Drug Safety Information for CLOXAPEN (Cloxacillin sodium)

Adverse Drug Reactions for CLOXAPEN* (Cloxacillin sodium)

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 CLOXAPEN
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Pyrexia	28
2	Drug interaction	21
3	Renal failure acute	18
4	Sepsis	17
5	Pancytopenia	15
6	Toxic epidermal necrolysis	13
7	Haemoglobin decreased	13
8	Staphylococcal infection	12
9	Dyspnoea	12
10	Pneumonia	12
11	Drug ineffective	11
12	Oedema peripheral	10
13	Pruritus	10
14	Erythema	9
15	Drug hypersensitivity	9
16	Blister	9
17	Rash	9
18	Eosinophilia	8
19	Renal failure	8
20	Hypotension	8

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	100
2	Staphylococcal infection	48
3	Infection	41
4	Erysipelas	36
5	Hordeolum	35
6	Arthritis bacterial	32
7	Upper respiratory tract infection	31
8	Beta haemolytic streptococcal infection	24
9	Pneumonia	23
10	Carbuncle	21

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

Types of Adverse Events for CLOXAPEN

Total Reports Filed with FDA: 1408

Number of FDA Adverse Event Reports by Patient Age for CLOXAPEN

Total Reports Filed with FDA: 1408*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cloxacillin sodium (Tegopen, Cloxacilina, Cloxacillin, Cloxacillin sodium, Cloxapen)

Charts are based on 1408 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.

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.