Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Mannitol
Drug ID BADD_D01349
Description Mannitol is an osmotic diuretic that is metabolically inert in humans and occurs naturally, as a sugar or sugar alcohol, in fruits and vegetables. Mannitol elevates blood plasma osmolality, resulting in enhanced flow of water from tissues, including the brain and cerebrospinal fluid, into interstitial fluid and plasma. As a result, cerebral edema, elevated intracranial pressure, and cerebrospinal fluid volume and pressure may be reduced. Mannitol may also be used for the promotion of diuresis before irreversible renal failure becomes established; the promotion of urinary excretion of toxic substances; as an Antiglaucoma agent; and as a renal function diagnostic aid. On October 30, 2020, mannitol was approved by the FDA as add-on maintenance therapy for the control of pulmonary symptoms associated with cystic fibrosis in adult patients and is currently marketed for this indication under the name BRONCHITOL® by Chiesi USA Inc.[L20024]
Indications and Usage Used for the promotion of diuresis before irreversible renal failure becomes established, the reduction of intracranial pressure, the treatment of cerebral edema, and the promotion of urinary excretion of toxic substances. Mannitol is also indicated as add-on maintenance therapy for improving pulmonary function in cystic fibrosis patients aged 18 and over who have passed the BRONCHITOL tolerance test (BTT). It is recommended that patients take an orally inhaled short-acting bronchodilator 5-15 minutes prior to every inhaled mannitol dose.[L20024]
Marketing Status approved; investigational
ATC Code A06AD16; B05BC01; B05CX04; R05CB16; V04CX04
DrugBank ID DB00742
KEGG ID D00062
MeSH ID D008353
PubChem ID 6251
TTD Drug ID D0P7EK
NDC Product Code 10122-212; 67850-552; 51662-1468; 0264-7578; 0338-0353; 0338-0357; 63323-024; 49574-527; 0990-7715; 0409-4031; 57821-013; 51552-0380; 0338-0355; 50516-002; 0404-9905; 52584-031
UNII 3OWL53L36A
Synonyms Mannitol | Osmitrol | Osmofundin | (L)-Mannitol
Chemical Information
Molecular Formula C6H14O6
CAS Registry Number 69-65-8
SMILES C(C(C(C(C(CO)O)O)O)O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Urinary tract disorder20.08.01.001---
Urticaria10.01.06.001; 23.04.02.001--
Venous thrombosis24.01.01.008---
Ventricular tachycardia02.03.04.0100.000132%
Vertigo04.04.01.003; 17.02.12.002--
Vision blurred06.02.06.007; 17.17.01.010--
Vomiting07.01.07.003--
Wheezing22.03.01.009--
Hernia pain08.01.08.027---
Morbid thoughts19.10.03.004---
Musculoskeletal chest pain15.03.04.012; 22.09.01.001--
Respiratory tract congestion22.02.07.003---
Musculoskeletal discomfort15.03.04.001---
Temperature intolerance08.01.09.0220.000198%-
Staphylococcal infection11.02.05.002---
Fungal test positive13.08.06.002---
Blood alkaline phosphatase increased13.04.02.004--
Connective tissue disorder10.04.04.026; 15.06.01.006---
Infestation11.09.01.001; 23.11.01.002---
Malnutrition14.03.02.004---
Mediastinal disorder22.09.03.001---
Mental disorder19.07.01.002---
Decreased appetite08.01.09.028; 14.03.01.005--
Renal injury12.01.05.001; 20.01.03.0150.000265%-
Ill-defined disorder08.01.03.049---
Inner ear disorder04.04.02.002---
Adverse drug reaction08.06.01.0090.000291%-
Obstructive airways disorder22.03.01.011---
Pulmonary function test decreased13.19.01.001---
Renal impairment20.01.03.0100.001719%-
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ADReCS-Target
Drug Name ADR Term Target
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