Drug Safety Information for MENTAX (Butenafine hydrochloride)

Adverse Drug Reactions for MENTAX* (Butenafine 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 MENTAX
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	76
2	Off label use	32
3	Drug effect decreased	19
4	Condition aggravated	18
5	Nausea	17
6	Fatigue	15
7	Dizziness	13
8	Drug ineffective for unapproved indication	12
9	Pruritus	12
10	Rash	12
11	Erythema	11
12	Decreased appetite	11
13	Pain	11
14	Diarrhoea	10
15	Anaemia	9
16	Arthralgia	9
17	Anxiety	8
18	Aspartate aminotransferase increased	8
19	Vomiting	8
20	Burning sensation	8

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	204
2	Tinea pedis	113
3	Tinea infection	62
4	Hypersensitivity	48
5	Onychomycosis	40
6	Tinea cruris	39
7	Diabetic neuropathy	34
8	Fungal skin infection	24
9	Fungal infection	20
10	Rash	20

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

Types of Adverse Events for MENTAX

Total Reports Filed with FDA: 1301

Number of FDA Adverse Event Reports by Patient Age for MENTAX

Total Reports Filed with FDA: 1301*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Butenafine hydrochloride (Lotrimin ultra, Mentax-tc, Butenafine, Mentax)

Charts are based on 1301 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.