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

Stem definition	Drug id	CAS RN
analogues of penicillanic acid antibiotics modified in the five-membered ring	1709	96036-03-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: meropenem hydrate meropenem merrem meropenem trihydrate	an antibacterial drug readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding-protein (PBP) targets, the bactericidal activity of meropenem results from the inhibition of cell wall synthesis Molecular weight: 383.46 Formula: C17H25N3O5S CLOGP: -2.29 LIPINSKI: 0 HAC: 8 HDO: 3 TPSA: 110.18 ALOGS: -1.83 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

meropenem hydrate
meropenem
merrem
meropenem trihydrate

an antibacterial drug readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding-protein (PBP) targets, the bactericidal activity of meropenem results from the inhibition of cell wall synthesis

Molecular weight: 383.46
Formula: C17H25N3O5S
CLOGP: -2.29
LIPINSKI: 0
HAC: 8
HDO: 3
TPSA: 110.18
ALOGS: -1.83
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
3	g	P
3	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	4	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	70 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	111.76 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	0 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.30 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	3.90 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.87 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
June 21, 1996	FDA	ASTRAZENECA

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
Multiple organ dysfunction syndrome	542.38	17.48	347	29048	49990	50525739
Septic shock	453.26	17.48	326	29069	56849	50518880
Drug reaction with eosinophilia and systemic symptoms	333.57	17.48	207	29188	28217	50547512
Drug resistance	325.77	17.48	177	29218	18812	50556917
Pathogen resistance	303.85	17.48	117	29278	5572	50570157
Sepsis	248.40	17.48	344	29051	132581	50443148
Respiratory failure	205.78	17.48	259	29136	90922	50484807
Febrile neutropenia	205.61	17.48	268	29127	97399	50478330
Thrombocytopenia	194.30	17.48	300	29095	127373	50448356
Pyrexia	172.71	17.48	548	28847	379655	50196074
Pain	172.44	17.48	61	29334	578842	49996887
Bronchopulmonary aspergillosis	156.36	17.48	80	29315	7512	50568217
Acute kidney injury	149.74	17.48	376	29019	227682	50348047
Toxic epidermal necrolysis	148.73	17.48	112	29283	20880	50554849
Fatigue	148.50	17.48	117	29278	707484	49868245
Systemic candida	147.61	17.48	57	29338	2733	50572996
Haemophagocytic lymphohistiocytosis	135.70	17.48	76	29319	8557	50567172
Arthralgia	134.31	17.48	44	29351	438658	50137071
Pancytopenia	132.69	17.48	201	29194	83829	50491900
Headache	126.03	17.48	69	29326	506466	50069263
Off label use	121.33	17.48	570	28825	473856	50101873
Joint swelling	117.79	17.48	6	29389	245280	50330449
Clostridium difficile colitis	111.14	17.48	88	29307	17654	50558075
Neutropenia	107.66	17.48	254	29141	147711	50428018
Enterococcal infection	106.44	17.48	60	29335	6838	50568891
Abdominal discomfort	104.25	17.48	8	29387	231633	50344096
Candida infection	101.06	17.48	94	29301	23429	50552300
Rheumatoid arthritis	100.35	17.48	4	29391	202546	50373183
Fall	99.95	17.48	35	29360	334897	50240832
Candida sepsis	93.26	17.48	33	29362	1234	50574495
Acinetobacter infection	93.12	17.48	34	29361	1393	50574336
Drug intolerance	92.07	17.48	10	29385	219094	50356635
Fungaemia	88.58	17.48	36	29359	1976	50573753
Aspergillus infection	85.87	17.48	52	29343	6769	50568960
Shock	85.78	17.48	81	29314	20569	50555160
Peripheral swelling	80.23	17.48	12	29383	205924	50369805
Dysbiosis	79.83	17.48	25	29370	635	50575094
Acute respiratory distress syndrome	78.69	17.48	78	29317	21021	50554708
Disseminated intravascular coagulation	78.52	17.48	71	29324	17064	50558665
Nasopharyngitis	75.71	17.48	11	29384	192916	50382813
Hepatic function abnormal	75.45	17.48	94	29301	32587	50543142
Stenotrophomonas infection	73.95	17.48	30	29365	1639	50574090
Product dose omission issue	73.26	17.48	10	29385	183828	50391901
Swelling	73.18	17.48	14	29381	200858	50374871
Agranulocytosis	72.24	17.48	75	29320	21346	50554383
Eosinophilia	69.64	17.48	69	29326	18583	50557146
Stevens-Johnson syndrome	65.99	17.48	72	29323	21680	50554049
Mucormycosis	65.56	17.48	31	29364	2452	50573277
Contraindicated product administered	64.62	17.48	6	29389	148952	50426777
Acute generalised exanthematous pustulosis	63.98	17.48	48	29347	8890	50566839
Pseudomonas infection	63.88	17.48	49	29346	9381	50566348
Pain in extremity	63.66	17.48	40	29355	272825	50302904
Renal impairment	62.86	17.48	137	29258	75524	50500205
Renal failure	62.77	17.48	169	29226	106464	50469265
Rash maculo-papular	62.09	17.48	77	29318	26564	50549165
Weight increased	62.06	17.48	20	29375	201871	50373858
Dizziness	61.94	17.48	66	29329	346303	50229426
Myelosuppression	61.91	17.48	56	29339	13461	50562268
Geotrichum infection	61.89	17.48	19	29376	451	50575278
Drug eruption	61.17	17.48	72	29323	23534	50552195
Pseudomembranous colitis	59.24	17.48	30	29365	2755	50572974
Therapeutic product effect decreased	57.65	17.48	6	29389	136044	50439685
Muscle spasms	57.40	17.48	4	29391	125549	50450180
Lactic acidosis	57.20	17.48	83	29312	33272	50542457
Cytokine release syndrome	56.60	17.48	44	29351	8590	50567139
Sinusitis	55.88	17.48	15	29380	170543	50405186
Klebsiella infection	54.56	17.48	40	29355	7154	50568575
Systemic lupus erythematosus	52.92	17.48	9	29386	140613	50435116
Pneumonia fungal	51.99	17.48	32	29363	4288	50571441
Depression	51.52	17.48	16	29379	165407	50410322
Acute respiratory failure	51.37	17.48	73	29322	28709	50547020
Drug level decreased	51.07	17.48	37	29358	6496	50569233
Cardiac arrest	50.65	17.48	134	29261	83517	50492212
Linear IgA disease	50.33	17.48	21	29374	1233	50574496
Coagulopathy	50.30	17.48	57	29338	17887	50557842
Encephalopathy	49.45	17.48	78	29317	33633	50542096
Alopecia	49.25	17.48	42	29353	245005	50330724
Platelet count decreased	48.93	17.48	149	29246	100577	50475152
Neutropenic sepsis	48.54	17.48	50	29345	14097	50561632
Peritonitis	48.26	17.48	52	29343	15434	50560295
Pneumonia	47.72	17.48	379	29016	378022	50197707
Blood bilirubin increased	46.81	17.48	74	29321	31964	50543765
Musculoskeletal stiffness	46.67	17.48	9	29386	128472	50447257
Haemodynamic instability	46.42	17.48	38	29357	7986	50567743
Fungal infection	46.27	17.48	71	29324	29894	50545835
Bacteraemia	45.92	17.48	49	29346	14384	50561345
Acute myeloid leukaemia	45.90	17.48	50	29345	15024	50560705
Asthenia	45.47	17.48	72	29323	318970	50256759
Excessive eye blinking	45.36	17.48	18	29377	928	50574801
Systemic inflammatory response syndrome	45.05	17.48	31	29364	5018	50570711
Malaise	44.79	17.48	79	29316	335453	50240276
Anuria	44.59	17.48	43	29352	11201	50564528
Hyperbilirubinaemia	44.52	17.48	40	29355	9530	50566199
Acute hepatic failure	44.29	17.48	50	29345	15627	50560102
Enterocolitis	44.21	17.48	34	29361	6533	50569196
Gait disturbance	44.10	17.48	16	29379	149989	50425740
Drug ineffective for unapproved indication	44.06	17.48	58	29337	21223	50554506
Wound	43.96	17.48	5	29390	105789	50469940
Rhinocerebral mucormycosis	43.36	17.48	12	29383	195	50575534
Brain abscess	43.15	17.48	21	29374	1770	50573959
Blood lactate dehydrogenase increased	43.13	17.48	55	29340	19507	50556222
Insomnia	43.05	17.48	24	29371	174841	50400888
Neutropenic colitis	42.72	17.48	23	29372	2394	50573335
Weight decreased	41.96	17.48	40	29355	221205	50354524
Anaemia	41.72	17.48	270	29125	252186	50323543
Procalcitonin increased	41.69	17.48	16	29379	754	50574975
Graft versus host disease	41.67	17.48	32	29363	6134	50569595
Neurotoxicity	41.62	17.48	47	29348	14693	50561036
Oliguria	41.53	17.48	36	29359	8180	50567549
Meningitis candida	41.17	17.48	9	29386	50	50575679
Multiple-drug resistance	41.03	17.48	25	29370	3289	50572440
Pleural effusion	40.97	17.48	122	29273	81332	50494397
Enterococcal sepsis	40.18	17.48	18	29377	1257	50574472
Hyperlactacidaemia	39.81	17.48	22	29373	2411	50573318
Eosinophilic pneumonia acute	38.57	17.48	12	29383	298	50575431
Anticonvulsant drug level decreased	38.40	17.48	17	29378	1154	50574575
Mucosal inflammation	38.35	17.48	77	29318	40065	50535664
Drug interaction	37.68	17.48	221	29174	199400	50376329
Guillain-Barre syndrome	37.43	17.48	24	29371	3453	50572276
Pneumonia bacterial	36.89	17.48	32	29363	7277	50568452
Trichosporon infection	36.75	17.48	11	29384	239	50575490
Weissella infection	36.55	17.48	7	29388	17	50575712
Discomfort	36.50	17.48	9	29386	108371	50467358
Perinephric abscess	36.22	17.48	10	29385	161	50575568
Hyperchloraemia	35.94	17.48	14	29381	687	50575042
Factor V inhibition	35.94	17.48	10	29385	166	50575563
Toxic encephalopathy	35.92	17.48	28	29367	5487	50570242
Leukopenia	35.73	17.48	103	29292	67425	50508304
Fungal sepsis	35.44	17.48	16	29379	1138	50574591
Asthma	35.23	17.48	5	29390	89332	50486397
Mixed liver injury	35.13	17.48	23	29372	3428	50572301
C-reactive protein increased	34.79	17.48	101	29294	66373	50509356
Hepatic failure	34.59	17.48	65	29330	32218	50543511
Pericarditis	34.57	17.48	3	29392	78686	50497043
Hepatic infarction	34.48	17.48	13	29382	583	50575146
Bone marrow failure	33.90	17.48	59	29336	27565	50548164
Anxiety	33.79	17.48	32	29363	177574	50398155
Product use in unapproved indication	33.73	17.48	145	29250	115674	50460055
Transaminases increased	33.59	17.48	59	29336	27765	50547964
Umbilical erythema	33.24	17.48	8	29387	72	50575657
Metabolic acidosis	33.02	17.48	71	29324	38754	50536975
Contusion	32.91	17.48	12	29383	112171	50463558
Feeling abnormal	32.69	17.48	16	29379	125476	50450253
Injection site erythema	32.53	17.48	3	29392	74933	50500796
Clostridium difficile infection	32.09	17.48	55	29340	25384	50550345
Blood pressure increased	31.72	17.48	19	29376	133113	50442616
Arthritis	31.64	17.48	6	29389	86715	50489014
Alanine aminotransferase increased	31.64	17.48	118	29277	88241	50487488
Product deposit	31.45	17.48	9	29386	166	50575563
Nausea	31.41	17.48	261	29134	705137	49870592
Emphysematous pyelonephritis	31.30	17.48	9	29386	169	50575560
Escherichia infection	31.08	17.48	35	29360	10906	50564823
Disease progression	31.04	17.48	124	29271	95742	50479987
Cholestasis	30.84	17.48	54	29341	25347	50550382
Abscess neck	30.70	17.48	12	29383	594	50575135
Nephropathy toxic	30.52	17.48	30	29365	7999	50567730
Pyelonephritis fungal	30.49	17.48	8	29387	105	50575624
Hypotension	30.23	17.48	237	29158	235232	50340497
Seizure	30.14	17.48	142	29253	117732	50457997
Renal abscess	29.92	17.48	12	29383	636	50575093
Infusion related reaction	29.48	17.48	33	29362	169524	50406205
Diabetic macroangiopathy	29.26	17.48	8	29387	124	50575605
Brain oedema	29.21	17.48	36	29359	12334	50563395
Haemorrhage intracranial	29.20	17.48	36	29359	12338	50563391
Adjusted calcium decreased	29.14	17.48	8	29387	126	50575603
Hypoxia	29.02	17.48	80	29315	51043	50524686
Blood alkaline phosphatase increased	28.95	17.48	66	29329	37460	50538269
Noninfectious peritonitis	28.68	17.48	8	29387	134	50575595
Pneumothorax	28.66	17.48	38	29357	13996	50561733
Aspartate aminotransferase increased	28.62	17.48	105	29290	77893	50497836
Central nervous system injury	28.57	17.48	8	29387	136	50575593
Haemostasis	28.39	17.48	9	29386	238	50575491
Posterior reversible encephalopathy syndrome	28.33	17.48	39	29356	14889	50560840
Cytopenia	28.28	17.48	30	29365	8745	50566984
Staphylococcal infection	27.87	17.48	63	29332	35553	50540176
Toxic skin eruption	26.98	17.48	33	29362	11218	50564511
Hypernatraemia	26.64	17.48	25	29370	6296	50569433
Respiratory distress	26.20	17.48	56	29339	30433	50545296
Gamma-glutamyltransferase increased	26.14	17.48	55	29340	29568	50546161
Splenic injury	26.09	17.48	8	29387	189	50575540
Drug hypersensitivity	26.04	17.48	68	29327	250942	50324787
Migraine	25.84	17.48	6	29389	75274	50500455
Liver abscess	25.71	17.48	17	29378	2576	50573153
Abdominal pain upper	25.57	17.48	33	29362	159276	50416453
Hyperchlorhydria	25.51	17.48	14	29381	1514	50574215
Hypoalbuminaemia	25.42	17.48	30	29365	9830	50565899
Globulins decreased	25.22	17.48	8	29387	212	50575517
Mycobacterium abscessus infection	25.10	17.48	10	29385	521	50575208
Hypersensitivity	24.92	17.48	55	29340	215106	50360623
Tubulointerstitial nephritis	24.84	17.48	37	29358	15174	50560555
Death neonatal	24.81	17.48	8	29387	224	50575505
Hypotonia	24.80	17.48	27	29368	8107	50567622
Cross sensitivity reaction	24.75	17.48	15	29380	1954	50573775
Haemorrhagic disorder	24.72	17.48	11	29384	756	50574973
Hyperoxaluria	24.68	17.48	7	29388	125	50575604
Acid base balance abnormal	24.31	17.48	8	29387	239	50575490
Rash morbilliform	24.28	17.48	17	29378	2829	50572900
Morganella infection	24.16	17.48	10	29385	575	50575154
Cerebral mass effect	23.99	17.48	11	29384	811	50574918
Type IV hypersensitivity reaction	23.95	17.48	16	29379	2466	50573263
Drug ineffective	23.89	17.48	633	28762	818700	49757029
Myocardial infarction	23.72	17.48	11	29384	89016	50486713
Herpes simplex viraemia	23.70	17.48	7	29388	145	50575584
Hyperkalaemia	23.20	17.48	71	29324	48018	50527711
Neutrophil count decreased	23.19	17.48	69	29326	45957	50529772
Relapsing fever	23.13	17.48	7	29388	158	50575571
Escherichia bacteraemia	22.89	17.48	17	29378	3099	50572630
Dermatitis exfoliative generalised	22.84	17.48	17	29378	3109	50572620
Nosocomial infection	22.83	17.48	13	29382	1509	50574220
Hypertransaminasaemia	22.80	17.48	18	29377	3593	50572136
Venoocclusive disease	22.70	17.48	14	29381	1882	50573847
Delayed graft function	22.69	17.48	11	29384	919	50574810
Epilepsy	22.57	17.48	43	29352	21524	50554205
Colitis	22.57	17.48	61	29334	38468	50537261
Metabolic alkalosis	22.57	17.48	16	29379	2715	50573014
Cytomegalovirus viraemia	22.53	17.48	20	29375	4689	50571040
Aplastic anaemia	22.49	17.48	25	29370	7678	50568051
Dry mouth	22.49	17.48	3	29392	56175	50519554
Status epilepticus	22.45	17.48	33	29362	13373	50562356
Vulvovaginitis	22.41	17.48	8	29387	307	50575422
Hyperhidrosis	22.39	17.48	12	29383	89414	50486315
Pulmonary haemorrhage	22.37	17.48	23	29372	6469	50569260
Lung abscess	22.33	17.48	13	29382	1573	50574156
Folate deficiency	22.31	17.48	14	29381	1941	50573788
Overgrowth fungal	22.13	17.48	6	29389	90	50575639
Hypochromasia	22.04	17.48	8	29387	322	50575407
Somnolence	22.01	17.48	35	29360	154950	50420779
Herpes simplex hepatitis	21.97	17.48	8	29387	325	50575404
Osteomyelitis bacterial	21.91	17.48	7	29388	190	50575539
Hyperaemia	21.70	17.48	14	29381	2036	50573693
Diffuse large B-cell lymphoma refractory	21.47	17.48	11	29384	1035	50574694
Hyperamylasaemia	21.45	17.48	8	29387	348	50575381
Intentional overdose	21.41	17.48	5	29390	62499	50513230
Pseudomonal sepsis	21.35	17.48	14	29381	2093	50573636
Exfoliative rash	21.32	17.48	15	29380	2515	50573214
Clostridial infection	21.22	17.48	18	29377	3972	50571757
Endocarditis	21.14	17.48	20	29375	5087	50570642
Sepsis syndrome	21.00	17.48	10	29385	803	50574926
Premature delivery	20.96	17.48	44	29351	23619	50552110
Anisocytosis	20.89	17.48	9	29386	572	50575157
Bronchitis	20.71	17.48	18	29377	104141	50471588
Candida endophthalmitis	20.67	17.48	5	29390	46	50575683
Bacterial sepsis	20.67	17.48	17	29378	3595	50572134
Hydrocephalus	20.30	17.48	19	29376	4769	50570960
Venoocclusive liver disease	20.19	17.48	18	29377	4243	50571486
Hepatosplenomegaly	20.16	17.48	14	29381	2298	50573431
Cardiac failure congestive	20.15	17.48	12	29383	84370	50491359
Mediastinal effusion	20.03	17.48	5	29390	53	50575676
Antibiotic level above therapeutic	20.01	17.48	7	29388	253	50575476
Blood fibrinogen decreased	19.91	17.48	9	29386	642	50575087
Suicidal ideation	19.85	17.48	4	29391	55381	50520348
Blood cholesterol increased	19.76	17.48	4	29391	55211	50520518
Abdominal sepsis	19.75	17.48	11	29384	1224	50574505
Coagulation test abnormal	19.58	17.48	9	29386	667	50575062
Enterococcal bacteraemia	19.56	17.48	11	29384	1247	50574482
Low cardiac output syndrome	19.52	17.48	7	29388	272	50575457
Klebsiella bacteraemia	19.41	17.48	11	29384	1266	50574463
Septal panniculitis	19.39	17.48	5	29390	61	50575668
Acute graft versus host disease in intestine	19.36	17.48	12	29383	1627	50574102
Injection site reaction	19.26	17.48	3	29392	50029	50525700
Myoclonus	19.20	17.48	32	29363	14438	50561291
Clostridium test positive	19.14	17.48	13	29382	2059	50573670
Musculoskeletal pain	19.10	17.48	9	29386	72168	50503561
Wound haemorrhage	19.04	17.48	13	29382	2077	50573652
Cytomegalovirus infection	19.03	17.48	36	29359	17926	50557803
Serum sickness	19.02	17.48	14	29381	2518	50573211
Acute graft versus host disease in skin	18.96	17.48	15	29380	3003	50572726
Leukocytosis	18.86	17.48	41	29354	22538	50553191
Herpes simplex	18.81	17.48	22	29373	7140	50568589
Cytomegalovirus test positive	18.73	17.48	14	29381	2578	50573151
Hospitalisation	18.71	17.48	8	29387	67929	50507800
Immunosuppressant drug level increased	18.68	17.48	15	29380	3067	50572662
Hyperammonaemia	18.61	17.48	18	29377	4706	50571023
Influenza	18.38	17.48	15	29380	89523	50486206
Encephalitis	18.27	17.48	22	29373	7358	50568371
Thrombotic microangiopathy	18.25	17.48	24	29371	8767	50566962
Systemic mycosis	18.17	17.48	10	29385	1087	50574642
Abdominal compartment syndrome	18.14	17.48	8	29387	538	50575191
Fusarium infection	18.09	17.48	8	29387	542	50575187
Cerebrovascular accident	18.06	17.48	17	29378	94663	50481066
Liver disorder	17.99	17.48	55	29340	37167	50538562
Pulseless electrical activity	17.94	17.48	21	29374	6820	50568909
Rhinorrhoea	17.92	17.48	4	29391	51579	50524150
Calcification of muscle	17.90	17.48	4	29391	25	50575704
Generalised tonic-clonic seizure	17.83	17.48	44	29351	26266	50549463
Cardiomyopathy acute	17.75	17.48	6	29389	195	50575534
Immune effector cell-associated neurotoxicity syndrome	17.73	17.48	10	29385	1140	50574589
Vision blurred	17.66	17.48	12	29383	78635	50497094
Hypokalaemia	17.60	17.48	99	29296	87893	50487836
Clostridial sepsis	17.51	17.48	7	29388	368	50575361

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
Multiple organ dysfunction syndrome	486.72	14.92	501	38227	62615	29473184
Septic shock	454.40	14.92	481	38247	62079	29473720
Drug resistance	346.39	14.92	260	38468	21280	29514519
Pathogen resistance	337.47	14.92	179	38549	7937	29527862
Drug reaction with eosinophilia and systemic symptoms	304.51	14.92	269	38459	27723	29508076
Bronchopulmonary aspergillosis	220.92	14.92	159	38569	12185	29523614
Drug ineffective	209.70	14.92	983	37745	362187	29173612
Sepsis	178.31	14.92	498	38230	142184	29393615
Enterococcal infection	174.84	14.92	118	38610	8150	29527649
Fatigue	173.89	14.92	100	38628	316721	29219078
Candida infection	172.86	14.92	150	38578	15075	29520724
Respiratory failure	169.46	14.92	385	38343	96746	29439053
Off label use	162.15	14.92	799	37929	300001	29235798
Pyrexia	160.74	14.92	772	37956	286850	29248949
Disseminated intravascular coagulation	157.94	14.92	161	38567	19819	29515980
Eosinophilia	152.77	14.92	166	38562	21995	29513804
Haemophagocytic lymphohistiocytosis	147.36	14.92	117	38611	10387	29525412
Hepatic function abnormal	144.38	14.92	215	38513	39044	29496755
Dizziness	139.62	14.92	38	38690	189646	29346153
Fall	127.58	14.92	37	38691	177141	29358658
Klebsiella infection	125.41	14.92	92	38636	7257	29528542
Rash maculo-papular	122.48	14.92	155	38573	24134	29511665
Systemic candida	109.02	14.92	59	38669	2721	29533078
Product dose omission issue	105.26	14.92	5	38723	96378	29439421
Toxic epidermal necrolysis	99.80	14.92	121	38607	18032	29517767
Pseudomonas infection	90.41	14.92	90	38638	10762	29525037
Pancytopenia	89.92	14.92	276	38452	82892	29452907
Aspergillus infection	88.61	14.92	88	38640	10493	29525306
Thrombocytopenia	87.61	14.92	379	38349	134444	29401355
Myocardial infarction	87.10	14.92	19	38709	110277	29425522
Drug abuse	84.53	14.92	5	38723	79878	29455921
Death	83.48	14.92	205	38523	341879	29193920
Geotrichum infection	81.02	14.92	28	38700	417	29535382
Drug ineffective for unapproved indication	78.54	14.92	95	38633	14119	29521680
Pain	78.02	14.92	66	38662	171366	29364433
Herpes simplex oesophagitis	74.17	14.92	20	38708	119	29535680
Dysbiosis	72.29	14.92	25	38703	373	29535426
Acute respiratory distress syndrome	70.88	14.92	116	38612	22819	29512980
Bone marrow failure	70.62	14.92	128	38600	27321	29508478
Headache	68.71	14.92	76	38652	173931	29361868
Febrile neutropenia	67.92	14.92	309	38419	111931	29423868
Renal impairment	65.02	14.92	244	38484	81089	29454710
Arthralgia	64.42	14.92	53	38675	139564	29396235
Depression	62.64	14.92	17	38711	85130	29450669
Asthenia	61.47	14.92	118	38610	215132	29320667
Fungaemia	60.65	14.92	37	38691	2144	29533655
Drug-induced liver injury	59.58	14.92	104	38624	21551	29514248
Pseudomembranous colitis	59.56	14.92	39	38689	2558	29533241
Anxiety	59.23	14.92	19	38709	85346	29450453
Mucormycosis	58.88	14.92	51	38677	5107	29530692
Stenotrophomonas infection	57.91	14.92	33	38695	1684	29534115
Trichosporon infection	57.36	14.92	24	38704	616	29535183
Back pain	56.26	14.92	32	38696	102252	29433547
Inflammatory marker increased	56.08	14.92	43	38685	3624	29532175
Cholestasis	56.07	14.92	106	38622	23356	29512443
Spinal muscular atrophy	55.92	14.92	19	38709	268	29535531
Pain in extremity	54.65	14.92	39	38689	110394	29425405
Pneumonia bacterial	54.16	14.92	64	38664	9279	29526520
Weight decreased	54.14	14.92	71	38657	150834	29384965
Hyphaema	52.98	14.92	21	38707	467	29535332
Hepatomegaly	52.66	14.92	63	38665	9254	29526545
Agranulocytosis	51.23	14.92	94	38634	20246	29515553
Clostridium difficile colitis	50.89	14.92	74	38654	13138	29522661
Pneumococcal sepsis	50.40	14.92	24	38704	842	29534957
Clostridium difficile infection	49.00	14.92	81	38647	16060	29519739
Liver injury	48.76	14.92	71	38657	12619	29523180
Blood pressure increased	48.47	14.92	18	38710	73785	29462014
Feeling abnormal	48.10	14.92	7	38721	54438	29481361
Joint swelling	47.21	14.92	5	38723	49625	29486174
Drug eruption	46.83	14.92	81	38647	16660	29519139
Pulmonary haemorrhage	46.45	14.92	59	38669	9211	29526588
Inappropriate schedule of product administration	46.38	14.92	3	38725	44469	29491330
Tachypnoea	46.08	14.92	76	38652	15039	29520760
Nausea	45.88	14.92	209	38519	289046	29246753
Myalgia	45.44	14.92	20	38708	73999	29461800
Cardiac failure congestive	44.99	14.92	22	38706	76559	29459240
Product use in unapproved indication	44.44	14.92	228	38500	86647	29449152
Systemic mycosis	43.51	14.92	25	38703	1296	29534503
Gait disturbance	43.20	14.92	21	38707	73328	29462471
Muscle spasms	42.52	14.92	16	38712	65066	29470733
Pneumothorax	42.17	14.92	75	38653	15767	29520032
Fungal infection	41.98	14.92	69	38659	13616	29522183
Aplastic anaemia	41.16	14.92	50	38678	7460	29528339
Coagulopathy	40.44	14.92	79	38649	17828	29517971
Brain abscess	40.31	14.92	31	38697	2624	29533175
Hepatic failure	39.18	14.92	110	38618	31402	29504397
Chest pain	38.80	14.92	54	38674	111919	29423880
Hypoalbuminaemia	38.64	14.92	57	38671	10248	29525551
Enterococcus test positive	38.64	14.92	19	38709	716	29535083
Coronary artery disease	38.30	14.92	6	38722	44184	29491615
Hypofibrinogenaemia	38.03	14.92	24	38704	1477	29534322
Hyperhidrosis	37.21	14.92	19	38709	64521	29471278
Sputum increased	37.18	14.92	26	38702	1901	29533898
Leukopenia	37.15	14.92	157	38571	55046	29480753
Nasopharyngitis	36.81	14.92	16	38712	59649	29476150
Weight increased	36.71	14.92	28	38700	76639	29459160
Syncope	36.13	14.92	32	38696	81339	29454460
Respiratory tract infection bacterial	35.71	14.92	17	38711	596	29535203
Cough	35.65	14.92	70	38658	126657	29409142
Portal fibrosis	35.50	14.92	14	38714	307	29535492
Acinetobacter infection	35.43	14.92	20	38708	1002	29534797
Acute generalised exanthematous pustulosis	35.31	14.92	40	38688	5543	29530256
Hyperferritinaemia	34.80	14.92	14	38714	324	29535475
Ototoxicity	34.67	14.92	23	38705	1542	29534257
Dyspnoea	33.88	14.92	270	38458	326462	29209337
C-reactive protein increased	33.85	14.92	131	38597	44132	29491667
Serum sickness-like reaction	33.10	14.92	10	38718	94	29535705
Tubulointerstitial nephritis	32.98	14.92	72	38656	17571	29518228
Enterocolitis	32.73	14.92	42	38686	6624	29529175
Abdominal discomfort	32.61	14.92	11	38717	47892	29487907
Hepatotoxicity	32.36	14.92	72	38656	17795	29518004
Hospitalisation	32.30	14.92	10	38718	45978	29489821
Treatment failure	32.16	14.92	114	38614	36825	29498974
Increased bronchial secretion	32.07	14.92	22	38706	1559	29534240
Intentional overdose	31.70	14.92	6	38722	38522	29497277
Rectal haemorrhage	31.56	14.92	4	38724	34545	29501254
Cross sensitivity reaction	31.53	14.92	20	38708	1242	29534557
Myelosuppression	31.41	14.92	57	38671	12170	29523629
Hypoxia	31.29	14.92	134	38594	47245	29488554
Respiratory gas exchange disorder	31.21	14.92	14	38714	427	29535372
Rheumatoid arthritis	31.20	14.92	3	38725	32149	29503650
Shock	30.92	14.92	79	38649	21325	29514474
Cryptococcal meningoencephalitis	30.90	14.92	10	38718	120	29535679
Liver abscess	30.26	14.92	29	38699	3309	29532490
Bacteraemia	29.81	14.92	66	38662	16257	29519542
Incorrect dose administered	29.70	14.92	4	38724	32980	29502819
Vision blurred	29.57	14.92	8	38720	40168	29495631
Neutropenia	29.28	14.92	282	38446	131429	29404370
Dehydration	29.24	14.92	67	38661	114681	29421118
Rash morbilliform	29.16	14.92	25	38703	2468	29533331
Procalcitonin increased	29.01	14.92	21	38707	1621	29534178
Encephalopathy	28.93	14.92	98	38630	30945	29504854
Cytomegalovirus infection	28.81	14.92	81	38647	23134	29512665
Cytokine release syndrome	28.56	14.92	57	38671	13062	29522737
Venoocclusive liver disease	28.48	14.92	40	38688	6877	29528922
Musculoskeletal stiffness	28.45	14.92	7	38721	37451	29498348
Clostridium test positive	28.44	14.92	23	38705	2094	29533705
Platelet count decreased	28.34	14.92	234	38494	104438	29431361
Therapeutic product effect decreased	27.92	14.92	3	38725	29448	29506351
Wrong technique in product usage process	27.85	14.92	4	38724	31424	29504375
Neutropenic colitis	27.84	14.92	24	38704	2387	29533412
Epidermolysis bullosa	27.81	14.92	9	38719	108	29535691
Insomnia	27.66	14.92	46	38682	88715	29447084
Vomiting	27.60	14.92	164	38564	212096	29323703
Oedema peripheral	27.58	14.92	59	38669	103498	29432301
Dermatitis bullous	27.11	14.92	36	38692	5870	29529929
Balance disorder	27.00	14.92	7	38721	36163	29499636
Cerebrovascular accident	26.72	14.92	37	38691	76874	29458925
Granulocyte count decreased	26.59	14.92	14	38714	610	29535189
Endocarditis	26.48	14.92	35	38693	5681	29530118
Constipation	26.46	14.92	70	38658	114090	29421709
Tumour lysis syndrome	26.33	14.92	57	38671	13827	29521972
Eosinophilic pneumonia	26.32	14.92	25	38703	2821	29532978
Aggression	26.30	14.92	7	38721	35534	29500265
Acute myeloid leukaemia	26.01	14.92	63	38665	16450	29519349
Renal failure	25.40	14.92	252	38476	118347	29417452
Condition aggravated	25.38	14.92	298	38430	145997	29389802
Blood glucose increased	25.22	14.92	24	38704	58960	29476839
CNS ventriculitis	25.16	14.92	10	38718	224	29535575
Vascular pseudoaneurysm thrombosis	25.11	14.92	7	38721	48	29535751
Aortoenteric fistula	24.88	14.92	8	38720	94	29535705
Toxicity to various agents	24.84	14.92	130	38598	173531	29362268
Pneumonia fungal	24.67	14.92	34	38694	5743	29530056
Factor V inhibition	24.37	14.92	9	38719	164	29535635
Cardiac valve vegetation	24.29	14.92	12	38716	457	29535342
Transaminases increased	24.24	14.92	75	38653	22587	29513212
Motor neurone disease	24.03	14.92	11	38717	352	29535447
Drug intolerance	24.02	14.92	17	38711	48362	29487437
Stevens-Johnson syndrome	23.94	14.92	61	38667	16436	29519363
Dyspnoea exertional	23.78	14.92	9	38719	36481	29499318
Hypertension	23.75	14.92	76	38652	116538	29419261
Respiratory paralysis	23.74	14.92	7	38721	60	29535739
Chest X-ray abnormal	23.68	14.92	27	38701	3767	29532032
Liver disorder	23.60	14.92	85	38643	27664	29508135
Intentional product misuse	23.52	14.92	8	38720	34653	29501146
Stoma closure	23.47	14.92	8	38720	114	29535685
Interleukin-2 receptor increased	23.47	14.92	8	38720	114	29535685
Neurotoxicity	23.29	14.92	56	38672	14557	29521242
Wound dehiscence	23.26	14.92	24	38704	2993	29532806
Contusion	23.25	14.92	6	38722	31089	29504710
Multiple-drug resistance	23.07	14.92	27	38701	3873	29531926
Disseminated cryptococcosis	22.97	14.92	16	38712	1162	29534637
Ischaemic cerebral infarction	22.82	14.92	15	38713	990	29534809
Peripheral swelling	22.81	14.92	30	38698	63709	29472090
Shock haemorrhagic	22.62	14.92	43	38685	9508	29526291
Haemorrhagic pneumonia	22.62	14.92	8	38720	128	29535671
Acute respiratory failure	22.56	14.92	81	38647	26321	29509478
Acute kidney injury	22.50	14.92	479	38249	264788	29271011
Blood alkaline phosphatase increased	22.47	14.92	85	38643	28321	29507478
Staphylococcal sepsis	22.36	14.92	41	38687	8821	29526978
Chronic obstructive pulmonary disease	22.23	14.92	13	38715	40942	29494857
Aspergillus test positive	22.16	14.92	11	38717	423	29535376
Disease complication	22.14	14.92	21	38707	2365	29533434
Nosocomial infection	22.12	14.92	15	38713	1043	29534756
Circulatory collapse	22.05	14.92	64	38664	18609	29517190
Lung consolidation	22.02	14.92	30	38698	5013	29530786
Faeces pale	22.01	14.92	16	38712	1243	29534556
Suicidal ideation	21.90	14.92	9	38719	34707	29501092
Gastrooesophageal reflux disease	21.84	14.92	7	38721	31489	29504310
Hepatic necrosis	21.76	14.92	25	38703	3517	29532282
Leukocytosis	21.72	14.92	69	38659	21073	29514726
Nocardiosis	21.71	14.92	24	38704	3236	29532563
Blood bilirubin increased	21.71	14.92	95	38633	33798	29502001
Epilepsy	21.60	14.92	63	38665	18369	29517430
Deep vein thrombosis	21.59	14.92	26	38702	57373	29478426
Hepatic cytolysis	21.55	14.92	39	38689	8308	29527491
Immune effector cell-associated neurotoxicity syndrome	21.42	14.92	17	38711	1507	29534292
Mobility decreased	21.24	14.92	4	38724	25776	29510023
Eosinophilic pneumonia acute	21.22	14.92	11	38717	464	29535335
Dysarthria	21.21	14.92	7	38721	30904	29504895
Injection site pain	21.15	14.92	8	38720	32438	29503361
Acute myeloid leukaemia recurrent	21.13	14.92	18	38710	1762	29534037
Rhinocerebral mucormycosis	21.12	14.92	9	38719	242	29535557
Nephrogenic diabetes insipidus	21.12	14.92	15	38713	1124	29534675
Urinary tract infection fungal	20.94	14.92	10	38718	353	29535446
Aeromonas infection	20.91	14.92	9	38719	248	29535551
Metabolic disorder	20.90	14.92	25	38703	3670	29532129
Intestinal ischaemia	20.87	14.92	34	38694	6658	29529141
Paraesthesia	20.67	14.92	24	38704	53821	29481978
Candida test positive	20.58	14.92	10	38718	367	29535432
Transient ischaemic attack	20.53	14.92	3	38725	23267	29512532
Alanine aminotransferase increased	20.49	14.92	161	38567	70783	29465016
Arthritis	20.36	14.92	4	38724	25015	29510784
Dyspepsia	20.36	14.92	7	38721	30118	29505681
Dermatitis exfoliative generalised	20.35	14.92	22	38706	2894	29532905
Resuscitation	20.28	14.92	15	38713	1197	29534602
Heart rate decreased	20.24	14.92	4	38724	24908	29510891
Antinuclear antibody negative	20.18	14.92	5	38723	20	29535779
Radiation fibrosis - lung	19.98	14.92	5	38723	21	29535778
Haemodynamic instability	19.93	14.92	37	38691	8036	29527763
Pneumonia	19.88	14.92	554	38174	319618	29216181
Septic embolus	19.87	14.92	14	38714	1036	29534763
Drug level decreased	19.84	14.92	32	38696	6215	29529584
Angina pectoris	19.65	14.92	6	38722	27844	29507955
Sleep disorder	19.63	14.92	4	38724	24382	29511417
Toxic skin eruption	19.59	14.92	41	38687	9716	29526083
Staphylococcal infection	19.53	14.92	83	38645	29157	29506642
Necrotising fasciitis	19.42	14.92	23	38705	3342	29532457
Hypokalaemia	19.21	14.92	122	38606	50081	29485718
Intra-abdominal fluid collection	19.11	14.92	14	38714	1101	29534698
Strongyloidiasis	18.93	14.92	19	38709	2293	29533506
Hepatitis cholestatic	18.81	14.92	33	38695	6860	29528939
Lower respiratory tract infection bacterial	18.79	14.92	9	38719	320	29535479
Nephrolithiasis	18.72	14.92	5	38723	25329	29510470
Chimerism	18.50	14.92	8	38720	223	29535576
Type IV hypersensitivity reaction	18.47	14.92	14	38714	1160	29534639
Hyperbilirubinaemia	18.42	14.92	52	38676	14882	29520917
Hypoaesthesia	18.28	14.92	26	38702	53441	29482358
Loss of consciousness	18.24	14.92	44	38684	74012	29461787
Acute hepatic failure	18.19	14.92	45	38683	11907	29523892
Fungal sepsis	18.19	14.92	12	38716	797	29535002
Lymphadenectomy	18.15	14.92	8	38720	234	29535565
Mediastinitis	18.14	14.92	11	38717	630	29535169
Coagulation time prolonged	18.09	14.92	14	38714	1196	29534603
Myasthenia gravis crisis	18.09	14.92	10	38718	481	29535318
Asthma	18.01	14.92	11	38717	33838	29501961
Myocardial calcification	17.97	14.92	5	38723	34	29535765
Flavobacterium infection	17.97	14.92	6	38722	80	29535719
ADAMTS13 activity decreased	17.90	14.92	6	38722	81	29535718
Drug interaction	17.88	14.92	360	38368	197025	29338774
Tremor	17.87	14.92	44	38684	73494	29462305
Infective aneurysm	17.86	14.92	10	38718	493	29535306
Dermatitis exfoliative	17.85	14.92	31	38697	6394	29529405
Malaise	17.84	14.92	129	38599	159473	29376326
Vascular pseudoaneurysm	17.79	14.92	17	38711	1932	29533867
Decreased appetite	17.46	14.92	115	38613	145227	29390572
Enterococcal sepsis	17.44	14.92	15	38713	1487	29534312
Potentiating drug interaction	17.29	14.92	25	38703	4413	29531386
Gamma-glutamyltransferase increased	17.17	14.92	75	38653	26662	29509137
Chest discomfort	17.11	14.92	21	38707	45962	29489837
Rectal perforation	17.06	14.92	9	38719	394	29535405
Soft tissue necrosis	17.03	14.92	8	38720	272	29535527
Overdose	16.96	14.92	51	38677	79768	29456031
Device related infection	16.95	14.92	52	38676	15584	29520215
Cardiac arrest	16.94	14.92	179	38549	85412	29450387
Candida sepsis	16.80	14.92	13	38715	1110	29534689
Graft versus host disease in gastrointestinal tract	16.74	14.92	21	38707	3237	29532562
Dry mouth	16.68	14.92	4	38724	21780	29514019
Blood lactate dehydrogenase increased	16.47	14.92	59	38669	19150	29516649
Bronchial disorder	16.42	14.92	13	38715	1148	29534651
Catheter site pain	16.39	14.92	13	38715	1151	29534648
Staphylococcus test positive	16.30	14.92	19	38709	2714	29533085
Splenomegaly	16.15	14.92	46	38682	13233	29522566
Scedosporium infection	16.10	14.92	11	38717	774	29535025
Candida pneumonia	16.09	14.92	8	38720	309	29535490
Influenza like illness	16	14.92	6	38722	24464	29511335
Mechanical ventilation	16.00	14.92	15	38713	1665	29534134
Hypernatraemia	15.97	14.92	32	38696	7354	29528445
Amnesia	15.76	14.92	5	38723	22638	29513161
Macule	15.73	14.92	12	38716	1004	29534795
Linear IgA disease	15.71	14.92	14	38714	1455	29534344
Drug level increased	15.51	14.92	57	38671	18730	29517069
Systemic inflammatory response syndrome	15.51	14.92	28	38700	5953	29529846
Hypoproteinaemia	15.46	14.92	15	38713	1737	29534062
Escherichia infection	15.46	14.92	30	38698	6734	29529065
Graft versus host disease	15.45	14.92	37	38691	9591	29526208
Alveolitis necrotising	15.42	14.92	4	38724	20	29535779
Red blood cell sedimentation rate decreased	15.38	14.92	5	38723	61	29535738
Cholangiolitis	15.26	14.92	4	38724	21	29535778
Intestinal pseudo-obstruction	15.24	14.92	13	38715	1275	29534524
Hypovolaemic shock	15.21	14.92	28	38700	6044	29529755
Pneumonia klebsiella	15.14	14.92	18	38710	2626	29533173
Endotracheal intubation	15	14.92	18	38710	2651	29533148
Red blood cell schistocytes present	14.98	14.92	7	38721	235	29535564
Acute graft versus host disease in skin	14.96	14.92	24	38704	4640	29531159

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
Multiple organ dysfunction syndrome	930.89	13.80	785	63308	100628	64334011
Septic shock	824.37	13.80	745	63348	104692	64329947
Drug resistance	643.73	13.80	413	63680	34689	64399950
Drug reaction with eosinophilia and systemic symptoms	625.11	13.80	480	63613	53737	64380902
Pathogen resistance	585.73	13.80	274	63819	12269	64422370
Sepsis	364.00	13.80	744	63349	229597	64205042
Bronchopulmonary aspergillosis	345.89	13.80	223	63870	18862	64415777
Respiratory failure	317.60	13.80	572	63521	160611	64274028
Pyrexia	312.94	13.80	1237	62856	557407	63877232
Fatigue	287.59	13.80	197	63896	748533	63686106
Enterococcal infection	283.77	13.80	175	63918	13691	64420948
Off label use	271.39	13.80	1293	62800	631513	63803126
Haemophagocytic lymphohistiocytosis	269.00	13.80	185	63908	17424	64417215
Pain	261.29	13.80	112	63981	553399	63881240
Thrombocytopenia	252.85	13.80	633	63460	223168	64211471
Candida infection	244.98	13.80	222	63871	31197	64403442
Drug ineffective	240.37	13.80	1538	62555	838709	63595930
Fall	226.10	13.80	67	64026	416759	64017880
Eosinophilia	219.62	13.80	228	63865	37848	64396791
Toxic epidermal necrolysis	215.18	13.80	223	63870	36943	64397696
Disseminated intravascular coagulation	214.66	13.80	209	63884	32139	64402500
Headache	214.22	13.80	131	63962	529336	63905303
Arthralgia	209.31	13.80	89	64004	442171	63992468
Febrile neutropenia	195.49	13.80	515	63578	187142	64247497
Dizziness	195.02	13.80	92	64001	430071	64004568
Pancytopenia	192.70	13.80	434	63659	142875	64291764
Hepatic function abnormal	190.57	13.80	275	63818	64038	64370601
Klebsiella infection	176.12	13.80	128	63965	13153	64421486
Joint swelling	173.72	13.80	10	64083	215372	64219267
Systemic candida	173.16	13.80	91	64002	5238	64429401
Pseudomonas infection	173.09	13.80	143	63950	17740	64416899
Rash maculo-papular	167.80	13.80	220	63873	46806	64387833
Aspergillus infection	162.77	13.80	133	63960	16246	64418393
Product dose omission issue	145.67	13.80	13	64080	194734	64239905
Rheumatoid arthritis	144.62	13.80	4	64089	164290	64270349
Pain in extremity	133.91	13.80	67	64026	303018	64131621
Clostridium difficile colitis	132.39	13.80	149	63944	27074	64407565
Acinetobacter infection	132.02	13.80	59	64034	2370	64432269
Geotrichum infection	131.36	13.80	45	64048	873	64433766
Acute respiratory distress syndrome	129.46	13.80	176	63917	38759	64395880
Acute kidney injury	123.07	13.80	815	63278	448425	63986214
Renal impairment	122.06	13.80	352	63741	134665	64299974
Abdominal discomfort	119.54	13.80	19	64074	182303	64252336
Fungaemia	118.35	13.80	63	64030	3722	64430917
Dysbiosis	116.97	13.80	41	64052	854	64433785
Nasopharyngitis	116.70	13.80	26	64067	196047	64238592
Mucormycosis	114.16	13.80	78	64015	7263	64427376
Agranulocytosis	111.06	13.80	162	63931	38067	64396572
Pseudomembranous colitis	110.74	13.80	66	64027	4850	64429789
Drug abuse	110.32	13.80	5	64088	132369	64302270
Drug intolerance	109.74	13.80	26	64067	187966	64246673
Drug ineffective for unapproved indication	105.42	13.80	142	63951	30991	64403648
Nausea	102.68	13.80	418	63675	785382	63649257
Peripheral swelling	100.50	13.80	41	64052	209112	64225527
Neutropenia	99.33	13.80	486	63607	239138	64195501
Bone marrow failure	99.13	13.80	174	63919	47778	64386861
Clostridium difficile infection	98.95	13.80	149	63944	36014	64398625
Stenotrophomonas infection	98.38	13.80	52	64041	3028	64431611
Weight increased	97.48	13.80	45	64048	213303	64221336
Depression	96.42	13.80	31	64062	183260	64251379
Asthenia	93.65	13.80	177	63916	427867	64006772
Blood pressure increased	92.89	13.80	28	64065	172524	64262115
Drug eruption	87.85	13.80	141	63952	35995	64398644
Anxiety	87.64	13.80	46	64047	202603	64232036
Trichosporon infection	87.26	13.80	33	64060	859	64433780
Swelling	86.23	13.80	26	64067	160192	64274447
Myocardial infarction	85.54	13.80	29	64064	165792	64268847
Therapeutic product effect decreased	85.42	13.80	8	64085	115343	64319296
Muscle spasms	85.31	13.80	18	64075	141005	64293634
Gait disturbance	83.92	13.80	33	64060	172122	64262517
Feeling abnormal	83.01	13.80	16	64077	133586	64301053
Acute generalised exanthematous pustulosis	82.50	13.80	85	64008	13973	64420666
Injection site pain	81.77	13.80	8	64085	111400	64323239
Brain abscess	81.06	13.80	51	64042	4130	64430509
Weight decreased	79.85	13.80	100	63993	285639	64149000
Myelosuppression	78.11	13.80	107	63986	23723	64410916
Pneumothorax	77.99	13.80	108	63985	24190	64410449
Coagulopathy	76.84	13.80	124	63969	31796	64402843
Shock	75.49	13.80	136	63957	38104	64396535
Sinusitis	74.43	13.80	26	64067	145902	64288737
Fungal infection	74.33	13.80	127	63966	34124	64400515
Cholestasis	74.23	13.80	148	63945	44724	64389915
Musculoskeletal stiffness	73.96	13.80	16	64077	123190	64311449
Platelet count decreased	72.93	13.80	345	63748	167366	64267273
Pneumonia bacterial	72.59	13.80	82	64011	14953	64419686
Candida sepsis	72.25	13.80	38	64055	2190	64432449
Memory impairment	72.16	13.80	3	64090	85679	64348960
Cytokine release syndrome	72.04	13.80	96	63997	20733	64413906
Leukopenia	71.17	13.80	242	63851	101000	64333639
Encephalopathy	71.12	13.80	171	63922	58648	64375991
Hepatic failure	70.18	13.80	164	63929	55230	64379409
Malaise	70.11	13.80	184	63909	396063	64038576
Neutropenic colitis	69.64	13.80	48	64045	4533	64430106
Enterocolitis	69.32	13.80	72	64021	11946	64422693
Stevens-Johnson syndrome	69.13	13.80	123	63970	34126	64400513
Product use in unapproved indication	68.73	13.80	352	63741	176266	64258373
Alopecia	68.17	13.80	40	64053	165650	64268989
Pneumonia fungal	67.74	13.80	62	64031	8815	64425824
Herpes simplex oesophagitis	67.09	13.80	20	64073	242	64434397
Hyphaema	66.86	13.80	25	64068	630	64434009
C-reactive protein increased	66.83	13.80	227	63866	94682	64339957
Contusion	66.01	13.80	16	64077	113949	64320690
Hypoalbuminaemia	65.06	13.80	84	64009	17590	64417049
Tubulointerstitial nephritis	64.97	13.80	113	63980	30796	64403843
Drug-induced liver injury	64.72	13.80	145	63948	47498	64387141
Renal failure	64.46	13.80	353	63740	181335	64253304
Insomnia	64.35	13.80	61	64032	197775	64236864
Bacteraemia	64.04	13.80	104	63989	26807	64407832
Procalcitonin increased	62.86	13.80	36	64057	2455	64432184
Inflammatory marker increased	62.50	13.80	58	64035	8393	64426246
Clostridium test positive	62.27	13.80	43	64050	4072	64430567
Drug level decreased	61.18	13.80	66	64027	11437	64423202
Spinal muscular atrophy	60.62	13.80	19	64074	275	64434364
Acute respiratory failure	60.18	13.80	145	63948	49789	64384850
Pneumonia	59.92	13.80	832	63261	558744	63875895
Cardiac arrest	59.89	13.80	307	63786	153757	64280882
Aplastic anaemia	58.99	13.80	71	64022	13849	64420790
Psoriasis	58.79	13.80	3	64090	71700	64362939
Rhinocerebral mucormycosis	58.58	13.80	21	64072	468	64434171
Intentional overdose	57.52	13.80	10	64083	89934	64344705
Hyperbilirubinaemia	57.47	13.80	87	64006	21118	64413521
Liver injury	57.23	13.80	105	63988	29827	64404812
Factor V inhibition	56.99	13.80	19	64074	338	64434301
Multiple-drug resistance	56.75	13.80	49	64044	6453	64428186
Linear IgA disease	56.71	13.80	35	64058	2739	64431900
Arthritis	56.59	13.80	8	64085	83806	64350833
Neurotoxicity	56.06	13.80	99	63994	27305	64407334
Tachypnoea	55.66	13.80	97	63996	26474	64408165
Liver abscess	54.83	13.80	44	64049	5236	64429403
Hyperhidrosis	54.51	13.80	28	64065	124892	64309747
Pulmonary haemorrhage	54.14	13.80	66	64027	13043	64421596
Back pain	54.13	13.80	104	63989	250067	64184572
Asthma	53.93	13.80	14	64079	95211	64339428
Drug interaction	53.79	13.80	573	63520	361510	64073129
Toxic skin eruption	53.52	13.80	80	64013	19204	64415435
Inappropriate schedule of product administration	53.36	13.80	13	64080	92273	64342366
Systemic inflammatory response syndrome	53.16	13.80	58	64035	10177	64424462
Lung consolidation	53.08	13.80	51	64042	7707	64426932
Cardiac failure congestive	53.04	13.80	32	64061	130548	64304091
Eosinophilic pneumonia acute	52.91	13.80	23	64070	864	64433775
Wound	52.34	13.80	7	64086	76470	64358169
Acute myeloid leukaemia	52.08	13.80	96	63997	27367	64407272
Systemic mycosis	51.84	13.80	31	64062	2292	64432347
Rash morbilliform	51.60	13.80	42	64051	5099	64429540
Staphylococcal infection	51.53	13.80	138	63955	50540	64384099
Epilepsy	51.20	13.80	107	63986	33424	64401215
Chest pain	51.14	13.80	98	63995	235882	64198757
Transaminases increased	51.09	13.80	127	63966	44467	64390172
Myalgia	50.30	13.80	50	64043	158567	64276072
Cough	49.90	13.80	145	63948	302003	64132636
Injection site erythema	49.62	13.80	6	64087	70794	64363845
Wrong technique in product usage process	49.47	13.80	4	64089	64970	64369669
Blood bilirubin increased	49.03	13.80	147	63946	57406	64377233
Hypoxia	48.74	13.80	195	63898	87954	64346685
Cross sensitivity reaction	48.19	13.80	34	64059	3333	64431306
Stress	48.18	13.80	3	64090	60531	64374108
Dyspnoea	47.99	13.80	470	63623	718204	63716435
Acute hepatic failure	47.92	13.80	90	64003	26022	64408617
Anticonvulsant drug level decreased	47.67	13.80	27	64066	1803	64432836
Blood lactate dehydrogenase increased	47.55	13.80	103	63990	32975	64401664
Discomfort	47.53	13.80	11	64082	80867	64353772
Haemodynamic instability	47.43	13.80	66	64027	14846	64419793
Contraindicated product administered	47.30	13.80	24	64069	107805	64326834
Enterococcal sepsis	47.29	13.80	30	64063	2464	64432175
Hepatomegaly	46.80	13.80	70	64023	16812	64417827
Systemic lupus erythematosus	46.73	13.80	10	64083	77602	64357037
Vision blurred	46.20	13.80	16	64077	90300	64344339
Hypofibrinogenaemia	45.68	13.80	26	64067	1752	64432887
Endocarditis	45.02	13.80	51	64042	9327	64425312
Migraine	44.70	13.80	5	64088	62672	64371967
Pneumococcal sepsis	44.46	13.80	23	64070	1281	64433358
Leukocytosis	43.78	13.80	108	63985	37632	64397007
Pleural effusion	43.59	13.80	244	63849	126315	64308324
Infusion related reaction	43.39	13.80	60	64033	164407	64270232
Anuria	43.38	13.80	72	64021	18892	64415747
Syncope	43.12	13.80	56	64037	157579	64277060
Cytomegalovirus infection	42.67	13.80	106	63987	37093	64397546
Dry mouth	42.63	13.80	5	64088	60413	64374226
Escherichia infection	42.20	13.80	63	64030	15105	64419534
Nephropathy toxic	42.10	13.80	68	64025	17446	64417193
Abdominal pain upper	41.22	13.80	69	64024	174961	64259678
Dermatitis bullous	40.83	13.80	55	64038	11999	64422640
Hospitalisation	40.82	13.80	12	64081	75195	64359444
Dermatitis exfoliative generalised	40.68	13.80	39	64054	5877	64428762
Death	40.56	13.80	297	63796	482408	63952231
Heart rate decreased	40.28	13.80	4	64089	55063	64379576
Sleep disorder	39.61	13.80	6	64087	59703	64374936
Nosocomial infection	39.55	13.80	27	64066	2510	64432129
Blood alkaline phosphatase increased	39.07	13.80	134	63959	56145	64378494
Unevaluable event	38.74	13.80	3	64090	50486	64384153
Type IV hypersensitivity reaction	38.72	13.80	30	64063	3392	64431247
Oedema peripheral	38.41	13.80	96	63997	210221	64224418
Coronary artery disease	38.03	13.80	7	64086	60426	64374213
Liver disorder	37.89	13.80	128	63965	53223	64381416
Cerebrovascular accident	37.50	13.80	49	64044	137534	64297105
Dehydration	37.25	13.80	102	63991	216661	64217978
Bronchitis	37.16	13.80	32	64061	108711	64325928
Alanine aminotransferase increased	37.12	13.80	251	63842	138780	64295859
Oliguria	36.97	13.80	58	64035	14518	64420121
Eosinophilic pneumonia	36.95	13.80	33	64060	4544	64430095
Vomiting	36.90	13.80	360	63733	550757	63883882
Respiratory distress	36.67	13.80	125	63968	52206	64382433
Mobility decreased	36.32	13.80	20	64073	85820	64348819
Dyspnoea exertional	36.12	13.80	14	64079	73716	64360923
Venoocclusive liver disease	35.92	13.80	47	64046	9968	64424671
Nocardiosis	35.80	13.80	33	64060	4734	64429905
Hyperferritinaemia	35.79	13.80	15	64078	514	64434125
Musculoskeletal pain	35.79	13.80	18	64075	81276	64353363
Pericarditis	35.76	13.80	9	64084	62507	64372132
Respiratory tract infection bacterial	35.40	13.80	17	64076	806	64433833
Blood pressure systolic increased	35.12	13.80	4	64089	49449	64385190
Sputum increased	35.02	13.80	29	64064	3606	64431033
Shock haemorrhagic	34.78	13.80	61	64032	16730	64417909
CNS ventriculitis	34.68	13.80	13	64080	330	64434309
Metabolic acidosis	34.55	13.80	151	63942	70807	64363832
Drug hypersensitivity	34.43	13.80	121	63972	237694	64196945
Immune effector cell-associated neurotoxicity syndrome	34.37	13.80	25	64068	2570	64432069
Brain oedema	34.35	13.80	71	64022	22004	64412635
Incorrect dose administered	34.27	13.80	9	64084	60756	64373883
Gamma-glutamyltransferase increased	34.10	13.80	116	63977	48394	64386245
Peritonitis	33.80	13.80	76	64017	24947	64409692
Rhinorrhoea	33.60	13.80	9	64084	59960	64374679
Enterococcus test positive	33.45	13.80	21	64072	1694	64432945
Hyperlactacidaemia	33.44	13.80	32	64061	4812	64429827
Influenza	33.29	13.80	34	64059	106497	64328142
Blood cholesterol increased	33.28	13.80	5	64088	50061	64384578
Chest discomfort	33.05	13.80	40	64053	116066	64318573
Gastrooesophageal reflux disease	32.89	13.80	21	64072	83122	64351517
Weissella infection	32.80	13.80	7	64086	17	64434622
Meningitis candida	32.75	13.80	10	64083	132	64434507
Somnolence	32.67	13.80	99	63994	203546	64231093
Drug level increased	32.65	13.80	91	64002	34105	64400534
Hepatosplenomegaly	32.61	13.80	33	64060	5310	64429329
Perinephric abscess	32.32	13.80	11	64082	209	64434430
Balance disorder	32.11	13.80	22	64071	83904	64350735
Toxic encephalopathy	32.05	13.80	44	64049	9771	64424868
Suicidal ideation	32	13.80	13	64080	66529	64368110
Neutropenic sepsis	31.79	13.80	71	64022	23201	64411438
Fungal sepsis	31.58	13.80	20	64073	1638	64433001
Nasal congestion	31.50	13.80	10	64083	59648	64374991
Neck pain	31.30	13.80	11	64082	61522	64373117
Hyperamylasaemia	31.20	13.80	16	64077	875	64433764
Hypersensitivity	31.16	13.80	96	63997	196356	64238283
Graft versus host disease	31.00	13.80	52	64041	13761	64420878
Tumour lysis syndrome	30.81	13.80	63	64030	19377	64415262
Seizure	30.52	13.80	276	63817	166616	64268023
Hepatotoxicity	30.27	13.80	98	63995	39864	64394775
Injection site reaction	30.25	13.80	5	64088	46659	64387980
Anaemia	30.11	13.80	536	63557	378144	64056495
Multiple sclerosis relapse	30.05	13.80	3	64090	41132	64393507
Dry skin	29.98	13.80	7	64086	51154	64383485
Influenza like illness	29.76	13.80	12	64081	61690	64372949
Constipation	29.75	13.80	122	63971	229215	64205424
Fluid retention	29.73	13.80	11	64082	59595	64375044
Pruritus	29.28	13.80	186	63907	312214	64122425
Cardiac valve vegetation	28.95	13.80	15	64078	838	64433801
Ototoxicity	28.93	13.80	23	64070	2700	64431939
Cholangitis	28.82	13.80	44	64049	10758	64423881
Cryptococcal meningoencephalitis	28.81	13.80	10	64083	202	64434437
Hyperammonaemia	28.79	13.80	42	64051	9862	64424777
Haemorrhagic pneumonia	28.79	13.80	9	64084	129	64434510
Scedosporium infection	28.67	13.80	17	64076	1237	64433402
Excessive eye blinking	28.60	13.80	17	64076	1243	64433396
Megacolon	28.48	13.80	24	64069	3058	64431581
Granulocyte count decreased	28.40	13.80	17	64076	1259	64433380
Hypertension	28.25	13.80	147	63946	259114	64175525
Increased bronchial secretion	28.07	13.80	23	64070	2819	64431820
Portal fibrosis	27.87	13.80	13	64080	577	64434062
Pneumonia pseudomonal	27.61	13.80	29	64064	4874	64429765
Hypernatraemia	27.51	13.80	46	64047	12143	64422496
Helicobacter infection	27.50	13.80	3	64090	38359	64396280
Immunosuppressant drug level increased	27.50	13.80	35	64058	7224	64427415
ADAMTS13 activity decreased	27.43	13.80	9	64084	152	64434487
Clostridial sepsis	27.36	13.80	14	64079	762	64433877
Neutrophil count decreased	27.34	13.80	150	63943	77046	64357593
Vascular pseudoaneurysm thrombosis	27.02	13.80	7	64086	48	64434591
Staphylococcal sepsis	26.89	13.80	47	64046	12852	64421787
Burning sensation	26.81	13.80	8	64085	49656	64384983
Paraesthesia	26.46	13.80	59	64034	134463	64300176
Blood fibrinogen decreased	26.31	13.80	17	64076	1441	64433198
Intentional product misuse	26.29	13.80	20	64073	72275	64362364
Enterococcal bacteraemia	26.28	13.80	21	64072	2484	64432155
Dermatitis exfoliative	25.99	13.80	41	64052	10311	64424328
White blood cell count increased	25.93	13.80	132	63961	65882	64368757
Staphylococcus test positive	25.92	13.80	30	64063	5615	64429024
Pyelonephritis fungal	25.90	13.80	8	64085	110	64434529
Device related infection	25.86	13.80	78	64015	30548	64404091
Interleukin-2 receptor increased	25.83	13.80	9	64084	184	64434455
Candida test positive	25.77	13.80	15	64078	1055	64433584
Infective aneurysm	25.73	13.80	14	64079	864	64433775
Respiratory paralysis	25.65	13.80	7	64086	60	64434579
Amnesia	25.65	13.80	8	64085	48261	64386378
Blood glucose increased	25.63	13.80	36	64057	98037	64336602
Renal abscess	25.30	13.80	14	64079	893	64433746
Aortoenteric fistula	25.26	13.80	8	64085	120	64434519
Disseminated cryptococcosis	25.20	13.80	17	64076	1550	64433089
Hypoaesthesia	24.99	13.80	64	64029	139044	64295595
Pseudomonas test positive	24.99	13.80	17	64076	1571	64433068
Motor neurone disease	24.94	13.80	11	64082	428	64434211
Circulatory collapse	24.89	13.80	82	64011	33650	64400989
Urticaria	24.79	13.80	70	64023	147247	64287392
Stoma closure	24.73	13.80	8	64085	129	64434510
Epidermolysis bullosa	24.68	13.80	9	64084	211	64434428
Respiratory gas exchange disorder	24.67	13.80	13	64080	752	64433887
Toxicity to various agents	24.47	13.80	237	63856	363276	64071363
Aspartate aminotransferase increased	24.45	13.80	203	63890	119585	64315054
Osteomyelitis bacterial	24.42	13.80	11	64082	450	64434189
Gait inability	24.42	13.80	6	64087	42362	64392277
Acute myeloid leukaemia recurrent	24.34	13.80	21	64072	2763	64431876
Abdominal compartment syndrome	24.18	13.80	16	64077	1412	64433227
Diabetic macroangiopathy	24.17	13.80	8	64085	139	64434500
Hepatic cytolysis	24.02	13.80	47	64046	14002	64420637
Emphysematous pyelonephritis	23.95	13.80	9	64084	230	64434409
Central nervous system injury	23.71	13.80	8	64085	148	64434491
Hepatitis cholestatic	23.69	13.80	43	64050	12112	64422527
Gastrointestinal disorder	23.38	13.80	33	64060	89676	64344963
Adjusted calcium decreased	23.31	13.80	8	64085	156	64434483
Cytopenia	23.18	13.80	49	64044	15422	64419217
Heart rate increased	23.13	13.80	39	64054	98636	64336003
Flavobacterium infection	23.09	13.80	7	64086	90	64434549
Cataract	23.09	13.80	11	64082	51251	64383388
Angina pectoris	23.03	13.80	8	64085	45073	64389566
Fusarium infection	22.82	13.80	16	64077	1553	64433086
Aspergillus test positive	22.74	13.80	12	64081	696	64433943
Product deposit	22.67	13.80	10	64083	389	64434250
Haemostasis	22.63	13.80	9	64084	269	64434370
Coagulation time prolonged	22.53	13.80	18	64075	2128	64432511
Strongyloidiasis	22.45	13.80	21	64072	3069	64431570
Product prescribing error	22.37	13.80	4	64089	35265	64399374
Nephrogenic diabetes insipidus	22.35	13.80	17	64076	1870	64432769
Hot flush	22.28	13.80	9	64084	46226	64388413
Abscess	22.13	13.80	55	64038	19249	64415390
Blood creatinine increased	22.05	13.80	219	63874	135563	64299076
Injection site swelling	21.71	13.80	7	64086	41346	64393293
Adverse drug reaction	21.67	13.80	9	64084	45455	64389184
Deep vein thrombosis	21.63	13.80	45	64048	105137	64329502
Antinuclear antibody negative	21.55	13.80	5	64088	20	64434619
Dyspepsia	21.47	13.80	29	64064	80283	64354356
Depressed mood	21.43	13.80	7	64086	41005	64393634
Encephalitis	21.43	13.80	42	64051	12529	64422110
Rectal haemorrhage	21.35	13.80	18	64075	61799	64372840
Mediastinitis	21.24	13.80	12	64081	797	64433842
Palpitations	21.23	13.80	45	64048	104443	64330196
Pneumonia klebsiella	21.18	13.80	23	64070	4014	64430625
Hepatic infarction	21.17	13.80	12	64081	802	64433837
Graft versus host disease in gastrointestinal tract	21.17	13.80	27	64066	5585	64429054
Klebsiella bacteraemia	21.17	13.80	18	64075	2322	64432317
Septic embolus	21.15	13.80	16	64077	1746	64432893
COVID-19 pneumonia	21.04	13.80	49	64044	16455	64418184
Red blood cell sedimentation rate increased	21.04	13.80	3	64090	31232	64403407
Meningitis	20.92	13.80	33	64060	8296	64426343
SJS-TEN overlap	20.89	13.80	10	64083	471	64434168
Cardiac disorder	20.86	13.80	15	64078	55801	64378838
Lactic acidosis	20.86	13.80	118	63975	61292	64373347
Aeromonas infection	20.85	13.80	9	64084	332	64434307
Hypoproteinaemia	20.84	13.80	21	64072	3361	64431278
Sepsis syndrome	20.84	13.80	14	64079	1267	64433372
Acidosis	20.71	13.80	51	64042	17744	64416895
Flatulence	20.66	13.80	5	64088	35661	64398978
Overdose	20.61	13.80	85	64008	159481	64275158
Road traffic accident	20.60	13.80	3	64090	30742	64403897
Immune reconstitution inflammatory syndrome	20.46	13.80	41	64052	12429	64422210
Osteonecrosis of jaw	20.46	13.80	7	64086	39818	64394821
Impaired healing	20.41	13.80	18	64075	60455	64374184
Escherichia bacteraemia	20.39	13.80	26	64067	5377	64429262
Hydrocephalus	20.36	13.80	31	64062	7560	64427079
Hepatitis fulminant	20.30	13.80	28	64065	6246	64428393
Nephrolithiasis	20.26	13.80	9	64084	43674	64390965
Disease complication	20.19	13.80	23	64070	4232	64430407
Herpes simplex	20.19	13.80	37	64056	10499	64424140
Splenic injury	20.12	13.80	8	64085	239	64434400
Endotracheal intubation	20.10	13.80	22	64071	3873	64430766
Mixed liver injury	20.09	13.80	26	64067	5455	64429184
Noninfectious peritonitis	20.06	13.80	8	64085	241	64434398
Adenovirus infection	19.99	13.80	30	64063	7225	64427414
Hypokalaemia	19.98	13.80	197	63896	121706	64312933
Lung abscess	19.91	13.80	21	64072	3545	64431094
HIV viraemia	19.73	13.80	6	64087	78	64434561
Extravasation blood	19.72	13.80	9	64084	380	64434259
Venoocclusive disease	19.69	13.80	22	64071	3963	64430676
Serum sickness-like reaction	19.62	13.80	10	64083	540	64434099
Potentiating drug interaction	19.57	13.80	31	64062	7821	64426818
Enterocolitis haemorrhagic	19.50	13.80	16	64077	1964	64432675
Acanthosis	19.35	13.80	9	64084	397	64434242
Chimerism	19.26	13.80	8	64085	268	64434371
Serum ferritin increased	19.16	13.80	32	64061	8436	64426203
Hepatic necrosis	19.15	13.80	32	64061	8441	64426198
Gastroenteritis staphylococcal	19.15	13.80	8	64085	272	64434367
Oropharyngeal pain	19.14	13.80	37	64056	88830	64345809
Meningitis bacterial	19.13	13.80	17	64076	2326	64432313
Hyperchloraemia	19.12	13.80	12	64081	967	64433672
Necrotising fasciitis	19.11	13.80	25	64068	5301	64429338
Endocarditis candida	19.07	13.80	6	64087	88	64434551
Vulvovaginitis	19.04	13.80	8	64085	276	64434363
Encephalitis viral	18.90	13.80	17	64076	2363	64432276
Organising pneumonia	18.89	13.80	33	64060	9022	64425617
Low cardiac output syndrome	18.76	13.80	11	64082	784	64433855
Overgrowth fungal	18.65	13.80	6	64087	95	64434544
Pulmonary alveolar haemorrhage	18.41	13.80	34	64059	9704	64424935
Myocardial calcification	18.31	13.80	5	64088	43	64434596
Abscess neck	18.26	13.80	12	64081	1047	64433592
Vertigo	18.24	13.80	19	64074	58992	64375647
Petechiae	18.21	13.80	50	64043	18576	64416063
Acid base balance abnormal	18.19	13.80	8	64085	309	64434330
White blood cell count decreased	18.15	13.80	238	63855	157599	64277040
Infectious pleural effusion	18.06	13.80	18	64075	2844	64431795
Acute graft versus host disease in intestine	17.96	13.80	20	64073	3589	64431050
Aggression	17.84	13.80	12	64081	46220	64388419
Faeces pale	17.78	13.80	17	64076	2554	64432085
Lower respiratory tract infection bacterial	17.71	13.80	10	64083	664	64433975
Cytokine storm	17.65	13.80	11	64082	876	64433763
Enterobacter infection	17.57	13.80	20	64073	3676	64430963
Urinary tract infection fungal	17.56	13.80	11	64082	884	64433755
Osteoporosis	17.52	13.80	10	64083	42070	64392569
Convulsive threshold lowered	17.51	13.80	11	64082	888	64433751
Guillain-Barre syndrome	17.48	13.80	29	64064	7606	64427033
Radiation fibrosis - lung	17.46	13.80	5	64088	52	64434587
Type 2 diabetes mellitus	17.44	13.80	6	64087	34014	64400625
Metabolic disorder	17.30	13.80	29	64064	7668	64426971
Generalised tonic-clonic seizure	17.29	13.80	82	64011	39775	64394864
Hypotension	17.23	13.80	498	63595	380476	64054163
Relapsing fever	17.22	13.80	8	64085	352	64434287
Mediastinal effusion	17.21	13.80	5	64088	55	64434584
Hypovolaemic shock	17.14	13.80	34	64059	10232	64424407
Hepatitis	17.11	13.80	90	64003	45492	64389147
Mucosal disorder	17.04	13.80	18	64075	3044	64431595
Hyperaemia	17.02	13.80	17	64076	2692	64431947
Resuscitation	16.98	13.80	15	64078	2036	64432603
Hyperpyrexia	16.94	13.80	23	64070	5054	64429585
Dry eye	16.94	13.80	4	64089	29015	64405624
Globulins decreased	16.93	13.80	8	64085	366	64434273
Orthostatic hypotension	16.90	13.80	13	64080	46725	64387914
Ischaemic cerebral infarction	16.85	13.80	15	64078	2057	64432582
Vascular pseudoaneurysm	16.74	13.80	18	64075	3106	64431533
Cognitive disorder	16.73	13.80	18	64075	55069	64379570
Neutrophilic dermatosis	16.68	13.80	9	64084	546	64434093
Bladder irrigation	16.66	13.80	5	64088	62	64434577
Intestinal ischaemia	16.64	13.80	36	64057	11513	64423126
Bacterial sepsis	16.64	13.80	28	64065	7429	64427210
Rectal perforation	16.59	13.80	10	64083	750	64433889
Neuralgia	16.54	13.80	3	64090	26181	64408458
Exfoliative rash	16.54	13.80	19	64074	3527	64431112
Alveolitis necrotising	16.51	13.80	4	64089	20	64434619
Hyperthermia	16.47	13.80	43	64050	15507	64419132
Acute lymphocytic leukaemia	16.44	13.80	21	64072	4350	64430289
Serum sickness	16.44	13.80	18	64075	3171	64431468
Herpes simplex viraemia	16.43	13.80	7	64086	250	64434389
Morganella infection	16.38	13.80	11	64082	995	64433644
Irritability	16.38	13.80	8	64085	36738	64397901
Graft versus host disease in liver	16.34	13.80	13	64080	1528	64433111
Diverticulitis	16.33	13.80	9	64084	38609	64396030
Body temperature decreased	16.32	13.80	3	64090	25925	64408714
Ill-defined disorder	16.25	13.80	12	64081	44040	64390599
Septal panniculitis	16.24	13.80	5	64088	68	64434571
Posterior reversible encephalopathy syndrome	16.24	13.80	55	64038	22891	64411748
Blast cell count increased	16.21	13.80	12	64081	1267	64433372
Organ failure	16.17	13.80	19	64074	3614	64431025
Chest X-ray abnormal	16.14	13.80	26	64067	6655	64427984
Hyperoxaluria	16.08	13.80	7	64086	264	64434375
Hypertransaminasaemia	16.04	13.80	27	64066	7164	64427475
Viral infection	15.91	13.80	8	64085	36132	64398507
Decreased appetite	15.85	13.80	191	63902	281098	64153541
Antibiotic level above therapeutic	15.85	13.80	9	64084	604	64434035
Candida endophthalmitis	15.84	13.80	6	64087	157	64434482
Night sweats	15.83	13.80	8	64085	36038	64398601
Product administration error	15.77	13.80	4	64089	27639	64407000
Ependymitis	15.67	13.80	3	64090	3	64434636
Renal injury	15.66	13.80	42	64051	15387	64419252
Viral haemorrhagic cystitis	15.66	13.80	13	64080	1622	64433017
Cardiovascular insufficiency	15.64	13.80	16	64077	2608	64432031
Abortion spontaneous	15.63	13.80	3	64090	25140	64409499
Cholangiolitis	15.63	13.80	4	64089	26	64434613
Sopor	15.61	13.80	5	64088	29656	64404983
Herpes simplex hepatitis	15.61	13.80	8	64085	437	64434202
Cytomegalovirus enterocolitis	15.60	13.80	12	64081	1343	64433296
Adverse event	15.58	13.80	10	64083	39479	64395160
Rash erythematous	15.57	13.80	92	64001	48541	64386098
Depressed level of consciousness	15.55	13.80	136	63957	81300	64353339
Medication error	15.54	13.80	16	64077	49950	64384689
Mucosal inflammation	15.52	13.80	111	63982	62473	64372166
Ileus paralytic	15.43	13.80	29	64064	8386	64426253
Pollakiuria	15.42	13.80	6	64087	31524	64403115
Splenomegaly	15.41	13.80	46	64047	17915	64416724
Cholangitis infective	15.37	13.80	8	64085	451	64434188
Basilar artery aneurysm	15.37	13.80	4	64089	28	64434611
Intestinal pseudo-obstruction	15.32	13.80	14	64079	1986	64432653
Clostridial infection	15.31	13.80	22	64071	5097	64429542
Haemorrhagic disorder	15.26	13.80	12	64081	1387	64433252
Bacterial infection	15.25	13.80	57	64036	24893	64409746
Pulmonary sepsis	15.23	13.80	17	64076	3058	64431581
Neoplasm malignant	15.23	13.80	3	64090	24685	64409954
Cytomegalovirus test positive	15.22	13.80	22	64071	5122	64429517
Candida pneumonia	15.21	13.80	8	64085	461	64434178
Myasthenia gravis crisis	15.20	13.80	10	64083	874	64433765
Pneumocystis jirovecii pneumonia	15.16	13.80	61	64032	27573	64407066
Perforation	15.07	13.80	11	64082	1137	64433502
Differentiation syndrome	15	13.80	14	64079	2040	64432599
Vitamin K deficiency	14.99	13.80	9	64084	670	64433969
Metabolic alkalosis	14.98	13.80	19	64074	3909	64430730
Cytotoxic oedema	14.92	13.80	7	64086	315	64434324
Cytomegalovirus viraemia	14.75	13.80	33	64060	10795	64423844
Cytomegalovirus infection reactivation	14.73	13.80	23	64070	5733	64428906
Thrombotic microangiopathy	14.61	13.80	43	64050	16612	64418027
Disseminated mucormycosis	14.61	13.80	8	64085	500	64434139
Hyperchlorhydria	14.58	13.80	13	64080	1786	64432853
Graft versus host disease in skin	14.57	13.80	22	64071	5325	64429314
Skin necrosis	14.54	13.80	39	64054	14290	64420349
Speech disorder	14.52	13.80	16	64077	48425	64386214
Colony stimulating factor therapy	14.51	13.80	8	64085	507	64434132
Wound dehiscence	14.38	13.80	23	64070	5851	64428788
Acute graft versus host disease in skin	14.32	13.80	25	64068	6830	64427809
Haemolysis	14.32	13.80	33	64060	11006	64423633
Aspartate aminotransferase	14.31	13.80	6	64087	206	64434433
Blood culture positive	14.28	13.80	27	64066	7841	64426798
Vesicoureteric reflux	14.27	13.80	5	64088	104	64434535
Normocytic anaemia	14.26	13.80	17	64076	3282	64431357
Limb injury	14.20	13.80	3	64090	23502	64411137
Purpura non-thrombocytopenic	14.20	13.80	6	64087	210	64434429
Injury	14.19	13.80	21	64072	55971	64378668
Ear infection	14.12	13.80	3	64090	23401	64411238
Arterial rupture	14.08	13.80	9	64084	749	64433890
Leukoencephalopathy	14.03	13.80	25	64068	6942	64427697
Vanishing bile duct syndrome	14.03	13.80	11	64082	1266	64433373
Hypoglossal nerve paresis	14.01	13.80	5	64088	110	64434529
Refractoriness to platelet transfusion	13.92	13.80	5	64088	112	64434527
Brain herniation	13.87	13.80	24	64069	6509	64428130
Anticonvulsant drug level below therapeutic	13.87	13.80	10	64083	1014	64433625
Acne	13.84	13.80	3	64090	23078	64411561

FDA Adverse Event Reporting System (Pediatric)

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
Drug ineffective	89.67	78.30	35	77	882	83684

Pharmacologic Action:

Source	Code	Description
ATC	J01DH02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Carbapenems
ATC	J01DH52	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE OTHER BETA-LACTAM ANTIBACTERIALS Carbapenems
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
CHEBI has role	CHEBI:36047	antibacterial drugs
CHEBI has role	CHEBI:33282	bactericides
CHEBI has role	CHEBI:88188	allergenic drug

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

Disease	Relation	SNOMED_ID	DOID
Streptococcal meningitis	indication	4510004	DOID:11574
Infection due to Pseudomonas aeruginosa	indication	11218009
Peritonitis	indication	48661000
Pneumococcal meningitis	indication	51169003
Abdominal abscess	indication	75100008
Bacterial meningitis	indication	95883001	DOID:9470
Infectious disease of abdomen	indication	128070006
Meningococcal meningitis	indication	192644005
Complicated appendicitis	indication	418171008
Peptostreptococcus Complicated Appendicitis	indication
Pseudomonas Aeruginosa Complicated Appendicitis	indication
E. Coli Complicated Appendicitis	indication
Streptococcal Peritonitis	indication
Bacteroides Peritonitis	indication
Streptococcus Complicated Appendicitis	indication
Klebsiella Pneumoniae Peritonitis	indication
Complicated Skin and Skin Structure Infection	indication
E. Coli Peritonitis	indication
Peptostreptococcus Peritonitis	indication
H. Influenzae Meningitis	indication
Klebsiella Complicated Appendicitis	indication
Bacteroides Complicated Appendicitis	indication
Pyrexia of unknown origin	off-label use	7520000
Bacterial septicemia	off-label use	10001005	DOID:0040085
Inhalational anthrax	off-label use	11389007
Nocardiosis	off-label use	29227009	DOID:2312
Bacterial pneumonia	off-label use	53084003	DOID:874
Cholangitis	off-label use	82403002	DOID:9446
Gastrointestinal anthrax	off-label use	111798006	DOID:13386
Infection by Campylobacter fetus	off-label use	111835002
Sepsis of the newborn	off-label use	206376005
Sepsis syndrome	off-label use	238150007
Diverticulitis of gastrointestinal tract	off-label use	271366000
Neonatal meningitis	off-label use	276674008
Anthrax	off-label use	409498004	DOID:7427
Nosocomial pneumonia	off-label use	425464007
Melioidosis	off-label use	428111003	DOID:5052
Pneumonia due to Gram negative bacteria	off-label use	430395005
Clostridium Perfringens Empyema	off-label use
Pseudomonas Respiratory Tract Infection in Cystic Fibrosis	off-label use
Diabetic Foot Infection	off-label use
Complicated Urinary Tract Infections	off-label use
Kidney disease	contraindication	90708001	DOID:557
Seizure disorder	contraindication	128613002
Lesion of brain	contraindication	301766008
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Pseudomembranous enterocolitis	contraindication	397683000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.79	acidic
pKa2	8.04	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
1GM/VIAL;1GM/VIAL	VABOMERE	REMPEX	N209776	Aug. 29, 2017	RX	POWDER	INTRAVENOUS	10183034	Aug. 8, 2031	TREATMENT OF COMPLICATED URINARY TRACT INFECTION (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, AND ENTEROBACTER CLOACAE SPECIES COMPLEX
1GM/VIAL;1GM/VIAL	VABOMERE	REMPEX	N209776	Aug. 29, 2017	RX	POWDER	INTRAVENOUS	10561675	Aug. 8, 2031	TREATMENT OF COMPLICATED URINARY TRACT INFECTION (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, AND ENTEROBACTER CLOACAE SPECIES COMPLEX
1GM/VIAL;1GM/VIAL	VABOMERE	REMPEX	N209776	Aug. 29, 2017	RX	POWDER	INTRAVENOUS	11007206	Aug. 8, 2031	TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS (CUTI) INCLUDING PYELONEPHRITIS CAUSED BY THE FOLLOWING SUSCEPTIBLE MICROORGANISMS: ESCHERICHIA COLI, KLEBSIELLA PNEUMONIA, ENTEROBACTER CLOACAE SPECIES COMPLEX WITH MEROPENEM & VABORBACTAM AS SPECIFIED
1GM/VIAL;1GM/VIAL	VABOMERE	REMPEX	N209776	Aug. 29, 2017	RX	POWDER	INTRAVENOUS	9694025	Aug. 8, 2031	TREATMENT OF PATIENTS 18 YEARS OF AGE AND OLDER WITH COMPLICATED URINARY TRACT INFECTIONS CAUSED BY SUSCEPTIBLE MICROORGANISMS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
1GM/VIAL;1GM/VIAL	VABOMERE	REMPEX	N209776	Aug. 29, 2017	RX	POWDER	INTRAVENOUS	Aug. 29, 2022	NEW CHEMICAL ENTITY
1GM/VIAL;1GM/VIAL	VABOMERE	REMPEX	N209776	Aug. 29, 2017	RX	POWDER	INTRAVENOUS	Aug. 29, 2027	GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

Target	Class	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
D-alanyl-D-alanine carboxypeptidase DacB	Enzyme	DACB_ECOLI	INHIBITOR			DRUGBANK	CHEMBL
Penicillin-binding protein 4	Enzyme	Q5D1E9_STAAU				WOMBAT-PK
D-ala-D-ala-carboxypeptidase; D-alanyl-D-alanine carboxypeptidase; D-alanyl-D-alanine carboxypeptidase family protein; Penicillin-binding protein 5	Enzyme	Q9X6V7_PSEAI				WOMBAT-PK
Penicillin-binding protein 1	Enzyme	A1KS91_NEIMF				WOMBAT-PK
D-alanyl-D-alanine carboxypeptidase; D-alanyl-D-alanine carboxypeptidase penicillin-binding protein 6	Enzyme	Q7CHG0_YERPE				WOMBAT-PK
Streptokinase A	Enzyme	STRP_STRP1		EC50	6.90	WOMBAT-PK
Beta-lactamase class B VIM-2	Unclassified	Q9K2N0_PSEAI		Kd	4.92	CHEMBL
Beta-lactamase NDM-1	Enzyme	BLAN1_KLEPN		Kd	4.96	CHEMBL
Penicillin-binding protein 2	Enzyme	Q9X6V3_PSEAI				WOMBAT-PK
Beta-lactamase	Enzyme	Q6XEC0_KLEPN		Kd	6.07	CHEMBL

External reference:

ID	Source
4021008	VUID
N0000148477	NUI
D02222	KEGG_DRUG
4021008	VANDF
C0066005	UMLSCUI
CHEBI:43968	CHEBI
MEM	PDB_CHEM_ID
CHEMBL127	ChEMBL_ID
DB00760	DRUGBANK_ID
D000077731	MESH_DESCRIPTOR_UI
441130	PUBCHEM_CID
10829	IUPHAR_LIGAND_ID
FV9J3JU8B1	UNII
29561	RXNORM
173661	MMSL
5055	MMSL
6047	MMSL
d04027	MMSL
005166	NDDF
387540000	SNOMEDCT_US
725669004	SNOMEDCT_US
96062004	SNOMEDCT_US
119478-56-7	SECONDARY_CAS_RN

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
MERREM IV	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0313	INJECTION	500 mg	INTRAVENOUS	NDA	30 sections
MERREM IV	HUMAN PRESCRIPTION DRUG LABEL	1	0069-0314	INJECTION	1 g	INTRAVENOUS	NDA	30 sections
Meropenem and Sodium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0264-3183	INJECTION, SOLUTION	500 mg	INTRAVENOUS	NDA	26 sections
Meropenem and Sodium Chloride	HUMAN PRESCRIPTION DRUG LABEL	1	0264-3185	INJECTION, SOLUTION	1 g	INTRAVENOUS	NDA	26 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1390	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	27 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1391	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	27 sections
MEROPENEM	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3000	INJECTION	500 mg	INTRAVENOUS	ANDA	30 sections
MEROPENEM	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3000	INJECTION	500 mg	INTRAVENOUS	ANDA	30 sections
MEROPENEM	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3098	INJECTION	1 g	INTRAVENOUS	ANDA	30 sections
MEROPENEM	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3098	INJECTION	1 g	INTRAVENOUS	ANDA	30 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	44567-145	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	28 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	44567-146	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	28 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	44567-400	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	28 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	44567-401	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	28 sections
MEROPENEM	HUMAN PRESCRIPTION DRUG LABEL	1	44647-032	INJECTION	500 mg	INTRAVENOUS	ANDA	30 sections
MEROPENEM	HUMAN PRESCRIPTION DRUG LABEL	1	44647-033	INJECTION	1 g	INTRAVENOUS	ANDA	30 sections
Meropenem	Human Prescription Drug Label	1	55150-207	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	26 sections
Meropenem	Human Prescription Drug Label	1	55150-208	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	26 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	63323-507	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	28 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	63323-507	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	28 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	63323-507	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	28 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	63323-508	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	28 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	63323-508	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	28 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	63323-508	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	28 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	68001-323	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	27 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	68001-324	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	27 sections
MEROPENEM	HUMAN PRESCRIPTION DRUG LABEL	1	68001-446	INJECTION	500 mg	INTRAVENOUS	ANDA	29 sections
MEROPENEM	HUMAN PRESCRIPTION DRUG LABEL	1	68001-447	INJECTION	1 g	INTRAVENOUS	ANDA	29 sections
Meropenem	Human Prescription Drug Label	1	68083-146	INJECTION	500 mg	INTRAVENOUS	ANDA	27 sections
Meropenem	Human Prescription Drug Label	1	68083-147	INJECTION	1 g	INTRAVENOUS	ANDA	27 sections