Drug Safety Information for ALBENZA (Albendazole)

Safety-related Labeling Changes for ALBENZA (ALBENDAZOLE) Rx Drug: FDA Link

Adverse Drug Reactions for ALBENZA* (Albendazole)

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 ALBENZA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Vomiting	103
2	Pyrexia	86
3	Asthenia	84
4	Headache*	75
5	Diarrhoea	60
6	Death	50
7	Nausea	44
8	Abdominal pain	43
9	Dizziness	38
10	Drug ineffective	30
11	Convulsion	30
12	Dehydration	30
13	Vision blurred	27
14	Somnolence	26
15	Decreased appetite	26
16	Stevens-johnson syndrome	25
17	Anaemia	25
18	Gastritis	24
19	Pancytopenia	24
20	Loss of consciousness	23

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

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

	Reason	# of FDA Reports
1	Filariasis lymphatic	400
2	Helminthic infection	276
3	Product used for unknown indication	238
4	Onchocerciasis	184
5	Echinococciasis	169
6	Strongyloidiasis	155
7	Infection parasitic	138
8	Toxocariasis	60
9	Ascariasis	60
10	Abdominal pain	53

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

Types of Adverse Events for ALBENZA

Total Reports Filed with FDA: 3529

Number of FDA Adverse Event Reports by Patient Age for ALBENZA

Total Reports Filed with FDA: 3529*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Albendazole (Eskazole, Zentel, Albenza)

Charts are based on 3529 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.