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)
Abdominal discomfort07.01.06.0010.006064%Not Available
Abdominal pain upper07.01.05.0030.007679%
Abnormal dreams19.02.03.001; 17.15.02.0010.000558%Not Available
Amnesia19.20.01.001; 17.03.02.0010.002081%
Amyloidosis10.02.05.0010.000381%Not Available
Aneurysm24.02.01.0010.000211%Not Available
Aortic aneurysm24.02.03.0010.000085%Not Available
Aortic dissection24.02.03.0020.000085%Not Available
Aphasia19.21.01.001; 17.02.03.0010.000829%
Aphonia22.12.03.001; 19.19.01.002; 17.02.08.0090.000474%
Arrhythmia02.03.02.001--Not Available
Aspiration22.02.07.0070.000397%
Asthenia08.01.01.0010.023106%Not Available
Atrial flutter02.03.03.0030.000127%
Autonomic nervous system imbalance24.06.01.005; 17.05.01.011; 08.01.01.0100.000296%Not Available
Bladder pain20.02.02.0010.000186%Not Available
Blindness transient06.02.10.006; 17.17.01.0040.000169%Not Available
Blindness unilateral06.02.10.007; 17.17.01.0160.000085%Not Available
Blood pressure fluctuation24.06.01.0020.023444%Not Available
Blood pressure increased13.14.03.005--Not Available
Cardiac failure congestive02.05.01.0020.001269%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.0070.002766%
Chest discomfort02.02.02.009; 22.12.02.002; 08.01.08.0190.004491%Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.010944%Not Available
Choking22.12.03.0030.000127%Not Available
Chromaturia20.02.01.0020.000803%
Circadian rhythm sleep disorder17.15.06.002; 19.02.06.0020.000186%Not Available
Cold sweat23.02.03.002; 08.01.03.0240.000271%Not Available
Condition aggravated08.01.03.0040.016450%Not Available
Confusional state17.02.03.005; 19.13.01.0010.013067%
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