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)
Polyuria20.02.03.002---
Productive cough22.02.03.005--
Prurigo23.03.04.017---
Pruritus23.03.12.0010.001058%
Pulmonary congestion02.05.02.002; 22.01.03.002; 24.03.08.001---
Pulmonary oedema02.05.02.003; 22.01.03.003--
Pyrexia08.05.02.0030.000331%
Rash23.03.13.0010.001124%-
Rash erythematous23.03.13.0290.000265%-
Rash pruritic23.03.13.0300.000132%-
Renal failure20.01.03.0050.000397%-
Respiratory depression17.02.05.047; 22.02.01.010---
Retching07.01.07.002---
Rhinitis11.01.13.004; 22.07.03.006--
Rhinorrhoea22.12.03.021--
Seizure17.12.03.001--
Skin disorder23.03.03.007---
Skin exfoliation23.03.07.003---
Skin necrosis23.03.03.011---
Sputum discoloured22.02.03.010---
Stomatitis07.05.06.005--
Tachycardia02.03.02.007---
Thirst08.01.09.021; 14.03.02.007---
Throat irritation07.05.05.037; 22.12.03.029---
Thrombophlebitis24.01.02.001---
Tremor17.01.06.0020.000529%
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urethral disorder20.07.01.002---
Urinary incontinence17.05.01.008; 20.02.02.010--
Urinary retention20.02.02.011--
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ADReCS-Target
Drug Name ADR Term Target
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