Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Droxidopa
Drug ID BADD_D00732
Description Droxidopa is a precursor of noradrenaline that is used in the treatment of Parkinsonism. It is approved for use in Japan and is currently in trials in the U.S. The racaemic form (dl-threo-3,4-dihydroxyphenylserine) has also been used, and has been investigated in the treatment of orthostatic hypotension. There is a deficit of noradrenaline as well as of dopamine in Parkinson's disease and it has been proposed that this underlies the sudden transient freezing seen usually in advanced disease. Though L-DOPS has been used in Japan and Southeast Asia already for some time, it is also currently in clinical trials at the phase III point in the United States (U.S.), Canada, Australia, and throughout Europe. Provided L-DOPS successfully completes clinical trials, it could be approved for the treatment of neurogenic orthostatic hypotension (NOH) as early as 2011. Additionally, phase II clinical trials for intradialytic hypotension are also underway. Chelsea Therapeutics obtained orphan drug status (ODS) for L-DOPS in the U.S. for NOH, and that of which associated with Parkinson's disease , pure autonomic failure, and multiple system atrophy, and is the pharmaceutical company developing it in that country.
Indications and Usage For treatment of neurogenic orthostatic hypotension (NOH) associated with various disorders including Multiple System Atrophy, Familial Amyloid Polyneuropathy, hemodialysis induced hypotension and Parkinson's Disease. Also investigated for use/treatment in neurologic disorders, nephropathy, blood (blood forming organ disorders, unspecified), and dizzy/fainting spells.
Marketing Status approved; investigational
ATC Code C01CA27
DrugBank ID DB06262
KEGG ID D01277
MeSH ID D015103
PubChem ID 92974
TTD Drug ID D0I3RO
NDC Product Code 0832-0721; 42973-237; 27808-200; 31722-015; 67386-822; 68180-987; 69452-256; 69539-088; 70436-140; 72606-019; 51407-767; 59651-375; 59651-376; 68180-988; 69539-089; 0054-0533; 70771-1610; 27808-201; 31722-010; 70436-142; 72205-072; 59651-377; 67386-820; 69452-258; 0054-0534; 70771-1609; 27241-199; 27808-199; 31722-014; 50228-430; 69539-146; 70436-141; 72205-074; 38217-0030; 76278-1120; 50228-431; 51407-765; 51407-766; 69452-257; 72205-073; 0832-0722; 53069-1060; 63304-086; 63304-104; 67877-704; 72606-018; 72606-020; 58159-049; 69766-032; 67877-705; 67877-706; 68180-989; 70710-1389; 70771-1611; 27241-201; 50228-429; 63304-112; 0054-0532; 70710-1390; 70710-1391; 27241-200; 67386-821; 0832-0720
UNII J7A92W69L7
Synonyms Droxidopa | threo-DOPS | threo DOPS | 3,4-threo-DOPS | 3,4 threo DOPS | DL-threo-3,4-Dihydroxyphenylserine | DL threo 3,4 Dihydroxyphenylserine | erythro-3,4-Dihydroxyphenylserine | erythro 3,4 Dihydroxyphenylserine | Droxidopa, (DL-Tyr)-Isomer | 3,4-Dihydroxyphenylserine | 3,4 Dihydroxyphenylserine
Chemical Information
Molecular Formula C9H11NO5
CAS Registry Number 23651-95-8
SMILES C1=CC(=C(C=C1C(C(C(=O)O)N)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)
Coordination abnormal17.02.02.0040.000288%-
Coronary artery occlusion24.04.04.013; 02.02.01.006; 12.02.01.0360.000127%-
Cyanosis23.06.04.005; 02.11.04.004; 24.03.01.007; 22.02.02.0070.000719%
Death08.04.01.0010.035191%
Decreased activity19.11.01.002; 08.01.01.0060.000474%-
Decubitus ulcer23.03.11.0060.000127%-
Dehydration14.05.05.0010.002529%
Delusion19.10.01.0010.000516%
Dementia19.20.02.001; 17.03.01.0010.000846%-
Dementia Alzheimer's type19.20.03.001; 17.03.06.0010.000169%-
Diplopia17.17.01.005; 06.02.06.0020.000846%-
Disorientation19.13.01.002; 17.02.05.0150.002106%-
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.0070.096339%
Dizziness postural02.11.04.008; 24.06.02.008; 17.02.05.0040.004119%-
Drooling17.02.05.0050.000600%-
Drug ineffective08.06.01.0060.072015%-
Drug withdrawal convulsions17.12.03.016; 08.06.02.0030.000085%-
Dry mouth07.06.01.0020.002284%
Dysarthria19.19.03.001; 17.02.08.0010.001472%
Dyskinesia17.01.02.0060.002596%
Dysphagia07.01.06.0030.006563%
Dyspnoea02.11.05.003; 22.02.01.0040.013515%
Dyspnoea at rest02.11.05.004; 22.02.01.0250.000085%-
Dyspnoea exertional02.11.05.005; 22.02.01.0050.001176%-
Electrolyte imbalance14.05.01.0020.000127%-
Embolic stroke24.01.04.010; 17.08.01.0320.000127%-
Extrasystoles02.03.02.0030.000431%-
Failure to thrive19.07.05.001; 18.04.01.003; 14.03.02.0080.000296%-
Fall12.01.08.002--
Fatigue08.01.01.0020.039767%
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