Generic name
Lactulose: adverse event reports filed with FDA
4,133 reports list it as a suspect or interacting product, 2004–2026. Class: Osmotic laxative. Also reported as Lactulose 30 Ml, Lactulose Oral Solution, Lactulose Syrup.
- 4,133
- reports as suspect product
- 0% of all reports · about 184 a year
- 353
- reports, 12 months to June 2026
- 304 in the 12 months before
- 87.1%
- marked serious by the reporter
- 54.5% across the class
- 13.1%
- record death among outcomes, as reported
- 543 reports · not verified by FDA
Between January 2004 and June 2026, 4,133 adverse event reports received by FDA list lactulose, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (32,982) are left out of every figure here.
In the 12 months to June 2026, 353 reports listed it, up 16% from 304 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 184 reports a year and 0% of the 20,646,523 reports in the database, and 3.2% of the reports for the osmotic laxative class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are constipation (20.9%), fall (20.6%) and cognitive disorder (16.2%). A report can list several reactions, so shares add to more than 100%; 885 different terms appear across these reports. Constipation is recorded in 20.9% of these reports, a larger share than in the median osmotic laxative drug (2%).
87.1% of the reports are marked serious by the reporter (54.5% across the class); 13.1% record death among the outcomes and 50.8% record hospitalisation, as reported. 39.3% of the reports came from other health professionals, and the largest patient age group is 75 and over (28%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Lactulose reports recording the termmedian drug in osmotic laxative
- Constipationconstipation20.9%865
- Falla fall20.6%852
- Cognitive disorderproblems with thinking or memory16.2%671
- Balance disorderproblems with balance16%662
- Hypotensionlow blood pressure15.8%651
- Orthostatic hypotension14.8%611
- Painpain, site not specified14.6%604
- Sedationdrowsiness from a medicine14.4%596
- Toxicity to various agentspoisoning or toxic effect of one or more substances13.9%576
- Depressed level of consciousness13.7%565
- Mobility decreasedreduced ability to move about13.3%551
- Sedation complication12.9%534
- Blood calcium decreased12.6%520
- Creatinine renal clearance decreased12.6%519
- Diarrhoealoose or frequent stools9.8%403
- Drug ineffectivethe medicine did not work as expected9.3%386
- Dyspnoeashortness of breath8.2%340
- Nauseafeeling sick6.8%280
- Off label useused for a purpose or in a way not on the label6.3%260
- Vomitingbeing sick5.7%234
- Drug interactionan interaction between medicines5%208
- Confusional stateconfusion4.6%189
- Product use in unapproved indicationused for a purpose not on the label4%165
- Pyrexiafever3.6%148
- Malaisegeneral feeling of being unwell3.6%147
- General physical health deteriorationgeneral decline in health3.5%143
- Headachehead pain3.4%140
- Abdominal painstomach or belly pain3.2%134
- Acute kidney injurysudden loss of kidney function3.2%132
- Weight decreasedweight loss3.1%130
Top 30 of 885 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 17 drugs in the osmotic laxative class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 129,514 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 36% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Constipation | 1,005 | 24.3% |
| Hepatic encephalopathy | 154 | 3.7% |
| Hyperammonaemia | 62 | 1.5% |
| Ill-defined disorder | 45 | 1.1% |
| Hepatic cirrhosis | 43 | 1% |
| Thyroid disorder | 34 | 0.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 4,133 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Lactulose reports |
|---|---|---|
| Furosemide | 1,188 | 28.7% |
| Acetaminophen | 1,008 | 24.4% |
| Omeprazole | 955 | 23.1% |
| Tiotropium bromide | 739 | 17.9% |
| Carbamazepine | 659 | 15.9% |
| Morphine sulfate | 640 | 15.5% |
| Oxazepam | 629 | 15.2% |
| Aspirin | 625 | 15.1% |
| Magnesium hydroxide | 618 | 15% |
| Nitroglycerin | 602 | 14.6% |
Other products listed in reports where Lactulose is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Lactulose | Osmotic laxative | All reports |
|---|---|---|---|
| Reports as suspect product | 4,133 | 129,514 | 20,646,523 |
| Share of that pool | — | 3.2% | 0% |
| Reports, latest 12 months | 353 | — | 1,332,454 |
| Marked serious | 87.1% | 54.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 131 | 152 | 91 |
| Hospitalisation recorded, per 1,000 reports | 508 | 286 | 213 |
| Consumer-filed share | 26.7% | 61% | 45.8% |
| Top term, share of reports | Constipation 20.9% | median 2% | 1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the osmotic laxative class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| MiraLAX | brand | 38,188 | 1,721 | 7.2% |
| Extraneal | brand | 30,830 | 733 | 83.6% |
| Sodium chloride | generic | 11,044 | 1,389 | 92.5% |
| Delflex | brand | 8,765 | 676 | 53.8% |
| Potassium chloride | generic | 8,172 | 518 | 86.4% |
| DIANEAL PD-2 with Dextrose | brand | 7,178 | 161 | 88.6% |
| Polyethylene glycol 3350 | generic | 5,750 | 726 | 17.8% |
| SUPREP Bowel Prep | brand | 3,664 | 35 | 9.1% |
| Sodium bicarbonate | generic | 3,342 | 308 | 92.1% |
| Dulcolax | brand | 2,893 | 137 | 63.8% |
| Sutab | brand | 1,513 | 151 | 12% |
| Bss | brand | 1,047 | 41 | 89.6% |
| DIANEAL Low Calcium with Dextrose | brand | 970 | 26 | 97.4% |
| Polyethylene glycol | generic | 760 | 58 | 85.5% |
| Sodium bicarbonate, sodium chloride | generic | 675 | 29 | 100% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Lactulose reports
How many adverse event reports has FDA received for Lactulose?
4,133 reports list Lactulose as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 353 of them arrived in the latest 12 months. Another 32,982 list it only as a concomitant medication.
What reactions are recorded in Lactulose reports?
constipation (20.9%), fall (20.6%), cognitive disorder (16.2%), balance disorder (16%) and hypotension (15.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Lactulose was responsible.
How serious are the reports?
87.1% are marked serious by the reporter. Among the outcomes recorded, 13.1% of reports include death and 50.8% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (39.3%), consumer or non-health professional (26.7%) and physician (20.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Lactulose rising?
353 reports in the 12 months to June 2026, up 16% from 304 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Lactulose was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Lactulose?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Lactulose as a suspect or interacting product; reports listing it only as a concomitant medication (32,982) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.