Drug Safety Information for DECADRON (Dexamethasone)

Safety-related Labeling Changes for DECADRON (DEXAMETHASONE) Brand name discontinued; available as generic: FDA Link

Safety-related Labeling Changes for MAXIDEX (DEXAMETHASONE) Rx Drug: FDA Link

Safety-related Labeling Changes for OZURDEX (DEXAMETHASONE) Rx Drug: FDA Link

Safety-related Labeling Changes for MAXITROL (DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE) Rx Drug: FDA Link

Safety-related Labeling Changes for TOBRADEX (DEXAMETHASONE; TOBRAMYCIN) Rx Drug: FDA Link

Safety-related Labeling Changes for TOBRADEX ST (DEXAMETHASONE; TOBRAMYCIN) Rx Drug: FDA Link

Adverse Drug Reactions for DECADRON* (Dexamethasone)

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 DECADRON
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Death4175
2Nausea3797
3Diarrhoea3707
4Fatigue3671
5Dyspnoea3548
6Pneumonia3504
7Pyrexia3453
8Vomiting3172
9Neutropenia2859
10Anaemia2761
11Asthenia2741
12Thrombocytopenia2636
13Disease progression2343
14Dehydration2289
15Platelet count decreased2073
16Sepsis2048
17Febrile neutropenia2037
18Pain*1980
19Neuropathy peripheral1940
20Hypotension1903

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

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

Reason # of FDA Reports
1Multiple myeloma41940
2Product used for unknown indication21159
3Premedication9733
4Prophylaxis5195
5Acute lymphocytic leukaemia4457
6Prophylaxis of nausea and vomiting2510
7Nausea1451
8Mantle cell lymphoma1413
9Metastases to central nervous system1252
10Amyloidosis1220

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


Types of Adverse Events for DECADRON

Total Reports Filed with FDA: 314237


Number of FDA Adverse Event Reports by Patient Age for DECADRON

Total Reports Filed with FDA: 314237*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Dexamethasone (Decaspray, Dexone 4, Dexone 1.5, Aeroseb-dex, Neopolydex, Hexadrol, Dexone 0.5, Ozurdex, Ak-trol, Dexone 0.75, Baycadron, Dexpak, Oradexon, Dexone, Zema pak, Decadron phosphate, Dexasone, Millicorten, Dalalone, Deca, Decaderm, Hexadrol phosphate, Maxidex, Decadron, Dexamethasone)

Charts are based on 314237 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 DECADRON 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.