Albenza (Albendazole) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The adverse event profile of albendazole differs between hydatid disease and neurocysticercosis. Adverse events occurring with a frequency of ≥1% in either disease are described in the table below.

These symptoms were usually mild and resolved without treatment. Treatment discontinuations were predominantly due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease). The following incidence reflects events that were reported by investigators to be at least possibly or probably related to albendazole.

Adverse Event Incidence ≥1% in Hydatid Disease and Neurocysticercosis

Adverse Event	Hydatid Disease	Neurocysticercosis
Abnormal Liver Function Tests	15.6	<1.0
Abdominal Pain	6.0	0
Nausea/Vomiting	3.7	6.2
Headache	1.3	11.0
Dizziness/Vertigo	1.2	<1.0
Raised Intracranial Pressure	0	1.5
Meningeal Signs	0	1.0
Reversible Alopecia	1.6	<1.0
Fever	1.0	0

The following adverse events were observed at an incidence of <1%:

Blood and Lymphatic System Disorders

Leukopenia. There have been rare reports of granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia (see WARNINGS). Patients with liver disease, including hepatic echinococcosis, appear to be more at risk of bone marrow suppression (see WARNINGS and PRECAUTIONS).

Immune System Disorders

Hypersensitivity reactions, including rash and urticaria.

Postmarketing Adverse Reactions

In addition to adverse events reported from clinical trials, the following events have been identified during world-wide post-approval use of ALBENZA. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to ALBENZA.

Blood and Lymphatic System Disorders

Aplastic anemia, bone marrow suppression, neutropenia.

Hepatobiliary Disorders

Elevations of hepatic enzymes, hepatitis, acute liver failure.

Skin and Subcutaneous Tissue Disorders

Erythema multiforme, Stevens-Johnson syndrome.

Renal and Urinary Disorders

Acute renal failure.

REPORTS OF SUSPECTED ALBENZA SIDE EFFECTS / ADVERSE REACTIONS

Possible Albenza side effects / adverse reactions in 45 year old female

Reported by a individual with unspecified qualification from France on 2012-01-18

Patient: 45 year old female

Reactions: Pco2 Decreased, Abdominal Pain, Autoimmune Hepatitis, Blood PH Decreased, Hepatic Failure, Cholestasis, Prothrombin Time Prolonged, Serum Ferritin Increased, Coagulation Factor V Level Decreased, Liver Transplant, Hepatic Calcification, Hepatitis A Antibody Positive, Schistosoma Test Positive, Blood Sodium Increased, Antineutrophil Cytoplasmic Antibody Positive, Hepatitis Fulminant, Klebsiella Sepsis, Back Pain, Vomiting, Drug Hypersensitivity, Strongyloidiasis, Transferrin Saturation Increased, Blood Chloride Increased, Protein Total Decreased, Anastomotic Stenosis, Blood Lactic Acid Increased, Haemoglobin Decreased, Blood Potassium Decreased, Platelet Count Decreased, PO2 Increased

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Acetaminophen
    Dosage: 1000-1500 mg qd;po ; 1000 mg;qd;po ; 500 mg;tid;po
    Administration route: Oral
    Indication: Back Pain
    Start date: 2006-08-01

Acetaminophen
    Dosage: 1000-1500 mg qd;po ; 1000 mg;qd;po ; 500 mg;tid;po
    Administration route: Oral
    Indication: Back Pain
    Start date: 2006-05-31
    End date: 2006-06-02

Acetaminophen
    Dosage: 1000-1500 mg qd;po ; 1000 mg;qd;po ; 500 mg;tid;po
    Administration route: Oral
    Indication: Back Pain
    Start date: 2006-07-01

Acetaminophen
    Dosage: 1000-1500 mg qd;po ; 1000 mg;qd;po ; 500 mg;tid;po
    Administration route: Oral
    Indication: Back Pain
    Start date: 2006-08-01

Albenza
    Dosage: po ; qd;po
    Administration route: Oral
    Indication: Abdominal Pain
    Start date: 2006-06-21
    End date: 2006-06-21

Albenza
    Dosage: po ; qd;po
    Administration route: Oral
    Indication: Strongyloidiasis
    Start date: 2006-06-21
    End date: 2006-06-21

Albenza
    Dosage: po ; qd;po
    Administration route: Oral
    Indication: Abdominal Pain
    Start date: 2006-08-01
    End date: 2006-08-01

Albenza
    Dosage: po ; qd;po
    Administration route: Oral
    Indication: Strongyloidiasis
    Start date: 2006-08-01
    End date: 2006-08-01

Albenza
    Dosage: po ; qd;po
    Administration route: Oral
    Indication: Abdominal Pain
    Start date: 2006-08-18
    End date: 2006-08-20

Albenza
    Dosage: po ; qd;po
    Administration route: Oral
    Indication: Strongyloidiasis
    Start date: 2006-08-18
    End date: 2006-08-20

Meloxicam
    Dosage: 15 mg;po ; po
    Administration route: Oral
    Indication: Pain
    Start date: 2006-07-01

Meloxicam
    Dosage: 15 mg;po ; po
    Administration route: Oral
    Indication: Pain
    Start date: 2006-05-31
    End date: 2006-06-02

Omeprazole
    Start date: 2006-05-31
    End date: 2006-06-02

Other drugs received by patient: Antihistamine

Possible Albenza side effects / adverse reactions in 70 year old female

Reported by a consumer/non-health professional from United States on 2012-04-23

Patient: 70 year old female weighing 65.8 kg (144.7 pounds)

Reactions: Blood Pressure Increased, Diplopia, Speech Disorder, Fatigue, Nausea, Aphasia, Dyskinesia, Dizziness, Asthenia, Loss of Consciousness

Suspect drug(s):
Albenza

Other drugs received by patient: Lipitor; Aspirin; Plavix

Possible Albenza side effects / adverse reactions in 70 year old female

Reported by a consumer/non-health professional from United States on 2012-05-08

Patient: 70 year old female weighing 65.8 kg (144.7 pounds)

Reactions: Sinus Polyp, Nausea, Dyskinesia, Aphasia, Supraventricular Tachycardia, Headache, Cyst, Loss of Consciousness, Diplopia, Fatigue, Syncope, Presyncope, Dizziness, Asthenia, Hypertension

Suspect drug(s):
Albenza
    Dosage: 400 mg;x1;
    Indication: Infection Parasitic
    Start date: 2012-04-03
    End date: 2012-04-03

Albenza
    Dosage: 400 mg;x1;
    Indication: Nematodiasis
    Start date: 2012-04-03
    End date: 2012-04-03

Other drugs received by patient: Plavix; Nexium; Hydrodiuril; Aspirin; Acetaminophen; Proventil Aero Inhaler; Flovent HFA; Lipitor; Micro-K