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 Lactulose is indicated for use as a laxative in the treatment of chronic constipation in adults and geriatric patients.[FDA Label,L6199,L6202] Additionally, lactulose is also employed as an adjunct to protein restriction and supportive therapy for the prevention and treatment of portal-systemic encephalopathy (PSE), including both the hepatic pre-coma and coma variations.[FDA Label,L6199,L6202] In particular, lactulose solution has been effective at managing PSE resulting from surgical portacaval shunts or from chronic hepatic diseases like cirrhosis.[L6199] Moreover, there have also been studies demonstrating the capacity for lactulose to minimize the formation of gallstones and even some investigations regarding the experimental use of the agent in developing novel anticancer agents owing to its ability to bind galactin carbohydrates involved in various tumor progressions [L6202].
Marketing Status approved
ATC Code A06AD11
DrugBank ID DB00581
KEGG ID D00352
MeSH ID D007792
PubChem ID 11333
TTD Drug ID D0T5BC
NDC Product Code 18124-007; 65932-395; 65932-396; 62135-003; 0527-5120; 0527-5125; 50383-357; 68071-1562; 61178-0001; 0121-1154; 55154-9448; 66220-719; 66220-729; 66689-038; 18124-003; 50065-000; 0116-4005; 0121-4577; 66689-039; 69067-010; 0121-0873; 50383-795; 45963-438; 63629-8800; 0121-0577; 0121-1746; 45963-439; 50383-356; 18124-002; 50383-779; 55700-892
UNII 9U7D5QH5AE
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
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)
Hyponatraemia14.05.04.002--
Hypotension24.06.03.0020.000403%
Ileus07.13.01.0010.000403%
Insomnia17.15.03.002; 19.02.01.002--
Laryngospasm22.04.02.0020.000268%
Lethargy19.04.04.004; 17.02.04.003; 08.01.01.008--
Leukopenia01.02.02.0010.000268%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.000268%Not Available
Malaise08.01.01.0030.002255%
Melaena07.12.02.004; 24.07.02.0130.000268%Not Available
Memory impairment19.20.01.003; 17.03.02.0030.000537%
Metabolic acidosis14.01.01.0030.000403%Not Available
Mood swings19.04.03.001--Not Available
Muscle rigidity17.05.02.005; 15.05.04.0010.000805%Not Available
Muscle spasms15.05.03.0040.000268%
Nausea07.01.07.001--
Nightmare19.02.03.003--Not Available
On and off phenomenon17.01.05.0040.000671%Not Available
Pain08.01.08.004--
Pallor24.03.04.001; 23.03.03.031; 08.01.03.0320.000268%Not Available
Posture abnormal15.03.05.029; 17.02.05.0330.000268%Not Available
Pulmonary embolism24.01.06.001; 22.06.02.0010.000268%Not Available
Rash23.03.13.0010.001315%Not Available
Rash maculo-papular23.03.13.0040.000268%
Renal failure20.01.03.0050.000268%Not Available
Respiratory depression17.02.05.047; 22.02.01.0100.000268%Not Available
Restlessness19.11.02.002; 17.02.05.0210.000403%
Rhabdomyolysis15.05.05.0020.000805%
Seizure17.12.03.0010.000403%
Shock24.06.02.0020.000268%Not Available
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