PREDNISOLONE
Prednisolone Adverse Events Reported to the FDA Over Time
How are Prednisolone adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Prednisolone, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Prednisolone is flagged as the suspect drug causing the adverse event.
Most Common Prednisolone Adverse Events Reported to the FDA
What are the most common Prednisolone 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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This graph shows the top adverse events submitted to the FDA for Prednisolone, 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 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
What are the most common Prednisolone adverse events reported to the FDA?
| Infections - Pathogen Unspecified | 5239 (7.54%) |
| Viral Infectious | 2288 (3.29%) |
| Respiratory | 2097 (3.02%) |
| Bacterial Infectious | 2068 (2.98%) |
| Fungal Infectious | 1817 (2.62%) |
| Hematology Investigations | 1591 (2.29%) |
| Gastrointestinal Signs | 1562 (2.25%) |
| Hepatic And Hepatobiliary | 1527 (2.2%) |
| Epidermal And Dermal Conditions | 1514 (2.18%) |
| Renal Disorders | 1462 (2.1%) |
| Neurological | 1419 (2.04%) |
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Share/Embed Graph Export Data
This graph shows the top categories of adverse events submitted to the FDA for Prednisolone, 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 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 According to Those Reporting Adverse Events
Why are people taking Prednisolone, according to those reporting adverse events to the FDA?
| Rheumatoid Arthritis | 7392 |
| Drug Use For Unknown Indication | 3210 |
| Product Used For Unknown Indication | 2234 |
| Renal Transplant | 1263 |
| Immunosuppression | 809 |
| Crohns Disease | 663 |
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Drug Labels
| Label | Labeler | Effective |
|---|---|---|
| Prednisolone Sodium Phosphate | Atlantic Biologicals Corps | 15-APR-09 |
| Millipred | Laser Pharmaceuticals, LLC | 01-SEP-09 |
| Prednisolone | Qualitest Pharmaceuticals | 17-SEP-09 |
| Prednisolone | Stat Rx USA | 27-OCT-09 |
| Veripred 20 | Hawthorne Pharmaceuticals, Inc. | 01-NOV-09 |
| Prednisolone Sodium Phosphate | Amneal Pharmaceuticals | 01-DEC-09 |
| Prednisolone | Physicians Total Care, Inc. | 05-JAN-10 |
| Prednisolone | ETHEX Corporation | 04-MAY-10 |
| Prednisolone Sodium Phosphate | Paddock Laboratories, Inc. | 09-JUN-10 |
| Prednisolone Sodium Phosphate | Hi-Tech Pharmacal Co., Inc. | 16-JUN-10 |
| Prednisolone Sodium Phosphate | Qualitest Pharmaceuticals | 01-SEP-10 |
| Prednisolone Sodium Phosphate | Bausch & Lomb Incorporated | 03-SEP-10 |
| Blephamide | Allergan, Inc. | 02-OCT-10 |
| Pred Mild | Allergan, Inc. | 08-OCT-10 |
| Prednisolone Sodium Phosphate | Butler Animal Health Supply | 04-NOV-10 |
| Prednisolone Sodium Phosphate | MWI/VetOne | 04-NOV-10 |
| Prednisolone | Rebel Distributors Corp | 10-NOV-10 |
| Sulfacetamide Sodium And Prednisolone Sodium Phosphate | Rebel Distributors Corp | 26-JAN-11 |
| Sulfacetamide Sodium And Prednisolone Sodium Phosphate | Bausch & Lomb Incoporated | 02-FEB-11 |
| Prednisolone | Preferred Pharmaceuticals, Inc | 11-JUL-11 |
| Prednisolone Acetate | Falcon Pharmaceuticals | 20-JUL-11 |
| Prednisolone Acetate | Pacific Pharma, Inc. | 22-JUL-11 |
| Pred-g | Allergan, Inc. | 22-JUL-11 |
| Omnipred | Alcon Laboratories, Inc. | 28-JUL-11 |
| Sulfacetamide Sodium And Prednisolone Sodium Phosphate | Falcon Pharmaceuticals, Ltd. | 08-AUG-11 |
| Prednisolone | Dispensing Solutions, Inc. | 03-OCT-11 |
| Prednisolone Acetate | H.J. Harkins Company, Inc. | 17-NOV-11 |
| Prednisolone Sodium Phosphate | Rebel Distributors Corp | 27-DEC-11 |
| Flo-pred | Taro Pharmaceuticals U.S.A., Inc. | 02-JAN-12 |
| Blephamide | Allergan, Inc. | 12-JAN-12 |
| Pred Forte | Allergan, Inc. | 20-JAN-12 |
| Prednisolone Sodium Phosphate | Morton Grove Pharmaceuticals, Inc. | 31-JAN-12 |
| Blephamide | Physicians Total Care, Inc. | 04-MAR-12 |
| Pred Mild | Preferred Pharmaceuticals, Inc | 05-MAR-12 |
| Prednisolone | Hi-Tech Pharmacal Co., Inc. | 02-APR-12 |
| Pred-g | Allergan, Inc. | 11-APR-12 |
| Prednisolone Sodium Phosphate | Physicians Total Care, Inc. | 16-MAY-12 |
| Prednisolone Sodium Phosphate | Pharmaceutical Associates, Inc. | 18-JUL-12 |
| Prednisolone Sodium Phosphate | Upstate Pharma, LLC | 29-AUG-12 |
| Pediapred | UCB Manufacturing, Inc. | 30-AUG-12 |
| Prednisolone Sodium Phosphate Oral Solution | Mission Pharmacal Company | 18-SEP-12 |
| Prednisolone Sodium Phosphate | Seton Pharmaceuticals | 11-OCT-12 |
| Prednisolone | Teva Pharmaceuticals USA Inc | 19-OCT-12 |
| Prednisolone Acetate | Preferred Pharmaceuticals, Inc. | 23-OCT-12 |
| Prednisolone Acetate | Physicians Total Care, Inc. | 23-OCT-12 |
| Orapredodt | Shionogi Inc. | 29-OCT-12 |
| Pred Mild | Physicians Total Care, Inc. | 02-JAN-13 |
| Prednisolone Sodium Phosphate | Cardinal Health | 15-MAR-13 |
| Prednisolone Acetate | REMEDYREPACK INC. | 12-APR-13 |
Prednisolone Case Reports
What Prednisolone safety concerns are being reported by doctors and researchers in the medical literature?
About Results
This report contains aggregated drug side effects and adverse events for Prednisolone. 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.
Comments
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