Drug Safety Information for VERMOX (Mebendazole)

Safety-related Labeling Changes for VERMOX (MEBENDAZOLE) Rx Drug: FDA Link

Adverse Drug Reactions for VERMOX* (Mebendazole)

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 VERMOX
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Nausea	26
2	Vomiting	25
3	Abdominal pain	20
4	Drug ineffective	17
5	Dizziness	16
6	Pyrexia	16
7	Asthenia	12
8	Self injurious behaviour	12
9	Pain	12
10	Pruritus	12
11	Convulsion	12
12	Hypersensitivity	11
13	Pain in extremity	11
14	Dyspnoea	11
15	Headache	11
16	Abortion spontaneous	11
17	Hypertension	10
18	Off label use	10
19	Abdominal pain upper	10
20	Urticaria	9

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	246
2	Enterobiasis	146
3	Helminthic infection	118
4	Echinococciasis	84
5	Hepatic echinococciasis	36
6	Nematodiasis	26
7	Infection parasitic	21
8	Hookworm infection	19
9	Maternal exposure during pregnancy	18
10	Prophylaxis	18

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

Types of Adverse Events for VERMOX

Total Reports Filed with FDA: 1550

Number of FDA Adverse Event Reports by Patient Age for VERMOX

Total Reports Filed with FDA: 1550*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Mebendazole (Vermox, Telmin, Mebendazole)

Charts are based on 1550 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.