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

Stem definition	Drug id	CAS RN
	1232	58-05-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: sodium folinate folinic acid leucovorin calcium folinate leucovorin calcium folinic acid calcium salt folinic acid calcium wellcovorin folinic acid calcium salt pentahydrate	The active metabolite of FOLIC ACID. Leucovorin is used principally as an antidote to FOLIC ACID ANTAGONISTS. Molecular weight: 473.45 Formula: C20H23N7O7 CLOGP: -1.98 LIPINSKI: 2 HAC: 14 HDO: 7 TPSA: 215.55 ALOGS: -3.20 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

sodium folinate
folinic acid
leucovorin
calcium folinate
leucovorin calcium
folinic acid calcium salt
folinic acid calcium
wellcovorin
folinic acid calcium salt pentahydrate

The active metabolite of FOLIC ACID. Leucovorin is used principally as an antidote to FOLIC ACID ANTAGONISTS.

Molecular weight: 473.45
Formula: C20H23N7O7
CLOGP: -1.98
LIPINSKI: 2
HAC: 14
HDO: 7
TPSA: 215.55
ALOGS: -3.20
ROTB: 9

Status: OFP

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

Drug dosage:

Dose	Unit	Route
60	mg	O
60	mg	P
60	mg	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	500 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	10 %	Benet LZ, Broccatelli F, Oprea TI
BA (Bioavailability)	4 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.25 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	5.80 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.09 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.30 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
June 20, 1952	FDA
Nov. 25, 2021	PMDA	PFIZER JAPAN INC

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
Neutropenia	962.33	11.98	938	48797	147027	50408362
Neuropathy peripheral	460.38	11.98	520	49215	96237	50459152
Neurotoxicity	445.97	11.98	239	49496	14501	50540888
Mucosal inflammation	387.99	11.98	319	49416	39823	50515566
Thrombocytopenia	366.54	11.98	534	49201	127139	50428250
Diarrhoea	305.82	11.98	1262	48473	587214	49968175
Skin toxicity	259.50	11.98	109	49626	3804	50551585
Disease progression	256.26	11.98	388	49347	95478	50459911
Febrile neutropenia	232.79	11.98	375	49360	97292	50458097
Haematotoxicity	213.78	11.98	119	49616	7776	50547613
Polyneuropathy	197.45	11.98	132	49603	11999	50543390
Leukopenia	187.03	11.98	278	49457	67250	50488139
Dermatitis acneiform	173.02	11.98	83	49652	3974	50551415
Stomatitis	148.92	11.98	316	49419	101028	50454361
Vomiting	144.19	11.98	857	48878	459901	50095488
Posterior reversible encephalopathy syndrome	130.42	11.98	112	49623	14816	50540573
Systemic lupus erythematosus	120.22	11.98	4	49731	140618	50414771
Pulmonary embolism	114.97	11.98	286	49449	101418	50453971
Palmar-plantar erythrodysaesthesia syndrome	114.56	11.98	119	49616	19979	50535410
Pancytopenia	114.25	11.98	254	49481	83776	50471613
Anaemia	112.14	11.98	518	49217	251938	50303451
Nausea	111.38	11.98	1118	48617	704280	49851109
Arteriospasm coronary	108.03	11.98	57	49678	3345	50552044
Enteritis	104.03	11.98	72	49663	6923	50548466
Malignant neoplasm progression	100.67	11.98	213	49522	67911	50487478
Non-cirrhotic portal hypertension	100.09	11.98	25	49710	147	50555242
Abdominal pain	99.97	11.98	478	49257	235750	50319639
Gastrointestinal toxicity	98.77	11.98	60	49675	4617	50550772
Bone marrow failure	97.74	11.98	128	49607	27496	50527893
Drug clearance decreased	96.75	11.98	38	49697	1111	50554278
Metastases to liver	93.59	11.98	107	49628	19997	50535392
Glossodynia	93.09	11.98	5	49730	115564	50439825
Focal nodular hyperplasia	89.93	11.98	29	49706	468	50554921
Arthropathy	79.41	11.98	28	49707	157878	50397511
Product dose omission issue	79.07	11.98	41	49694	183797	50371592
Peripheral swelling	75.96	11.98	55	49680	205881	50349508
Swelling	74.93	11.98	53	49682	200819	50354570
Proteinuria	73.33	11.98	86	49649	16511	50538878
Gastrointestinal perforation	71.75	11.98	42	49693	3019	50552370
Myelosuppression	68.14	11.98	75	49660	13442	50541947
Hypomagnesaemia	66.44	11.98	97	49638	23059	50532330
Colorectal cancer metastatic	65.29	11.98	23	49712	492	50554897
Human bocavirus infection	64.21	11.98	21	49714	355	50555034
Secondary immunodeficiency	62.14	11.98	28	49707	1160	50554229
Paronychia	60.97	11.98	44	49691	4520	50550869
Hypertension	60.11	11.98	384	49351	210819	50344570
Fall	59.27	11.98	153	49582	334779	50220610
Peripheral sensory neuropathy	58.68	11.98	50	49685	6541	50548848
Dehydration	57.65	11.98	299	49436	152150	50403239
Dysarthria	56.45	11.98	118	49617	37285	50518104
Portal hypertension	55.40	11.98	37	49698	3355	50552034
Pneumatosis intestinalis	55.02	11.98	31	49704	2072	50553317
Therapy partial responder	54.63	11.98	48	49687	6543	50548846
Loss of employment	54.44	11.98	28	49707	1558	50553831
General physical health deterioration	53.60	11.98	279	49456	142155	50413234
Off label use	51.25	11.98	700	49035	473726	50081663
Synovitis	51.22	11.98	29	49706	123836	50431553
Insomnia	50.99	11.98	58	49677	174807	50380582
Hyperammonaemia	50.80	11.98	40	49695	4684	50550705
Neoplasm progression	49.98	11.98	97	49638	29060	50526329
Splenomegaly	49.38	11.98	54	49681	9606	50545783
Abdominal discomfort	48.94	11.98	96	49639	231545	50323844
Metastases to lung	48.51	11.98	57	49678	10963	50544426
Hand deformity	48.28	11.98	19	49716	100180	50455209
Gene mutation	48.19	11.98	24	49711	1247	50554142
Pyrexia	47.78	11.98	577	49158	379626	50175763
Pericarditis	46.93	11.98	10	49725	78679	50476710
Wound	46.34	11.98	23	49712	105771	50449618
Hyperammonaemic encephalopathy	45.73	11.98	27	49708	1972	50553417
Discomfort	45.35	11.98	25	49710	108355	50447034
Pain	45.09	11.98	359	49376	578544	49976845
Enterobacter infection	44.50	11.98	26	49709	1862	50553527
Lower respiratory tract infection	44.33	11.98	19	49716	95182	50460207
Leukoencephalopathy	44.19	11.98	34	49701	3849	50551540
Hospitalisation	44.02	11.98	7	49728	67930	50487459
Cholangitis	43.37	11.98	36	49699	4543	50550846
Ileus	43.26	11.98	59	49676	13170	50542219
Metastases to meninges	43.09	11.98	26	49709	1976	50553413
Hepatocellular injury	42.87	11.98	85	49650	25862	50529527
Intestinal perforation	42.52	11.98	52	49683	10427	50544962
Crystal nephropathy	41.97	11.98	19	49716	796	50554593
Drug abuse	41.52	11.98	5	49730	59841	50495548
Hypersensitivity vasculitis	41.04	11.98	33	49702	3982	50551407
Steatohepatitis	40.82	11.98	16	49719	465	50554924
Neutrophil count decreased	40.43	11.98	118	49617	45908	50509481
Drug hypersensitivity	40.38	11.98	120	49615	250890	50304499
Herpes simplex	40.07	11.98	42	49693	7120	50548269
Cystitis radiation	39.58	11.98	10	49725	62	50555327
Atypical haemolytic uraemic syndrome	38.55	11.98	16	49719	541	50554848
Bladder tamponade	38.41	11.98	10	49725	71	50555318
Gastroenteritis norovirus	38.41	11.98	23	49712	1724	50553665
Venous thrombosis	37.97	11.98	33	49702	4433	50550956
Hepatic enzyme increased	37.45	11.98	48	49687	137332	50418057
Contraindicated product administered	36.67	11.98	56	49679	148902	50406487
Epistaxis	36.65	11.98	142	49593	63812	50491577
Hypokalaemia	36.34	11.98	177	49558	87815	50467574
Interstitial lung disease	36.32	11.98	125	49610	53051	50502338
Neuromyotonia	36.16	11.98	9	49726	52	50555337
Factor VII deficiency	35.86	11.98	8	49727	26	50555363
Embolism	35.70	11.98	39	49696	6929	50548460
Mucosal toxicity	35.62	11.98	13	49722	309	50555080
Leukoerythroblastosis	35.49	11.98	12	49723	226	50555163
Rash pustular	34.48	11.98	37	49698	6444	50548945
Neoplasm recurrence	34.32	11.98	24	49711	2345	50553044
Injury	34.16	11.98	4	49731	48921	50506468
Joint swelling	34.11	11.98	125	49610	245161	50310228
Venous pressure jugular decreased	33.81	11.98	8	49727	36	50555353
Dizziness	33.71	11.98	201	49534	346168	50209221
Depression	33.68	11.98	70	49665	165353	50390036
Trichomegaly	33.45	11.98	8	49727	38	50555351
Blood cholesterol increased	32.95	11.98	7	49728	55208	50500181
Short-bowel syndrome	32.69	11.98	13	49722	393	50554996
Ascites	32.52	11.98	93	49642	35768	50519621
Helicobacter infection	32.47	11.98	5	49730	49697	50505692
Immune thrombocytopenia	32.22	11.98	42	49693	8975	50546414
Nicotinic acid deficiency	32.18	11.98	8	49727	46	50555343
Cardiotoxicity	32.02	11.98	37	49698	6990	50548399
Myelodysplastic syndrome	31.82	11.98	55	49680	15077	50540312
Thrombocytopenic purpura	31.61	11.98	18	49717	1228	50554161
Laryngospasm	31.61	11.98	24	49711	2664	50552725
Sepsis	31.41	11.98	231	49504	132694	50422695
Septic shock	31.18	11.98	125	49610	57050	50498339
Duodenal ulcer perforation	31.18	11.98	4	49731	45607	50509782
Drug ineffective	30.97	11.98	594	49141	818739	49736650
Aortic thrombosis	29.79	11.98	16	49719	973	50554416
Cholestasis	29.25	11.98	72	49663	25329	50530060
Anastomotic leak	28.96	11.98	12	49723	404	50554985
Nasal septum perforation	28.89	11.98	14	49721	685	50554704
Stress cardiomyopathy	28.59	11.98	37	49698	7850	50547539
Intestinal obstruction	28.51	11.98	73	49662	26310	50529079
Vena cava thrombosis	28.18	11.98	20	49715	2001	50553388
Injection site pain	28.03	11.98	41	49694	110983	50444406
Encapsulating peritoneal sclerosis	27.83	11.98	11	49724	327	50555062
Rhinovirus infection	27.82	11.98	25	49710	3509	50551880
Device related infection	27.38	11.98	62	49673	20673	50534716
Pain in extremity	27.24	11.98	157	49578	272708	50282681
Carcinoembryonic antigen increased	26.32	11.98	17	49718	1457	50553932
Catabolic state	26.05	11.98	7	49728	57	50555332
Wrong technique in product usage process	25.96	11.98	11	49724	55499	50499890
Contusion	25.88	11.98	44	49691	112139	50443250
Sinusitis	25.66	11.98	84	49651	170474	50384915
Tumour lysis syndrome	25.64	11.98	34	49701	7387	50548002
Aortic intramural haematoma	25.63	11.98	7	49728	61	50555328
Haemolytic anaemia	25.32	11.98	38	49697	9254	50546135
Chills	25.14	11.98	172	49563	96515	50458874
Female genital tract fistula	25.12	11.98	24	49711	3642	50551747
Large intestinal obstruction	25.10	11.98	18	49717	1831	50553558
ECG signs of myocardial ischaemia	25.04	11.98	7	49728	67	50555322
Respiratory symptom	25.01	11.98	20	49715	2394	50552995
Myeloid leukaemia	24.67	11.98	10	49725	318	50555071
Gait disturbance	24.61	11.98	71	49664	149934	50405455
Memory impairment	24.58	11.98	25	49710	79335	50476054
Clostridium difficile colitis	24.49	11.98	54	49681	17688	50537701
Second primary malignancy	24.39	11.98	32	49703	6882	50548507
Chronic obstructive pulmonary disease	24.34	11.98	11	49724	53424	50501965
Suicidal ideation	24.31	11.98	12	49723	55373	50500016
Sleep disorder	24.26	11.98	13	49722	57270	50498119
Blister	24.16	11.98	29	49706	85389	50470000
Type II hypersensitivity	24.15	11.98	5	49730	10	50555379
Meningitis streptococcal	23.89	11.98	8	49727	146	50555243
Mobility decreased	23.85	11.98	26	49709	79922	50475467
Fluid retention	23.74	11.98	10	49725	50639	50504750
Human herpesvirus 6 infection	23.67	11.98	20	49715	2586	50552803
Asthma	23.53	11.98	32	49703	89305	50466084
Peritonitis	23.52	11.98	49	49686	15437	50539952
Multiple-drug resistance	23.29	11.98	22	49713	3292	50552097
Depilation	23.24	11.98	5	49730	13	50555376
Cholinergic syndrome	23.20	11.98	10	49725	372	50555017
Electrocardiogram QT prolonged	23.14	11.98	11	49724	51875	50503514
Neutropenic colitis	22.88	11.98	19	49716	2398	50552991
Ocular toxicity	22.78	11.98	11	49724	534	50554855
Gastrointestinal anastomotic leak	22.54	11.98	8	49727	175	50555214
Weight increased	22.44	11.98	112	49623	201779	50353610
K-ras gene mutation	22.24	11.98	5	49730	17	50555372
Arthralgia	22.16	11.98	301	49434	438401	50116988
Venoocclusive liver disease	22.09	11.98	24	49711	4237	50551152
Inferior vena cava stenosis	22.02	11.98	5	49730	18	50555371
Petechiae	21.90	11.98	42	49693	12470	50542919
Blood pressure fluctuation	21.72	11.98	81	49654	35742	50519647
Superior vena cava syndrome	21.61	11.98	11	49724	599	50554790
Folliculitis	21.40	11.98	6	49729	39219	50516170
Gastrointestinal stoma complication	21.19	11.98	15	49720	1495	50553894
Metastases to lymph nodes	20.99	11.98	30	49705	6994	50548395
Subileus	20.71	11.98	19	49716	2740	50552649
Portal vein dilatation	20.53	11.98	5	49730	26	50555363
Amnesia	20.37	11.98	8	49727	42252	50513137
Subacute cutaneous lupus erythematosus	20.12	11.98	17	49718	2198	50553191
Hip arthroplasty	20.02	11.98	3	49732	30426	50524963
Deep vein thrombosis	20.01	11.98	132	49603	73172	50482217
Abortion spontaneous	19.98	11.98	8	49727	41764	50513625
Cutaneous tuberculosis	19.86	11.98	7	49728	150	50555239
Vitiligo	19.84	11.98	13	49722	1141	50554248
Venous thrombosis limb	19.57	11.98	18	49717	2604	50552785
Soft tissue necrosis	19.51	11.98	9	49726	394	50554995
Large intestine perforation	19.50	11.98	30	49705	7464	50547925
Occult blood	19.31	11.98	13	49722	1194	50554195
Maternal exposure during pregnancy	19.30	11.98	86	49649	159692	50395697
Red cell fragmentation syndrome	19.15	11.98	5	49730	36	50555353
Pelvic fluid collection	19.03	11.98	11	49724	772	50554617
Hypertrichosis	18.91	11.98	12	49723	997	50554392
Overdose	18.80	11.98	44	49691	99683	50455706
Peripheral sensorimotor neuropathy	18.79	11.98	13	49722	1249	50554140
Haemoglobin increased	18.75	11.98	19	49716	3096	50552293
Adverse drug reaction	18.74	11.98	16	49719	55206	50500183
Varices oesophageal	18.62	11.98	18	49717	2771	50552618
Exposure during pregnancy	18.61	11.98	59	49676	120956	50434433
Ovarian fibroma	18.59	11.98	6	49729	97	50555292
Impaired healing	18.38	11.98	25	49710	69761	50485628
Joint noise	18.24	11.98	20	49715	3567	50551822
Gastric varices haemorrhage	18.21	11.98	6	49729	104	50555285
Endometrial dysplasia	18.17	11.98	4	49731	12	50555377
Feeling abnormal	18.05	11.98	63	49672	125429	50429960
Encephalopathy	17.82	11.98	73	49662	33638	50521751
Acute promyelocytic leukaemia	17.79	11.98	11	49724	873	50554516
Rash maculo-papular	17.64	11.98	62	49673	26579	50528810
Headache	17.60	11.98	372	49363	506163	50049226
Hypocapnia	17.54	11.98	8	49727	341	50555048
Portal shunt	17.49	11.98	4	49731	15	50555374
Haemolytic uraemic syndrome	17.46	11.98	16	49719	2303	50553086
Acute kidney injury	17.46	11.98	318	49417	227740	50327649
Proctalgia	17.41	11.98	23	49712	4980	50550409
Cytopenia	17.29	11.98	31	49704	8744	50546645
Coronary artery disease	17.27	11.98	4	49731	29722	50525667
Jugular vein thrombosis	17.25	11.98	17	49718	2679	50552710
Oesophageal fistula	17.22	11.98	6	49729	124	50555265
Administration site extravasation	17.18	11.98	10	49725	711	50554678
Tumour necrosis	17.01	11.98	10	49725	724	50554665
Productive cough	17.01	11.98	16	49719	52678	50502711
Migraine	16.93	11.98	30	49705	75250	50480139
Cardiomyopathy	16.71	11.98	43	49692	15543	50539846
Intentional product misuse	16.53	11.98	13	49722	46721	50508668
Cardiac arrest	16.51	11.98	36	49699	83615	50471774
Confusional state	16.45	11.98	111	49624	185817	50369572
Product use in unapproved indication	16.36	11.98	180	49555	115639	50439750
Hemiparesis	16.27	11.98	50	49685	19998	50535391
Portal vein thrombosis	16.15	11.98	15	49720	2197	50553192
Nodular regenerative hyperplasia	16.12	11.98	7	49728	265	50555124
Unevaluable event	16.06	11.98	13	49722	46053	50509336
Pruritus	15.99	11.98	190	49545	283378	50272011
Liver abscess	15.94	11.98	16	49719	2577	50552812
Small intestinal obstruction	15.87	11.98	43	49692	16025	50539364
Acquired gene mutation	15.87	11.98	10	49725	821	50554568
Rotator cuff syndrome	15.78	11.98	35	49700	11509	50543880
Paraesthesia	15.69	11.98	184	49551	120059	50435330
Toxic encephalopathy	15.67	11.98	23	49712	5492	50549897
Colitis	15.53	11.98	77	49658	38452	50516937
Depressed mood	15.50	11.98	7	49728	34016	50521373
Knee arthroplasty	15.38	11.98	8	49727	35838	50519551
Pneumothorax spontaneous	15.37	11.98	9	49726	647	50554742
Pneumothorax	15.34	11.98	39	49696	13995	50541394
Disease recurrence	15.30	11.98	49	49686	20032	50535357
Hallucination	15.26	11.98	14	49721	46643	50508746
Product intolerance	15.17	11.98	4	49731	30	50555359
No adverse event	15.15	11.98	7	49728	33571	50521818
Dysphagia	15.15	11.98	129	49606	77389	50478000
Throat tightness	15.11	11.98	50	49685	20797	50534592
Balance disorder	15.10	11.98	29	49706	70561	50484828
Pelvic abscess	15.08	11.98	12	49723	1426	50553963
Mouth ulceration	15.06	11.98	61	49674	27963	50527426
Somnolence	15.00	11.98	90	49645	154895	50400494
Asthenia	14.99	11.98	415	49320	318627	50236762
Plasma cell myeloma	14.98	11.98	6	49729	31316	50524073
Overgrowth fungal	14.95	11.98	5	49730	91	50555298
Treatment failure	14.92	11.98	77	49658	137560	50417829
Pneumonia	14.91	11.98	272	49463	378129	50177260
Hepatitis toxic	14.84	11.98	16	49719	2800	50552589
Optic nerve disorder	14.84	11.98	9	49726	690	50554699
Gait inability	14.82	11.98	9	49726	37018	50518371
Hypertransaminasaemia	14.78	11.98	18	49717	3593	50551796
Hepatic vein stenosis	14.73	11.98	4	49731	34	50555355
Cardiomyopathy acute	14.68	11.98	6	49729	195	50555194
Benign hydatidiform mole	14.55	11.98	5	49730	99	50555290
Acute myeloid leukaemia	14.55	11.98	40	49695	15034	50540355
Rhinocerebral mucormycosis	14.51	11.98	6	49729	201	50555188
Cachexia	14.49	11.98	20	49715	4513	50550876
Accessory spleen	14.49	11.98	3	49732	6	50555383
Optic disc hyperaemia	14.49	11.98	3	49732	6	50555383
Mixed adenoneuroendocrine carcinoma	14.49	11.98	3	49732	6	50555383
Periportal sinus dilatation	14.49	11.98	3	49732	6	50555383
Sedation	14.42	11.98	6	49729	30604	50524785
Myalgia	14.36	11.98	68	49667	124251	50431138
Irritability	14.34	11.98	5	49730	28421	50526968
Psychiatric decompensation	14.28	11.98	11	49724	1247	50554142
Tumour perforation	14.23	11.98	5	49730	106	50555283
Hyperbilirubinaemia	14.21	11.98	30	49705	9540	50545849
Psoriasis	14.19	11.98	29	49706	68971	50486418
Tumour rupture	14.19	11.98	5	49730	107	50555282
Upper respiratory tract infection	14.16	11.98	27	49708	65871	50489518
Tubular breast carcinoma	13.98	11.98	4	49731	42	50555347
Intracranial pressure increased	13.96	11.98	19	49716	4233	50551156
Muscle atrophy	13.86	11.98	23	49712	6098	50549291
Hepatic steatosis	13.84	11.98	54	49681	24330	50531059
Colon cancer metastatic	13.83	11.98	10	49725	1030	50554359
Rectal perforation	13.80	11.98	7	49728	378	50555011
Anxiety	13.80	11.98	110	49625	177496	50377893
Hemianaesthesia	13.72	11.98	7	49728	383	50555006
Acute lymphocytic leukaemia recurrent	13.67	11.98	13	49722	1962	50553427
Vaginal infection	13.55	11.98	23	49712	6213	50549176
Escherichia bacteraemia	13.52	11.98	16	49719	3100	50552289
Peripheral nerve injury	13.52	11.98	7	49728	395	50554994
Colon cancer recurrent	13.49	11.98	4	49731	48	50555341
Vaginal fistula	13.47	11.98	7	49728	398	50554991
Hepatic failure	13.36	11.98	65	49670	32218	50523171
Bradycardia	13.32	11.98	27	49708	64399	50490990
Agitation	13.19	11.98	20	49715	53364	50502025
Loss of personal independence in daily activities	13.13	11.98	31	49704	70019	50485370
Reticulocytosis	13.10	11.98	5	49730	135	50555254
Eczema asteatotic	13.08	11.98	6	49729	259	50555130
Metastases to peritoneum	13.05	11.98	15	49720	2818	50552571
Aortitis	13.02	11.98	9	49726	863	50554526
COVID-19	13.02	11.98	16	49719	46646	50508743
Chronic kidney disease	12.92	11.98	12	49723	39759	50515630
Anaemia of malignant disease	12.89	11.98	7	49728	435	50554954
Visual acuity reduced transiently	12.80	11.98	5	49730	144	50555245
Loss of consciousness	12.70	11.98	56	49679	104297	50451092
Metastases to bone marrow	12.69	11.98	6	49729	278	50555111
Enterocolitis	12.69	11.98	23	49712	6544	50548845
Granulomatous lymphadenitis	12.64	11.98	5	49730	149	50555240
Ovarian cystectomy	12.64	11.98	5	49730	149	50555240
Tubal rupture	12.59	11.98	3	49732	14	50555375
Hypocalcaemia	12.57	11.98	56	49679	26760	50528629
Psychotic disorder	12.54	11.98	3	49732	21809	50533580
Condition aggravated	12.50	11.98	211	49524	296847	50258542
Neuroendocrine carcinoma of the skin	12.46	11.98	7	49728	465	50554924
Drug resistance	12.41	11.98	44	49691	18945	50536444
Finger deformity	12.40	11.98	21	49714	5661	50549728
Gastrointestinal necrosis	12.38	11.98	14	49721	2584	50552805
Post procedural diarrhoea	12.36	11.98	5	49730	158	50555231
Bone pain	12.35	11.98	17	49718	47212	50508177
Pharyngotonsillitis	12.34	11.98	5	49730	159	50555230
Blood glucose increased	12.25	11.98	33	49702	71291	50484098
Drug eruption	12.17	11.98	4	49731	23602	50531787
Wheezing	12.00	11.98	27	49708	62020	50493369

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
Neutropenia	928.21	12.79	1189	54644	130522	29388172
Neuropathy peripheral	538.09	12.79	666	55167	70361	29448333
Skin toxicity	525.19	12.79	215	55618	3556	29515138
Diarrhoea	461.38	12.79	1523	54310	331175	29187519
Mucosal inflammation	378.66	12.79	377	55456	31218	29487476
Neurotoxicity	337.92	12.79	254	55579	14359	29504335
Dermatitis acneiform	330.20	12.79	175	55658	5316	29513378
Disease progression	323.22	12.79	565	55268	81351	29437343
Thrombocytopenia	297.85	12.79	732	55101	134091	29384603
Stomatitis	286.98	12.79	352	55481	36761	29481933
Palmar-plantar erythrodysaesthesia syndrome	281.60	12.79	229	55604	14530	29504164
Metastases to liver	262.87	12.79	201	55632	11655	29507039
Polyneuropathy	220.18	12.79	183	55650	11969	29506725
Arteriospasm coronary	210.73	12.79	101	55732	2464	29516230
Gastrointestinal toxicity	160.29	12.79	79	55754	2052	29516642
Proteinuria	157.57	12.79	171	55662	15633	29503061
Skin reaction	149.43	12.79	97	55736	4320	29514374
Completed suicide	147.98	12.79	5	55828	90241	29428453
Febrile neutropenia	145.37	12.79	504	55329	111736	29406958
Leukopenia	143.63	12.79	320	55513	54883	29463811
Paronychia	130.79	12.79	77	55756	2876	29515818
Pyrexia	119.17	12.79	938	54895	286684	29232010
Product dose omission issue	118.03	12.79	20	55813	96363	29422331
Portal hypertension	116.56	12.79	76	55757	3410	29515284
Decreased appetite	113.91	12.79	559	55274	144783	29373911
Vomiting	112.59	12.79	735	55098	211525	29307169
Haematotoxicity	111.30	12.79	96	55737	6603	29512091
Bone marrow failure	110.15	12.79	191	55642	27258	29491436
Nausea	106.17	12.79	918	54915	288337	29230357
Cardiotoxicity	101.99	12.79	79	55754	4665	29514029
Metastases to lung	101.95	12.79	98	55735	7757	29510937
Carcinoembryonic antigen increased	98.68	12.79	39	55794	585	29518109
General physical health deterioration	97.11	12.79	418	55415	102439	29416255
Drug abuse	96.86	12.79	17	55816	79866	29438828
Peripheral sensory neuropathy	96.42	12.79	84	55749	5855	29512839
Cardiac failure congestive	95.74	12.79	15	55818	76566	29442128
Alopecia	94.44	12.79	146	55687	18938	29499756
Rash pustular	94.13	12.79	75	55758	4616	29514078
Hyperammonaemia	93.76	12.79	81	55752	5582	29513112
Drug ineffective	91.44	12.79	365	55468	362805	29155889
Chills	88.57	12.79	316	55517	70984	29447710
Intestinal obstruction	87.82	12.79	142	55691	19135	29499559
Therapy partial responder	87.37	12.79	75	55758	5124	29513570
Abdominal pain	87.02	12.79	493	55340	134864	29383830
Myelosuppression	83.34	12.79	109	55724	12118	29506576
Rhabdomyolysis	78.10	12.79	11	55822	60797	29457897
Neoplasm progression	77.93	12.79	132	55701	18480	29500214
Myalgia	77.19	12.79	22	55811	73997	29444697
Hyperammonaemic encephalopathy	75.52	12.79	47	55786	1943	29516751
Drug interaction	75.26	12.79	163	55670	197222	29321472
Pulmonary embolism	74.47	12.79	314	55519	76220	29442474
Focal nodular hyperplasia	73.34	12.79	22	55811	133	29518561
Gastrointestinal perforation	72.70	12.79	57	55776	3426	29515268
Fall	67.78	12.79	146	55687	177032	29341662
Interstitial lung disease	65.10	12.79	248	55585	57470	29461224
Malignant neoplasm progression	63.48	12.79	292	55541	73567	29445127
Myocardial infarction	63.19	12.79	69	55764	110227	29408467
Enteritis	61.67	12.79	70	55763	6721	29511973
Ascites	60.54	12.79	179	55654	36440	29482254
Colorectal cancer metastatic	58.28	12.79	26	55807	535	29518159
Pneumonia	57.39	12.79	362	55471	319810	29198884
Death	56.70	12.79	396	55437	341688	29177006
Anxiety	56.36	12.79	47	55786	85318	29433376
Insomnia	56.02	12.79	51	55782	88710	29429984
Metastases to peritoneum	55.42	12.79	35	55798	1485	29517209
Febrile bone marrow aplasia	53.97	12.79	68	55765	7283	29511411
Ileus	53.61	12.79	97	55736	14305	29504389
Bradycardia	52.87	12.79	29	55804	65600	29453094
Small intestinal obstruction	52.52	12.79	91	55742	12970	29505724
Paraesthesia	52.41	12.79	221	55612	53624	29465070
Plasma cell myeloma	51.91	12.79	5	55828	37110	29481584
Somnolence	51.39	12.79	61	55772	93894	29424800
Transdifferentiation of neoplasm	49.91	12.79	14	55819	64	29518630
Hiccups	49.89	12.79	72	55761	8781	29509913
Asthma	48.85	12.79	4	55829	33845	29484849
Headache	48.75	12.79	167	55666	173840	29344854
Arthralgia	48.56	12.79	121	55712	139496	29379198
Hypomagnesaemia	48.47	12.79	104	55729	17364	29501330
Subileus	47.66	12.79	41	55792	2809	29515885
Dehydration	47.63	12.79	375	55458	114373	29404321
Anastomotic leak	47.53	12.79	23	55810	573	29518121
Drug clearance decreased	47.37	12.79	31	55802	1399	29517295
Cholangitis	46.48	12.79	64	55769	7473	29511221
Influenza	46.41	12.79	11	55822	41870	29476824
Metastases to lymph nodes	46.33	12.79	47	55786	3970	29514724
Coronary artery disease	46.30	12.79	13	55820	44177	29474517
Subclavian vein thrombosis	45.68	12.79	25	55808	810	29517884
Device related infection	45.60	12.79	95	55738	15541	29503153
Hospitalisation	45.53	12.79	15	55818	45973	29472721
Intentional overdose	44.97	12.79	9	55824	38519	29480175
Weight increased	44.96	12.79	47	55786	76620	29442074
Proteus infection	44.58	12.79	25	55808	850	29517844
Febrile infection	44.45	12.79	34	55799	1970	29516724
Aggression	44.31	12.79	7	55826	35534	29483160
Conjunctivitis	43.55	12.79	64	55769	7934	29510760
Tumour necrosis	43.52	12.79	27	55806	1110	29517584
Blood glucose increased	43.40	12.79	29	55804	58955	29459739
Dizziness	43.01	12.79	198	55635	189486	29329208
Intravascular haemolysis	42.50	12.79	19	55814	393	29518301
Anastomotic complication	42.20	12.79	18	55815	331	29518363
Feeling abnormal	41.10	12.79	26	55807	54419	29464275
Peripheral swelling	40.95	12.79	36	55797	63703	29454991
Ileal perforation	40.84	12.79	22	55811	690	29518004
Epistaxis	40.45	12.79	199	55634	51505	29467189
Nicotinic acid deficiency	40.36	12.79	12	55821	70	29518624
Leukoencephalopathy	39.71	12.79	42	55791	3725	29514969
Chronic obstructive pulmonary disease	39.43	12.79	14	55819	40941	29477753
Injection site pain	39.10	12.79	7	55826	32439	29486255
Anal haemorrhage	38.57	12.79	31	55802	1931	29516763
Erythema	37.58	12.79	258	55575	75348	29443346
Carbohydrate antigen 19-9 increased	37.45	12.79	14	55819	179	29518515
Pain in extremity	36.61	12.79	98	55735	110335	29408359
Sinusitis	36.18	12.79	10	55823	34340	29484354
Pelvic abscess	36.18	12.79	22	55811	872	29517822
Administration site extravasation	35.94	12.79	18	55815	484	29518210
Suicidal ideation	34.93	12.79	11	55822	34705	29483989
Recall phenomenon	34.86	12.79	18	55815	517	29518177
Unevaluable event	34.78	12.79	7	55826	29844	29488850
Intestinal perforation	34.70	12.79	58	55775	8028	29510666
Type II hypersensitivity	34.56	12.79	9	55824	29	29518665
Depression	34.32	12.79	68	55765	85079	29433615
Hypersensitivity	34.10	12.79	193	55640	52710	29465984
Rectal tenesmus	34.07	12.79	19	55814	639	29518055
Foetal disorder	33.58	12.79	20	55813	763	29517931
Vena cava thrombosis	33.56	12.79	22	55811	996	29517698
Colon cancer recurrent	33.38	12.79	11	55822	94	29518600
Tumour lysis syndrome	33.30	12.79	78	55755	13806	29504888
Intentional product misuse	33.11	12.79	12	55821	34649	29484045
Hallucination	32.86	12.79	22	55811	44690	29474004
Contusion	32.85	12.79	9	55824	31086	29487608
Pneumatosis intestinalis	32.82	12.79	35	55798	3134	29515560
Necrotising fasciitis	32.81	12.79	36	55797	3329	29515365
Anal fissure	32.65	12.79	33	55800	2775	29515919
Asthenia	32.63	12.79	579	55254	214671	29304023
Wheezing	32.62	12.79	11	55822	33229	29485465
Small intestinal perforation	32.54	12.79	26	55807	1606	29517088
Neoplasm recurrence	32.16	12.79	28	55805	1949	29516745
Treatment noncompliance	32.01	12.79	4	55829	24223	29494471
Cellulitis	31.79	12.79	24	55809	45816	29472878
Colitis	31.75	12.79	130	55703	31118	29487576
Muscle spasms	31.73	12.79	46	55787	65036	29453658
Hyperbilirubinaemia	31.65	12.79	80	55753	14854	29503840
Adverse drug reaction	31.65	12.79	4	55829	24016	29494678
Jugular vein thrombosis	31.59	12.79	24	55809	1376	29517318
Induration	31.51	12.79	20	55813	856	29517838
Hypoglycaemia	31.42	12.79	27	55806	48319	29470375
Psoriasis	31.05	12.79	11	55822	32216	29486478
Peritonitis	30.99	12.79	79	55754	14745	29503949
Colitis microscopic	30.78	12.79	26	55807	1737	29516957
Proctalgia	30.74	12.79	39	55794	4206	29514488
Anaemia of malignant disease	30.73	12.79	15	55818	381	29518313
Cholinergic syndrome	30.66	12.79	16	55817	470	29518224
Prothrombin level decreased	30.41	12.79	21	55812	1037	29517657
Blood creatine phosphokinase increased	29.87	12.79	20	55813	40624	29478070
Abdominal pain lower	29.41	12.79	56	55777	8582	29510112
Acute coronary syndrome	29.29	12.79	69	55764	12256	29506438
Electrocardiogram ST segment elevation	29.00	12.79	39	55794	4453	29514241
Catheter site thrombosis	28.99	12.79	8	55825	34	29518660
Neutropenia neonatal	28.75	12.79	17	55816	640	29518054
Overdose	28.64	12.79	68	55765	79751	29438943
Hypoalbuminaemia	28.18	12.79	61	55772	10244	29508450
Toxic erythema of chemotherapy	28.16	12.79	9	55824	69	29518625
Peripheral sensorimotor neuropathy	27.56	12.79	22	55811	1357	29517337
Venoocclusive liver disease	27.55	12.79	48	55785	6869	29511825
Evans syndrome	27.21	12.79	12	55821	240	29518454
Enterovesical fistula	27.14	12.79	16	55817	599	29518095
Sarcoidosis	27.06	12.79	29	55804	2611	29516083
Confusional state	26.90	12.79	137	55696	127740	29390954
Perforation	26.74	12.79	11	55822	184	29518510
Large intestine perforation	26.68	12.79	49	55784	7307	29511387
Portal vein thrombosis	26.53	12.79	32	55801	3277	29515417
Perihepatic abscess	26.51	12.79	9	55824	85	29518609
Fluid retention	26.47	12.79	6	55827	23554	29495140
Anaemia	26.45	12.79	529	55304	200422	29318272
Koebner phenomenon	26.44	12.79	8	55825	50	29518644
Off label use	25.97	12.79	747	55086	300053	29218641
Enterocutaneous fistula	25.94	12.79	17	55816	769	29517925
Hypokalaemia	25.94	12.79	173	55660	50030	29468664
Cerebral vasoconstriction	25.65	12.79	11	55822	205	29518489
Injury	25.52	12.79	3	55830	19043	29499651
Memory impairment	25.41	12.79	19	55814	36451	29482243
Pelvic fluid collection	25.21	12.79	9	55824	100	29518594
Wrong technique in product usage process	25.13	12.79	14	55819	31414	29487280
Disturbance in attention	25.00	12.79	5	55828	21419	29497275
Electrocardiogram QT prolonged	24.96	12.79	19	55814	36118	29482576
Stoma site haemorrhage	24.87	12.79	16	55817	701	29517993
Clostridial infection	24.87	12.79	31	55802	3284	29515410
Rectal perforation	24.66	12.79	13	55820	390	29518304
Oesophagitis	24.36	12.79	63	55770	11860	29506834
Perioral dermatitis	24.22	12.79	9	55824	113	29518581
Stoma site pain	24.21	12.79	14	55819	505	29518189
Abdominal discomfort	24.20	12.79	33	55800	47870	29470824
Interventricular septum rupture	24.16	12.79	6	55827	15	29518679
Nail disorder	24.12	12.79	23	55810	1801	29516893
Nephrotic syndrome	24.03	12.79	43	55790	6285	29512409
Peritoneal neoplasm	23.97	12.79	7	55826	38	29518656
Splenomegaly	23.95	12.79	67	55766	13212	29505482
Superior vena cava syndrome	23.67	12.79	14	55819	527	29518167
Product prescribing error	23.67	12.79	3	55830	17973	29500721
Device related thrombosis	23.39	12.79	17	55816	911	29517783
Mucosal toxicity	23.19	12.79	10	55823	189	29518505
Anal erythema	23.07	12.79	8	55825	81	29518613
Acute abdomen	23.05	12.79	22	55811	1725	29516969
Pneumoperitoneum	23.05	12.79	21	55812	1552	29517142
Sleep apnoea syndrome	23.02	12.79	3	55830	17596	29501098
Liver function test abnormal	22.95	12.79	13	55820	28905	29489789
Cardiac disorder	22.80	12.79	22	55811	37241	29481453
Organising pneumonia	22.73	12.79	37	55796	5011	29513683
Influenza like illness	22.49	12.79	9	55824	24461	29494233
Acne	22.33	12.79	52	55781	9168	29509526
Oesophageal haemorrhage	22.21	12.79	18	55815	1135	29517559
Rheumatoid arthritis	22.08	12.79	17	55816	32135	29486559
Cerebrovascular accident	22.05	12.79	73	55760	76838	29441856
Colon cancer metastatic	22.03	12.79	20	55813	1471	29517223
Perforation bile duct	22.03	12.79	6	55827	24	29518670
Pulmonary oedema	22.03	12.79	29	55804	42706	29475988
Pulmonary artery thrombosis	22.02	12.79	14	55819	601	29518093
International normalised ratio increased	21.98	12.79	31	55802	44341	29474353
Incorrect dose administered	21.95	12.79	18	55815	32966	29485728
Trichomegaly	21.84	12.79	6	55827	25	29518669
Seizure	21.78	12.79	96	55737	93027	29425667
Intentional product use issue	21.74	12.79	29	55804	42469	29476225
Product use issue	21.67	12.79	40	55793	51404	29467290
Mouth ulceration	21.45	12.79	55	55778	10300	29508394
Aplasia	21.38	12.79	32	55801	4031	29514663
Varices oesophageal	21.36	12.79	28	55805	3118	29515576
Anastomotic fistula	21.22	12.79	7	55826	60	29518634
Haematopoietic stem cell mobilisation	21.17	12.79	9	55824	164	29518530
Ischiorectal hernia	20.90	12.79	5	55828	10	29518684
Pulmonary infarction	20.65	12.79	17	55816	1096	29517598
Hepatectomy	20.45	12.79	7	55826	68	29518626
Sedation	20.44	12.79	4	55829	17401	29501293
B-cell small lymphocytic lymphoma	20.42	12.79	8	55825	117	29518577
Dyspnoea	20.37	12.79	466	55367	326266	29192428
Cholecystitis chronic	20.36	12.79	15	55818	821	29517873
Venous thrombosis	20.26	12.79	27	55806	3055	29515639
ECG signs of myocardial ischaemia	20.23	12.79	9	55824	184	29518510
Embolism	20.22	12.79	42	55791	6854	29511840
Dysaesthesia	20.10	12.79	22	55811	2028	29516666
Liver abscess	20.07	12.79	28	55805	3310	29515384
Cranial nerve disorder	20.03	12.79	12	55821	463	29518231
Circulatory collapse	20.02	12.79	79	55754	18594	29500100
Eyelash changes	19.99	12.79	5	55828	13	29518681
Respiratory arrest	19.96	12.79	12	55821	25821	29492873
Sepsis	19.89	12.79	379	55454	142303	29376391
Oral pain	19.87	12.79	50	55783	9257	29509437
Acute motor-sensory axonal neuropathy	19.83	12.79	8	55825	127	29518567
Productive cough	19.66	12.79	18	55815	31241	29487453
Dysphonia	19.61	12.79	80	55753	19116	29499578
Allodynia	19.60	12.79	13	55820	600	29518094
Hepatitis B surface antigen positive	19.49	12.79	8	55825	133	29518561
Visceral venous thrombosis	19.47	12.79	5	55828	15	29518679
K-ras gene mutation	19.23	12.79	5	55828	16	29518678
Performance status decreased	19.11	12.79	29	55804	3698	29514996
Haematoma	19.06	12.79	10	55823	23202	29495492
Catheter site extravasation	19.05	12.79	7	55826	85	29518609
Arthritis	18.80	12.79	12	55821	25007	29493687
Oesophagobronchial fistula	18.61	12.79	8	55825	150	29518544
Rectal abscess	18.60	12.79	15	55818	939	29517755
Pseudocirrhosis	18.56	12.79	5	55828	19	29518675
Mobility decreased	18.52	12.79	13	55820	25767	29492927
Chronic kidney disease	18.48	12.79	25	55808	36391	29482303
Haemolytic anaemia	18.46	12.79	49	55784	9370	29509324
Klebsiella infection	18.40	12.79	42	55791	7307	29511387
Neutrophil count decreased	18.37	12.79	143	55690	43424	29475270
Bacterial colitis	18.34	12.79	6	55827	50	29518644
Angioedema	18.21	12.79	20	55813	31895	29486799
Agitation	18.16	12.79	44	55789	51260	29467434
Soft tissue swelling	18.16	12.79	10	55823	328	29518366
Neurosarcoidosis	18.05	12.79	8	55825	162	29518532
Joint swelling	18.02	12.79	42	55791	49588	29469106
Contraindicated product administered	18.00	12.79	6	55827	18260	29500434
Portal venous gas	17.99	12.79	10	55823	334	29518360
Streptococcal bacteraemia	17.90	12.79	19	55814	1692	29517002
Electromyogram abnormal	17.84	12.79	6	55827	55	29518639
Proctitis	17.82	12.79	21	55812	2098	29516596
Non-cirrhotic portal hypertension	17.80	12.79	9	55824	247	29518447
Colorectal cancer recurrent	17.80	12.79	5	55828	23	29518671
Organic brain syndrome	17.64	12.79	9	55824	252	29518442
Candida infection	17.62	12.79	66	55767	15159	29503535
Cerebral haemorrhage	17.60	12.79	20	55813	31406	29487288
Heart rate increased	17.55	12.79	29	55804	38909	29479785
Vocal cord paralysis	17.53	12.79	14	55819	864	29517830
Lung neoplasm malignant	17.51	12.79	3	55830	14354	29504340
Abnormal behaviour	17.51	12.79	11	55822	23116	29495578
Radiation interaction	17.46	12.79	5	55828	25	29518669
Pelvic inflammatory disease	17.44	12.79	4	55829	6	29518688
Hypertension	17.37	12.79	313	55520	116301	29402393
Fatigue	17.36	12.79	747	55086	316074	29202620
Deep vein thrombosis	17.28	12.79	175	55658	57224	29461470
Perineal disorder	17.20	12.79	6	55827	62	29518632
Malignant ascites	17.14	12.79	10	55823	367	29518327
Toxicity to various agents	17.13	12.79	228	55605	173433	29345261
Fistula	17.11	12.79	33	55800	5106	29513588
Brief psychotic disorder with marked stressors	16.92	12.79	8	55825	189	29518505
Posterior reversible encephalopathy syndrome	16.89	12.79	46	55787	8930	29509764
Hypervolaemia	16.88	12.79	6	55827	17539	29501155
Renal disorder	16.76	12.79	11	55822	22584	29496110
Emotional distress	16.73	12.79	3	55830	13892	29504802
Cardiac arrest	16.70	12.79	94	55739	85497	29433197
Cachexia	16.70	12.79	37	55796	6312	29512382
Skin fissures	16.67	12.79	28	55805	3891	29514803
Metastasis	16.63	12.79	26	55807	3403	29515291
Intestinal strangulation	16.56	12.79	5	55828	31	29518663
Thrombotic thrombocytopenic purpura	16.52	12.79	25	55808	3181	29515513
Neck pain	16.51	12.79	10	55823	21437	29497257
Cataract	16.45	12.79	11	55822	22367	29496327
Hepatic cancer recurrent	16.40	12.79	9	55824	293	29518401
Bronchitis	16.12	12.79	28	55805	36840	29481854
Tumour marker increased	16.11	12.79	11	55822	533	29518161
Tumour fistulisation	16.11	12.79	4	55829	10	29518684
Multiple organ dysfunction syndrome	16.03	12.79	63	55770	63053	29455641
Change of bowel habit	16.01	12.79	14	55819	980	29517714
Astringent therapy	15.83	12.79	4	55829	11	29518683
Faeces discoloured	15.82	12.79	3	55830	13348	29505346
Duodenal perforation	15.81	12.79	15	55818	1167	29517527
Hypersplenism	15.81	12.79	9	55824	315	29518379
Upper gastrointestinal haemorrhage	15.81	12.79	11	55822	21903	29496791
Onychoclasis	15.80	12.79	18	55815	1735	29516959
Haemorrhage intracranial	15.75	12.79	4	55829	14538	29504156
Temperature difference of extremities	15.57	12.79	4	55829	12	29518682
Acinetobacter sepsis	15.57	12.79	5	55828	39	29518655
Portal shunt	15.57	12.79	5	55828	39	29518655
Road traffic accident	15.53	12.79	5	55828	15556	29503138
Retinitis viral	15.43	12.79	6	55827	86	29518608
Balance disorder	15.34	12.79	28	55805	36142	29482552
Retroperitoneal abscess	15.18	12.79	7	55826	156	29518538
Gastrointestinal haemorrhage	15.17	12.79	88	55745	79445	29439249
Bladder hypertrophy	15.09	12.79	11	55822	592	29518102
Gastrointestinal anastomotic leak	14.91	12.79	9	55824	352	29518342
Urticaria	14.90	12.79	53	55780	54607	29464087
Irritability	14.85	12.79	12	55821	22140	29496554
Medication error	14.84	12.79	11	55822	21200	29497494
Injection site erythema	14.81	12.79	4	55829	13952	29504742
Drug clearance increased	14.77	12.79	6	55827	97	29518597
Prostatic calcification	14.72	12.79	6	55827	98	29518596
Laryngospasm	14.71	12.79	15	55818	1275	29517419
Paraesthesia mucosal	14.69	12.79	4	55829	16	29518678
Limbic encephalitis	14.66	12.79	9	55824	363	29518331
Rectal adenocarcinoma	14.65	12.79	12	55821	768	29517926
Peritoneal disorder	14.59	12.79	8	55825	260	29518434
Crystal nephropathy	14.46	12.79	9	55824	372	29518322
Immune thrombocytopenia	14.46	12.79	40	55793	7837	29510857
Metastases to pelvis	14.40	12.79	8	55825	267	29518427
Tremor	14.22	12.79	81	55752	73457	29445237
Ocular toxicity	14.19	12.79	7	55826	182	29518512
Ventricular tachycardia	14.19	12.79	13	55820	22561	29496133
Rectal cancer recurrent	14.14	12.79	4	55829	19	29518675
Bacteriuria	14.08	12.79	8	55825	279	29518415
Hepatic lesion	14.06	12.79	23	55810	3127	29515567
Therapy non-responder	13.95	12.79	23	55810	30888	29487806
Renal impairment	13.95	12.79	93	55740	81240	29437454
Nodular regenerative hyperplasia	13.87	12.79	11	55822	672	29518022
Blood pressure decreased	13.84	12.79	42	55791	45435	29473259
Iatrogenic infection	13.81	12.79	5	55828	58	29518636
VIth nerve disorder	13.81	12.79	4	55829	21	29518673
Psychotic disorder	13.67	12.79	11	55822	20343	29498351
Tracheal inflammation	13.66	12.79	5	55828	60	29518634
Electric shock	13.65	12.79	6	55827	119	29518575
Abscess	13.61	12.79	45	55788	9717	29508977
Diffuse alveolar damage	13.59	12.79	18	55815	2025	29516669
Obstruction gastric	13.51	12.79	12	55821	858	29517836
Chemotherapeutic drug level increased	13.50	12.79	7	55826	203	29518491
Adenocarcinoma	13.50	12.79	16	55817	1609	29517085
Oesophageal irritation	13.44	12.79	5	55828	63	29518631
Intestinal mucosal hypertrophy	13.44	12.79	5	55828	63	29518631
Pulmonary toxicity	13.43	12.79	29	55804	4861	29513833
Peritoneal adhesions	13.43	12.79	6	55827	124	29518570
Laboratory test interference	13.41	12.79	9	55824	424	29518270
Aphthous ulcer	13.39	12.79	26	55807	4042	29514652
Jaundice	13.39	12.79	98	55735	29198	29489496
Oedema	13.34	12.79	36	55797	40447	29478247
Dyskinesia	13.28	12.79	11	55822	20050	29498644
Colorectal cancer	13.28	12.79	17	55816	1850	29516844
Neuropathic muscular atrophy	13.22	12.79	4	55829	25	29518669
Pleural fistula	13.22	12.79	4	55829	25	29518669
Central pain syndrome	13.16	12.79	5	55828	67	29518627
Abdominal sepsis	13.14	12.79	12	55821	890	29517804
Disseminated intravascular coagulation	12.93	12.79	73	55760	19907	29498787
Lip dry	12.86	12.79	13	55820	1093	29517601
Gout	12.86	12.79	8	55825	16903	29501791
Splenic abscess	12.85	12.79	8	55825	331	29518363
Gastrooesophageal reflux disease	12.81	12.79	25	55808	31471	29487223

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
Neutropenia	1825.74	11.55	1992	92826	237632	64166282
Neuropathy peripheral	1134.06	11.55	1111	93707	116414	64287500
Neurotoxicity	735.79	11.55	474	94344	26930	64376984
Mucosal inflammation	704.71	11.55	645	94173	61939	64341975
Skin toxicity	695.12	11.55	287	94531	6315	64397599
Diarrhoea	663.85	11.55	2443	92375	720261	63683653
Disease progression	648.68	11.55	914	93904	140766	64263148
Thrombocytopenia	644.57	11.55	1168	93650	222633	64181281
Dermatitis acneiform	448.30	11.55	228	94590	8215	64395699
Polyneuropathy	370.85	11.55	275	94543	19619	64384295
Stomatitis	343.10	11.55	594	94224	109011	64294903
Febrile neutropenia	334.44	11.55	805	94013	186852	64217062
Palmar-plantar erythrodysaesthesia syndrome	331.91	11.55	301	94517	28518	64375396
Arteriospasm coronary	308.95	11.55	154	94664	5311	64398603
Leukopenia	306.86	11.55	541	94277	100701	64303213
Completed suicide	304.52	11.55	5	94813	224409	64179505
Haematotoxicity	295.07	11.55	202	94616	12694	64391220
Neoplasm progression	281.79	11.55	324	94494	40640	64363274
Metastases to liver	275.58	11.55	250	94568	23691	64380223
Proteinuria	257.27	11.55	257	94561	27466	64376448
Gastrointestinal toxicity	234.85	11.55	127	94691	5195	64398719
Bone marrow failure	216.96	11.55	308	94510	47644	64356270
Secondary immunodeficiency	194.16	11.55	90	94728	2634	64401280
Malignant neoplasm progression	175.43	11.55	460	94358	112411	64291503
Vomiting	173.39	11.55	1392	93426	549725	63854189
Portal hypertension	172.83	11.55	110	94708	6109	64397805
Myelosuppression	163.03	11.55	188	94630	23642	64380272
Pulmonary embolism	158.99	11.55	525	94293	145831	64258083
Enteritis	154.67	11.55	134	94684	11943	64391971
Focal nodular hyperplasia	152.28	11.55	51	94767	606	64403308
Product dose omission issue	149.34	11.55	50	94768	194697	64209217
Nausea	149.06	11.55	1785	93033	784015	63619899
Pyrexia	147.78	11.55	1358	93460	557286	63846628
Cardiotoxicity	145.95	11.55	121	94697	10153	64393761
Paronychia	144.52	11.55	100	94718	6392	64397522
Therapy partial responder	142.06	11.55	119	94699	10129	64393785
Hyperammonaemia	135.22	11.55	114	94704	9790	64394124
Metastases to lung	135.18	11.55	138	94680	15126	64388788
Peripheral sensory neuropathy	133.24	11.55	120	94698	11258	64392656
General physical health deterioration	130.80	11.55	621	94197	203804	64200110
Fall	129.67	11.55	261	94557	416565	63987349
Drug clearance decreased	128.26	11.55	67	94751	2552	64401362
Drug abuse	124.80	11.55	22	94796	132352	64271562
Peripheral swelling	122.76	11.55	78	94740	209075	64194839
Abdominal pain	121.23	11.55	830	93988	311545	64092369
Intestinal obstruction	113.82	11.55	197	94621	36089	64367825
Hyperammonaemic encephalopathy	110.83	11.55	71	94747	3987	64399927
Rash pustular	109.39	11.55	101	94717	9784	64394130
Posterior reversible encephalopathy syndrome	109.13	11.55	151	94667	22795	64381119
Carcinoembryonic antigen increased	106.51	11.55	53	94765	1820	64402094
Gastrointestinal perforation	105.61	11.55	77	94741	5347	64398567
Mycobacterium chelonae infection	102.75	11.55	54	94764	2083	64401831
Non-cirrhotic portal hypertension	100.91	11.55	33	94785	362	64403552
Anaemia	99.57	11.55	920	93898	377760	64026154
Colorectal cancer metastatic	98.55	11.55	41	94777	919	64402995
Intentional overdose	93.95	11.55	11	94807	89933	64313981
Swelling	93.65	11.55	60	94758	160158	64243756
Chills	93.62	11.55	425	94393	136839	64267075
Arthralgia	93.55	11.55	335	94483	441925	63961989
Systemic lupus erythematosus	93.52	11.55	5	94813	77607	64326307
Venoocclusive liver disease	93.17	11.55	93	94725	9922	64393992
Interstitial lung disease	92.47	11.55	335	94483	97397	64306517
Rhabdomyolysis	91.51	11.55	13	94805	91713	64312201
Arthropathy	91.06	11.55	32	94786	120935	64282979
Cholangitis	90.85	11.55	95	94723	10707	64393207
Insomnia	89.74	11.55	95	94723	197741	64206173
Joint swelling	89.50	11.55	111	94707	215271	64188643
Hypomagnesaemia	86.25	11.55	178	94640	37198	64366716
Pneumatosis intestinalis	85.77	11.55	67	94751	5162	64398752
Drug ineffective	84.39	11.55	810	94008	839437	63564477
Decreased appetite	83.48	11.55	702	94116	280587	64123327
Ileus	83.16	11.55	133	94685	22833	64381081
Epistaxis	80.97	11.55	322	94496	97809	64306105
Ascites	80.74	11.55	237	94581	61764	64342150
Leukoencephalopathy	80.63	11.55	73	94745	6894	64397020
Synovitis	78.47	11.55	24	94794	99066	64304848
Intestinal perforation	77.71	11.55	104	94714	15209	64388705
Splenomegaly	76.28	11.55	112	94706	17849	64386065
Headache	75.90	11.55	462	94356	529005	63874909
Skin reaction	75.47	11.55	92	94726	12260	64391654
Pain	75.23	11.55	491	94327	553020	63850894
Device related infection	74.40	11.55	149	94669	30477	64373437
Dizziness	73.98	11.55	353	94465	429810	63974104
Bacterial infection	72.49	11.55	131	94687	24819	64379095
Administration site extravasation	72.41	11.55	34	94784	1025	64402889
Cardiac failure congestive	72.15	11.55	52	94766	130528	64273386
Asthma	71.99	11.55	25	94793	95200	64308714
Nicotinic acid deficiency	71.18	11.55	20	94798	124	64403790
Myalgia	70.99	11.55	77	94741	158540	64245374
Anxiety	69.88	11.55	119	94699	202530	64201384
Anastomotic leak	69.11	11.55	32	94786	934	64402980
Tumour lysis syndrome	68.23	11.55	111	94707	19329	64384585
Weight increased	67.57	11.55	132	94686	213216	64190698
Subileus	67.35	11.55	57	94761	4920	64398994
Glossodynia	67.34	11.55	8	94810	64688	64339226
Pain in extremity	67.09	11.55	225	94593	302860	64101054
Dehydration	65.34	11.55	543	94275	216220	64187694
Depression	64.70	11.55	106	94712	183185	64220729
Somnolence	64.49	11.55	126	94692	203519	64200395
Human bocavirus infection	64.11	11.55	26	94792	545	64403369
Injection site pain	63.35	11.55	43	94775	111365	64292549
Injury	63.34	11.55	5	94813	55987	64347927
Myocardial infarction	63.23	11.55	91	94727	165730	64238184
Hypertension	63.11	11.55	620	94198	258641	64145273
Febrile bone marrow aplasia	62.64	11.55	80	94738	11175	64392739
Contusion	62.16	11.55	46	94772	113919	64289995
Intentional product misuse	60.03	11.55	16	94802	72279	64331635
Pseudomonal sepsis	59.48	11.55	54	94764	5118	64398796
Abdominal discomfort	59.30	11.55	111	94707	182211	64221703
Vena cava thrombosis	59.00	11.55	40	94778	2472	64401442
Hospitalisation	58.14	11.55	19	94799	75188	64328726
Pancytopenia	57.96	11.55	385	94433	142924	64260990
Parainfluenzae virus infection	57.47	11.55	51	94767	4692	64399222
Paraesthesia	57.21	11.55	366	94452	134156	64269758
Tumour necrosis	57.09	11.55	34	94784	1675	64402239
Bradycardia	55.59	11.55	55	94763	118164	64285750
Drug hypersensitivity	55.06	11.55	173	94645	237642	64166272
Hyperbilirubinaemia	54.94	11.55	106	94712	21099	64382815
Embolism	54.44	11.55	78	94740	12157	64391757
Sepsis	53.70	11.55	546	94272	229795	64174119
Small intestinal obstruction	52.90	11.55	111	94707	23462	64380452
Pelvic abscess	52.18	11.55	33	94785	1812	64402102
Hiccups	52.17	11.55	63	94755	8313	64395601
Diffuse alveolar damage	52.09	11.55	41	94777	3194	64400720
Hepatic enzyme increased	51.84	11.55	69	94749	129874	64274040
Sinusitis	50.92	11.55	85	94733	145843	64258071
Maternal exposure during pregnancy	50.63	11.55	40	94778	95844	64308070
Mucosal toxicity	50.46	11.55	21	94797	471	64403443
Neutrophil count decreased	50.36	11.55	236	94582	76960	64326954
Electrocardiogram QT prolonged	50.29	11.55	27	94791	79421	64324493
Chronic obstructive pulmonary disease	49.80	11.55	21	94797	71027	64332887
Crystal nephropathy	49.79	11.55	28	94790	1237	64402677
Contraindicated product administered	49.74	11.55	51	94767	107778	64296136
Transdifferentiation of neoplasm	49.39	11.55	14	94804	90	64403824
Suicidal ideation	49.39	11.55	18	94800	66524	64337390
Feeling abnormal	49.28	11.55	75	94743	133527	64270387
Mobility decreased	48.98	11.55	33	94785	85807	64318107
Wheezing	48.69	11.55	29	94789	80550	64323364
Metastases to lymph nodes	48.57	11.55	62	94756	8655	64395259
Overdose	48.56	11.55	101	94717	159465	64244449
Metastases to meninges	48.20	11.55	37	94781	2778	64401136
Abscess bacterial	47.66	11.55	23	94795	738	64403176
Memory impairment	47.48	11.55	34	94784	85648	64318266
Drug interaction	47.17	11.55	325	94493	361758	64042156
Neoplasm recurrence	46.89	11.55	41	94777	3698	64400216
Metastases to peritoneum	46.72	11.55	40	94778	3507	64400407
Steatohepatitis	46.27	11.55	23	94795	788	64403126
Peritonitis	46.21	11.55	109	94709	24914	64379000
Gene mutation	46.17	11.55	32	94786	2050	64401864
Off label use	45.99	11.55	1236	93582	631570	63772344
Lower respiratory tract infection	45.66	11.55	43	94775	94571	64309343
Colitis	45.57	11.55	189	94629	58485	64345429
Cholinergic syndrome	45.42	11.55	23	94795	820	64403094
Plasma cell myeloma	44.87	11.55	7	94811	46068	64357846
Fluid retention	44.45	11.55	16	94802	59590	64344324
Wrong technique in product usage process	44.28	11.55	20	94798	64954	64338960
Anastomotic complication	44.13	11.55	18	94800	383	64403531
Coronary artery disease	43.76	11.55	17	94801	60416	64343498
Pneumonia	43.48	11.55	571	94247	559005	63844909
Venous thrombosis	43.06	11.55	50	94768	6331	64397583
Asthenia	43.05	11.55	875	93943	427169	63976745
Superior vena cava syndrome	42.87	11.55	24	94794	1051	64402863
Dysarthria	42.77	11.55	187	94631	59219	64344695
Trichomegaly	42.63	11.55	12	94806	75	64403839
Hypokalaemia	42.54	11.55	316	94502	121587	64282327
Haemolytic anaemia	42.51	11.55	81	94737	15972	64387942
Human herpesvirus 6 infection	41.06	11.55	42	94776	4612	64399302
Sedation	41.06	11.55	6	94812	41456	64362458
Gait disturbance	40.70	11.55	124	94694	172031	64231883
Type II hypersensitivity	40.70	11.55	10	94808	33	64403881
Lymphoid tissue hypoplasia	40.62	11.55	18	94800	473	64403441
Proteus infection	40.60	11.55	27	94791	1616	64402298
Confusional state	40.45	11.55	222	94596	260922	64142992
Portal vein thrombosis	40.38	11.55	43	94775	4948	64398966
Hand deformity	40.22	11.55	21	94797	62750	64341164
Hallucination	40.17	11.55	29	94789	72759	64331155
Peripheral sensorimotor neuropathy	39.99	11.55	32	94786	2553	64401361
Treatment noncompliance	39.31	11.55	8	94810	43474	64360440
Thymus hypoplasia	39.20	11.55	18	94800	515	64403399
ECG signs of myocardial ischaemia	39.12	11.55	16	94802	343	64403571
K-ras gene mutation	39.01	11.55	10	94808	41	64403873
Jugular vein thrombosis	38.29	11.55	37	94781	3794	64400120
Influenza	38.14	11.55	61	94757	106470	64297444
Productive cough	38.06	11.55	31	94787	73172	64330742
Drug dependence	37.60	11.55	3	94815	33309	64370605
Helicobacter infection	36.97	11.55	6	94812	38356	64365558
Loss of employment	36.96	11.55	27	94791	1880	64402034
Deep vein thrombosis	36.89	11.55	273	94545	104909	64299005
Febrile infection	36.76	11.55	32	94786	2869	64401045
Proctalgia	36.32	11.55	50	94768	7509	64396405
Nodular regenerative hyperplasia	36.27	11.55	20	94798	850	64403064
Immune thrombocytopenia	36.23	11.55	73	94745	14993	64388921
Blood glucose increased	36.21	11.55	55	94763	98018	64305896
Septic shock	36.04	11.55	272	94546	105165	64298749
Rectal perforation	35.96	11.55	19	94799	741	64403173
International normalised ratio increased	35.88	11.55	38	94780	79129	64324785
Pelvic fluid collection	35.86	11.55	18	94800	630	64403284
Small intestinal perforation	35.84	11.55	30	94788	2550	64401364
Enterobacter infection	35.64	11.55	35	94783	3661	64400253
Wound	35.46	11.55	36	94782	76441	64327473
Blister	35.44	11.55	40	94778	80927	64322987
Clostridium difficile colitis	35.36	11.55	104	94714	27119	64376795
Discomfort	35.36	11.55	40	94778	80838	64323076
Psoriasis	35.29	11.55	32	94786	71671	64332243
Unevaluable event	35.26	11.55	15	94803	50474	64353440
Product prescribing error	35.17	11.55	5	94813	35264	64368650
Respiratory arrest	35.04	11.55	17	94801	52968	64350946
Rectal tenesmus	34.94	11.55	21	94797	1052	64402862
Stress	34.89	11.55	23	94795	60511	64343403
Anal haemorrhage	34.79	11.55	33	94785	3307	64400607
Subclavian vein thrombosis	34.43	11.55	28	94790	2286	64401628
Varices oesophageal	34.29	11.55	40	94778	5090	64398824
Balance disorder	34.04	11.55	44	94774	83882	64320032
Emotional distress	33.92	11.55	6	94812	36032	64367882
Gastrointestinal anastomotic leak	33.75	11.55	15	94803	397	64403517
Acute coronary syndrome	33.39	11.55	82	94736	19228	64384686
Cystitis bacterial	33.37	11.55	15	94803	408	64403506
Exposure during pregnancy	33.32	11.55	39	94779	77636	64326278
Ileal perforation	33.03	11.55	19	94799	877	64403037
Ocular toxicity	32.99	11.55	17	94801	629	64403285
Factor VII deficiency	32.65	11.55	8	94810	26	64403888
Large intestinal obstruction	32.63	11.55	29	94789	2673	64401241
Norovirus test positive	32.45	11.55	15	94803	436	64403478
Enterocutaneous fistula	32.36	11.55	23	94795	1534	64402380
Gastrooesophageal reflux disease	32.29	11.55	45	94773	83098	64320816
Cardiac arrest	32.27	11.55	117	94701	153947	64249967
Anastomotic fistula	32.15	11.55	10	94808	92	64403822
Enterovesical fistula	32.05	11.55	19	94799	928	64402986
Oesophageal atresia	32.00	11.55	9	94809	56	64403858
Electrocardiogram ST segment elevation	31.89	11.55	46	94772	7213	64396701
Intentional self-injury	31.74	11.55	3	94815	29041	64374873
Blood cholesterol increased	31.71	11.55	17	94801	50049	64353865
Carbohydrate antigen 19-9 increased	31.69	11.55	14	94804	365	64403549
Hypoglycaemia	31.68	11.55	52	94766	89840	64314074
Intravascular haemolysis	31.26	11.55	17	94801	703	64403211
Neutropenic colitis	31.09	11.55	36	94782	4545	64399369
Recall phenomenon	30.99	11.55	19	94799	987	64402927
Injection site erythema	30.96	11.55	35	94783	70765	64333149
Arthritis	30.95	11.55	47	94771	83767	64320147
Portal shunt	30.73	11.55	9	94809	66	64403848
Cystitis radiation	30.31	11.55	10	94808	113	64403801
Blood creatine phosphokinase increased	30.19	11.55	25	94793	58533	64345381
Liver abscess	30.12	11.55	38	94780	5242	64398672
Leukoerythroblastosis	30.01	11.55	12	94806	242	64403672
Hypersensitivity vasculitis	29.93	11.55	43	94775	6718	64397196
Acute abdomen	29.60	11.55	28	94790	2796	64401118
Teratogenicity	29.52	11.55	9	94809	77	64403837
Hypoalbuminaemia	29.45	11.55	74	94744	17600	64386314
Gait inability	28.93	11.55	13	94805	42355	64361559
Neuromyotonia	28.82	11.55	9	94809	84	64403830
Medication error	28.78	11.55	19	94799	49947	64353967
Nephrotic syndrome	28.77	11.55	51	94767	9516	64394398
Liver function test abnormal	28.65	11.55	27	94791	59374	64344540
Koebner phenomenon	28.56	11.55	8	94810	49	64403865
Aortic thrombosis	28.36	11.55	21	94797	1493	64402421
Nasal septum perforation	28.35	11.55	16	94802	712	64403202
Necrotising fasciitis	28.30	11.55	37	94781	5289	64398625
Organising pneumonia	28.18	11.55	49	94769	9006	64394908
Klebsiella infection	28.03	11.55	61	94757	13220	64390694
Colon cancer recurrent	28.00	11.55	9	94809	93	64403821
Adverse drug reaction	27.98	11.55	16	94802	45448	64358466
Large intestine perforation	27.87	11.55	59	94759	12545	64391369
Cardio-respiratory arrest	27.69	11.55	65	94753	98328	64305586
Intentional product use issue	27.64	11.55	62	94756	95302	64308612
Influenza like illness	27.53	11.55	30	94788	61672	64342242
Encephalopathy	27.48	11.55	164	94654	58655	64345259
Stoma site haemorrhage	27.18	11.55	21	94797	1592	64402322
Short-bowel syndrome	27.00	11.55	13	94805	415	64403499
Encapsulating peritoneal sclerosis	26.49	11.55	16	94802	809	64403105
Prothrombin level decreased	26.47	11.55	20	94798	1466	64402448
Atypical haemolytic uraemic syndrome	26.38	11.55	15	94803	677	64403237
Migraine	26.32	11.55	32	94786	62645	64341269
Aggression	26.06	11.55	18	94800	46214	64357700
Agitation	25.98	11.55	57	94761	88310	64315604
Colon cancer metastatic	25.97	11.55	22	94796	1901	64402013
Cytomegalovirus chorioretinitis	25.90	11.55	34	94784	4878	64399036
Venous thrombosis limb	25.78	11.55	30	94788	3807	64400107
Dyspnoea	25.78	11.55	833	93985	717841	63686073
Oesophageal candidiasis	25.75	11.55	44	94774	7973	64395941
Condition aggravated	25.34	11.55	390	94428	372036	64031878
Loss of consciousness	25.28	11.55	122	94696	148243	64255671
Injection site haemorrhage	25.27	11.55	3	94815	24275	64379639
Gastrointestinal stoma complication	25.12	11.55	23	94795	2203	64401711
Perihepatic abscess	25.08	11.55	9	94809	133	64403781
Performance status decreased	25.05	11.55	35	94783	5329	64398585
Cytopenia	24.97	11.55	64	94754	15407	64388507
Laryngospasm	24.95	11.55	28	94790	3417	64400497
Cerebral haemorrhage	24.90	11.55	23	94795	51067	64352847
Venous pressure jugular decreased	24.86	11.55	8	94810	83	64403831
Duodenal ulcer perforation	24.64	11.55	10	94808	34615	64369299
Perineal disorder	24.61	11.55	6	94812	19	64403895
Evans syndrome	24.53	11.55	12	94806	397	64403517
Induration	24.47	11.55	20	94798	1644	64402270
Device related thrombosis	24.43	11.55	22	94796	2063	64401851
Pulmonary arterial hypertension	24.37	11.55	4	94814	25363	64378551
Knee arthroplasty	24.34	11.55	5	94813	26994	64376920
Hepatic lesion	24.27	11.55	36	94782	5788	64398126
Anal fissure	24.24	11.55	33	94785	4903	64399011
Visual impairment	24.15	11.55	45	94773	74032	64329882
Toxic erythema of chemotherapy	24.12	11.55	10	94808	222	64403692
Pericarditis	24.11	11.55	34	94784	62482	64341432
Viraemia	24.07	11.55	23	94795	2326	64401588
Irritability	23.98	11.55	12	94806	36734	64367180
Injection site reaction	23.96	11.55	20	94798	46644	64357270
Anaemia of malignant disease	23.91	11.55	14	94804	668	64403246
Cachexia	23.78	11.55	46	94772	9171	64394743
Interventricular septum rupture	23.72	11.55	6	94812	23	64403891
Urticaria	23.47	11.55	124	94694	147193	64256721
Proctitis	23.43	11.55	26	94792	3133	64400781
Meningitis streptococcal	23.20	11.55	9	94809	167	64403747
Depressed mood	23.08	11.55	16	94802	40996	64362918
C-reactive protein abnormal	23.05	11.55	7	94811	29040	64374874
Psychotic disorder	23.00	11.55	11	94807	34567	64369347
Oesophagitis	22.91	11.55	77	94741	21553	64382361
Chronic kidney disease	22.84	11.55	31	94787	57888	64346026
Dyskinesia	22.65	11.55	15	94803	39373	64364541
Pulmonary congestion	22.42	11.55	4	94814	23876	64380038
Allodynia	22.27	11.55	17	94801	1266	64402648
Vasospasm	22.18	11.55	15	94803	923	64402991
Ischiorectal hernia	22.14	11.55	5	94813	10	64403904
Bacteriuria	22.12	11.55	15	94803	927	64402987
Poisoning	22.05	11.55	3	94815	21876	64382038
Metastasis	22.03	11.55	34	94784	5661	64398253
Clostridial infection	21.85	11.55	32	94786	5087	64398827
Musculoskeletal stiffness	21.76	11.55	100	94718	123106	64280808
Nasopharyngitis	21.71	11.55	184	94634	195889	64208025
Hepatocellular injury	21.69	11.55	127	94691	45108	64358806
Incorrect dose administered	21.55	11.55	35	94783	60730	64343184
Haematopoietic stem cell mobilisation	21.42	11.55	9	94809	207	64403707
Periportal sinus dilatation	21.38	11.55	6	94812	37	64403877
Joint stiffness	21.28	11.55	9	94809	30395	64373519
Depilation	21.23	11.55	5	94813	13	64403901
Pulmonary toxicity	21.21	11.55	42	94776	8519	64395395
Oesophageal haemorrhage	21.14	11.55	18	94800	1566	64402348
Treatment failure	21.11	11.55	94	94724	116722	64287192
Erythema	20.97	11.55	389	94429	186681	64217233
Injection site pruritus	20.96	11.55	15	94803	37811	64366103
Hypoacusis	20.95	11.55	6	94812	25861	64378053
Aplasia	20.82	11.55	37	94781	6916	64396998
Pneumonitis	20.76	11.55	136	94682	50229	64353685
Injection site bruising	20.72	11.55	14	94804	36359	64367555
Hepatic failure	20.69	11.55	146	94672	55248	64348666
Muscle spasms	20.67	11.55	122	94696	140901	64263013
Full blood count abnormal	20.52	11.55	9	94809	29748	64374166
Obesity	20.30	11.55	3	94815	20559	64383355
Conjunctivitis	20.28	11.55	71	94747	20283	64383631
Visceral venous thrombosis	20.24	11.55	5	94813	17	64403897
Catabolic state	20.19	11.55	7	94811	93	64403821
Therapeutic product effect decreased	20.15	11.55	94	94724	115257	64288657
Swelling face	20.13	11.55	35	94783	59131	64344783
Stress cardiomyopathy	20.09	11.55	43	94775	9214	64394700
Myeloid leukaemia	20.06	11.55	12	94806	596	64403318
Abortion spontaneous	20.06	11.55	6	94812	25137	64378777
Acute kidney injury	20.04	11.55	829	93989	448411	63955503
Chemotherapy cardiotoxicity attenuation	20.02	11.55	5	94813	18	64403896
Multiple-drug resistance	19.99	11.55	35	94783	6467	64397447
Hypothyroidism	19.97	11.55	18	94800	40439	64363475
Heart rate increased	19.96	11.55	76	94742	98599	64305315
Haemolytic uraemic syndrome	19.93	11.55	27	94791	3994	64399920
Portal vein dilatation	19.92	11.55	6	94812	49	64403865
Tremor	19.78	11.55	132	94686	148098	64255816
Hepatitis B surface antigen positive	19.67	11.55	8	94810	169	64403745
Cataract	19.65	11.55	28	94790	51234	64352680
Pneumoperitoneum	19.57	11.55	22	94796	2689	64401225
Skin discolouration	19.51	11.55	14	94804	35241	64368673
Loss of personal independence in daily activities	19.48	11.55	49	94769	72405	64331509
Rectal cancer recurrent	19.41	11.55	5	94813	21	64403893
Perioral dermatitis	19.39	11.55	9	94809	264	64403650
Bronchitis	19.36	11.55	88	94730	108655	64295259
Hepatectomy	19.28	11.55	8	94810	178	64403736
Anal erythema	19.20	11.55	8	94810	180	64403734
Cerebrovascular accident	19.13	11.55	121	94697	137462	64266452
Sleep apnoea syndrome	19.08	11.55	10	94808	29822	64374092
Radiation interaction	18.84	11.55	6	94812	60	64403854
Product use issue	18.82	11.55	138	94680	151577	64252337
Pulmonary artery thrombosis	18.81	11.55	15	94803	1191	64402723
Jaundice	18.79	11.55	129	94689	48383	64355531
Endometrial dysplasia	18.70	11.55	5	94813	25	64403889
Hypertransaminasaemia	18.69	11.55	36	94782	7155	64396759
Aortic intramural haematoma	18.66	11.55	7	94811	118	64403796
Panic attack	18.64	11.55	4	94814	20949	64382965
Cerebral vasoconstriction	18.63	11.55	15	94803	1207	64402707
Adrenal insufficiency	18.62	11.55	5	94813	22482	64381432
Impaired healing	18.62	11.55	38	94780	60435	64343479
Prostatic calcification	18.58	11.55	6	94812	63	64403851
Laboratory test interference	18.56	11.55	14	94804	1024	64402890
Pregnancy	18.53	11.55	4	94814	20861	64383053
Cranial nerve disorder	18.43	11.55	13	94805	857	64403057
Cholestasis	18.39	11.55	121	94697	44751	64359163
Palpitations	18.33	11.55	85	94733	104403	64299511
Duodenal perforation	18.33	11.55	18	94800	1882	64402032
Oesophageal fistula	18.28	11.55	9	94809	302	64403612
Psoriatic arthropathy	18.27	11.55	22	94796	43259	64360655
Bladder hypertrophy	18.27	11.55	11	94807	553	64403361
Upper respiratory tract infection	18.23	11.55	51	94767	72734	64331180
Mouth ulceration	18.17	11.55	95	94723	32349	64371565
Cardiac disorder	18.11	11.55	34	94784	55782	64348132
Product administration error	18.08	11.55	9	94809	27634	64376280
Pain in jaw	17.98	11.55	20	94798	40735	64363179
Viral hepatitis carrier	17.93	11.55	5	94813	30	64403884
Oesophagobronchial fistula	17.92	11.55	8	94810	214	64403700
Hypotension	17.88	11.55	425	94393	380549	64023365
Cough	17.72	11.55	325	94493	301823	64102091
Mixed adenoneuroendocrine carcinoma	17.71	11.55	4	94814	8	64403906
Blood pressure decreased	17.69	11.55	66	94752	86133	64317781
Obstructive airways disorder	17.67	11.55	6	94812	23179	64380735
Fear	17.64	11.55	4	94814	20167	64383747
Product quality issue	17.61	11.55	11	94807	29788	64374126
Injection site swelling	17.48	11.55	21	94797	41332	64362582
Rhinovirus infection	17.47	11.55	32	94786	6124	64397790
Tumour perforation	17.44	11.55	9	94809	334	64403580
Perineal abscess	17.41	11.55	10	94808	460	64403454
Rectal abscess	17.40	11.55	16	94802	1541	64402373
Faeces discoloured	17.40	11.55	8	94810	25721	64378193
Biliary tract infection	17.39	11.55	13	94805	938	64402976
Hypertrichosis	17.31	11.55	14	94804	1134	64402780
Road traffic accident	17.29	11.55	12	94806	30733	64373181
Systemic scleroderma	17.24	11.55	13	94805	950	64402964
Portal venous gas	17.22	11.55	9	94809	343	64403571
Hyperthyroidism	17.17	11.55	3	94815	18176	64385738
Hepatotoxicity	17.13	11.55	109	94709	39853	64364061
Restlessness	17.03	11.55	20	94798	39765	64364149
Perforation bile duct	17.03	11.55	5	94813	37	64403877
Head injury	16.96	11.55	14	94804	32828	64371086
Type 2 diabetes mellitus	16.96	11.55	15	94803	34005	64369909
Gastrointestinal necrosis	16.83	11.55	28	94790	4964	64398950
Hypocalcaemia	16.75	11.55	112	94706	41641	64362273
Adverse event	16.75	11.55	20	94798	39469	64364445
Catheter site extravasation	16.71	11.55	9	94809	365	64403549
Anal erosion	16.69	11.55	5	94813	40	64403874
Peritoneal neoplasm	16.64	11.55	6	94812	90	64403824
Female genital tract fistula	16.57	11.55	20	94798	2638	64401276
Abnormal behaviour	16.55	11.55	15	94803	33607	64370307
Obstruction gastric	16.44	11.55	15	94803	1431	64402483
Herpes simplex	16.40	11.55	43	94775	10493	64393421
Lymphopenia	16.40	11.55	78	94740	25579	64378335
Brief psychotic disorder with marked stressors	16.40	11.55	8	94810	263	64403651
Thrombocytopenic purpura	16.39	11.55	18	94800	2144	64401770
Bladder tamponade	16.35	11.55	10	94808	517	64403397
Soft tissue necrosis	16.26	11.55	11	94807	677	64403237
Rheumatoid arthritis	16.09	11.55	159	94659	164135	64239779
Subacute cutaneous lupus erythematosus	16.05	11.55	21	94797	3004	64400910
Dysstasia	16.04	11.55	7	94811	23208	64380706
Amnesia	16.02	11.55	29	94789	48240	64355674
Coronavirus infection	16.01	11.55	29	94789	5501	64398413
Red cell fragmentation syndrome	15.98	11.55	5	94813	47	64403867
Retinitis viral	15.90	11.55	6	94812	103	64403811
Temperature difference of extremities	15.89	11.55	4	94814	15	64403899
Upper gastrointestinal haemorrhage	15.85	11.55	17	94801	35203	64368711
Adenocarcinoma of colon	15.85	11.55	27	94791	4881	64399033
Nephropathy toxic	15.68	11.55	59	94759	17455	64386459
Hypervolaemia	15.60	11.55	20	94798	38265	64365649
Catheter site thrombosis	15.59	11.55	7	94811	190	64403724
Breast cancer	15.58	11.55	12	94806	29136	64374778
Inferior vena cava stenosis	15.53	11.55	5	94813	52	64403862
Dysaesthesia	15.50	11.55	27	94791	4968	64398946
Portal vein embolisation	15.49	11.55	4	94814	17	64403897
Hallucination, visual	15.47	11.55	11	94807	27823	64376091
Hypersplenism	15.40	11.55	9	94809	428	64403486
Full blood count decreased	15.31	11.55	7	94811	22575	64381339
Dysaesthesia pharynx	15.29	11.55	7	94811	199	64403715
Intestinal strangulation	15.28	11.55	5	94813	55	64403859
Acinetobacter sepsis	15.20	11.55	5	94813	56	64403858
Iatrogenic infection	15.04	11.55	5	94813	58	64403856
Organic brain syndrome	15.01	11.55	9	94809	449	64403465
Cutaneous tuberculosis	14.94	11.55	7	94811	210	64403704
Delusion	14.92	11.55	4	94814	18010	64385904
Diabetes mellitus	14.91	11.55	49	94769	66425	64337489
Portal tract inflammation	14.83	11.55	6	94812	125	64403789
Vocal cord paralysis	14.79	11.55	17	94801	2129	64401785
Pruritus	14.78	11.55	348	94470	312052	64091862
Neurosarcoidosis	14.77	11.55	8	94810	328	64403586
Product substitution issue	14.73	11.55	4	94814	17857	64386057
Mania	14.71	11.55	3	94815	16283	64387631
Astringent therapy	14.64	11.55	4	94814	22	64403892
Gastric varices haemorrhage	14.62	11.55	8	94810	335	64403579
Optic neuropathy	14.59	11.55	20	94798	2991	64400923
Splenic abscess	14.55	11.55	9	94809	475	64403439
Anal fistula	14.52	11.55	27	94791	5226	64398688
Myopathy	14.51	11.55	4	94814	17676	64386238
Tumour fistulisation	14.49	11.55	4	94814	23	64403891
Therapy non-responder	14.49	11.55	49	94769	65850	64338064
Encephalitis	14.43	11.55	46	94772	12525	64391389
Fistula of small intestine	14.37	11.55	10	94808	645	64403269
Pleural fistula	14.35	11.55	4	94814	24	64403890
Mood altered	14.32	11.55	3	94815	15976	64387938
Streptococcal bacteraemia	14.30	11.55	20	94798	3047	64400867
Haematoma	14.29	11.55	29	94789	46221	64357693
Angioedema	14.26	11.55	45	94773	61776	64342138
Prescribed overdose	14.26	11.55	6	94812	20325	64383589
Joint injury	14.23	11.55	8	94810	22939	64380975
Fibromyalgia	14.21	11.55	19	94799	35712	64368202
Toxic encephalopathy	14.21	11.55	39	94779	9776	64394138
Disseminated aspergillosis	14.19	11.55	10	94808	658	64403256
Electromyogram abnormal	14.12	11.55	6	94812	142	64403772
Benign hydatidiform mole	14.05	11.55	5	94813	72	64403842
Neck pain	14.05	11.55	45	94773	61488	64342426
Injection site mass	14.00	11.55	4	94814	17266	64386648
Escherichia bacteraemia	13.98	11.55	27	94791	5376	64398538
Malaise	13.98	11.55	460	94358	395787	64008127
Dermatitis	13.93	11.55	58	94760	17971	64385943
Vitiligo	13.89	11.55	15	94803	1753	64402161
Device issue	13.89	11.55	8	94810	22640	64381274
Bacteraemia	13.85	11.55	77	94741	26834	64377080
Dysphonia	13.84	11.55	116	94702	46266	64357648
VIth nerve disorder	13.82	11.55	4	94814	28	64403886
Product intolerance	13.82	11.55	4	94814	28	64403886
Oedema	13.75	11.55	79	94739	91856	64312058
Disseminated intravascular coagulation	13.72	11.55	88	94730	32260	64371654
Rash maculo-papular	13.71	11.55	117	94701	46909	64357005
Lip swelling	13.70	11.55	16	94802	31891	64372023
Pneumomediastinum	13.66	11.55	19	94799	2881	64401033
Rectal haemorrhage	13.64	11.55	145	94673	61672	64342242
Neuralgia	13.53	11.55	75	94743	26109	64377805
Rectal adenocarcinoma	13.48	11.55	13	94805	1330	64402584
Biliary obstruction	13.47	11.55	22	94796	3842	64400072
Mydriasis	13.47	11.55	3	94815	15309	64388605
Ovarian fibroma	13.40	11.55	5	94813	83	64403831
Underdose	13.35	11.55	11	94807	25818	64378096
Colitis microscopic	13.32	11.55	32	94786	7400	64396514
Radiation hepatitis	13.29	11.55	3	94815	6	64403908
Ovarian cystectomy	13.24	11.55	5	94813	86	64403828
Therapy cessation	13.21	11.55	17	94801	32472	64371442
Accidental overdose	13.19	11.55	18	94800	33539	64370375
Ulcerative gastritis	13.19	11.55	5	94813	87	64403827
Oesophageal varices haemorrhage	13.11	11.55	21	94797	3608	64400306
Illness	13.10	11.55	8	94810	21930	64381984
Blood glucose decreased	13.04	11.55	9	94809	23114	64380800
Occult blood	13.00	11.55	13	94805	1389	64402525
Anal infection	12.98	11.55	5	94813	91	64403823
Adenocarcinoma	12.95	11.55	20	94798	3331	64400583
Hypocapnia	12.92	11.55	9	94809	581	64403333
Sinus bradycardia	12.79	11.55	9	94809	22884	64381030
Bacterial colitis	12.78	11.55	5	94813	95	64403819
Cognitive disorder	12.78	11.55	40	94778	55047	64348867
Mental disorder	12.77	11.55	12	94806	26433	64377481
Overgrowth fungal	12.73	11.55	5	94813	96	64403818
Sleep disorder	12.72	11.55	45	94773	59664	64344250
Fanconi syndrome	12.71	11.55	17	94801	2484	64401430
Sarcoidosis	12.71	11.55	28	94790	6118	64397796
Cardiomyopathy	12.68	11.55	72	94746	25284	64378630
Axonal neuropathy	12.68	11.55	14	94804	1678	64402236
Fluid balance positive	12.65	11.55	4	94814	39	64403875
Multiple sclerosis	12.64	11.55	6	94812	18935	64384979
No adverse event	12.62	11.55	14	94804	28547	64375367
Urticarial vasculitis	12.59	11.55	8	94810	443	64403471
Granulomatous liver disease	12.59	11.55	12	94806	1210	64402704
Gout	12.52	11.55	8	94810	21405	64382509
Muscle rigidity	12.51	11.55	5	94813	17468	64386446
Lactobacillus infection	12.51	11.55	6	94812	190	64403724
Paraesthesia mucosal	12.48	11.55	4	94814	41	64403873
Gastric ulcer perforation, obstructive	12.43	11.55	3	94815	9	64403905
Hepatitis B DNA increased	12.39	11.55	9	94809	621	64403293
Hemianaesthesia	12.36	11.55	8	94810	457	64403457
Endocarditis	12.34	11.55	36	94782	9342	64394572
Dyspnoea exertional	12.34	11.55	61	94757	73669	64330245
B-cell small lymphocytic lymphoma	12.28	11.55	5	94813	106	64403808
Malignant ascites	12.26	11.55	11	94807	1027	64402887
Pseudocirrhosis	12.20	11.55	9	94809	636	64403278
Hypothermia	12.20	11.55	7	94811	19849	64384065
Optic disc hyperaemia	12.19	11.55	3	94815	10	64403904
Peritoneal disorder	12.15	11.55	9	94809	640	64403274
Keratitis	12.07	11.55	19	94799	3218	64400696
Device occlusion	12.05	11.55	37	94781	9876	64394038
Enterocolitis	12.04	11.55	42	94776	11976	64391938
Hand-foot-genital syndrome	11.97	11.55	3	94815	11	64403903
Ventricular tachycardia	11.90	11.55	20	94798	34245	64369669
Retroperitoneal abscess	11.90	11.55	7	94811	337	64403577
Arrhythmia	11.89	11.55	39	94779	52905	64351009
Limbic encephalitis	11.89	11.55	9	94809	662	64403252
Cytomegalovirus viraemia	11.87	11.55	39	94779	10789	64393125
Nephrectasia	11.76	11.55	3	94815	12	64403902
Neuropathic muscular atrophy	11.76	11.55	4	94814	50	64403864
Drug eruption	11.73	11.55	22	94796	36114	64367800
Presyncope	11.72	11.55	21	94797	35068	64368846
Respiratory disorder	11.71	11.55	22	94796	36089	64367825
Cellulitis	11.70	11.55	85	94733	93572	64310342
Myelodysplastic syndrome	11.68	11.55	75	94743	27504	64376410
Granulomatous lymphadenitis	11.64	11.55	6	94812	222	64403692
Intra-abdominal fluid collection	11.62	11.55	17	94801	2700	64401214
Hyperkalaemia	11.59	11.55	94	94724	101035	64302879
Sopor	11.57	11.55	16	94802	29645	64374269

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	V03AF03	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Detoxifying agents for antineoplastic treatment
ATC	V03AF06	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Detoxifying agents for antineoplastic treatment
FDA CS	M0008658	Folic Acid
MeSH PA	D000931	Antidotes
MeSH PA	D018977	Micronutrients
MeSH PA	D020011	Protective Agents
MeSH PA	D014803	Vitamin B Complex
MeSH PA	D014815	Vitamins
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:76971	Escherichia coli metabolites
FDA EPC	N0000178369	Folate Analog

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

Disease	Relation	SNOMED_ID	DOID
Megaloblastic anemia	indication	53165003	DOID:13382
Folic acid deficiency	indication	190633005
Bone Marrow Suppression due to Folic Acid Antagonism	indication
Methotrexate Toxicity	indication
Trimethoprim Toxicity	indication
Trimetrexate Toxicity	indication
Sulfadiazine Toxicity	indication
Pyrimethamine Toxicity	indication
Adjunct to Fluorouracil Treatment of Colorectal Cancer	indication
Pernicious anemia	contraindication	84027009	DOID:13381
Cobalamin deficiency	contraindication	190634004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.61	acidic
pKa2	5.29	acidic
pKa3	10.26	acidic
pKa4	12.96	acidic
pKa5	4.59	Basic
pKa6	2.23	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Thymidylate synthase	Enzyme	P04818	TYSY_HUMAN		Ki	4.07		WOMBAT-PK
Dihydrofolate reductase	Enzyme	P00374	DYR_HUMAN		Ki	5.63		CHEMBL

External reference:

ID	Source
4019798	VUID
N0000147887	NUI
D01211	KEGG_DRUG
1492-18-8	SECONDARY_CAS_RN
4018768	VANDF
4019798	VANDF
4031236	VANDF
C0023413	UMLSCUI
CHEBI:15640	CHEBI
CHEMBL1679	ChEMBL_ID
CHEMBL3707260	ChEMBL_ID
CHEMBL1232801	ChEMBL_ID
CHEMBL1201138	ChEMBL_ID
D002955	MESH_DESCRIPTOR_UI
DB00650	DRUGBANK_ID
4816	IUPHAR_LIGAND_ID
Q573I9DVLP	UNII
135403648	PUBCHEM_CID
225852	RXNORM
1728	MMSL
39896	MMSL
4964	MMSL
51342	MMSL
d00275	MMSL
001050	NDDF
001051	NDDF
009520	NDDF
126223008	SNOMEDCT_US
1528001	SNOMEDCT_US
396065004	SNOMEDCT_US
768550004	SNOMEDCT_US
690	INN_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4496	TABLET	5 mg	ORAL	ANDA	15 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4497	TABLET	10 mg	ORAL	ANDA	15 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4498	TABLET	15 mg	ORAL	ANDA	15 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0054-4499	TABLET	25 mg	ORAL	ANDA	15 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0054-8496	TABLET	5 mg	ORAL	ANDA	15 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9368	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	200 mg	INTRAMUSCULAR	ANDA	19 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9552	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	350 mg	INTRAMUSCULAR	ANDA	19 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9553	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	200 mg	INTRAMUSCULAR	ANDA	19 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAMUSCULAR	ANDA	19 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9555	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAMUSCULAR	ANDA	19 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0555-0484	TABLET	5 mg	ORAL	ANDA	17 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0555-0485	TABLET	25 mg	ORAL	ANDA	17 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5140	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAMUSCULAR	ANDA	18 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5145	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	350 mg	INTRAMUSCULAR	ANDA	18 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0703-5145	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	350 mg	INTRAMUSCULAR	ANDA	18 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6703	TABLET	25 mg	ORAL	ANDA	15 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	25021-813	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg	INTRAVENOUS	ANDA	21 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	25021-814	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	21 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	25021-815	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	200 mg	INTRAVENOUS	ANDA	21 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	25021-816	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	350 mg	INTRAVENOUS	ANDA	21 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	25021-828	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	21 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	42806-133	TABLET	10 mg	ORAL	ANDA	16 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	42806-134	TABLET	15 mg	ORAL	ANDA	16 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	42806-358	TABLET	5 mg	ORAL	ANDA	16 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	42806-359	TABLET	25 mg	ORAL	ANDA	16 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	50742-181	TABLET	5 mg	ORAL	ANDA	17 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	50742-182	TABLET	10 mg	ORAL	ANDA	17 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	50742-183	TABLET	15 mg	ORAL	ANDA	17 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	50742-184	TABLET	25 mg	ORAL	ANDA	17 sections
Leucovorin Calcium	HUMAN PRESCRIPTION DRUG LABEL	1	51079-581	TABLET	5 mg	ORAL	ANDA	17 sections