Drug Safety Information for MEDROL ACETATE (Methylprednisolone acetate)

Safety-related Labeling Changes for DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) Rx Drug: FDA Link

Adverse Drug Reactions for MEDROL ACETATE* (Methylprednisolone acetate)

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 MEDROL ACETATE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
6Pain in extremity129
9Drug ineffective*115
13Back pain97
16Off label use85
17Chest pain82
19Oedema peripheral80

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

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

Reason # of FDA Reports
1Product used for unknown indication530
2Back pain406
3Rheumatoid arthritis*364
5Intervertebral disc protrusion218
8Spinal column stenosis160
10Acute lymphocytic leukaemia156

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

Types of Adverse Events for MEDROL ACETATE

Total Reports Filed with FDA: 16149

Number of FDA Adverse Event Reports by Patient Age for MEDROL ACETATE

Total Reports Filed with FDA: 16149*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Methylprednisolone acetate (M-predrol, Depo-medrol, Hybrisil, Depo-medrone, Medrol acetate)

Charts are based on 16149 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 MEDROL ACETATE 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.

Visit   DrugInformer.com more on MEDROL ACETATE's side effects.