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PREDNISOLONE ACETATE

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Prednisolone Acetate Adverse Events Reported to the FDA Over Time

How are Prednisolone Acetate adverse event reports trending over time?

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

Most Common Prednisolone Acetate Adverse Events Reported to the FDA

What are the most common Prednisolone Acetate adverse events reported to the FDA?

Pyrexia
974 (1.4%)
Pneumonia
794 (1.14%)
Sepsis
683 (.98%)
Pneumocystis Jiroveci Pneumonia
626 (.9%)
Anaemia
494 (.71%)
Drug Ineffective
472 (.68%)
Cytomegalovirus Infection
470 (.68%)
Diarrhoea
441 (.63%)
Renal Impairment
429 (.62%)
Respiratory Failure
421 (.61%)
Neutropenia
402 (.58%)
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Vomiting
386 (.56%)
Dyspnoea
372 (.54%)
Condition Aggravated
364 (.52%)
Nausea
353 (.51%)
Interstitial Lung Disease
338 (.49%)
Herpes Zoster
328 (.47%)
Pleural Effusion
322 (.46%)
Blood Creatinine Increased
309 (.44%)
Febrile Neutropenia
308 (.44%)
Multi-organ Failure
304 (.44%)
Renal Failure Acute
301 (.43%)
Urinary Tract Infection
300 (.43%)
Hypertension
298 (.43%)
Pancytopenia
296 (.43%)
Septic Shock
286 (.41%)
Haemoglobin Decreased
282 (.41%)
Drug Interaction
276 (.4%)
Thrombocytopenia
273 (.39%)
Disseminated Intravascular Coagulat...
271 (.39%)
Renal Failure
266 (.38%)
Infection
264 (.38%)
General Physical Health Deteriorati...
249 (.36%)
Malaise
247 (.36%)
Leukopenia
244 (.35%)
Gastrointestinal Haemorrhage
242 (.35%)
Headache
240 (.35%)
Hepatic Function Abnormal
238 (.34%)
Drug Exposure During Pregnancy
235 (.34%)
Diabetes Mellitus
234 (.34%)
Abdominal Pain
230 (.33%)
C-reactive Protein Increased
228 (.33%)
Cardiac Failure
222 (.32%)
Cough
221 (.32%)
Platelet Count Decreased
220 (.32%)
Rash
220 (.32%)
Hypotension
202 (.29%)
Alanine Aminotransferase Increased
199 (.29%)
Back Pain
198 (.29%)
Staphylococcal Infection
194 (.28%)
White Blood Cell Count Decreased
194 (.28%)
Osteonecrosis
193 (.28%)
Oedema Peripheral
190 (.27%)
Arthralgia
186 (.27%)
Liver Disorder
182 (.26%)
Transplant Rejection
182 (.26%)
Dehydration
180 (.26%)
Basal Cell Carcinoma
178 (.26%)
Cellulitis
177 (.25%)
Decreased Appetite
177 (.25%)
Fatigue
172 (.25%)
Asthenia
168 (.24%)
Weight Decreased
164 (.24%)
Blood Lactate Dehydrogenase Increas...
163 (.23%)
Death
163 (.23%)
Pulmonary Embolism
161 (.23%)
Acute Respiratory Distress Syndrome
159 (.23%)
Dizziness
159 (.23%)
Aspartate Aminotransferase Increase...
158 (.23%)
Hepatitis B
157 (.23%)
Visual Acuity Reduced
152 (.22%)
Muscular Weakness
151 (.22%)
Aspergillosis
150 (.22%)
Ascites
149 (.21%)
Melaena
148 (.21%)
Pain
146 (.21%)
Gastric Ulcer
145 (.21%)
Deep Vein Thrombosis
144 (.21%)
Tachycardia
143 (.21%)
Tendon Rupture
143 (.21%)
White Blood Cell Count Increased
143 (.21%)
Haemodialysis
141 (.2%)
Weight Increased
139 (.2%)
Disease Progression
138 (.2%)
Fall
138 (.2%)
Pain In Extremity
137 (.2%)
Atrial Fibrillation
132 (.19%)
Hyperglycaemia
132 (.19%)
Bronchopulmonary Aspergillosis
131 (.19%)
Lymphoproliferative Disorder
131 (.19%)
Disease Recurrence
130 (.19%)
Hypogammaglobulinaemia
130 (.19%)
Peritonitis
130 (.19%)
Bronchiectasis
129 (.19%)
Lymphadenopathy
128 (.18%)
Osteoporosis
127 (.18%)
Cardiac Arrest
124 (.18%)
Graft Versus Host Disease
124 (.18%)
Hepatic Failure
123 (.18%)
Abdominal Pain Upper
122 (.18%)
Convulsion
122 (.18%)

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

What are the most common Prednisolone Acetate adverse events reported to the FDA?

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

Common Uses of Prednisolone Acetate According to Those Reporting Adverse Events

Why are people taking Prednisolone Acetate, according to those reporting adverse events to the FDA?

Rheumatoid Arthritis
7391
Drug Use For Unknown Indication
3208
Product Used For Unknown Indication
2231
Renal Transplant
1263
Immunosuppression
809
Crohns Disease
663
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Diffuse Large B-cell Lymphoma
612
Systemic Lupus Erythematosus
523
Non-hodgkins Lymphoma
515
Colitis Ulcerative
399
Asthma
393
Prostate Cancer
375
B-cell Lymphoma
373
Multiple Myeloma
369
Prostate Cancer Metastatic
325
Prophylaxis Against Transplant Reje...
315
Chronic Obstructive Pulmonary Disea...
278
Acute Lymphocytic Leukaemia
274
Interstitial Lung Disease
258
Idiopathic Thrombocytopenic Purpura
234
Juvenile Arthritis
234
Premedication
230
Lupus Nephritis
210
Immunosuppressant Drug Therapy
207
Prophylaxis
206
Lymphoma
193
Nephrotic Syndrome
187
Prophylaxis Against Graft Versus Ho...
182
Graft Versus Host Disease
175
Polymyalgia Rheumatica
167
Liver Transplant
163
Heart Transplant
157
Hodgkins Disease
156
Arthritis
153
Wegeners Granulomatosis
152
Postoperative Care
150
Psoriatic Arthropathy
148
Burkitts Lymphoma
144
Lung Transplant
123
Myasthenia Gravis
117
Inflammation
112
Dermatomyositis
108
Behcets Syndrome
108
Uveitis
100
Temporal Arteritis
96
Ill-defined Disorder
94
Chemotherapy
92
Musculoskeletal Pain
85
Polyarthritis
84
Chronic Lymphocytic Leukaemia
84
Aplastic Anaemia
80

Drug Labels

LabelLabelerEffective
BlephamideAllergan, Inc.02-OCT-10
Pred MildAllergan, Inc.08-OCT-10
Prednisolone AcetateFalcon Pharmaceuticals20-JUL-11
Prednisolone AcetatePacific Pharma, Inc.22-JUL-11
Pred-gAllergan, Inc.22-JUL-11
OmnipredAlcon Laboratories, Inc.28-JUL-11
Prednisolone AcetateH.J. Harkins Company, Inc.17-NOV-11
Flo-predTaro Pharmaceuticals U.S.A., Inc.02-JAN-12
BlephamideAllergan, Inc.12-JAN-12
Pred ForteAllergan, Inc.20-JAN-12
BlephamidePhysicians Total Care, Inc.04-MAR-12
Pred MildPreferred Pharmaceuticals, Inc05-MAR-12
Pred-gAllergan, Inc.11-APR-12
Prednisolone AcetatePreferred Pharmaceuticals, Inc.23-OCT-12
Prednisolone AcetatePhysicians Total Care, Inc.23-OCT-12
Pred MildPhysicians Total Care, Inc.02-JAN-13
Prednisolone AcetateREMEDYREPACK INC. 12-APR-13

Prednisolone Acetate Case Reports

What Prednisolone Acetate safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Prednisolone Acetate. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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