Lactulose 3.1-3.7g/5ml oral solution
Available from a pharmacy with pharmacist advice
Safety information for pregnancy and breastfeeding
Official documents, adverse reaction reporting, and safety monitoring
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Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Lactulose
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Lactulose
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
25 branded products available
MHRA licensed products
View all licensed products for Lactulose on the MHRA register
Lactulose 3.1-3.7g/5ml oral solution
Lactulose 3.1-3.7g/5ml oral solution
Lactulose 3.1-3.7g/5ml oral solution
Lactulose 3.1-3.7g/5ml oral solution
Lactulose 3.1-3.7g/5ml oral solution
Lactulose 3.1-3.7g/5ml oral solution
Lactulose 3.1-3.7g/5ml oral solution
Lactulose 3.1-3.7g/5ml oral solution
Lactulose 3.1-3.7g/5ml oral solution
Lactulose 3.1-3.7g/5ml oral solution
Lactulose 3.1-3.7g/5ml oral solution
This is the NHS Drug Tariff indicative price used for reimbursement purposes. It may not reflect the price paid by patients or pharmacies.
View full Drug TariffSource: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.
WHO defined daily dose (DDD)
6.7 gram
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via the NHS dm+d supplementary BNF/ATC mapping files (NHSBSA). Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(5)
Rifaximin for preventing episodes of overt hepatic encephalopathy (TA337)
Constipation in children and young people: diagnosis and management (CG99)
Irritable bowel syndrome in adults: diagnosis and management (CG61)
Cirrhosis in over 16s: assessment and management (NG50)
Cystic fibrosis: diagnosis and management (NG78)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF code shown is the factual mapping value distributed by NHS Business Services Authority (NHSBSA) in the dm+d supplementary file under OGL v3.0; it is not affiliated with, nor licensed from, the publishers of the British National Formulary. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 19 · Randomised trials: 23 · 1985–2026
Showing the 50 most relevant studies, sorted by most relevant.
D. Denno, Kelley VanBuskirk, Zakia C Nelson, et al.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2014
B. Sharma, Praveen Sharma, M. Lunia, et al.
The American Journal of Gastroenterology, 2013
Oriko DO, Khawaj Z, Cheema MU, et al.
2025
This systematic review aimed to compare the clinical efficacy of rifaximin versus lactulose in the management of hepatic encephalopathy (HE) by analyzing evidence from randomized controlled trials (RCTs). A comprehensive search across major databases identified seven eligible RCTs encompassing 693 adult patients diagnosed with overt or minimal HE. Findings demonstrated that rifaximin is at least as effective as lactulose in reversing HE symptoms, with some studies reporting significantly higher HE reversal rates when rifaximin was used in combination with lactulose (e.g., 76% vs. 50.8%, ppp=0.001). While other trials reported similar efficacy between the two agents (e.g., HE improvement: 84.4% vs. 95.4%, p=0.315), rifaximin was generally associated with better tolerability and fewer gastrointestinal side effects. These results support rifaximin as an effective and well-tolerated therapeutic option, either as monotherapy or in combination with lactulose. Further large-scale, multicenter trials are warranted to assess long-term outcomes, recurrence rates, and cost-effectiveness.
Abstract licence: CC BY
Liaquat National Journal of Primary Care, 2023
Background: Hepatic Encephalopathy (HE), a neuropsychiatric complication of hepatic failure, is currently managed with lactulose as a first-line treatment followed by other adjuncts if needed. In this meta-analysis, we determined the effect of lactulose and rifaximin combination in terms of efficacy and mortality reduction compared to lactulose alone. Materials and Methods: We searched databases (PubMed, BioMed Central, and Cochrane-Central) until July 2022 for original studies inspecting the effects of Rifaximin and Lactulose (combination therapy) vs. lactulose as a monotherapy in the treatment of HE on outcomes of clinical efficacy, hospital stay length, HE recurrence, drugs’ side effects and mortality. Data was analyzed via Review Manager (version 5.4.1) and OpenMetaAnalyst. Relative risks (RR) and weighted mean differences (WMD) with 95% confidence intervals were calculated. Results: Fifteen studies with 4327 patients were included. Pooled analysis showed combination therapy to be associated with a significantly lower mortality rate in patients having HE when compared to lactulose alone (RR 0.71 95% CI 0.58-0.88, P=0.002, I2= 68%), and clinical efficacy was also improved in the combination group (RR 1.33, 95%CI 1.19-1.48, P <0.00001, I2= 52%). HE recurrence rate, adverse events, and length of hospital stay did not significantly differ among the two groups (RR= 0.61, 95 % CI= 0.35 to 1.05, P= 0.08, I2= 84%), (RR= 0.92, 95% CI= 0.51 to 1.69, P= 0.80, I2 = 0) and (WMD −1.52, 95% CI −3.22 to 0.18, P=0.08, I2 = 83%) respectively. Conclusions: Combination therapy shows survival benefits and superior clinical efficacy over lactulose monotherapy in managing hepatic encephalopathy.
Abstract licence: CC BY
Jian Fu, Yi Gao, Li-Jun Shi
PLoS ONE, 2022
A. Moon, Hannah P. Kim, Yue Jiang, et al.
The American journal of gastroenterology, 2022
He Q, Chen Z, Deng Y, et al.
2026
BackgroundMinimal hepatic encephalopathy (MHE) represents a reversible, early-stage form of hepatic encephalopathy (HE). Although probiotics have been extensively studied for MHE management, direct comparative evidence against standard lactulose therapy remains limited. This meta-analysis aimed to quantitatively evaluate the relative efficacy and safety of probiotics versus lactulose in cirrhotic patients with MHE.MethodsPubMed, the Cochrane Library, Embase, Web of Science, and the Chinese Biomedical Literature Database (CBM) were systematically searched from inception to August 2025 to identify randomized controlled trials (RCTs) comparing probiotics with lactulose for the treatment of MHE in patients with cirrhosis. Extracted outcomes included MHE reversal, overt hepatic encephalopathy (OHE) development, serum ammonia reduction, and adverse events (AEs).ResultsFive studies involving 345 cirrhotic patients were included. Pooled analyses showed no statistically significant differences between probiotics and lactulose in reversing MHE (RR: 0.98, 95% CI: 0.79-1.20; p = 0.822), preventing OHE development (RR: 1.40, 95% CI: 0.75-2.61; p = 0.289), and reducing serum ammonia levels (SMD: -0.05, 95% CI: -0.29 to 0.19; p = 0.678). In contrast, probiotics were associated with a significantly lower incidence of AEs compared with lactulose (RR: 0.17, 95% CI: 0.05-0.60; p = 0.005).ConclusionThis meta-analysis found no evidence that probiotics are superior or inferior to lactulose in terms of MHE reversal, prevention of OHE, and reduction of serum ammonia levels. Probiotics were associated with fewer AEs, suggesting a potential safety advantage. Further large-scale, high-quality RCTs are warranted to confirm these findings.
Abstract licence: CC BY
Xia HB, Ruan WL, Wu M, et al.
2025
Zhida Wang, Pei Chu, Wen-jin Wang
Drug Design, Development and Therapy, 2018
Ji Yao Wang, J. Bajaj, Jiang-bin Wang, et al.
Journal of Digestive Diseases, 2019
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
Not available
Mechanism
Lactulose is a synthetic disaccharide derivative of lactose that consists of one…
Food interactions
2 warnings
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
3%
[L6199]…
Half-life
Protein binding
Volume of distribution
Metabolism
Elimination
3%
Clearance
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
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]
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]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 686 interactions
It is expected that overdosage with lactulose would result in abdominal cramps and diarrhea, both of which should be treated with fluid and electrolyte replacement as required.[FDA Label,L6199,L6202]
Considering the use of lactulose during pregnancy in humans has not been formally investigated, the agent should only be used during pregnancy only when clearly needed.[FDA Label,L6199,L6202] Similarly, it is unknown whether lactulose is distributed into human breastmilk.[FDA Label,L6199,L6202] Use of the medication in nursing women should subsequently be undertaken with caution.[FDA Label,L6199,L6202]
Reproduction studies in rats, mice, and rabbits have not revealed any evidence of impaired fertility as a result of administering lactulose.[FDA Label,L6199,L6202]
Data regarding the safety and efficacy of using lactulose in children for the treatment of chronic constipation or portal-systemic encephalopathy (PSE) is either very limited or yet to be established.[FDA Label,L6199,L6202]
Information regarding the long-term mutagenic potential of lactulose solution in animals or humans and about the long-term carcinogenic potential in humans are not available.[FDA Label,L6199,L6202]
At the same time, the formation of such acids via the metabolism of lactulose by colonic bacteria also acidifies the contents of the colon, thereby contributing to the treatment of portal-systemic encephalopathy (PSE).[FDA Label,L6199,L6202] As one of the principal features of PSE involves the accumulation of nitrogenous waste products like ammonia in the systemic circulation, a state in which the colonic contents become more acidic than blood allows ammonia in the circulation to diffuse into the colon.[FDA Label,L6199,L6202]. Furthermore, ammonia that diffuses into the acidic colon is ionized to ammonium ions that are incapable of being absorbed back into the blood.[FDA Label,L6199,L6202] These effects, combined with the laxative action of lactulose facilitates the excretion of excess ammonia.[FDA Label,L6199,L6202] And finally, it is also believed that an acidic colonic environment results in the elimination of urease-producing bacteria that contribute to the formation of ammonia while surviving colonic bacteria use up any trapped ammonia in the colon as a source of nitrogen for protein synthesis.[L6202]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L6199]
The remaining unabsorbed lactulose reaches the large intestine where it is metabolized - but even then, negligible quantities of unchanged lactulose or its metabolites are absorbed across the colon.
[L6199][L6202]
[L6199]
ATC A06AD61
ATC A06AD11
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Lactulose
Additional database identifiers
Drugs Product Database (DPD)
2395
ChemSpider
10856
BindingDB
50377984
ZINC
ZINC000003977952
GenBank Gene Database
M64441
GenBank Protein Database
145821
UniProt Accession
BGA2_ECOLI
DrugBank citations
If you use DrugBank data in your research, please cite the following publications:
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Structured knowledge from the free knowledge base
ATC classifications (Wikidata)
Linked open data from Wikidata (Q422689), a free and open knowledge base operated by the Wikimedia Foundation. Data is available under the Creative Commons CC0 1.0 Public Domain Dedication. WHO INN from the World Health Organization.