What the label lists and what reports show
Mannitol side effects
Mannitol's FDA label: “The most common adverse reactions are hypersensitivity reactions, renal failure, CNS toxicity, hypo/hypervolemia, hypo/hypernatremia, hypo/hyperkalemia, and infusion site reactions.” FAERS holds 4,912 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 pain (617 reports).
- Generic listed
Check it at the source: the mannitol FDA label on DailyMed (effective August 26, 2025, Baxter Healthcare Company); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions are hypersensitivity reactions, renal failure, CNS toxicity, hypo/hypervolemia, hypo/hypernatremia, hypo/hyperkalemia, and infusion site reactions.
Table 2: Adverse reactions with an incidence ≥1% within a day after bronchial challenge…
This table is printed in the Aridol Bronchial Challenge Test Kit label published by Methapharm, Inc. of April 23, 2026; the label quoted above does not print one.
| Reaction | Adverse Reactions ARIDOL (N=1046) n (%) | Treatment Methacholine Challenge (N=420) n (%) |
|---|---|---|
| Headache | 59 (6) | 4 (1) |
| Pharyngolaryngeal pain | 25 (2) | 0 |
| Throat irritation | 19 (2) | 1 (<1) |
| Nausea | 19 (2) | 0 |
| Cough | 17 (2) | 8 (2) |
| Rhinorrhea | 16 (2) | 0 |
| Dyspnea | 15 (1) | 21 (5) |
| Chest discomfort | 13 (1) | 18 (4) |
| Wheezing | 8 (1) | 6 (1) |
| Retching | 6 (1) | 0 |
| Dizziness | 5 (1) | 13 (3) |
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.
From the label: adverse reactions, continuedThe following adverse reactions from voluntary reports or clinical studies have been reported with OSMITROL. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Source: FDA drug label, Baxter Healthcare Company, effective August 26, 2025 (SPL set 0d914965-7001-45cb-ba51-d7c5964b05bc), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,912 reports list mannitol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,410 are coded as a death and 2,144 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 21 reactions below, 7 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?
- Mannitol: 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