Lactulose

Common brands: Enulose, Generlac, Constulose, Kristalose, Lactulose Crystalline

Top reporter: Actavis Pharma, Inc.

Osmotic Laxative [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Proton Pump Inhibitor [EPC]Loop Diuretic [EPC]Corticosteroid [EPC]
37,564
Total Reports
15,518
Serious Reports
6,591
Death Reports
30
Reported Reactions
Death Report Ratio: High (17.55%)

Patient Demographics

Male
16,889
Female
18,161

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Lactulose.

# Reaction Reports % of Total
1 NAUSEA 2,573
5.8%
2 CONSTIPATION 2,527
5.7%
3 FALL 2,267
5.1%
4 VOMITING 2,096
4.8%
5 FATIGUE 2,056
4.7%
6 DEATH 1,968
4.5%
7 DYSPNOEA 1,935
4.4%
8 DIARRHOEA 1,924
4.4%
9 PAIN 1,733
3.9%
10 PNEUMONIA 1,715
3.9%
11 OFF LABEL USE 1,607
3.6%
12 HYPOTENSION 1,545
3.5%
13 CONFUSIONAL STATE 1,491
3.4%
14 PYREXIA 1,415
3.2%
15 ASTHENIA 1,353
3.1%
16 ABDOMINAL PAIN 1,297
2.9%
17 MALAISE 1,246
2.8%
18 HEADACHE 1,231
2.8%
19 DIZZINESS 1,227
2.8%
20 ACUTE KIDNEY INJURY 1,202
2.7%
21 ANAEMIA 1,155
2.6%
22 DRUG INEFFECTIVE 1,148
2.6%
23 URINARY TRACT INFECTION 981
2.2%
24 WEIGHT DECREASED 972
2.2%
25 BALANCE DISORDER 963
2.2%
26 DECREASED APPETITE 954
2.2%
27 CONDITION AGGRAVATED 941
2.1%
28 DEHYDRATION 882
2.0%
29 GENERAL PHYSICAL HEALTH DETERIORATION 871
2.0%
30 COGNITIVE DISORDER 835
1.9%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.