Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pramipexole dihydrochloride
Drug ID BADD_D01818
Description Pramipexole is a drug used to treat the symptoms of Parkinson's Disease (PD). It is a _non-ergot dopamine agonist_ drug that is efficacious in treating various Parkinson's symptoms such as tremor, rigidity, and bradykinesia (slow movement) [A176867]. It was first approved by the FDA in 1997 [L5882]. Parkinson's Disease is one of the most common neurodegenerative disorders and causes a high level of disability in patients [A176855], leading to increased difficulty in performing activities of daily living due to symptoms that progress over time [A176858]. The prevalence of Parkinson's Disease worldwide has increased from approximately 2.5 million in 1990 to about 6.1 million in 2016 [A176861]. This increase may be attributed to an aging population along with other contributing factors [A176861]. In addition to the above FDA approval for Parkinson's Disease, pramipexole was also approved by the FDA in 2006 for the treatment of Restless Legs Syndrome (RLS) [A176873]. RLS is a sleep-related disorder characterized by unpleasant sensations in the lower extremities, often accompanied by an uncontrollable urge to move the legs [A176876].
Indications and Usage For the treatment of signs and symptoms of idiopathic Parkinson's disease
Marketing Status Prescription; Discontinued
ATC Code N04BC05
DrugBank ID DB00413
KEGG ID D00559
MeSH ID D000077487
PubChem ID 119569
TTD Drug ID D0G8NN
NDC Product Code 33342-212; 46708-615; 68462-334; 55111-612; 62332-006; 33342-211; 50090-2455; 65862-506; 70771-1333; 0597-0287; 50742-332; 46708-613; 46708-574; 68382-478; 70771-1328; 62332-160; 65085-0056; 33342-209; 16714-921; 68382-474; 55111-614; 46708-614; 16714-919; 50742-331; 0597-0285; 65862-605; 62332-007; 50742-336; 55111-615; 50742-337; 64380-748; 68382-198; 46708-007; 16714-920; 62332-154; 13668-093; 68382-874; 71335-1537; 64380-751; 46708-577; 57237-183; 33342-208; 50228-128; 49706-1868; 65841-738; 55111-613; 65977-0021; 57237-184; 29300-210; 29300-207; 65862-607; 65862-604; 60429-090; 57237-180; 33342-210; 29300-211; 33342-213; 68382-477; 50090-3350; 14501-0052; 46708-576; 46708-004; 65862-609; 62332-156; 65862-608; 0597-0286; 68382-875; 50090-2190; 50228-126; 50228-130; 46708-580; 46708-006; 0597-0115; 62332-159; 62332-157; 82245-0120; 16714-922; 50742-335; 16714-918; 50742-333; 29300-208; 63629-5034; 46708-575; 68382-200; 50742-334; 46708-003; 62332-158; 0597-0109; 53104-7589; 60429-087; 71335-1504; 60429-086; 57237-185; 70771-1334; 62332-005; 46708-579; 65841-735; 68382-475; 64380-750; 68382-199; 50090-3280; 63629-8289; 13668-094; 13668-092; 68462-331; 64380-747; 63629-5013; 60429-085; 68462-330; 70771-1332; 50228-129; 68382-196; 33342-214; 68462-627; 62332-155; 29300-209; 71335-0584; 71034-002; 65841-737; 50090-2217; 70771-1331; 0904-6704; 68462-332; 50090-5036; 16714-917; 60687-581; 68382-197; 62332-003; 60687-592; 68382-476; 50228-131; 13668-095; 64380-746; 29300-270; 62332-004; 46708-611; 71335-1877; 13668-184; 55111-611; 63629-5042; 71034-003; 46708-612; 0597-0113; 57237-182; 50228-127; 16714-916; 65862-606; 68462-333; 60429-089; 70771-1330; 71335-1808; 57237-181; 69680-146; 65089-0040; 46708-578; 65841-734; 64380-749; 70771-1329; 69680-145; 60687-570; 65841-736; 13668-091; 46708-005; 0597-0116
Synonyms Pramipexole | 4,5,6,7-Tetrahydro-N6-propyl-2,6-benzothiazole-diamine | Pramipexol | 2-Amino-4,5,6,7-tetrahydro-6-propylaminobenzothiazole | Dexpramipexole | Pramipexol, (R)-isomer | Mirapex | Pramipexol Dihydrobromide, (+-)-isomer | Pramipexol Dihydrochloride, (S)-isomer | Pramipexole Dihydrochloride Anhydrous | Sifrol | SND 919CL2x | SND919CL2x | SND-919CL2x | SND-919 | SND 919 | KNS 760704 | KNS760704 | KNS-760704 | Pramipexol, (+-)-isomer | Pramipexole Dihydrochloride | Pramipexole Hydrochloride Monohydrate | 2-Amino-6-propylaminotetrahydrobenzothiazole | 2 Amino 6 propylaminotetrahydrobenzothiazole | 6,7-Tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate
Chemical Information
Molecular Formula C10H19Cl2N3S
CAS Registry Number 104632-25-9
SMILES CCCNC1CCC2=C(C1)SC(=N2)N.Cl.Cl
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams17.15.02.001; 19.02.03.001--Not Available
Abnormal sensation in eye06.01.01.001--Not Available
Abscess11.01.08.001--Not Available
Accident12.01.08.001--Not Available
Accommodation disorder06.02.04.001--Not Available
Acne23.02.01.001--Not Available
Adenocarcinoma16.16.01.004--Not Available
Adenoma benign16.02.02.001--Not Available
Ageusia07.14.03.003; 17.02.07.001--Not Available
Aggression19.05.01.001--Not Available
Agitation17.02.05.012; 19.06.02.001--
Akathisia17.01.02.002; 19.06.02.006--
Akinesia17.01.02.003--Not Available
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.003--Not Available
Amaurosis fugax06.02.02.005; 17.08.04.002; 24.04.06.006--Not Available
Amenorrhoea05.05.01.002; 21.01.02.001--
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.001--
Aneurysm24.02.01.001--Not Available
Angina pectoris02.02.02.002; 24.04.04.002--
Anticholinergic syndrome17.05.01.001--Not Available
Anxiety19.06.02.002--
Apathy19.04.04.002--Not Available
Aphasia17.02.03.001; 19.21.01.001--
Aphthous ulcer07.05.06.002--Not Available
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