Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lactulose
Drug ID BADD_D01240
Description Lactulose is a synthetic disaccharide derivative of lactose that is most commonly used as a laxative agent despite also being formally indicated to serve as an adjunct therapy in treating portal-systemic encephalopathy (PSE).[FDA Label,L6199,L6202] Despite being first synthesized in 1929[A178081], investigations regarding its possible use as a laxative for the treatment of chronic constipation did not occur until the 1960s and its first clinical use for treating PSE was not until 1966.[L6202] Nevertheless, although lactulose received formal FDA approval in 1977 and has since become a readily available generic and brand-name non-prescription medication listed on the World Health Organization's List of Essential Medicines as one of the most effective and safe medicines employed in a health system[L6205], data regarding its optimal place in therapy is often ambiguous.[L6202] Especially considering the use of lactulose as a laxative is typically only considered after lifestyle and dietary modifications fail and the fact that lactulose therapy cannot be ethically withheld from patients diagnosed with PSE in a placebo study, the substance may just be one of many options available for treating constipation and its efficacy in managing PSE may never be formally confirmed or refuted via clinical investigation.[L6202]
Indications and Usage For the treatment of constipation and hepatic encephalopathy.
Marketing Status Prescription; Discontinued
ATC Code A06AD11
DrugBank ID DB00581
KEGG ID D00352
MeSH ID D007792
PubChem ID 11333
TTD Drug ID D0T5BC
NDC Product Code 68071-1562; 50090-3436; 60432-038; 0527-5125; 18124-003; 66689-039; 18124-002; 0121-0873; 13668-574; 17856-1378; 66220-729; 0121-0577; 61178-0001; 55700-892; 0121-1154; 13668-580; 45963-438; 62135-003; 63629-8800; 50065-000; 50383-779; 0121-1746; 50383-795; 65932-395; 66220-719; 69067-010; 0121-4577; 45963-439; 0527-5120; 66689-038; 65932-396; 60432-037
Synonyms Lactulose | Duphalac | Normase | Amivalex
Chemical Information
Molecular Formula C12H22O11
CAS Registry Number 4618-18-2
SMILES C(C1C(C(C(C(O1)OC2C(OC(C2O)(CO)O)CO)O)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 discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.001814%
Abdominal pain07.01.05.0020.002418%
Abdominal pain upper07.01.05.0030.002418%
Abnormal dreams19.02.03.001; 17.15.02.0010.001814%Not Available
Acute respiratory failure14.01.04.004; 22.02.06.0010.000315%Not Available
Anaemia01.03.02.0010.001814%
Angioedema23.04.01.001; 10.01.05.0090.001814%Not Available
Arthralgia15.01.02.0010.001814%
Asthenia08.01.01.0010.003023%Not Available
Back pain15.03.04.0050.001209%
Bradycardia02.03.02.0020.001209%Not Available
Bronchospasm10.01.03.012; 22.03.01.0040.001814%
Confusional state19.13.01.001; 17.02.03.0050.003628%
Constipation07.02.02.0010.003023%
Cough22.02.03.0010.001209%
Death08.04.01.001--
Dehydration14.05.05.001--
Delirium19.13.02.0010.001209%
Dementia17.03.01.001; 19.20.02.0010.001209%Not Available
Depressed level of consciousness17.02.04.0020.001209%
Depression19.15.01.0010.001209%
Diarrhoea07.02.01.0010.005441%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.0040.003628%
Drug withdrawal syndrome19.07.02.011; 08.06.02.0040.001814%Not Available
Dyskinesia17.01.02.0060.001209%
Dysphagia07.01.06.0030.001209%
Dyspnoea22.02.01.004; 02.01.03.002--
Electrocardiogram QT prolonged13.14.05.0040.003628%
Eructation07.01.02.003--
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