Drug Safety Information for SOLU-MEDROL (Methylprednisolone sodium succinate)

Safety-related Labeling Changes for SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) Rx Drug: FDA Link

Adverse Drug Reactions for SOLU-MEDROL* (Methylprednisolone sodium succinate)

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 SOLU-MEDROL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia921
2Dyspnoea821
3Nausea593
4Pain*569
5Pneumonia504
6Vomiting479
7Diarrhoea475
8Renal failure460
9Infusion related reaction448
10Fatigue443
11Hypotension401
12Headache*400
13Asthenia399
14Thrombocytopenia394
15Sepsis386
16Respiratory failure381
17Anxiety380
18Death378
19Drug ineffective375
20Rash373

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

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

Reason # of FDA Reports
1Premedication6292
2Product used for unknown indication4768
3Multiple sclerosis*1764
4Prophylaxis1127
5Asthma913
6Multiple sclerosis relapse*852
7Renal transplant829
8Ill-defined disorder443
9Interstitial lung disease437
10Immunosuppression368

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


Types of Adverse Events for SOLU-MEDROL

Total Reports Filed with FDA: 69792


Number of FDA Adverse Event Reports by Patient Age for SOLU-MEDROL

Total Reports Filed with FDA: 69792*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Methylprednisolone sodium succinate (A-methapred, Solu-medrol)

Charts are based on 69792 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 SOLU-MEDROL 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.