Drug Safety Information for VANCOCIN HYDROCHLORIDE (Vancomycin hydrochloride)

FDA Safety-related Labeling Changes for VANCOCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER (VANCOMYCIN HYDROCHLORIDE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for VANCOCIN HYDROCHLORIDE* (Vancomycin hydrochloride)

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 VANCOCIN HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia*1802
2Renal failure acute1563
3Renal failure1428
4Death1128
5Hypotension1057
6Sepsis1052
7Pain*1040
8Rash*947
9Multi-organ failure922
10Pneumonia911
11Diarrhoea863
12Thrombocytopenia856
13Anxiety822
14Renal impairment784
15Dyspnoea771
16Nausea*743
17Injury734
18Blood creatinine increased680
19Anaemia660
20Vomiting636

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

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

Reason # of FDA Reports
1Product used for unknown indication12055
2Staphylococcal infection*2644
3Infection*2188
4Cellulitis1411
5Pneumonia1405
6Sepsis1405
7Pyrexia1000
8Endocarditis892
9Clostridial infection869
10Prophylaxis855

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


Types of Adverse Events for VANCOCIN HYDROCHLORIDE

Total Reports Filed with FDA: 115536


Number of FDA Adverse Event Reports by Patient Age for VANCOCIN HYDROCHLORIDE

Total Reports Filed with FDA: 115536*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Vancomycin hydrochloride (Vancocin hcl, Vancomycin hcl, Vancocine, Vancomycin, Vanco, Vancocin, Vancomicina, Vancor, Vancoled)

Charts are based on 115536 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.

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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.