Drug · FAERS side-effect profile with label screen
Lactulose side effects: what 38,109 FDA adverse event reports show
Brand names
Generlac
openFDA label
Who reports
38,109 reports · 88% serious · 6,655 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns.
FDA label, Indications and Usage
What it is
DESCRIPTION Generlac Solution (Lactulose Solution, USP) is a synthetic disaccharide in solution form for oral or rectal administration. Each 15 mL of Generlac Solution contains: 10 g lactulose (and less than 1.6 g galactose, less than 1.2 g lactose, less than 0.8 g epilactose and 0.1 g or less of fructose).
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 2Lab value / disease marker 5No label text to screen 33
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,192 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Heart sounds | 53 | 668.0 446.8–998.6ROR 668.9 · calibrated p 2e-14 ✓ | 270.5 EB05 214.7 · IC025 +5.8 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=53 · ♀ 100% (drug 52%) | not reported in cached trials |
| Femoral hernia incarcerated | 28 | 344.9 214.7–553.8ROR 345.1 · calibrated p 3e-11 ✓ | 184.7 EB05 134.1 · IC025 +4.9 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Total lung capacity increased | 96 | 299.0 233.1–383.5ROR 299.7 · calibrated p 2e-11 ✓ | 185.9 EB05 156.8 · IC025 +6.3 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=96 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Lymphatic fistula | 29 | 224.5 145.7–346.1ROR 224.7 · calibrated p 8e-10 ✓ | 144.1 EB05 105.3 · IC025 +4.8 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=29 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Sedation complication | 550 | 155.4 141.4–170.8ROR 157.7 · calibrated p 3e-9 ✓ | 120.5 EB05 112.3 · IC025 +6.6 3/3 methods agree vs other Osmotic Laxatives: only this drug | Reporting / coding artifact | serious n=550 · ♀ 100% (drug 52%) | not reported in cached trials |
| Prolonged expiration | 54 | 141.4 104.8–190.7ROR 141.6 · calibrated p 2e-8 ✓ | 108.1 EB05 86.0 · IC025 +5.3 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=54 · ♀ 100% (drug 52%) | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 97 | 126.1 101.1–157.2ROR 126.4 · calibrated p 3e-8 ✓ | 100.5 EB05 84.8 · IC025 +5.7 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=97 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Creatinine renal clearance decreased | 555 | 87.9 80.4–96.1ROR 89.2 · calibrated p 3e-7 ✓ | 75.6 EB05 70.4 · IC025 +6.0 3/3 methods agree vs other Osmotic Laxatives: only this drug | Lab value / disease marker | serious n=554 · ♀ 100% (drug 52%) | not reported in cached trials |
| Multiple drug therapy | 90 | 81.4 65.3–101.6ROR 81.6 · calibrated p 7e-7 ✓ | 69.9 EB05 58.6 · IC025 +5.3 3/3 methods agree vs other Osmotic Laxatives: only this drug | Reporting / coding artifact | serious n=90 · ♀ 100% (drug 52%) | not reported in cached trials |
| Ammonia increased | 648 | 80.0 73.8–86.9ROR 81.4 · calibrated p 5e-7 ✓ | 69.7 EB05 65.3 · IC025 +5.9 3/3 methods agree vs other Osmotic Laxatives: PRR 1,042.8 (519.3–2,093.8) | Lab value / disease marker | serious n=601 · 70% consumer | not reported in cached trials |
| Nail bed inflammation | 37 | 72.4 51.4–102.0ROR 72.5 · calibrated p 2e-6 ✓ | 62.0 EB05 47.0 · IC025 +4.6 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=36 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Pancreatic steatosis | 28 | 64.6 43.6–95.5ROR 64.6 · calibrated p 6e-6 ✓ | 55.7 EB05 40.5 · IC025 +4.2 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Wound infection pseudomonas | 32 | 62.8 43.6–90.6ROR 62.9 · calibrated p 6e-6 ✓ | 54.7 EB05 40.5 · IC025 +4.3 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Vascular encephalopathy | 28 | 59.5 40.3–87.9ROR 59.5 · calibrated p 9e-6 ✓ | 51.9 EB05 37.7 · IC025 +4.2 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Chronic hepatic failure | 59 | 54.7 41.8–71.4ROR 54.7 · calibrated p 1e-5 ✓ | 49.0 EB05 39.4 · IC025 +4.7 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=58 | not reported in cached trials |
| Hepatic encephalopathy | 839 | 54.3 50.6–58.2ROR 55.5 · calibrated p 7e-6 ✓ | 49.4 EB05 46.6 · IC025 +5.5 3/3 methods agree vs other Osmotic Laxatives: PRR 900.1 (509.2–1,591.1) | No label text to screen label has no adverse-reaction text | serious PRR 32.1 | not reported in cached trials |
| Ammonia abnormal | 33 | 48.9 34.2–69.8ROR 48.9 · calibrated p 3e-5 ✓ | 43.8 EB05 32.7 · IC025 +4.2 3/3 methods agree vs other Osmotic Laxatives: only this drug | Lab value / disease marker | serious n=26 · 100% consumer | not reported in cached trials |
| Skin candida | 42 | 48.6 35.5–66.7ROR 48.7 · calibrated p 2e-5 ✓ | 43.9 EB05 33.8 · IC025 +4.4 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=42 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Creatinine renal clearance increased | 59 | 46.8 35.9–61.1ROR 46.9 · calibrated p 3e-5 ✓ | 42.6 EB05 34.2 · IC025 +4.6 3/3 methods agree vs other Osmotic Laxatives: only this drug | Lab value / disease marker | serious n=59 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Portal hypertensive gastropathy | 43 | 46.1 33.7–62.9ROR 46.1 · calibrated p 3e-5 ✓ | 41.8 EB05 32.3 · IC025 +4.3 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=42 · 100% clinician | not reported in cached trials |
| Cardiospasm | 43 | 45.9 33.6–62.6ROR 45.9 · calibrated p 3e-5 ✓ | 41.6 EB05 32.2 · IC025 +4.3 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=43 · ♀ 100% (drug 52%) | not reported in cached trials |
| Cirrhosis alcoholic | 35 | 45.4 32.1–64.1ROR 45.4 · calibrated p 4e-5 ✓ | 41.1 EB05 30.9 · IC025 +4.2 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=35 · ♀ 0% (drug 52%) · 100% clinician | not reported in cached trials |
| Nasal mucosal disorder | 40 | 40.4 29.3–55.7ROR 40.4 · calibrated p 7e-5 ✓ | 37.0 EB05 28.4 · IC025 +4.2 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 100% (drug 52%) · 100% clinician | not reported in cached trials |
| Immunisation | 29 | 39.4 27.0–57.4ROR 39.4 · calibrated p 1e-4 ✓ | 36.0 EB05 26.3 · IC025 +3.9 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=29 · ♀ 100% (drug 52%) | not reported in cached trials |
| Palmoplantar keratoderma | 44 | 35.7 26.4–48.5ROR 35.8 · calibrated p 1e-4 ✓ | 33.2 EB05 25.7 · IC025 +4.1 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 100% (drug 52%) | not reported in cached trials |
| Blood calcium decreased | 602 | 31.0 28.5–33.6ROR 31.5 · calibrated p 2e-4 ✓ | 29.3 EB05 27.4 · IC025 +4.7 3/3 methods agree vs other Osmotic Laxatives: PRR 267.2 (184.1–387.8) | Lab value / disease marker | serious PRR 23.8 · ♀ 92% (drug 52%) | not reported in cached trials |
| Jaundice cholestatic | 186 | 30.5 26.3–35.3ROR 30.6 · calibrated p 3e-4 ✓ | 28.8 EB05 25.5 · IC025 +4.5 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=186 · ♀ 100% (drug 52%) · 96% clinician | not reported in cached trials |
| Hypomania | 173 | 27.0 23.2–31.5ROR 27.2 · calibrated p 5e-4 ✓ | 25.7 EB05 22.7 · IC025 +4.3 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=173 · ♀ 100% (drug 52%) · 95% clinician | not reported in cached trials |
| Orthostatic hypotension (dizziness on standing) | 803 | 26.5 24.7–28.4ROR 27.1 · calibrated p 5e-4 ✓ | 25.3 EB05 23.9 · IC025 +4.5 3/3 methods agree vs other Osmotic Laxatives: PRR 172.3 (132.6–223.9) | No label text to screen label has no adverse-reaction text | serious PRR 18.7 · ♀ 86% (drug 52%) | not reported in cached trials |
| Varices oesophageal | 138 | 26.3 22.2–31.2ROR 26.4 · calibrated p 6e-4 ✓ | 25.1 EB05 21.8 · IC025 +4.3 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=135 | not reported in cached trials |
| Streptococcal sepsis | 51 | 24.5 18.5–32.5ROR 24.6 · calibrated p 9e-4 ✓ | 23.3 EB05 18.4 · IC025 +3.8 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=51 · ♀ 100% (drug 52%) | not reported in cached trials |
| Hepatorenal syndrome | 67 | 22.6 17.7–28.8ROR 22.6 · calibrated p 0.001 ✓ | 21.6 EB05 17.6 · IC025 +3.8 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=67 | not reported in cached trials |
| Oesophageal varices haemorrhage | 83 | 21.8 17.5–27.1ROR 21.8 · calibrated p 0.001 ✓ | 20.9 EB05 17.4 · IC025 +3.9 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=82 · ♀ 28% (drug 52%) | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 39 | 20.7 15.0–28.4ROR 20.7 · calibrated p 0.002 ✓ | 19.8 EB05 15.1 · IC025 +3.5 3/3 methods agree vs other Osmotic Laxatives: PRR 12.9 (8.3–20.1) | No label text to screen label has no adverse-reaction text | serious n=39 · ♀ 0% (drug 52%) | not reported in cached trials |
| Faecaloma | 191 | 20.0 17.3–23.1ROR 20.1 · calibrated p 0.002 ✓ | 19.3 EB05 17.1 · IC025 +4.0 3/3 methods agree vs other Osmotic Laxatives: PRR 41.0 (30.7–54.8) | No label text to screen label has no adverse-reaction text | serious n=189 | not reported in cached trials |
| Pseudomonal sepsis | 59 | 19.0 14.7–24.7ROR 19.1 · calibrated p 0.003 ✓ | 18.3 EB05 14.7 · IC025 +3.6 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=59 · ♀ 100% (drug 52%) | not reported in cached trials |
| Aortic arteriosclerosis | 86 | 18.9 15.3–23.5ROR 19.0 · calibrated p 0.003 ✓ | 18.3 EB05 15.2 · IC025 +3.7 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=86 | not reported in cached trials |
| Systemic infection | 52 | 17.7 13.4–23.4ROR 17.7 · calibrated p 0.004 ✓ | 17.1 EB05 13.5 · IC025 +3.4 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=52 · ♀ 29% (drug 52%) · 100% clinician | not reported in cached trials |
| Hyperammonaemic encephalopathy | 51 | 16.9 12.8–22.3ROR 16.9 · calibrated p 0.005 ✓ | 16.2 EB05 12.8 · IC025 +3.4 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=51 · 100% clinician | not reported in cached trials |
| Asterixis | 30 | 16.0 11.1–23.0ROR 16.0 · calibrated p 0.007 ✓ | 15.3 EB05 11.0 · IC025 +3.0 3/3 methods agree vs other Osmotic Laxatives: only this drug | No label text to screen label has no adverse-reaction text | serious n=30 · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Lactulose as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00508482 — A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipat (N=475, PHASE2; 4 AE terms posted; arms: Deep Needling Group; Shallow Needling Group; Lactulose Group)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nausea | 2,620 | 1.8 1.8–1.9ROR 1.9 · calibrated p 0.883 | 1.8 EB05 1.8 · IC025 +0.8 vs other Osmotic Laxatives: PRR 16.1 (15.2–17.0) | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | not reported in cached trials |
| Constipation | 2,563 | 6.6 6.3–6.8ROR 7.0 · calibrated p 0.099 | 6.5 EB05 6.3 · IC025 +2.6 3/3 methods agree vs other Osmotic Laxatives: PRR 28.3 (26.4–30.3) | No label text to screen label has no adverse-reaction text | serious PRR 6.9 | not reported in cached trials |
| Fall | 2,295 | 3.8 3.7–4.0ROR 4.0 · calibrated p 0.378 | 3.8 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other Osmotic Laxatives: PRR 41.8 (38.5–45.5) | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | not reported in cached trials |
| Vomiting | 2,140 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.768 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree vs other Osmotic Laxatives: PRR 15.8 (14.8–16.8) | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | not reported in cached trials |
| Fatigue (tiredness) | 2,095 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.650 | 1.5 EB05 1.4 · IC025 +0.5 vs other Osmotic Laxatives: PRR 23.5 (21.9–25.2) | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | NCT00508482: 1/228 (0.4%) on Lactulose |
| Death | 2,000 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.504 | 1.3 EB05 1.2 · IC025 +0.3 vs other Osmotic Laxatives: PRR 32.0 (29.5–34.7) | Outcome field, not a reaction | serious PRR 0.8 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,960 | 1.7 1.6–1.8ROR 1.7 · calibrated p 0.779 | 1.7 EB05 1.6 · IC025 +0.7 vs other Osmotic Laxatives: PRR 18.3 (17.1–19.6) | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | NCT00508482: 10/115 (8.7%) on Lactulose |
| Dyspnoea (shortness of breath) | 1,956 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.919 | 1.9 EB05 1.8 · IC025 +0.9 vs other Osmotic Laxatives: PRR 25.4 (23.5–27.4) | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | not reported in cached trials |
| Pain | 1,749 | 1.6 1.5–1.6ROR 1.6 · calibrated p 0.702 | 1.6 EB05 1.5 · IC025 +0.6 vs other Osmotic Laxatives: PRR 26.7 (24.6–29.0) | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | not reported in cached trials |
| Pneumonia (lung infection) | 1,739 | 3.0 2.8–3.1ROR 3.1 · calibrated p 0.606 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other Osmotic Laxatives: PRR 29.7 (27.3–32.4) | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | not reported in cached trials |
| Off label use (used outside approved label) | 1,658 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.342 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC vs other Osmotic Laxatives: PRR 11.9 (11.2–12.7) | Reporting / coding artifact | serious PRR 1.1 | not reported in cached trials |
| Hypotension (low blood pressure) | 1,558 | 4.3 4.1–4.5ROR 4.4 · calibrated p 0.304 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Osmotic Laxatives: PRR 34.2 (31.2–37.6) | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | not reported in cached trials |
| Confusional state (confusion) | 1,504 | 5.1 4.9–5.4ROR 5.3 · calibrated p 0.203 | 5.1 EB05 4.9 · IC025 +2.3 3/3 methods agree vs other Osmotic Laxatives: PRR 45.2 (40.7–50.3) | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | not reported in cached trials |
| Pyrexia (fever) | 1,428 | 2.3 2.2–2.4ROR 2.3 · calibrated p 0.892 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Osmotic Laxatives: PRR 20.6 (19.0–22.4) | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | not reported in cached trials |
| Asthenia (weakness) | 1,376 | 2.0 1.9–2.1ROR 2.1 · calibrated p 0.974 | 2.0 EB05 1.9 · IC025 +0.9 vs other Osmotic Laxatives: PRR 22.3 (20.4–24.3) | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | not reported in cached trials |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Lactulose?
In FDA FAERS, the most frequently co-reported reaction terms for Lactulose are nausea, constipation, fall, vomiting, fatigue, diarrhoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Lactulose have an FDA boxed warning?
No. The FDA label retrieved for Lactulose has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lactulose causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 35207edd-a5fe-4369-a079-7a8b0d2f2e91, effective 20240716; matched on
openfda.generic_name.exact:"LACTULOSE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,232 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
LACTULOSE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.