Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cysteamine bitartrate
Drug ID BADD_D00557
Description Cystinosis is a rare disease caused by mutations in the CTNS gene that encodes for cystinosin, a protein responsible for transporting cystine out of the cell lysosome. A defect in cystinosin function is followed by cystine accumulation throughout the body, especially the eyes and kidneys.[A218721] Several preparations of cysteamine exist for the treatment of cystinosis manifestations, some in capsule form, and others in ophthalmic solution form.[L15606,L15616] In particular, cystine deposits on the eye can cause significant discomfort throughout the day and require frequent treatment with eye drops, typically every waking hour.[L15611] On August 25th 2020, the first ophthalmic solution for cystinosis requiring only 4 daily treatments was granted FDA approval.[L15606] Cysteamine eye drops are a practical and effective option for those affected by ocular cystinosis. Marketed by Recordati Rare Diseases Inc., CYSTADROPS® reduce the burden of multiple frequent medications normally administered to those with cystinosis.[L15601]
Indications and Usage Not Available
Marketing Status Prescription
ATC Code A16AA04
DrugBank ID DB00847
KEGG ID D10468
MeSH ID D003543
PubChem ID 23111531
TTD Drug ID D0VD6Q
NDC Product Code 71666-010; 0378-9045; 12828-0068; 0378-9040; 46439-8762; 75987-140; 75987-100; 75987-145; 75987-101
Synonyms Cysteamine | beta-Mercaptoethylamine | beta Mercaptoethylamine | Mercaptoethylamine | Mercamine | Mercaptamine | 2-Aminoethanethiol | 2 Aminoethanethiol | Cysteinamine | Cystagon | Cysteamine Bitartrate | Bitartrate, Cysteamine | Cysteamine Tartrate (1:1) | Cysteamine Tartrate | Tartrate, Cysteamine | Cysteamine Dihydrochloride | Dihydrochloride, Cysteamine | Cysteamine Hydrochloride | Hydrochloride, Cysteamine | Cysteamine Maleate (1:1) | Cysteamine Tosylate | Tosylate, Cysteamine | Cysteamine, 35S-Labeled | 35S-Labeled Cysteamine | Cysteamine, 35S Labeled | Becaptan | Cysteamine Hydrobromide | Hydrobromide, Cysteamine
Chemical Information
Molecular Formula C6H13NO6S
CAS Registry Number 27761-19-9
SMILES C(CS)N.C(C(C(=O)O)O)(C(=O)O)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Anaemia01.03.02.001--
Ataxia17.02.02.001; 08.01.02.004--
Benign intracranial hypertension17.07.02.001--Not Available
Breath odour07.01.06.002--Not Available
Compression fracture12.04.02.008; 15.08.02.004--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Dehydration14.05.05.001--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness02.01.02.004; 24.06.02.007; 17.02.05.003--
Duodenitis07.08.03.001--Not Available
Dyspepsia07.01.02.001--
Encephalopathy17.13.02.001--
Feeling jittery08.01.09.016--Not Available
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Hallucination19.10.02.002--
Headache17.14.01.001--
Hepatic function abnormal09.01.02.001--Not Available
Hyperkinesia17.01.02.008--Not Available
Hypertension24.08.02.001--
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Leukopenia01.02.02.001--Not Available
Mass08.03.05.003--Not Available
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Nightmare19.02.03.003--Not Available
Pain in extremity15.03.04.010--
Pyrexia08.05.02.003--
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