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 This drug is indicated for the symptomatic treatment of Parkinson’s disease [FDA label]. This drug can be administered as monotherapy or in conjunction with levodopa. It is also indicated for symptomatic treatment of moderate to severe primary Restless Legs Syndrome (RLS) [FDA label].
Marketing Status approved; investigational
ATC Code N04BC05
DrugBank ID DB00413
KEGG ID D00559
MeSH ID D000077487
PubChem ID 119569
TTD Drug ID D0G8NN
NDC Product Code 82245-0120; 33342-210; 33342-211; 46708-003; 57237-183; 64380-748; 65862-604; 68382-196; 70771-1334; 29300-208; 33342-208; 33342-213; 46708-580; 50090-2455; 50228-126; 50228-128; 50742-332; 50742-337; 57237-180; 57237-185; 60429-086; 62332-006; 62332-007; 62332-160; 65841-735; 70771-1329; 70771-1331; 71335-1877; 0597-0115; 53104-7589; 65085-0056; 13668-091; 13668-093; 46708-007; 46708-574; 55111-611; 55111-615; 57237-184; 62332-156; 63629-5042; 64380-751; 68382-874; 68382-875; 69680-145; 70771-1328; 70771-1332; 71335-0584; 60429-085; 60687-592; 65862-606; 68382-474; 68462-331; 68462-332; 71335-1504; 0597-0286; 0904-6704; 65862-605; 16714-916; 16714-918; 29300-207; 50228-131; 60429-089; 60687-581; 64380-747; 64380-750; 65841-734; 65841-738; 68382-478; 68462-330; 68462-333; 0597-0285; 14501-0052; 49706-1868; 65862-607; 13668-184; 16714-919; 16714-922; 33342-212; 50090-3280; 50228-127; 55111-613; 65841-844; 65862-609; 68382-197; 13668-092; 13668-095; 29300-211; 46708-004; 46708-575; 50742-333; 57237-181; 60429-090; 62332-003; 63629-8289; 64380-746; 68462-627; 69680-146; 71335-1537; 71335-2167; 0597-0287; 65089-0040; 65862-506; 65862-608; 16714-917; 29300-270; 33342-209; 46708-005; 46708-578; 50742-331; 55111-612; 55111-614; 60429-087; 60687-570; 62332-005; 70771-1330; 0597-0109; 0597-0113; 65977-0021; 29300-209; 50228-129; 50228-130; 62332-154; 62332-157; 62332-158; 62332-159; 65841-736; 68382-198; 68382-199; 68382-440; 68382-475; 68382-477; 68462-334; 70771-1333; 71034-003; 16714-920; 46708-576; 50090-5036; 50742-336; 62332-004; 62332-155; 64380-749; 65841-737; 68382-200; 68382-476; 71034-002; 71335-1808; 0597-0116; 13668-094; 29300-210; 33342-214; 46708-006; 46708-577; 46708-579; 50742-334; 50742-335; 57237-182
UNII 3D867NP06J
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
*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 discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; 17.15.02.001--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
Ageusia17.02.07.001; 07.14.03.003--Not Available
Aggression19.05.01.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Akathisia19.06.02.006; 17.01.02.002--
Akinesia17.01.02.003--Not Available
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.001--Not Available
Amaurosis fugax06.02.10.002; 24.04.06.006; 17.08.04.002--Not Available
Amenorrhoea21.01.02.001; 05.05.01.002--
Amnesia17.03.02.001; 19.20.01.001--
Anaemia01.03.02.001--
Aneurysm24.02.01.001--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Anticholinergic syndrome17.05.01.001--Not Available
Anxiety19.06.02.002--
Apathy19.04.04.002--Not Available
Aphasia19.21.01.001; 17.02.03.001--
Aphthous ulcer07.05.06.002--Not Available
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