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ALBENDAZOLE

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Albendazole Adverse Events Reported to the FDA Over Time

How are Albendazole adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Albendazole, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Albendazole is flagged as the suspect drug causing the adverse event.

Most Common Albendazole Adverse Events Reported to the FDA

What are the most common Albendazole adverse events reported to the FDA?

Vomiting
67 (4.26%)
Pyrexia
38 (2.42%)
Asthenia
31 (1.97%)
Death
30 (1.91%)
Headache
30 (1.91%)
Dizziness
25 (1.59%)
Somnolence
24 (1.53%)
Diarrhoea
23 (1.46%)
Gastritis
23 (1.46%)
Drug Exposure During Pregnancy
22 (1.4%)
Stevens-johnson Syndrome
22 (1.4%)
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Loss Of Consciousness
19 (1.21%)
Rash
19 (1.21%)
Abdominal Pain
18 (1.15%)
Dehydration
17 (1.08%)
Convulsion
16 (1.02%)
Vision Blurred
16 (1.02%)
Gastroenteritis
14 (.89%)
Nausea
14 (.89%)
Sedation
14 (.89%)
Encephalopathy
13 (.83%)
Conjunctival Hyperaemia
12 (.76%)
Pruritus Generalised
12 (.76%)
Ocular Hyperaemia
11 (.7%)
Palpitations
11 (.7%)
Sepsis
11 (.7%)
Strongyloidiasis
11 (.7%)
Depressed Level Of Consciousness
10 (.64%)
Oedema Peripheral
10 (.64%)
Toxic Epidermal Necrolysis
10 (.64%)
Abortion Spontaneous
9 (.57%)
Hepatitis
9 (.57%)
Mouth Ulceration
9 (.57%)
Back Pain
8 (.51%)
Chills
8 (.51%)
Conjunctival Haemorrhage
8 (.51%)
Dyspnoea
8 (.51%)
Haematemesis
8 (.51%)
Jaundice
8 (.51%)
Oral Pain
8 (.51%)
Pruritus
8 (.51%)
Skin Lesion
8 (.51%)
Swelling Face
8 (.51%)
Abdominal Pain Upper
7 (.45%)
Abortion Induced
7 (.45%)
Adverse Drug Reaction
7 (.45%)
Alanine Aminotransferase Increased
7 (.45%)
Arthralgia
7 (.45%)
Cardiac Arrest
7 (.45%)
Gait Disturbance
7 (.45%)
Hypovolaemic Shock
7 (.45%)
Muscular Weakness
7 (.45%)
Pain
7 (.45%)
Renal Failure Acute
7 (.45%)
Transaminases Increased
7 (.45%)
Vertigo
7 (.45%)
Visual Acuity Reduced
7 (.45%)
Aspartate Aminotransferase Increase...
6 (.38%)
Asphyxia
6 (.38%)
Cheilitis
6 (.38%)
Coma
6 (.38%)
Condition Aggravated
6 (.38%)
Decreased Appetite
6 (.38%)
Drug Ineffective
6 (.38%)
Dysarthria
6 (.38%)
Epilepsy
6 (.38%)
Eye Pruritus
6 (.38%)
Hepatotoxicity
6 (.38%)
Oedema
6 (.38%)
Overdose
6 (.38%)
Pancytopenia
6 (.38%)
Pitting Oedema
6 (.38%)
Restlessness
6 (.38%)
Septic Shock
6 (.38%)
Shock
6 (.38%)
Skin Exfoliation
6 (.38%)
Syncope
6 (.38%)
Urinary Incontinence
6 (.38%)
Anorexia
5 (.32%)
Cyanosis
5 (.32%)
Drug Interaction
5 (.32%)
Erythema
5 (.32%)
Fatigue
5 (.32%)
Glossitis
5 (.32%)
Hyperhidrosis
5 (.32%)
Hypersensitivity
5 (.32%)
Lethargy
5 (.32%)
Lymphadenopathy
5 (.32%)
Malaise
5 (.32%)
Ocular Icterus
5 (.32%)
Odynophagia
5 (.32%)
Thrombocytopenia
5 (.32%)
Abdominal Distension
4 (.25%)
Abnormal Behaviour
4 (.25%)
Anaemia
4 (.25%)
Blindness Unilateral
4 (.25%)
Blister
4 (.25%)
Blood Electrolytes Abnormal
4 (.25%)
Brain Oedema
4 (.25%)
Choking
4 (.25%)
Confusional State
4 (.25%)

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This graph shows the top adverse events submitted to the FDA for Albendazole, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Albendazole is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Albendazole

What are the most common Albendazole adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Albendazole, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Albendazole is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Albendazole According to Those Reporting Adverse Events

Why are people taking Albendazole, according to those reporting adverse events to the FDA?

Filariasis Lymphatic
68
Product Used For Unknown Indication
54
Helminthic Infection
51
Strongyloidiasis
21
Drug Use For Unknown Indication
16
Infection Parasitic
13
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Echinococciasis
11
Onchocerciasis
11
Therapeutic Procedure
5
Toxocariasis
5
Neurocysticercosis
4
Taeniasis
4
Ascariasis
3
Hepatic Echinococciasis
2
Microsporidia Infection
2
Tremor
2
Abdominal Pain
2
Paraesthesia
2
Visceral Larva Migrans
2
Parasitic Infection Prophylaxis
2
Prophylaxis
1
Infection
1
Infestation
1
Colitis
1
Cholestasis
1
Dehydration
1
Streptococcal Bacteraemia
1
Cutaneous Larva Migrans
1
Brain Neoplasm
1
Proteus Infection
1
Enterobacter Bacteraemia
1
Enterobiasis
1
Nervous System Disorder
1
Pruritus
1
Drug Exposure During Pregnancy
1
Hepatic Cyst
1
Cestode Infection
1
Parasitic Infection Intestinal
1
Ascites
1
Sydenhams Chorea
1
Parasite Stool Test Positive
1

Drug Labels

LabelLabelerEffective
AlbenzaAmedra Pharmaceuticals22-DEC-11
AlbenzaPreferred Pharmaceuticals, Inc03-OCT-12

Albendazole Case Reports

What Albendazole safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Albendazole. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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