Drug Safety Information for PREDNISONE INTENSOL (Prednisone)

Safety-related Labeling Changes for RAYOS (PREDNISONE) Rx Drug: FDA Link

Adverse Drug Reactions for PREDNISONE INTENSOL* (Prednisone)

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 PREDNISONE INTENSOL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
2Drug ineffective5974
13Pain in extremity3369
16Oedema peripheral3236
17Injection site pain3231
19Abdominal pain3002

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

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

Reason # of FDA Reports
1Product used for unknown indication58713
2Rheumatoid arthritis*32730
3Crohn's disease*9946
4Renal transplant7688
5Multiple myeloma6101
6Diffuse large b-cell lymphoma5136
9Systemic lupus erythematosus4018

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

Types of Adverse Events for PREDNISONE INTENSOL

Total Reports Filed with FDA: 568586

Number of FDA Adverse Event Reports by Patient Age for PREDNISONE INTENSOL

Total Reports Filed with FDA: 568586*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Prednisone (Servisone, Dacortin, Paracort, Fernisone, Predni tablinen, Delta-dome, Apo-prednisone, Liquid pred, Prednicot, Cutason, Sone, Prednicen-m, Perrigo prednisone, Prednisone intensol, Meticorten, Encorton, Sterapred ds, Cortancyl, Rectodelt, Ultracorten, Sterapred, Panafcort, Prednison hexal, Rayos, Cortan, Orasone, Prednisone, Deltasone)

Charts are based on 568586 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 PREDNISONE INTENSOL Reviews and Review Summary .

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.

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