Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Docusate
Drug ID BADD_D02551
Description Docusate, or dioctyl sulfosuccinate, is a stool softener indicated for the treatment of constipation[A32201]. Docusate acts by increasing the amount of water the stool absorbs in the gut, making the stool softer and easier to pass [L1801]. Docusate can be orally or rectally administered. Docusate is on the World Health Organization's List of Essential Medicines[L5915]. However the effectiveness of docusate in treating constipation remains unclear, as several studies report docusate to be no more effective than placebo for increasing the frequency of stool or stool softening [A32200,A32202,A176987]. Recently there has been pressure to stop prescribing docusate as it has been identified as an ineffective medicine[A176972,A176987,L5912]. Additionally, it does not appear to lessen symptoms associated with constipation such as abdominal cramps. Still docusate is available in over-the-counter products as a common laxative.
Indications and Usage Indicated for the treatment of constipation associated with dry, hard stools or opioid induced constipation[A176984]. Though recently, pressure has been building to end the use of docusate over concerns of efficacy[A176972,A176987,L5912].
Marketing Status approved
ATC Code A06AA02
DrugBank ID DB11089
KEGG ID D00305; D03885; D03886
MeSH ID D004143
PubChem ID 11339
TTD Drug ID D0X4FM
NDC Product Code Not Available
UNII M7P27195AG
Synonyms Dioctyl Sulfosuccinic Acid | Sulfosuccinic Acid bis(2-Ethylhexyl) Ester | Colace | Dioctyl Sulfosuccinates | Sulfosuccinates, Dioctyl | Dioctyl Sulfosuccinic Acid, Ammonium Salt | Dioctyl Sulfosuccinic Acid, Barium Salt | Docusate | Dioctylsulfosuccinate | DOSS | Dioctyl Sulfosuccinate | Sulfosuccinate, Dioctyl | Docusate Calcium | Dioctyl Sulfosuccinic Acid, Calcium Salt | Docusate Potassium | Dioctyl Sulfosuccinic Acid, Potassium Salt | Docusate Sodium | Dioctyl Sulfosuccinic Acid, Sodium Salt | Sodium Bis(2-ethylhexyl)sulfosuccinate | DEH-Na-SS | DEH Na SS | Sodium Dioctylsulphosuccinate | Dioctylsulphosuccinate, Sodium | Diethylhexyl Sodium Sulfosuccinate | Sodium Sulfosuccinate, Diethylhexyl | Sulfosuccinate, Diethylhexyl Sodium | Sodium Dioctyl Sulfosuccinate | Dioctyl Sulfosuccinate, Sodium | Aerosol OT | Dioctyl Sulfosuccinic Acid, Magnesium Salt
Chemical Information
Molecular Formula C20H38O7S
CAS Registry Number 10041-19-7
SMILES CCCCC(CC)COC(=O)CC(C(=O)OCC(CC)CCCC)S(=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 distension07.01.04.001--
Abdominal pain07.01.05.0020.000055%
Abdominal pain upper07.01.05.0030.000121%
Anaemia01.03.02.0010.000083%
Angina pectoris02.02.02.002; 24.04.04.0020.000055%
Arthralgia15.01.02.001--
Asthenia08.01.01.001---
Bradycardia02.03.02.002---
Condition aggravated08.01.03.004---
Constipation07.02.02.0010.000110%
Dehydration14.05.05.001--
Diarrhoea07.02.01.0010.000193%
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Drug abuse19.07.06.010---
Drug ineffective08.06.01.006---
Fatigue08.01.01.0020.000149%
Haematochezia07.12.02.003; 24.07.02.012---
Hyperhidrosis08.01.03.028; 23.02.03.004--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Malaise08.01.01.003--
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Nausea07.01.07.0010.000083%
Pain08.01.08.0040.000055%
Pruritus23.03.12.0010.000055%
Pulmonary embolism22.06.02.001; 24.01.06.0010.000055%-
Pulmonary oedema02.05.02.003; 22.01.03.0030.000055%
Rash23.03.13.0010.000055%-
Skin discolouration23.03.03.005---
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