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LACTULOSE

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Lactulose Adverse Events Reported to the FDA Over Time

How are Lactulose adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Lactulose, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Lactulose is flagged as the suspect drug causing the adverse event.

Most Common Lactulose Adverse Events Reported to the FDA

What are the most common Lactulose adverse events reported to the FDA?

Constipation
90 (2.99%)
Malaise
83 (2.76%)
Pyrexia
66 (2.19%)
Urinary Tract Infection
65 (2.16%)
Sinus Tachycardia
61 (2.03%)
Cardiac Murmur
60 (1.99%)
Diabetes Mellitus
58 (1.93%)
Iron Deficiency Anaemia
58 (1.93%)
White Blood Cell Count Increased
57 (1.89%)
Abdominal Tenderness
56 (1.86%)
Hiatus Hernia
56 (1.86%)
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Mean Cell Volume Decreased
55 (1.83%)
Neutrophil Count Increased
55 (1.83%)
Staphylococcal Infection
55 (1.83%)
Skin Disorder
54 (1.79%)
Body Mass Index Decreased
52 (1.73%)
Monocyte Count Increased
52 (1.73%)
Jaundice
45 (1.49%)
Drug Exposure During Pregnancy
43 (1.43%)
Hypertension
43 (1.43%)
Therapeutic Agent Toxicity
40 (1.33%)
White Blood Cell Disorder
40 (1.33%)
Mesothelioma
38 (1.26%)
Physical Assault
38 (1.26%)
Abdominal Pain
33 (1.1%)
Lung Neoplasm Malignant
33 (1.1%)
Nausea
32 (1.06%)
Premature Baby
31 (1.03%)
Cleft Lip And Palate
28 (.93%)
Maternal Drugs Affecting Foetus
27 (.9%)
Caesarean Section
24 (.8%)
Back Pain
23 (.76%)
Toxic Epidermal Necrolysis
23 (.76%)
Musculoskeletal Stiffness
22 (.73%)
Pancreatic Carcinoma
22 (.73%)
Drug Interaction
21 (.7%)
Teratogenicity
21 (.7%)
Confusional State
19 (.63%)
Ascites
18 (.6%)
Dehydration
18 (.6%)
Emphysema
18 (.6%)
Diarrhoea
17 (.56%)
Drug Ineffective
17 (.56%)
Haematuria
17 (.56%)
Inguinal Hernia
17 (.56%)
Pancreatitis Acute
17 (.56%)
Portal Vein Thrombosis
17 (.56%)
Vomiting
17 (.56%)
Pulmonary Hypertension
16 (.53%)
Chronic Obstructive Pulmonary Disea...
15 (.5%)
Maternal Condition Affecting Foetus
14 (.46%)
Pulmonary Embolism
14 (.46%)
Agitation
13 (.43%)
Sudden Cardiac Death
13 (.43%)
Amnesia
12 (.4%)
Death
12 (.4%)
Abortion Induced
11 (.37%)
Aggression
11 (.37%)
Convulsion
11 (.37%)
Disorientation
11 (.37%)
Hepatic Encephalopathy
11 (.37%)
Nuclear Magnetic Resonance Imaging ...
11 (.37%)
Renal Impairment
11 (.37%)
Bedridden
10 (.33%)
Cough
10 (.33%)
Hydronephrosis
10 (.33%)
Kidney Malformation
10 (.33%)
Neonatal Disorder
10 (.33%)
Rash
10 (.33%)
Urinoma
10 (.33%)
Abdominal Distension
9 (.3%)
Anaemia
9 (.3%)
Dizziness
9 (.3%)
Hypersensitivity
9 (.3%)
Hypotension
9 (.3%)
Pain
9 (.3%)
Restlessness
9 (.3%)
Anaesthetic Complication
8 (.27%)
Delayed Recovery From Anaesthesia
8 (.27%)
Stevens-johnson Syndrome
8 (.27%)
Tracheo-oesophageal Fistula
8 (.27%)
Ammonia Increased
7 (.23%)
Blood Creatinine Increased
7 (.23%)
Cerebrovascular Accident
7 (.23%)
Gastrooesophageal Reflux Disease
7 (.23%)
Hepatic Cirrhosis
7 (.23%)
Melaena
7 (.23%)
Premature Labour
7 (.23%)
Thrombocytopenia
7 (.23%)
Aspartate Aminotransferase Increase...
6 (.2%)
Product Substitution Issue
6 (.2%)
Pruritus
6 (.2%)
Treatment Noncompliance
6 (.2%)
Twin Pregnancy
6 (.2%)
Arrhythmia
5 (.17%)
Chest Pain
5 (.17%)
Dyspnoea
5 (.17%)
Feeling Abnormal
5 (.17%)
Flushing
5 (.17%)
Gastrointestinal Haemorrhage
5 (.17%)
Lower Respiratory Tract Infection
5 (.17%)

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This graph shows the top adverse events submitted to the FDA for Lactulose, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Lactulose is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Lactulose

What are the most common Lactulose adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Lactulose, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Lactulose is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Lactulose According to Those Reporting Adverse Events

Why are people taking Lactulose, according to those reporting adverse events to the FDA?

Constipation
1306
Drug Use For Unknown Indication
489
Product Used For Unknown Indication
459
Constipation Prophylaxis
96
Hepatic Encephalopathy
83
Prophylaxis
50
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Laxative Supportive Care
43
Encephalopathy
42
Hepatic Cirrhosis
40
Hyperammonaemia
27
Ill-defined Disorder
24
Hepatic Encephalopathy Prophylaxis
13
Hepatic Failure
13
Hepatitis C
11
Liver Disorder
11
Gastrointestinal Disorder
10
Crohns Disease
10
Post Procedural Constipation
9
Drug Exposure During Pregnancy
8
Ammonia Increased
7
Intestinal Functional Disorder
7
Bowel Movement Irregularity
6
Ammonia Abnormal
6
Dyspepsia
5
Hepatitis B
5
Confusional State
5
Chronic Hepatic Failure
5
Haemorrhoid Operation
4
Haemolysis
4
Gastrointestinal Motility Disorder
4
Subcutaneous Abscess
3
Maternal Exposure During Pregnancy
3
Premedication
3
Chronic Hepatitis
3
Irritable Bowel Syndrome
3
Diabetes Mellitus
2
Metastases To Bone
2
Intestinal Obstruction
2
Hyponatraemia
2
Adverse Event
2
Antidepressant Therapy
2
Impaired Gastric Emptying
2
Pyrexia
2
Oedema Peripheral
2
Dyschezia
2
Delusional Disorder, Persecutory Ty...
2
Growth Retardation
2
Renal Failure Chronic
2
Alcoholic Liver Disease
2
Encephalitis
2
Haemorrhoids
2

Drug Labels

LabelLabelerEffective
LactuloseApotex Corp.04-DEC-08
LactuloseRoxane Laboratories, Inc19-OCT-09
LactuloseQualitest Pharmaceuticals08-DEC-09
LactuloseAtlantic Biologicals Corps08-DEC-09
LactulosePhysicians Total Care, Inc.31-DEC-09
LactuloseVistaPharm, Inc12-MAY-10
ConstuloseActavis Inc.10-JAN-11
EnuloseActavis Inc.10-JAN-11
LactuloseMcKesson Packaging Services a business unit of McKesson Corporation01-NOV-11
LactuloseHi-Tech Pharmacal Co., Inc.17-NOV-11
GenerlacMorton Grove Pharmaceuticals, Inc.30-JAN-12
LactuloseMorton Grove Pharmaceuticals, Inc.15-FEB-12
LactuloseRebel Distributors Corp27-MAR-12
LactuloseLake Erie Medical & Surgical Supply DBA Quality Care Products LLC27-JUN-12
LactulosePharmaceutical Associates, Inc,16-JUL-12
KristaloseCumberland Pharmaceuticals Inc.21-SEP-12
LactuloseLake Erie Medical DBA Quality Care Products LLC20-NOV-12
LactuloseCardinal Health22-MAR-13
LactuloseHi-Tech Pharmacal Co., Inc.23-MAR-13

Lactulose Case Reports

What Lactulose safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Lactulose. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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