lactulose 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	1536	4618-18-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: lactulose bifiteral cephulac D-Lactulose isolactose lactulose hydrate	A synthetic disaccharide used in the treatment of constipation and hepatic encephalopathy. It has also been used in the diagnosis of gastrointestinal disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p887) Molecular weight: 342.30 Formula: C12H22O11 CLOGP: -3.59 LIPINSKI: 2 HAC: 11 HDO: 8 TPSA: 189.53 ALOGS: 0.36 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

lactulose
bifiteral
cephulac
D-Lactulose
isolactose
lactulose hydrate

A synthetic disaccharide used in the treatment of constipation and hepatic encephalopathy. It has also been used in the diagnosis of gastrointestinal disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p887)

Molecular weight: 342.30
Formula: C12H22O11
CLOGP: -3.59
LIPINSKI: 2
HAC: 11
HDO: 8
TPSA: 189.53
ALOGS: 0.36
ROTB: 5

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
6.70	g	O

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	1669.38 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	3 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
March 25, 1976	FDA
Sept. 21, 2018	PMDA	Sanwa Kagaku Kenkyusho Co., Ltd.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Sedation complication	541.21	10.82	228	46607	8538	50549751
Orthostatic hypotension	518.38	10.82	329	46506	29152	50529137
Creatinine renal clearance decreased	493.05	10.82	234	46601	11647	50546642
Sedation	441.82	10.82	302	46533	30308	50527981
Cognitive disorder	405.48	10.82	332	46503	43791	50514498
Blood calcium decreased	391.39	10.82	242	46593	20464	50537825
Balance disorder	313.82	10.82	356	46479	70234	50488055
Drug ineffective	313.03	10.82	187	46648	819146	49739143
Depressed level of consciousness	309.10	10.82	306	46529	51647	50506642
Hepatic encephalopathy	302.45	10.82	157	46678	9479	50548810
Constipation	240.10	10.82	530	46305	185178	50373111
Fall	193.48	10.82	714	46121	334218	50224071
Ammonia increased	159.15	10.82	78	46757	4163	50554126
Mobility decreased	153.91	10.82	270	46565	79678	50478611
Jaundice cholestatic	151.04	10.82	80	46755	5031	50553258
Hypotension	144.19	10.82	512	46323	234957	50323332
Hypomania	137.34	10.82	72	46763	4433	50553856
Hyponatraemia	128.07	10.82	278	46557	95861	50462428
Blood bilirubin increased	124.60	10.82	151	46684	31887	50526402
Schizophrenia	123.57	10.82	80	46755	7317	50550972
Drug hypersensitivity	120.59	10.82	41	46794	250969	50307320
Drug intolerance	110.17	10.82	33	46802	219071	50339218
Faecaloma	109.31	10.82	73	46762	7035	50551254
Rheumatoid arthritis	106.49	10.82	28	46807	202522	50355767
Treatment failure	100.23	10.82	7	46828	137630	50420659
Systemic lupus erythematosus	99.99	10.82	8	46827	140614	50417675
Arthropathy	99.49	10.82	14	46821	157892	50400397
Synovitis	97.35	10.82	4	46831	123861	50434428
Hepatic cirrhosis	96.13	10.82	99	46736	17478	50540811
Maternal exposure during pregnancy	86.06	10.82	21	46814	159757	50398532
Inability to afford medication	85.16	10.82	37	46798	1493	50556796
Completed suicide	82.36	10.82	12	46823	131877	50426412
Psychotic disorder	81.88	10.82	101	46734	21711	50536578
Swelling	80.17	10.82	43	46792	200829	50357460
Joint swelling	78.53	10.82	67	46768	245219	50313070
Glossodynia	78.32	10.82	8	46827	115561	50442728
Ascites	78.06	10.82	128	46707	35733	50522556
Contraindicated product administered	77.49	10.82	21	46814	148937	50409352
Hyperkalaemia	76.88	10.82	150	46685	47939	50510350
Hand deformity	76.24	10.82	4	46831	100195	50458094
Sinusitis	74.95	10.82	32	46803	170526	50387763
Alopecia	72.44	10.82	72	46763	244975	50313314
Infusion related reaction	71.09	10.82	34	46801	169523	50388766
Confusional state	68.08	10.82	346	46489	185582	50372707
Haematemesis	67.27	10.82	104	46731	27621	50530668
Therapeutic product effect decreased	65.65	10.82	22	46813	136028	50422261
Neutropenic sepsis	65.57	10.82	73	46762	14074	50544215
Injection site pain	65.07	10.82	12	46823	111012	50447277
Arthralgia	64.15	10.82	201	46634	438501	50119788
Cholelithiasis	60.14	10.82	118	46717	37855	50520434
Skin candida	57.69	10.82	27	46808	1299	50556990
General physical health deterioration	57.06	10.82	272	46563	142162	50416127
Toxicity to various agents	55.22	10.82	361	46474	212138	50346151
Discomfort	55.01	10.82	16	46819	108364	50449925
Pericarditis	54.48	10.82	5	46830	78684	50479605
Abdominal discomfort	53.77	10.82	82	46753	231559	50326730
Lymphatic fistula	51.30	10.82	21	46814	729	50557560
Intestinal pseudo-obstruction	51.19	10.82	21	46814	733	50557556
Femoral hernia incarcerated	51.01	10.82	21	46814	740	50557549
Product use issue	50.07	10.82	39	46796	149436	50408853
Wound infection pseudomonas	49.52	10.82	24	46811	1249	50557040
Pancreatic steatosis	46.97	10.82	21	46814	908	50557381
Rash	46.87	10.82	227	46608	437244	50121045
Abdominal pain	46.77	10.82	376	46459	235852	50322437
Vomiting	46.37	10.82	639	46196	460119	50098170
Hepatotoxicity	46.05	10.82	87	46748	27139	50531150
Off label use	45.87	10.82	255	46580	474171	50084118
Therapeutic product effect incomplete	43.78	10.82	15	46820	91500	50466789
Hepatic failure	43.66	10.82	94	46741	32189	50526100
Nasopharyngitis	43.13	10.82	70	46765	192857	50365432
Wound	43.13	10.82	22	46813	105772	50452517
Haemarthrosis	42.64	10.82	29	46806	2879	50555410
Injection site erythema	42.01	10.82	9	46826	74927	50483362
Jaundice	41.69	10.82	82	46753	26347	50531942
Heart sounds	40.92	10.82	17	46818	613	50557676
Fatigue	40.00	10.82	441	46394	707160	49851129
Urinary retention	39.80	10.82	80	46755	26110	50532179
Dehydration	39.56	10.82	259	46576	152190	50406099
Arterial haemorrhage	39.41	10.82	22	46813	1535	50556754
Varices oesophageal	38.97	10.82	27	46808	2762	50555527
Prolonged expiration	38.71	10.82	17	46818	704	50557585
Seroma	38.57	10.82	23	46812	1818	50556471
Hypersensitivity	36.21	10.82	92	46743	215069	50343220
Acute kidney injury	35.78	10.82	345	46490	227713	50330576
Urinary tract infection	35.69	10.82	340	46495	223680	50334609
Encephalopathy	35.53	10.82	89	46746	33622	50524667
Musculoskeletal stiffness	35.40	10.82	40	46795	128441	50429848
Chronic hepatic failure	34.72	10.82	14	46821	467	50557822
Aortic arteriosclerosis	34.39	10.82	33	46802	5349	50552940
Hepatocellular carcinoma	34.32	10.82	22	46813	1977	50556312
Hypokalaemia	33.73	10.82	166	46669	87826	50470463
Diverticulum intestinal	33.49	10.82	34	46801	5899	50552390
Delirium	33.32	10.82	94	46741	38098	50520191
Abdominal tenderness	32.77	10.82	37	46798	7243	50551046
Dementia	32.00	10.82	55	46780	15942	50542347
Duodenal ulcer	31.46	10.82	35	46800	6740	50551549
Urticaria	30.87	10.82	45	46790	129516	50428773
Aortic valve stenosis	30.72	10.82	24	46811	2951	50555338
Peritonitis bacterial	30.58	10.82	29	46806	4632	50553657
Psoriasis	30.20	10.82	13	46822	68987	50489302
Oesophageal varices haemorrhage	30.08	10.82	16	46819	1014	50557275
Drug abuse	30.06	10.82	9	46826	59837	50498452
Suicide attempt	29.44	10.82	6	46829	51726	50506563
Alkalosis hypochloraemic	29.11	10.82	9	46826	134	50558155
Exposure during pregnancy	28.86	10.82	42	46793	120973	50437316
Neutrophil count increased	28.65	10.82	49	46786	14146	50544143
Wound dehiscence	28.52	10.82	27	46808	4303	50553986
Ileus	28.48	10.82	47	46788	13182	50545107
Weight increased	28.36	10.82	94	46741	201797	50356492
Hypertriglyceridaemia	28.35	10.82	30	46805	5461	50552828
Haemoglobin decreased	28.19	10.82	208	46627	127008	50431281
Product monitoring error	27.90	10.82	22	46813	2742	50555547
Insurance issue	27.28	10.82	21	46814	2527	50555762
Intentional overdose	27.00	10.82	12	46823	62492	50495797
Superinfection	26.63	10.82	19	46816	2037	50556252
Melaena	26.32	10.82	69	46766	26795	50531494
Arthritis	26.13	10.82	25	46810	86696	50471593
Product prescribing error	26.04	10.82	59	46776	20902	50537387
Cholestasis of pregnancy	25.98	10.82	15	46820	1116	50557173
Hepatic cyst	25.82	10.82	26	46809	4467	50553822
Therapeutic response decreased	25.81	10.82	6	46829	47225	50511064
Irritable bowel syndrome	25.36	10.82	8	46827	51433	50506856
Anaemia	25.24	10.82	350	46485	252106	50306183
Dermatitis bullous	24.98	10.82	32	46803	7141	50551148
Intestinal dilatation	24.82	10.82	16	46819	1452	50556837
Headache	24.59	10.82	326	46509	506209	50052080
Ill-defined disorder	24.39	10.82	10	46825	54644	50503645
Tachyarrhythmia	24.04	10.82	24	46811	4081	50554208
Body mass index decreased	23.83	10.82	10	46825	370	50557919
Psoriatic arthropathy	23.75	10.82	7	46828	47025	50511264
Abortion spontaneous	23.45	10.82	5	46830	41767	50516522
Urinary incontinence	23.22	10.82	68	46767	28140	50530149
Hiatus hernia	23.20	10.82	52	46783	18292	50539997
Hyperammonaemia	22.97	10.82	25	46810	4699	50553590
Infection	22.62	10.82	83	46752	172871	50385418
Injection site reaction	22.58	10.82	9	46826	50023	50508266
White blood cell count increased	22.52	10.82	88	46747	42152	50516137
Injection site pruritus	22.35	10.82	5	46830	40406	50517883
Intestinal obstruction	22.10	10.82	64	46771	26319	50531970
Portal hypertension	22.05	10.82	21	46814	3371	50554918
Nail dystrophy	22.01	10.82	12	46823	799	50557490
Mucosal inflammation	21.70	10.82	84	46751	40058	50518231
Cirrhosis alcoholic	21.50	10.82	8	46827	214	50558075
Disorientation	21.48	10.82	77	46758	35407	50522882
Abdominal distension	21.47	10.82	128	46707	72775	50485514
Peripheral swelling	21.32	10.82	108	46727	205828	50352461
Sepsis	21.26	10.82	202	46633	132723	50425566
Pneumonia	21.08	10.82	478	46357	377923	50180366
Blood pressure increased	20.81	10.82	59	46776	133073	50425216
Helicobacter infection	20.75	10.82	10	46825	49692	50508597
Mouth ulceration	20.67	10.82	65	46770	27959	50530330
Eructation	20.56	10.82	29	46806	7092	50551197
Hepatitis C	20.46	10.82	24	46811	4893	50553396
Abdominal rigidity	20.37	10.82	15	46820	1689	50556600
Blood cholesterol increased	20.32	10.82	13	46822	55202	50503087
Vascular encephalopathy	20.31	10.82	9	46826	381	50557908
Bradycardia	20.20	10.82	115	46720	64311	50493978
Spinal cord paralysis	19.95	10.82	5	46830	32	50558257
Product dose omission issue	19.84	10.82	95	46740	183743	50374546
Pneumatosis intestinalis	19.66	10.82	16	46819	2087	50556202
Left ventricular dysfunction	19.56	10.82	35	46800	10471	50547818
Injection site bruising	19.45	10.82	5	46830	36763	50521526
Seizure	19.28	10.82	180	46655	117694	50440595
Gastrointestinal haemorrhage	19.26	10.82	125	46710	73196	50485093
Blood albumin abnormal	18.94	10.82	9	46826	448	50557841
Thrombocytopenia	18.94	10.82	191	46644	127482	50430807
Hallucination, visual	18.77	10.82	45	46790	16537	50541752
Syncope	18.75	10.82	161	46674	102841	50455448
Gastrointestinal disorder	18.63	10.82	37	46798	94419	50463870
Portal hypertensive gastropathy	18.57	10.82	10	46825	650	50557639
Pulmonary vein occlusion	18.51	10.82	6	46829	105	50558184
Hip arthroplasty	18.45	10.82	3	46832	30426	50527863
Femoral neck fracture	18.03	10.82	28	46807	7462	50550827
Cholestasis	17.90	10.82	58	46777	25343	50532946
Anuria	17.87	10.82	35	46800	11209	50547080
Mouth swelling	17.79	10.82	20	46815	3896	50554393
Upper gastrointestinal haemorrhage	17.59	10.82	43	46792	15992	50542297
Salivary gland enlargement	17.57	10.82	8	46827	361	50557928
Ejection fraction decreased	17.56	10.82	47	46788	18473	50539816
Depressive symptom	17.45	10.82	18	46817	3182	50555107
Device expulsion	17.13	10.82	3	46832	28819	50529470
Oral contusion	16.87	10.82	5	46830	64	50558225
Axillary pain	16.84	10.82	13	46822	1571	50556718
Postoperative wound infection	16.77	10.82	29	46806	8446	50549843
Blood alkaline phosphatase increased	16.72	10.82	74	46761	37452	50520837
Lethargy	16.67	10.82	90	46745	49342	50508947
Respiration abnormal	16.58	10.82	22	46813	5080	50553209
Liver function test abnormal	16.52	10.82	83	46752	44256	50514033
Inflammation	16.46	10.82	17	46818	56895	50501394
Alkalosis	16.21	10.82	7	46828	278	50558011
Escherichia infection	16.12	10.82	33	46802	10908	50547381
Feeling abnormal	15.90	10.82	61	46774	125431	50432858
Hepatorenal syndrome	15.74	10.82	13	46822	1730	50556559
Plasma cell myeloma	15.69	10.82	64	46771	31258	50527031
Pancytopenia	15.64	10.82	132	46703	83898	50474391
Pustule	15.52	10.82	11	46824	1167	50557122
Herpes zoster	15.50	10.82	26	46809	70760	50487529
Cardiac ventricular thrombosis	15.48	10.82	8	46827	478	50557811
Electrocardiogram T wave inversion	15.41	10.82	17	46818	3244	50555045
Pain in extremity	15.33	10.82	170	46665	272695	50285594
Tumour hyperprogression	15.24	10.82	5	46830	91	50558198
Inappropriate schedule of product administration	15.17	10.82	27	46808	71804	50486485
Death	15.09	10.82	401	46434	324978	50233311
Cardiomyopathy acute	15.03	10.82	6	46829	195	50558094
Aspiration	14.92	10.82	29	46806	9235	50549054
Inflammatory marker increased	14.89	10.82	22	46813	5612	50552677
Cardiovascular disorder	14.78	10.82	31	46804	10423	50547866
Aplastic anaemia	14.78	10.82	26	46809	7677	50550612
Hypomagnesaemia	14.66	10.82	51	46784	23105	50535184
Vascular parkinsonism	14.53	10.82	5	46830	106	50558183
Circulatory collapse	14.39	10.82	46	46789	19954	50538335
Haematocrit increased	14.34	10.82	13	46822	1961	50556328
Portopulmonary hypertension	14.31	10.82	5	46830	111	50558178
Haemoglobin increased	14.31	10.82	16	46819	3099	50555190
C-reactive protein abnormal	14.30	10.82	4	46831	27805	50530484
Pruritus	14.27	10.82	181	46654	283387	50274902
Type 2 diabetes mellitus	14.22	10.82	7	46828	34368	50523921
Activated partial thromboplastin time abnormal	14.15	10.82	5	46830	115	50558174
Visual impairment	14.12	10.82	26	46809	68249	50490040
Blood albumin decreased	14.00	10.82	35	46800	13201	50545088
Mechanical urticaria	14.00	10.82	7	46828	390	50557899
Mutism	13.96	10.82	11	46824	1370	50556919
Thrombocytosis	13.92	10.82	20	46815	4976	50553313
Product administration error	13.90	10.82	45	46790	19654	50538635
Spinal cord infarction	13.79	10.82	6	46829	243	50558046
Spinal subdural haematoma	13.72	10.82	5	46830	126	50558163
Hiccups	13.72	10.82	12	46823	1727	50556562
Depressed mood	13.61	10.82	65	46770	33958	50524331
Migraine	13.58	10.82	31	46804	75249	50483040
Oropharyngeal pain	13.27	10.82	33	46802	77768	50480521
Physical assault	13.18	10.82	9	46826	899	50557390
Asterixis	13.16	10.82	10	46825	1181	50557108
Flail chest	13.04	10.82	4	46831	58	50558231
Bronchitis	12.95	10.82	51	46784	104108	50454181
Gamma-glutamyltransferase increased	12.89	10.82	58	46777	29565	50528724
Therapy non-responder	12.86	10.82	17	46818	51005	50507284
Decreased appetite	12.83	10.82	259	46576	200664	50357625
Systemic infection	12.73	10.82	13	46822	2270	50556019
Tricuspid valve incompetence	12.71	10.82	33	46802	12737	50545552
Jugular vein thrombosis	12.64	10.82	14	46821	2682	50555607
Lung perforation	12.56	10.82	4	46831	66	50558223
Hypoaesthesia	12.45	10.82	68	46767	127189	50431100
Hepatic hydrothorax	12.44	10.82	3	46832	16	50558273
Subileus	12.38	10.82	14	46821	2745	50555544
Fracture	12.37	10.82	39	46796	16794	50541495
Gastrointestinal sounds abnormal	12.32	10.82	16	46819	3618	50554671
Blood creatinine increased	12.30	10.82	116	46719	76044	50482245
Foetal exposure during pregnancy	12.21	10.82	5	46830	27354	50530935
Mental status changes	12.20	10.82	66	46769	36206	50522083
False positive investigation result	12.16	10.82	7	46828	518	50557771
Disease progression	12.15	10.82	139	46696	95727	50462562
Febrile neutropenia	12.11	10.82	141	46694	97526	50460763
Hyperglycaemia	12.08	10.82	66	46769	36339	50521950
Intentional product use issue	12.08	10.82	34	46801	76884	50481405
Product selection error	12.03	10.82	4	46831	76	50558213
Chronotropic incompetence	11.94	10.82	4	46831	78	50558211
Sinus arrhythmia	11.93	10.82	10	46825	1359	50556930
Dyskinesia	11.71	10.82	54	46781	27807	50530482
Ballismus	11.66	10.82	4	46831	84	50558205
Adverse event	11.64	10.82	14	46821	43749	50514540
Change of bowel habit	11.51	10.82	11	46824	1773	50556516
Joint injury	11.45	10.82	3	46832	21786	50536503
Adverse drug reaction	11.44	10.82	21	46814	55201	50503088
Toxic epidermal necrolysis	11.40	10.82	44	46791	20948	50537341
Joint dislocation	11.39	10.82	31	46804	12302	50545987
Skin abrasion	11.33	10.82	24	46811	8126	50550163
COVID-19	11.31	10.82	16	46819	46646	50511643
Anticonvulsant drug level below therapeutic	11.31	10.82	7	46828	592	50557697
Coma hepatic	11.13	10.82	7	46828	609	50557680
Toxic encephalopathy	11.08	10.82	19	46816	5496	50552793
Antipsychotic drug level increased	11.03	10.82	14	46821	3095	50555194
Hypermagnesaemia	10.98	10.82	8	46827	886	50557403
No adverse event	10.93	10.82	9	46826	33569	50524720
Appetite disorder	10.91	10.82	20	46815	6094	50552195
Pregnancy	10.83	10.82	7	46828	29570	50528719

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hepatic encephalopathy	620.50	10.84	323	41630	12712	29519862
Hepatic cirrhosis	169.30	10.84	150	41803	14294	29518280
Confusional state	142.94	10.84	452	41501	127425	29405149
Ascites	138.41	10.84	212	41741	36407	29496167
Hepatic failure	134.26	10.84	193	41760	31319	29501255
Ammonia increased	121.24	10.84	74	41879	3957	29528617
Inability to afford medication	105.47	10.84	43	41910	949	29531625
Drug ineffective	103.14	10.84	227	41726	362943	29169631
Hepatorenal syndrome	81.55	10.84	47	41906	2259	29530315
Completed suicide	74.85	10.84	18	41935	90228	29442346
Drug abuse	68.10	10.84	15	41938	79868	29452706
Varices oesophageal	65.80	10.84	46	41907	3100	29529474
Constipation	64.35	10.84	326	41627	113834	29418740
Toxic epidermal necrolysis	60.13	10.84	99	41854	18054	29514520
Hepatocellular carcinoma	57.62	10.84	60	41893	6978	29525596
Pneumatosis intestinalis	56.37	10.84	42	41911	3127	29529447
Encephalopathy	52.70	10.84	128	41825	30915	29501659
Faecaloma	51.95	10.84	45	41908	4157	29528417
Hyperammonaemia	51.32	10.84	51	41902	5612	29526962
Peritonitis bacterial	50.62	10.84	51	41902	5705	29526869
Off label use	46.73	10.84	244	41709	300556	29232018
Oesophageal varices haemorrhage	46.26	10.84	35	41918	2667	29529907
Chronic hepatic failure	45.75	10.84	19	41934	440	29532134
Blood bilirubin increased	44.51	10.84	127	41826	33766	29498808
Abdominal distension	43.76	10.84	154	41799	45757	29486817
Hyponatraemia	42.99	10.84	200	41753	67433	29465141
Portal hypertension	42.42	10.84	37	41916	3449	29529125
General physical health deterioration	41.65	10.84	269	41684	102588	29429986
Arthralgia	41.31	10.84	85	41868	139532	29393042
Abdominal pain	40.40	10.84	329	41624	135028	29397546
Haematemesis	40.16	10.84	100	41853	24526	29508048
Alveolar lung disease	39.25	10.84	16	41937	353	29532221
Insurance issue	38.13	10.84	21	41932	924	29531650
Pulmonary interstitial emphysema syndrome	35.65	10.84	16	41937	450	29532124
Gastric varices	35.13	10.84	15	41938	373	29532201
Pyramidal tract syndrome	33.34	10.84	12	41941	186	29532388
Liver transplant	33.16	10.84	27	41926	2289	29530285
Jaundice	33.00	10.84	104	41849	29192	29503382
Antipsychotic drug level increased	32.75	10.84	31	41922	3212	29529362
Hepatitis C	31.42	10.84	50	41903	8860	29523714
High-grade B-cell lymphoma	30.93	10.84	9	41944	67	29532507
Cirrhosis alcoholic	30.91	10.84	17	41936	746	29531828
Benign gastrointestinal neoplasm	29.05	10.84	10	41943	135	29532439
Ileus	28.40	10.84	63	41890	14339	29518235
Stoma site discharge	28.00	10.84	17	41936	900	29531674
Neutrophil count increased	27.41	10.84	63	41890	14679	29517895
Product use in unapproved indication	26.43	10.84	52	41901	86823	29445751
Injection site pain	25.86	10.84	7	41946	32439	29500135
Toxicity to various agents	25.70	10.84	143	41810	173518	29359056
Hypermagnesaemia	25.53	10.84	10	41943	198	29532376
Therapy interrupted	25.46	10.84	44	41909	8342	29524232
Myocardial infarction	24.94	10.84	77	41876	110219	29422355
Rash	24.58	10.84	163	41790	189656	29342918
Foetal exposure during pregnancy	23.99	10.84	9	41944	33858	29498716
Conjunctival irritation	23.73	10.84	8	41945	101	29532473
Rheumatoid arthritis	23.70	10.84	8	41945	32144	29500430
Fall	23.43	10.84	367	41586	176811	29355763
Cardiac failure congestive	23.15	10.84	46	41907	76535	29456039
Joint swelling	22.84	10.84	22	41931	49608	29482966
Hypernatraemia	22.75	10.84	39	41914	7347	29525227
Stoma site erythema	22.62	10.84	13	41940	621	29531953
On and off phenomenon	22.53	10.84	20	41933	1908	29530666
Therapeutic product effect incomplete	22.43	10.84	14	41939	39291	29493283
Atrial fibrillation	22.33	10.84	76	41877	105570	29427004
Portal hypertensive gastropathy	22.32	10.84	12	41941	503	29532071
Polypectomy	22.12	10.84	12	41941	512	29532062
Myalgia	21.91	10.84	45	41908	73974	29458600
Acute kidney injury	21.88	10.84	511	41442	264756	29267818
Mesothelioma	21.85	10.84	11	41942	402	29532172
Wrong patient received product	21.51	10.84	21	41932	2261	29530313
Treatment failure	21.30	10.84	13	41940	36926	29495648
Lower respiratory tract infection	21.15	10.84	84	41869	26418	29506156
White blood cell count increased	20.98	10.84	107	41846	37409	29495165
Hepatitis C RNA positive	20.21	10.84	8	41945	163	29532411
Vomiting	20.05	10.84	417	41536	211843	29320731
Pneumonia aspiration	20.01	10.84	104	41849	36633	29495941
Genital erythema	19.90	10.84	8	41945	170	29532404
Interstitial lung disease	19.84	10.84	32	41921	57686	29474888
Delirium	19.74	10.84	109	41844	39288	29493286
Metamyelocyte count increased	19.60	10.84	10	41943	376	29532198
Periarthritis calcarea	19.52	10.84	6	41947	55	29532519
Urinary tract infection	19.50	10.84	172	41781	72182	29460392
Epilepsy	19.45	10.84	64	41889	18368	29514206
Product dose omission issue	19.25	10.84	71	41882	96312	29436262
Articular calcification	19.24	10.84	6	41947	58	29532516
Nasopharyngitis	18.76	10.84	35	41918	59630	29472944
Spleen congestion	18.64	10.84	9	41944	300	29532274
Drug resistance	18.43	10.84	4	41949	21536	29511038
Asterixis	18.34	10.84	14	41939	1081	29531493
Acute abdomen	18.22	10.84	17	41936	1730	29530844
Blood pressure increased	17.78	10.84	50	41903	73753	29458821
Mental status changes	17.74	10.84	97	41856	34830	29497744
Hepatic calcification	17.72	10.84	9	41944	335	29532239
Immature granulocyte count increased	17.70	10.84	6	41947	77	29532497
Adrenomegaly	17.41	10.84	9	41944	348	29532226
Adrenal cyst	17.36	10.84	6	41947	82	29532492
Haemoglobin decreased	17.28	10.84	232	41721	108143	29424431
Myelocyte count increased	17.26	10.84	9	41944	354	29532220
Hepatic cancer	17.20	10.84	32	41921	6424	29526150
Costal cartilage fracture	17.19	10.84	8	41945	245	29532329
Pneumonia	16.95	10.84	583	41370	319589	29212985
Rectal haemorrhage	16.91	10.84	95	41858	34454	29498120
Orthostatic hypotension	16.69	10.84	70	41883	22559	29510015
Portal vein thrombosis	16.68	10.84	22	41931	3287	29529287
Hypophagia	16.53	10.84	66	41887	20806	29511768
Dysphagia	16.07	10.84	133	41820	54793	29477781
Diffuse alveolar damage	15.98	10.84	17	41936	2026	29530548
Coronary artery disease	15.66	10.84	24	41929	44166	29488408
Arthritis	15.58	10.84	8	41945	25011	29507563
Wrong technique in product usage process	15.57	10.84	13	41940	31415	29501159
Intentional product misuse	15.22	10.84	16	41937	34645	29497929
Bacterial translocation	15.21	10.84	7	41946	209	29532365
Hypersensitivity	14.95	10.84	33	41920	52870	29479704
Therapeutic product effect decreased	14.82	10.84	12	41941	29439	29503135
Blast cells present	14.73	10.84	9	41944	482	29532092
Product use issue	14.62	10.84	32	41921	51412	29481162
Peripheral artery stenosis	14.56	10.84	11	41942	836	29531738
Hyperkalaemia	14.55	10.84	142	41811	61250	29471324
Dehydration	14.50	10.84	236	41717	114512	29418062
Urinary retention	14.50	10.84	86	41867	31812	29500762
Neutropenic sepsis	14.48	10.84	43	41910	11684	29520890
Liver function test abnormal	14.47	10.84	80	41873	28838	29503736
Sepsis	14.34	10.84	283	41670	142399	29390175
Intentional product use issue	14.20	10.84	24	41929	42474	29490100
Erosive duodenitis	14.17	10.84	13	41940	1294	29531280
Hypertension	14.15	10.84	102	41851	116512	29416062
Gastrointestinal tract mucosal pigmentation	14.06	10.84	8	41945	375	29532199
Inappropriate schedule of product administration	14.06	10.84	26	41927	44446	29488128
Portal tract inflammation	13.98	10.84	5	41948	76	29532498
Abdominal tenderness	13.88	10.84	21	41932	3561	29529013
Bloody discharge	13.85	10.84	8	41945	386	29532188
Lethargy	13.80	10.84	96	41857	37484	29495090
Sexually inappropriate behaviour	13.70	10.84	8	41945	394	29532180
Erythema	13.63	10.84	58	41895	75548	29457026
Paracentesis	13.63	10.84	8	41945	398	29532176
Peritonitis	13.49	10.84	49	41904	14775	29517799
Salivary gland disorder	13.46	10.84	6	41947	166	29532408
Platelet count increased	13.41	10.84	34	41919	8429	29524145
Vascular purpura	13.39	10.84	13	41940	1390	29531184
Asthma	13.38	10.84	17	41936	33832	29498742
Upper gastrointestinal haemorrhage	13.32	10.84	64	41889	21850	29510724
Activated partial thromboplastin time prolonged	13.21	10.84	32	41921	7710	29524864
Arteriosclerosis coronary artery	13.20	10.84	39	41914	10566	29522008
Activated partial thromboplastin time shortened	13.18	10.84	8	41945	423	29532151
Coma hepatic	13.00	10.84	8	41945	434	29532140
Myoclonus	12.97	10.84	45	41908	13264	29519310
Contraindication to medical treatment	12.87	10.84	8	41945	442	29532132
Spinal cord injury thoracic	12.81	10.84	5	41948	98	29532476
Portal shunt	12.70	10.84	4	41949	40	29532534
Aortic arteriosclerosis	12.64	10.84	21	41932	3855	29528719
Freezing phenomenon	12.61	10.84	12	41941	1251	29531323
Differential white blood cell count abnormal	12.57	10.84	12	41941	1257	29531317
Adrenal adenoma	12.56	10.84	7	41946	315	29532259
Hypercreatininaemia	12.56	10.84	8	41945	461	29532113
Hyperbilirubinaemia	12.45	10.84	48	41905	14886	29517688
Platelet count decreased	12.39	10.84	213	41740	104459	29428115
Anti-erythropoietin antibody negative	12.29	10.84	6	41947	205	29532369
Cytomegalovirus infection	12.26	10.84	9	41944	23206	29509368
Abdominal cavity drainage	12.11	10.84	7	41946	338	29532236
Monocyte count decreased	12.06	10.84	11	41942	1087	29531487
Escherichia urinary tract infection	12.04	10.84	18	41935	3021	29529553
Psoriatic arthropathy	12.03	10.84	3	41950	14688	29517886
Hypoalbuminaemia	11.98	10.84	37	41916	10268	29522306
Application site hypersensitivity	11.87	10.84	5	41948	120	29532454
Transcription medication error	11.76	10.84	5	41948	123	29532451
Headache	11.71	10.84	175	41778	173832	29358742
Cerebral arteriovenous malformation haemorrhagic	11.62	10.84	4	41949	54	29532520
Embedded device	11.56	10.84	6	41947	234	29532340
Portal shunt procedure	11.50	10.84	3	41950	14	29532560
Eosinophilic pneumonia	11.48	10.84	17	41936	2829	29529745
Monocyte count increased	11.29	10.84	20	41933	3866	29528708
Transfusion	11.23	10.84	29	41924	7269	29525305
Melaena	11.07	10.84	79	41874	31097	29501477
Flat affect	10.85	10.84	9	41944	783	29531791

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hepatic encephalopathy	821.35	10.32	433	77356	20633	64400310
Sedation complication	506.04	10.32	248	77541	10106	64410837
Orthostatic hypotension	444.88	10.32	402	77387	46336	64374607
Creatinine renal clearance decreased	428.77	10.32	248	77541	14173	64406770
Sedation	337.55	10.32	327	77462	41135	64379808
Blood calcium decreased	336.34	10.32	265	77524	25289	64395654
Drug ineffective	326.47	10.32	321	77468	839926	63581017
Cognitive disorder	320.43	10.32	363	77426	54724	64366219
Balance disorder	273.83	10.32	416	77373	83510	64337433
Constipation	249.58	10.32	723	77066	228614	64192329
Ammonia increased	223.50	10.32	126	77663	6851	64414092
Depressed level of consciousness	222.10	10.32	372	77417	81064	64339879
Hepatic cirrhosis	209.47	10.32	205	77584	26093	64394850
Confusional state	208.25	10.32	740	77049	260404	64160539
Ascites	205.97	10.32	310	77479	61691	64359252
Inability to afford medication	189.48	10.32	75	77714	1811	64419132
Fall	185.16	10.32	990	76799	415836	64005107
Completed suicide	177.26	10.32	29	77760	224385	64196558
Hepatic failure	152.25	10.32	254	77535	55140	64365803
Blood bilirubin increased	150.37	10.32	258	77531	57295	64363648
Mobility decreased	148.35	10.32	323	77466	85517	64335426
Faecaloma	134.72	10.32	104	77685	9624	64411319
Hyponatraemia	132.61	10.32	437	77352	147902	64273041
Rheumatoid arthritis	115.54	10.32	28	77761	164266	64256677
Hypotension	115.28	10.32	820	76969	380154	64040789
Jaundice cholestatic	107.82	10.32	87	77702	8583	64412360
Arthralgia	107.17	10.32	234	77555	442026	63978917
Hypomania	106.91	10.32	73	77716	5581	64415362
Drug hypersensitivity	102.41	10.32	82	77707	237733	64183210
Haematemesis	100.27	10.32	193	77596	46806	64374137
Drug abuse	96.18	10.32	21	77768	132353	64288590
Schizophrenia	94.45	10.32	90	77699	11078	64409865
Injection site pain	91.10	10.32	13	77776	111395	64309548
Joint swelling	90.57	10.32	76	77713	215306	64205637
Arthropathy	90.33	10.32	18	77771	120949	64299994
Off label use	89.54	10.32	426	77363	632380	63788563
Varices oesophageal	89.41	10.32	63	77726	5067	64415876
Hepatocellular carcinoma	89.31	10.32	77	77712	8326	64412617
Hepatorenal syndrome	84.50	10.32	54	77735	3692	64417251
Treatment failure	83.92	10.32	19	77770	116797	64304146
General physical health deterioration	79.46	10.32	469	77320	203956	64216987
Drug intolerance	79.45	10.32	66	77723	187926	64233017
Pneumatosis intestinalis	79.25	10.32	59	77730	5170	64415773
Sinusitis	78.35	10.32	39	77750	145889	64275054
Encephalopathy	77.31	10.32	199	77590	58620	64362323
Therapeutic product effect decreased	76.63	10.32	22	77767	115329	64305614
Infusion related reaction	71.66	10.32	56	77733	164411	64256532
Systemic lupus erythematosus	71.17	10.32	6	77783	77606	64343337
Nasopharyngitis	69.93	10.32	80	77709	195993	64224950
Therapeutic product effect incomplete	68.26	10.32	20	77769	103462	64317481
Abdominal pain	68.00	10.32	624	77165	311751	64109192
Insurance issue	66.90	10.32	42	77747	2784	64418159
Hyperkalaemia	65.88	10.32	269	77520	100860	64320083
Hyperammonaemia	65.74	10.32	70	77719	9834	64411109
Oesophageal varices haemorrhage	64.25	10.32	45	77744	3584	64417359
Peritonitis bacterial	63.75	10.32	66	77723	8977	64411966
Swelling	63.17	10.32	60	77729	160158	64260785
Chronic hepatic failure	62.07	10.32	27	77762	832	64420111
Toxic epidermal necrolysis	62.06	10.32	138	77651	37028	64383915
Neutropenic sepsis	61.64	10.32	105	77684	23167	64397776
Jaundice	61.56	10.32	162	77627	48350	64372593
Hand deformity	59.98	10.32	4	77785	62767	64358176
Maternal exposure during pregnancy	58.87	10.32	21	77768	95863	64325080
Rash	58.87	10.32	319	77470	458230	63962713
Acute kidney injury	56.78	10.32	807	76982	448433	63972510
Portal hypertension	56.20	10.32	52	77737	6167	64414776
Abdominal distension	55.29	10.32	246	77543	95748	64325195
Hepatitis C	54.72	10.32	67	77722	10948	64409995
Psychotic disorder	53.97	10.32	125	77664	34453	64386490
Contraindicated product administered	53.24	10.32	32	77757	107797	64313146
Hypersensitivity	52.54	10.32	98	77691	196354	64224589
Ileus	49.82	10.32	95	77694	22871	64398072
Glossodynia	49.62	10.32	9	77780	64687	64356256
Product use issue	48.75	10.32	67	77722	151648	64269295
Cholelithiasis	47.92	10.32	142	77647	45364	64375579
Aortic arteriosclerosis	46.40	10.32	51	77738	7425	64413518
Injection site erythema	46.11	10.32	14	77775	70786	64350157
Delirium	45.79	10.32	185	77604	69009	64351934
Alopecia	45.78	10.32	81	77708	165609	64255334
Lymphatic fistula	45.74	10.32	21	77768	737	64420206
Femoral hernia incarcerated	45.66	10.32	21	77768	740	64420203
Neutrophil count increased	44.90	10.32	96	77693	25078	64395865
Urinary retention	44.84	10.32	146	77643	49055	64371888
Abdominal tenderness	44.77	10.32	56	77733	9349	64411594
Skin candida	44.61	10.32	27	77762	1676	64419267
Blood pressure increased	42.76	10.32	90	77699	172462	64248481
Wound infection pseudomonas	41.96	10.32	25	77764	1508	64419435
Dehydration	41.19	10.32	421	77368	216342	64204601
Urinary tract infection	40.35	10.32	442	77347	231154	64189789
Pancreatic steatosis	40.05	10.32	21	77768	987	64419956
Headache	39.21	10.32	429	77360	529038	63891905
Alveolar lung disease	39.20	10.32	17	77772	520	64420423
Vomiting	38.44	10.32	902	76887	550215	63870728
Pulmonary interstitial emphysema syndrome	38.24	10.32	16	77773	447	64420496
Discomfort	37.20	10.32	26	77763	80852	64340091
Sepsis	36.69	10.32	432	77357	229909	64191034
Haemoglobin decreased	36.64	10.32	378	77411	194685	64226258
Arthritis	35.91	10.32	29	77760	83785	64337158
Pneumonia	35.46	10.32	904	76885	558672	63862271
Injection site reaction	34.70	10.32	7	77782	46657	64374286
Pericarditis	34.62	10.32	16	77773	62500	64358443
Portal hypertensive gastropathy	34.41	10.32	20	77769	1152	64419791
Heart sounds	34.19	10.32	16	77773	587	64420356
White blood cell count increased	34.18	10.32	164	77625	65850	64355093
Weight increased	34.05	10.32	137	77652	213211	64207732
Liver function test abnormal	34.02	10.32	152	77637	59249	64361694
Abdominal discomfort	33.78	10.32	110	77679	182212	64238731
Intestinal pseudo-obstruction	33.56	10.32	24	77765	1976	64418967
Arterial haemorrhage	33.42	10.32	25	77764	2206	64418737
Musculoskeletal stiffness	33.33	10.32	61	77728	123145	64297798
Gastric varices	32.97	10.32	15	77774	515	64420428
Injection site bruising	32.83	10.32	3	77786	36370	64384573
Fatigue	32.80	10.32	672	77117	748058	63672885
Liver transplant	32.76	10.32	32	77757	4060	64416883
Cirrhosis alcoholic	32.37	10.32	18	77771	952	64419991
Prolonged expiration	32.29	10.32	17	77772	806	64420137
Therapy interrupted	31.89	10.32	73	77716	19963	64400980
Psoriasis	31.74	10.32	24	77765	71679	64349264
Inappropriate schedule of product administration	31.44	10.32	39	77750	92247	64328696
High-grade B-cell lymphoma	31.38	10.32	9	77780	76	64420867
Injection site swelling	31.18	10.32	6	77783	41347	64379596
Therapeutic response decreased	31.07	10.32	12	77777	52176	64368767
Melaena	30.65	10.32	137	77652	53411	64367532
Benign gastrointestinal neoplasm	30.37	10.32	10	77779	139	64420804
Hypokalaemia	30.34	10.32	251	77538	121652	64299291
Hypermagnesaemia	30.31	10.32	18	77771	1079	64419864
Mental status changes	30.27	10.32	150	77639	61012	64359931
Hepatotoxicity	29.82	10.32	111	77678	39851	64381092
Wrong technique in product usage process	29.73	10.32	21	77768	64953	64355990
Injection site pruritus	29.58	10.32	5	77784	37821	64383122
Seroma	28.53	10.32	22	77767	2032	64418911
Hypernatraemia	28.40	10.32	52	77737	12137	64408806
Peripheral swelling	28.16	10.32	143	77646	209010	64211933
Asterixis	27.88	10.32	23	77766	2340	64418603
Psoriatic arthropathy	27.39	10.32	9	77780	43272	64377671
Disorientation	26.97	10.32	136	77653	55692	64365251
Lethargy	26.52	10.32	164	77625	72430	64348513
Ill-defined disorder	26.44	10.32	10	77779	44042	64376901
COVID-19	26.12	10.32	24	77765	65116	64355827
Diverticulum intestinal	25.90	10.32	38	77751	7382	64413561
Urticaria	25.83	10.32	91	77698	147226	64273717
Folliculitis	25.80	10.32	3	77786	30074	64390869
Wrong patient received product	25.70	10.32	27	77762	3735	64417208
Suicide attempt	25.26	10.32	29	77760	70978	64349965
Exposure during pregnancy	25.24	10.32	34	77755	77641	64343302
Antipsychotic drug level increased	25.22	10.32	31	77758	5084	64415859
Gastrointestinal haemorrhage	24.64	10.32	256	77533	132056	64288887
Drug resistance	24.62	10.32	6	77783	35096	64385847
Anaemia	24.58	10.32	614	77175	378066	64042877
Erythema	24.01	10.32	130	77659	186940	64234003
Dementia	23.99	10.32	67	77722	20699	64400244
Intentional overdose	23.91	10.32	45	77744	89899	64331044
Pyramidal tract syndrome	23.45	10.32	12	77777	536	64420407
Herpes zoster	23.44	10.32	37	77752	79150	64341793
Intentional product use issue	23.39	10.32	50	77739	95314	64325629
Conjunctival irritation	23.26	10.32	8	77781	128	64420815
Upper gastrointestinal haemorrhage	23.16	10.32	94	77695	35126	64385817
Product prescribing error	23.09	10.32	94	77695	35175	64385768
Product use in unapproved indication	23.07	10.32	122	77667	176496	64244447
Hepatic cyst	23.05	10.32	30	77759	5210	64415733
Spinal cord paralysis	23.04	10.32	8	77781	132	64420811
Cholestasis of pregnancy	22.53	10.32	14	77775	911	64420032
Product dose omission issue	22.50	10.32	140	77649	194607	64226336
Muscle injury	21.80	10.32	3	77786	26434	64394509
Gastrointestinal disorder	21.21	10.32	48	77741	89661	64331282
Aspiration	21.02	10.32	56	77733	16829	64404114
Hypophagia	20.96	10.32	99	77690	39488	64381455
Epilepsy	20.88	10.32	88	77701	33443	64387500
Intestinal dilatation	20.59	10.32	19	77770	2245	64418698
Periarthritis calcarea	20.48	10.32	6	77783	55	64420888
Hypertension	20.37	10.32	207	77582	259054	64161889
Bradycardia	20.27	10.32	225	77564	117994	64302949
Pain in extremity	20.27	10.32	251	77538	302834	64118109
Intentional product misuse	20.26	10.32	35	77754	72260	64348683
Hepatic cancer	20.24	10.32	34	77755	7414	64413529
Femoral neck fracture	20.05	10.32	37	77752	8687	64412256
Haemarthrosis	20.05	10.32	28	77761	5201	64415742
Irritable bowel syndrome	20.02	10.32	10	77779	37359	64383584
Hypoaesthesia	19.94	10.32	93	77696	139015	64281928
Migraine	19.80	10.32	28	77761	62649	64358294
Dyskinesia	19.77	10.32	97	77692	39291	64381652
Blood pressure fluctuation	19.76	10.32	20	77769	51851	64369092
Wound	19.68	10.32	39	77750	76438	64344505
Genital erythema	19.34	10.32	8	77781	217	64420726
Feeling abnormal	19.34	10.32	89	77700	133513	64287430
Therapy non-responder	19.31	10.32	31	77758	65868	64355075
Erosive duodenitis	19.11	10.32	16	77773	1662	64419281
Oropharyngeal pain	19.08	10.32	50	77739	88817	64332126
Nail dystrophy	19.04	10.32	12	77777	801	64420142
Arteriosclerosis coronary artery	18.83	10.32	51	77738	15478	64405465
Hepatitis C RNA positive	18.72	10.32	8	77781	236	64420707
Hepatic calcification	18.62	10.32	9	77780	355	64420588
Escherichia infection	18.57	10.32	50	77739	15118	64405825
Rectal haemorrhage	18.56	10.32	133	77656	61684	64359259
Costal cartilage fracture	18.38	10.32	8	77781	247	64420696
Seizure	18.35	10.32	293	77496	166599	64254344
Adrenomegaly	18.28	10.32	9	77780	370	64420573
Aortic valve stenosis	18.27	10.32	25	77764	4555	64416388
Peritonitis	18.25	10.32	69	77720	24954	64395989
Abortion spontaneous	18.23	10.32	4	77785	25139	64395804
Dermatitis bullous	18.17	10.32	43	77746	12011	64408932
Body mass index decreased	18.16	10.32	10	77779	519	64420424
Helicobacter infection	18.08	10.32	12	77777	38350	64382593
Portal vein thrombosis	18.06	10.32	26	77763	4965	64415978
Joint injury	18.01	10.32	3	77786	22944	64397999
Adrenal cyst	17.99	10.32	6	77783	87	64420856
Adverse drug reaction	17.93	10.32	17	77772	45447	64375496
Systemic infection	17.87	10.32	24	77765	4297	64416646
Blood pressure systolic increased	17.80	10.32	20	77769	49433	64371510
Wound dehiscence	17.57	10.32	28	77761	5846	64415097
Articular calcification	17.56	10.32	6	77783	94	64420849
Hallucination, visual	17.29	10.32	73	77716	27761	64393182
Spleen congestion	16.97	10.32	9	77780	433	64420510
Myalgia	16.81	10.32	117	77672	158500	64262443
C-reactive protein abnormal	16.77	10.32	7	77782	29040	64391903
Urinary incontinence	16.72	10.32	87	77702	36064	64384879
Alkalosis hypochloraemic	16.63	10.32	9	77780	451	64420492
Osteoarthritis	16.56	10.32	32	77757	63304	64357639
Metamyelocyte count increased	16.55	10.32	10	77779	619	64420324
Pruritus	16.54	10.32	271	77518	312129	64108814
Abdominal rigidity	16.44	10.32	18	77771	2609	64418334
Anaphylactic shock	16.42	10.32	8	77781	30320	64390623
Product monitoring error	16.31	10.32	26	77763	5428	64415515
Hip arthroplasty	16.30	10.32	3	77786	21348	64399595
Hyperbilirubinaemia	15.90	10.32	59	77730	21146	64399797
Intestinal obstruction	15.87	10.32	86	77703	36200	64384743
Monocyte count increased	15.80	10.32	32	77757	8047	64412896
Accidental exposure to product	15.80	10.32	6	77783	26358	64394585
Pulmonary vein occlusion	15.72	10.32	6	77783	131	64420812
Plasma cell myeloma	15.53	10.32	102	77687	45973	64374970
Oral contusion	15.49	10.32	5	77784	65	64420878
Suicidal ideation	15.41	10.32	36	77753	66506	64354437
Acute abdomen	15.38	10.32	18	77771	2806	64418137
Salivary gland enlargement	15.28	10.32	8	77781	375	64420568
Asthma	15.27	10.32	61	77728	95164	64325779
Subileus	15.27	10.32	24	77765	4953	64415990
Pneumonia aspiration	15.25	10.32	123	77666	59148	64361795
Intentional self-injury	15.22	10.32	8	77781	29036	64391907
Splenomegaly	15.20	10.32	52	77737	17909	64403034
Activated partial thromboplastin time abnormal	15.18	10.32	7	77782	248	64420695
Portal shunt	15.15	10.32	5	77784	70	64420873
Blood sodium decreased	15.08	10.32	73	77716	29409	64391534
Stoma site discharge	15.07	10.32	14	77775	1668	64419275
Platelet count decreased	15.04	10.32	285	77504	167426	64253517
Hiccups	15.00	10.32	32	77757	8344	64412599
Bleeding time prolonged	14.96	10.32	12	77777	1174	64419769
Flushing	14.87	10.32	47	77742	78601	64342342
Bronchitis	14.82	10.32	74	77715	108669	64312274
Vascular encephalopathy	14.81	10.32	9	77780	563	64420380
Toxic encephalopathy	14.78	10.32	35	77754	9780	64411163
Axillary pain	14.72	10.32	14	77775	1718	64419225
Blood alkaline phosphatase increased	14.60	10.32	117	77672	56162	64364781
Thrombocytopenia	14.53	10.32	363	77426	223438	64197505
Blood albumin decreased	14.46	10.32	57	77732	21016	64399927
Red blood cell sedimentation rate increased	14.41	10.32	10	77779	31225	64389718
Throat irritation	14.41	10.32	11	77778	32700	64388243
Paracentesis	14.33	10.32	12	77777	1247	64419696
Heart rate decreased	14.24	10.32	28	77761	55039	64365904
Differential white blood cell count abnormal	14.20	10.32	14	77775	1796	64419147
Neutropenia	14.20	10.32	384	77405	239240	64181703
Visual impairment	14.19	10.32	44	77745	74033	64346910
Freezing phenomenon	14.11	10.32	13	77776	1533	64419410
Hallucination	14.10	10.32	142	77647	72646	64348297
Blood albumin abnormal	14.03	10.32	9	77780	619	64420324
Blast cells present	13.85	10.32	10	77779	836	64420107
Anxiety	13.85	10.32	167	77622	202482	64218461
Injection site haemorrhage	13.77	10.32	6	77783	24272	64396671
Salivary gland disorder	13.76	10.32	7	77782	309	64420634
Hiatus hernia	13.71	10.32	54	77735	19903	64401040
Superinfection	13.71	10.32	20	77769	3866	64417077
Death	13.62	10.32	712	77077	481993	63938950
Cardiac failure congestive	13.50	10.32	97	77692	130483	64290460
Pustule	13.48	10.32	12	77777	1353	64419590
Pleural effusion	13.46	10.32	221	77568	126338	64294605
Groin pain	13.40	10.32	37	77752	11356	64409587
Vascular parkinsonism	13.37	10.32	5	77784	103	64420840
Electrolyte imbalance	13.27	10.32	63	77726	25180	64395763
Unresponsive to stimuli	13.20	10.32	105	77684	50288	64370655
Tachyarrhythmia	13.16	10.32	25	77764	6001	64414942
Cardiac disorder	13.08	10.32	30	77759	55786	64365157
Inflammation	13.07	10.32	38	77751	65262	64355681
Gastrointestinal tract mucosal pigmentation	13.03	10.32	10	77779	917	64420026
Heart rate increased	12.97	10.32	68	77721	98607	64322336
Feeling hot	12.89	10.32	22	77767	45641	64375302
Diabetic gastropathy	12.78	10.32	3	77786	10	64420933
Peripheral artery stenosis	12.69	10.32	11	77778	1198	64419745
Polypectomy	12.66	10.32	10	77779	956	64419987
Myelocyte count increased	12.56	10.32	9	77780	743	64420200
Spinal cord injury thoracic	12.54	10.32	5	77784	123	64420820
Blood cholesterol increased	12.48	10.32	26	77763	50040	64370903
Hypervolaemia	12.45	10.32	84	77705	38201	64382742
Cardiomyopathy acute	12.43	10.32	6	77783	236	64420707
Portal tract inflammation	12.43	10.32	5	77784	126	64420817
Duodenal ulcer	12.40	10.32	42	77747	14393	64406550
Duodenal ulcer haemorrhage	12.31	10.32	25	77764	6300	64414643
Eye pain	12.27	10.32	12	77777	31613	64389330
Coma hepatic	12.25	10.32	10	77779	1002	64419941
Mouth swelling	12.17	10.32	22	77767	5085	64415858
Influenza	12.08	10.32	77	77712	106454	64314489
Incontinence	12.06	10.32	37	77752	12044	64408899
Inguinal hernia	11.99	10.32	23	77766	5558	64415385
On and off phenomenon	11.99	10.32	15	77774	2504	64418439
Interstitial lung disease	11.94	10.32	69	77720	97663	64323280
Diffuse alveolar damage	11.92	10.32	17	77772	3218	64417725
Drug ineffective for unapproved indication	11.86	10.32	12	77777	31121	64389822
Vascular purpura	11.82	10.32	15	77774	2541	64418402
Portopulmonary hypertension	11.81	10.32	5	77784	144	64420799
Alkalosis	11.72	10.32	7	77782	424	64420519
Infection	11.64	10.32	155	77634	184725	64236218
Tumour hyperprogression	11.56	10.32	5	77784	152	64420791
Dysphagia	11.54	10.32	187	77602	106625	64314318
Premature delivery	11.53	10.32	4	77785	18585	64402358
Portal shunt procedure	11.49	10.32	3	77786	17	64420926
Functional gastrointestinal disorder	11.42	10.32	19	77770	4112	64416831
Adrenoleukodystrophy	11.41	10.32	4	77785	68	64420875
Incoherent	11.40	10.32	26	77763	7092	64413851
Cytomegalovirus infection	11.37	10.32	17	77772	37182	64383761
Food refusal	11.37	10.32	7	77782	448	64420495
Lung perforation	11.35	10.32	4	77785	69	64420874
Anti-erythropoietin antibody negative	11.35	10.32	6	77783	287	64420656
Dry eye	11.27	10.32	11	77778	29008	64391935
Throat tightness	11.25	10.32	7	77782	23153	64397790
Sexually inappropriate behaviour	11.19	10.32	7	77782	461	64420482
Flail chest	11.15	10.32	4	77785	73	64420870
Colitis ulcerative	11.13	10.32	7	77782	23021	64397922
Megacolon	11.07	10.32	16	77773	3066	64417877
Lactic acidosis	11.04	10.32	118	77671	61292	64359651
Transfusion	11.03	10.32	47	77742	17947	64402996
Decreased appetite	11.00	10.32	429	77360	280860	64140083
Circulatory collapse	10.96	10.32	74	77715	33658	64387285
Nodule	10.89	10.32	4	77785	17943	64403000
Product quality issue	10.78	10.32	12	77777	29787	64391156
Decubitus ulcer	10.69	10.32	38	77751	13341	64407602
Myoclonus	10.63	10.32	59	77730	25059	64395884
Pregnancy	10.57	10.32	6	77783	20859	64400084
Multiple sclerosis relapse	10.56	10.32	21	77768	41114	64379829
Stoma site erythema	10.50	10.32	10	77779	1229	64419714
Depressed mood	10.49	10.32	85	77704	40927	64380016
Contraindication to medical treatment	10.47	10.32	9	77780	969	64419974
Gastrointestinal sounds abnormal	10.46	10.32	20	77769	4823	64416120
Radiation proctitis	10.45	10.32	4	77785	88	64420855
Nail infection	10.44	10.32	12	77777	1835	64419108
Ballismus	10.35	10.32	5	77784	197	64420746
Transcription medication error	10.33	10.32	6	77783	345	64420598

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A06AD11	ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Osmotically acting laxatives
ATC	A06AD61	ALIMENTARY TRACT AND METABOLISM DRUGS FOR CONSTIPATION DRUGS FOR CONSTIPATION Osmotically acting laxatives
FDA PE	N0000009871	Stimulation Large Intestine Fluid/Electrolyte Secretion
FDA MoA	N0000010288	Osmotic Activity
MeSH PA	D005765	Gastrointestinal Agents
CHEBI has role	CHEBI:50503	laxante
CHEBI has role	CHEBI:55324	gastrointestinal drugs
FDA EPC	N0000175811	Osmotic Laxative
FDA MoA	N0000175833	Acidifying Activity

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Hyperammonemia	indication	9360008
Hepatic encephalopathy	indication	13920009	DOID:13413
Constipation	indication	14760008	DOID:2089
Diabetes mellitus	contraindication	73211009	DOID:9351
Appendicitis	contraindication	74400008	DOID:8337
Gastrointestinal obstruction	contraindication	126765001
Galactosemia	contraindication	190745006	DOID:9870

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.04	acidic
pKa2	13.36	acidic
pKa3	13.8	acidic
pKa4	13.97	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

ID	Source
4018617	VUID
N0000146930	NUI
D00352	KEGG_DRUG
4018617	VANDF
C0022957	UMLSCUI
CHEBI:6359	CHEBI
CHEMBL1237068	ChEMBL_ID
CHEMBL296306	ChEMBL_ID
DB00581	DRUGBANK_ID
D007792	MESH_DESCRIPTOR_UI
11333	PUBCHEM_CID
2137	INN_ID
9U7D5QH5AE	UNII
215949	RXNORM
117	MMSL
4512	MMSL
4955	MMSL
d01024	MMSL
001241	NDDF
111137007	SNOMEDCT_US
273945008	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0577	SOLUTION	10 g	ORAL	ANDA	22 sections
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-0873	SOLUTION	10 g	ORAL	ANDA	22 sections
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-1154	SOLUTION	20 g	ORAL	ANDA	22 sections
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-1746	SOLUTION	20 g	ORAL	ANDA	22 sections
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	0121-4577	SOLUTION	10 g	ORAL	ANDA	22 sections
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	0527-5120	SOLUTION	10 g	ORAL	ANDA	22 sections
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	0527-5125	SOLUTION	10 g	ORAL	ANDA	22 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	13668-574	SOLUTION	10 g	ORAL	ANDA	12 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	13668-574	SOLUTION	10 g	ORAL	ANDA	12 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	13668-580	SOLUTION	10 g	ORAL	ANDA	21 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	13668-580	SOLUTION	10 g	ORAL	ANDA	21 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	17856-1378	SOLUTION	10 g	ORAL	ANDA	22 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	18124-002	SOLUTION	10 g	ORAL	ANDA	16 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	21695-997	SOLUTION	10 g	ORAL	ANDA	11 sections
Enulose	HUMAN PRESCRIPTION DRUG LABEL	1	45963-438	SOLUTION	10 g	ORAL	ANDA	17 sections
Constulose	HUMAN PRESCRIPTION DRUG LABEL	1	45963-439	SOLUTION	10 g	ORAL	ANDA	19 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0679	SOLUTION	10 g	ORAL	ANDA	21 sections
Constulose	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3436	SOLUTION	10 g	ORAL	ANDA	19 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	50383-779	SOLUTION	10 g	ORAL	ANDA	20 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	50383-779	SOLUTION	10 g	ORAL	ANDA	20 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	50383-795	SOLUTION	10 g	ORAL	ANDA	18 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	50383-795	SOLUTION	10 g	ORAL	ANDA	18 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	53217-009	SOLUTION	10 g	ORAL	ANDA	13 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	54868-3101	SOLUTION	10 g	ORAL	ANDA	11 sections
LACTULOSE	HUMAN PRESCRIPTION DRUG LABEL	1	55700-892	SOLUTION	10 g	ORAL	ANDA	22 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	59741-249	SOLUTION	10 g	ORAL	ANDA	21 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	60432-037	SOLUTION	10 g	ORAL	ANDA	19 sections
Generlac	HUMAN PRESCRIPTION DRUG LABEL	1	60432-038	SOLUTION	10 g	ORAL	ANDA	18 sections
Lactulose Solution	HUMAN PRESCRIPTION DRUG LABEL	1	61037-471	SOLUTION	10 g	ORAL	ANDA	16 sections
Lactulose	HUMAN PRESCRIPTION DRUG LABEL	1	62135-003	SOLUTION	10 g	ORAL	ANDA	20 sections