Applies to albendazole: oral tablet.

Serious side effects of Albendazole

Along with its needed effects, albendazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking albendazole:

Less common

• Fever

Rare

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• chest pain
• chills
• cough
• painful or difficult urination
• pinpoint red spots on the skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• Blistering, peeling, or loosening of the skin
• blurred vision
• dark urine
• diarrhea
• general feeling of tiredness or weakness
• headache
• itching
• joint or muscle pain
• light-colored stools
• red, irritated eyes
• seizures
• stomach pain, continuing
• tightness in the chest
• vomiting
• yellow eyes or skin

Other side effects of Albendazole

Some side effects of albendazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Stomach pain

Less common

• Nausea

Rare

• Dizziness
• thinning or loss of the hair

Incidence not known

• Lack or loss of strength

For Healthcare Professionals

Applies to albendazole: compounding powder, oral tablet, oral tablet chewable.

General

Side effects differed between hydatid disease and neurocysticercosis. Symptoms were generally mild and resolved without treatment. Therapy was discontinued primarily due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease).^[Ref]

Hepatic

Very common (10% or more): Elevated liver enzymes (up to 16%)

Uncommon (0.1% to 1%): Hepatitis

Frequency not reported: Hepatotoxicity, hepatic abnormalities, jaundice, hepatocellular damage

Postmarketing reports: Acute liver failure^[Ref]

Mild to moderate elevated liver enzymes were very common.

Severe hepatic abnormalities, including jaundice and hepatocellular damage (possibly irreversible), have been reported during prolonged higher dose treatment of hydatid disease.

Elevated liver enzymes and hepatitis have also been reported during postmarketing experience.^[Ref]

Nervous system

Very common (10% or more): Headache (up to 11%)

Common (1% to 10%): Raised intracranial pressure, dizziness, neurological events

Uncommon (0.1% to 1%): Vertigo, meningeal signs

Postmarketing reports: Somnolence, convulsion^[Ref]

Headache has also been reported during postmarketing experience.^[Ref]

Gastrointestinal

Upper GI symptoms (e.g., epigastric/abdominal pain, nausea, vomiting) and GI disturbances (abdominal pain, nausea, vomiting) were reported.

Diarrhea has also been reported during postmarketing experience.^[Ref]

Common (1% to 10%): Epigastric/abdominal pain, nausea, vomiting, upper gastrointestinal (GI) symptoms, GI disturbances

Uncommon (0.1% to 1%): Diarrhea

Rare (less than 0.1%): Pancreatitis^[Ref]

Dermatologic

Common (1% to 10%): Reversible alopecia (thinning of hair, moderate hair loss)

Uncommon (0.1% to 1%): Itchiness, skin rashes

Postmarketing reports: Erythema multiforme, Stevens-Johnson syndrome^[Ref]

Reversible alopecia (thinning of hair and moderate hair loss) has also been reported during postmarketing experience.^[Ref]

Other

Fever has also been reported during postmarketing experience.^[Ref]

Common (1% to 10%): Fever, hyperpyrexia

Postmarketing reports: Asthenia^[Ref]

Hematologic

Common (1% to 10%): Leukopenia

Rare (less than 0.1%): Low red cell count, pancytopenia, thrombocytopenia

Frequency not reported: Granulocytopenia, agranulocytosis

Postmarketing reports: Aplastic anemia, bone marrow suppression, neutropenia^[Ref]

Agranulocytosis and pancytopenia have also been reported during postmarketing experience.

Patients with liver disease (including hepatic echinococcosis) appeared more susceptible to bone marrow suppression.^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (including rash, pruritus, urticaria)^[Ref]

Ocular

Rare (less than 0.1%): Ocular maculopathy

Frequency not reported: Retinal damage

Postmarketing reports: Blurred vision^[Ref]

Musculoskeletal

Rare (less than 0.1%): Bone pain

Postmarketing reports: Rhabdomyolysis^[Ref]

Genitourinary

Rare (less than 0.1%): Proteinuria

Renal

Postmarketing reports: Acute renal failure^[Ref]