
Adrenal Gland	159 (.21%)
Acid-base	155 (.2%)
Hematological	148 (.19%)
Ocular Neuromuscular	148 (.19%)
Metastases	142 (.18%)
Skin Neoplasms Malignant And Unspec...	141 (.18%)
Disturbances In Thinking	139 (.18%)
Skin And Subcutaneous Tissue	138 (.18%)
Eye	135 (.18%)

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