Drug Safety Information for PREDNISOLONE (Prednisolone)

Safety-related Labeling Changes for BLEPHAMIDE (PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for PRED FORTE (PREDNISOLONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for PRED MILD (PREDNISOLONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for OMNIPRED (PREDNISOLONE ACETATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ORAPRED ODT (PREDNISOLONE SODIUM PHOSPHATE) Rx Drug: FDA Link

Safety-related Labeling Changes for FLO-PRED (PREDNISOLONE ACETATE) Discontinued Drug: FDA Link

Adverse Drug Reactions for PREDNISOLONE* (Prednisolone)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with PREDNISOLONE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia3067
2Pneumonia2414
3Dyspnoea1903
4Sepsis1695
5Diarrhoea1694
6Drug ineffective1555
7Nausea1505
8Anaemia1449
9Vomiting1425
10Interstitial lung disease1395
11Malaise1325
12Condition aggravated1310
13Rash1234
14Drug interaction1159
15Platelet count decreased1157
16Respiratory failure1136
17Headache1112
18Renal impairment1053
19Alanine aminotransferase increased1017
20Arthralgia963

* This side effect also appears in "Top 10 Side Effects of PREDNISOLONE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking PREDNISOLONE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Rheumatoid arthritis*23009
2Product used for unknown indication18968
3Renal transplant6002
4Immunosuppression3750
5Systemic lupus erythematosus*2237
6Diffuse large b-cell lymphoma2096
7Crohn's disease*2069
8Asthma1816
9Multiple myeloma1672
10Prophylaxis against transplant rejection1436

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for PREDNISOLONE

Total Reports Filed with FDA: 218290


Number of FDA Adverse Event Reports by Patient Age for PREDNISOLONE

Total Reports Filed with FDA: 218290*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Prednisolone (Predonine, Sterane, Meti-derm, Cortalone, Fernisolone-p, Predfoam, Di-adreson-f, Minims prednisolone, Prednisolone, Predsol, Prednesol, Codelsol, Prednisol, Millipred, Delta-cortef, Econopred plus, Prelone)

Charts are based on 218290 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and PREDNISOLONE Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.