What the label lists and what reports show
Albendazole side effects
Albendazole's FDA label lists its adverse reactions in its own words. FAERS holds 1,886 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (243 reports).
- Generic listed
Check it at the source: the albendazole FDA label on DailyMed (effective September 30, 2019, Amneal Pharmaceuticals of New York LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAdverse reactions 1% or greater in hydatid disease: abnormal liver function tests, abdominal pain, nausea/vomiting, reversible alopecia, headache, dizziness/vertigo, fever. ( 6.1 ) Adverse reactions 1% or greater in neurocysticercosis: headache, nausea/vomiting, raised intracranial pressure, meningeal signs. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction profile of albendazole differs between hydatid disease and neurocysticercosis. …
Table 2: Adverse Reaction Incidence 1% or Greater in Hydatid Disease and Neurocysticercosis
This table is printed in the ALBENZA label published by Amneal Pharmaceuticals LLC of September 23, 2019; the label quoted above does not print one.
| Adverse Reaction | Hydatid Disease | Neurocysticercosis |
|---|---|---|
| Abdominal Pain | 6 | 0 |
| Nausea | 4 | 6 |
| Vomiting | 4 | 6 |
| Fever | 1 | 0 |
| Elevated Hepatic Enzymes | 16 | less than 1 |
| Dizziness | 1 | less than 1 |
| Headache | 1 | 11 |
| Meningeal Signs | 0 | 1 |
| Raised Intracranial Pressure | 0 | 2 |
| Vertigo | 1 | less than 1 |
| Reversible Alopecia | 2 | less than 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, NDA020666 (Impax Labs Inc), as published by Amneal Pharmaceuticals of New York LLC, effective September 30, 2019 (SPL set 06b5eefc-0b95-4862-b9b6-770063f2adf0), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,886 reports list albendazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 310 are coded as a death and 690 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Albendazole: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions