Drug Safety Information for SILVADENE (Silver sulfadiazine)

Safety-related Labeling Changes for SILVADENE (SILVER SULFADIAZINE) Rx Drug: FDA Link

Adverse Drug Reactions for SILVADENE* (Silver sulfadiazine)

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 SILVADENE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain61
2Nausea60
3Dyspnoea53
4Anxiety51
5Drug hypersensitivity49
6Asthenia47
7Rash47
8Anaemia43
9Fatigue42
10Diarrhoea41
11Vomiting41
12Dizziness38
13Skin ulcer35
14Renal failure acute35
15Cellulitis35
16Injury34
17Back pain34
18Sepsis33
19Oedema peripheral32
20Cardiac failure congestive31

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

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

Reason # of FDA Reports
1Product used for unknown indication456
2Thermal burn133
3Wound93
4Localised infection55
5Skin ulcer46
6Open wound29
7Decubitus ulcer26
8Infection24
9Rash19
10Post procedural infection19

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


Types of Adverse Events for SILVADENE

Total Reports Filed with FDA: 5945


Number of FDA Adverse Event Reports by Patient Age for SILVADENE

Total Reports Filed with FDA: 5945*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Silver sulfadiazine (Sildaflo, Silver sulfadiazene, Ssd af, Ssd cream, Silver sulfadiazine, Flamazine, Flammazine, Ssd, Silvadene, Thermazene)

Charts are based on 5945 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 SILVADENE 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.