Last reviewed 2026-04-20 · How we verify

Cephulac (LACTULOSE)

At a glance

Approved indications

• Constipation
• Hepatic encephalopathy
• Hyperammonemia

Common side effects

• Nausea
• Diarrhea
• Abdominal Distension
• Abdominal Pain
• Flatulence
• Vomiting
• Dizziness
• Headache
• Fatigue
• Asthenia
• Anorexia
• Dehydration

Key clinical trials

• Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation (PHASE2)
• Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial) (NA)
• Breath Test-Based Assessment of SIBO in Chronic Pancreatitis and Partial Pancreatectomy
• Evaluation of the Outcome of Fecal Microbiota Transplantation (PHASE1,PHASE2)
• Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy (PHASE1,PHASE2)
• LiveSMART Trial to Prevent Falls in Patients With Cirrhosis - Supplementary Study
• Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure. (NA)
• Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Cephulac CI brief — competitive landscape report
• Cephulac updates RSS · CI watch RSS
• Sanwa Kagaku Kenkyusho Co., Ltd. portfolio CI