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--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Venous thrombosis24.01.01.008--Not Available
Ventricular tachycardia02.03.04.0100.000132%
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Wheezing22.03.01.009--
Hernia pain08.01.08.027--Not Available
Morbid thoughts19.10.03.004--Not Available
Musculoskeletal chest pain22.09.01.001; 15.03.04.012--
Respiratory tract congestion22.02.07.003--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Temperature intolerance08.01.09.0220.000198%Not Available
Staphylococcal infection11.02.05.002--Not Available
Fungal test positive13.08.06.002--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Renal injury20.01.03.015; 12.01.05.0010.000265%Not Available
Ill-defined disorder08.01.03.049--Not Available
Inner ear disorder04.04.02.002--Not Available
Adverse drug reaction08.06.01.0090.000291%Not Available
Obstructive airways disorder22.03.01.011--Not Available
Pulmonary function test decreased13.19.01.001--Not Available
Renal impairment20.01.03.0100.001719%Not Available
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ADReCS-Target
Drug Name ADR Term Target
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