meropenem 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: -3.28 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	521.00	16.86	342	28495	55335	53264894
Septic shock	454.13	16.86	328	28509	61901	53258328
Drug resistance	309.95	16.86	170	28667	19792	53300437
Drug reaction with eosinophilia and systemic symptoms	305.36	16.86	201	28636	32599	53287630
Sepsis	289.02	16.86	375	28462	146054	53174175
Pathogen resistance	264.70	16.86	108	28729	6452	53313777
Febrile neutropenia	257.44	16.86	300	28537	104636	53215593
Pyrexia	204.00	16.86	576	28261	402617	52917612
Respiratory failure	195.86	16.86	256	28581	100256	53219973
Pain	171.31	16.86	53	28784	588345	52731884
Thrombocytopenia	168.60	16.86	283	28554	138444	53181785
Bronchopulmonary aspergillosis	166.17	16.86	85	28752	8580	53311649
Rheumatoid arthritis	151.50	16.86	4	28833	314527	53005702
Systemic candida	146.53	16.86	57	28780	3000	53317229
Toxic epidermal necrolysis	142.28	16.86	111	28726	23439	53296790
Haemophagocytic lymphohistiocytosis	142.28	16.86	78	28759	9059	53311170
Fatigue	138.13	16.86	116	28721	730390	52589839
Acute kidney injury	135.17	16.86	370	28467	253498	53066731
Pancytopenia	126.03	16.86	197	28640	90731	53229498
Headache	122.92	16.86	69	28768	536752	52783477
Arthralgia	118.47	16.86	45	28792	439738	52880491
Off label use	107.23	16.86	521	28316	471691	52848538
Clostridium difficile colitis	106.24	16.86	87	28750	19678	53300551
Enterococcal infection	105.06	16.86	60	28777	7538	53312691
Candida infection	103.01	16.86	95	28742	25178	53295051
Joint swelling	102.78	16.86	6	28831	234632	53085597
Fall	97.59	16.86	36	28801	358404	52961825
Acinetobacter infection	97.54	16.86	35	28802	1468	53318761
Neutropenia	96.80	16.86	244	28593	158941	53161288
Candida sepsis	90.65	16.86	33	28804	1443	53318786
Abdominal discomfort	90.08	16.86	8	28829	221054	53099175
Aspergillus infection	84.80	16.86	52	28785	7444	53312785
Acute respiratory distress syndrome	78.64	16.86	79	28758	23253	53296976
Fungaemia	78.21	16.86	33	28804	2144	53318085
Shock	77.35	16.86	78	28759	23061	53297168
Drug intolerance	77.18	16.86	10	28827	205483	53114746
Hepatic function abnormal	76.48	16.86	97	28740	36802	53283427
Pseudomonas infection	75.97	16.86	55	28782	10373	53309856
Dysbiosis	74.53	16.86	23	28814	599	53319630
Disseminated intravascular coagulation	74.36	16.86	71	28766	19648	53300581
Nasopharyngitis	73.08	16.86	9	28828	192286	53127943
Product dose omission issue	72.75	16.86	9	28828	191611	53128618
Klebsiella infection	72.30	16.86	48	28789	7878	53312351
Peripheral swelling	68.54	16.86	14	28823	206094	53114135
Agranulocytosis	68.53	16.86	74	28763	23675	53296554
Stenotrophomonas infection	68.03	16.86	28	28809	1708	53318521
Mucormycosis	66.32	16.86	31	28806	2569	53317660
Pneumonia	65.16	16.86	409	28428	406760	52913469
Eosinophilia	64.24	16.86	68	28769	21267	53298962
Acute generalised exanthematous pustulosis	63.25	16.86	49	28788	10232	53309997
Dizziness	63.09	16.86	65	28772	372194	52948035
Drug eruption	61.81	16.86	72	28765	25022	53295207
Myelosuppression	61.77	16.86	53	28784	12775	53307454
Swelling	61.46	16.86	14	28823	191091	53129138
Rash maculo-papular	59.74	16.86	77	28760	29672	53290557
Pain in extremity	59.02	16.86	41	28796	285009	53035220
Bacteraemia	58.65	16.86	56	28781	15493	53304736
Weight increased	58.26	16.86	19	28818	204548	53115681
Stevens-Johnson syndrome	58.00	16.86	69	28768	24513	53295716
Muscle spasms	57.34	16.86	4	28833	134791	53185438
Pseudomembranous colitis	56.55	16.86	30	28807	3261	53316968
Renal impairment	56.19	16.86	133	28704	83185	53237044
Depression	55.77	16.86	15	28822	183037	53137192
Cytokine release syndrome	54.98	16.86	41	28796	8088	53312141
Drug level decreased	54.59	16.86	38	28799	6736	53313493
Renal failure	53.51	16.86	163	28674	118289	53201940
Lactic acidosis	53.35	16.86	82	28755	37171	53283058
Asthenia	52.74	16.86	65	28772	343525	52976704
Contraindicated product administered	52.37	16.86	6	28831	135623	53184606
Pneumonia fungal	51.90	16.86	32	28805	4624	53315605
Geotrichum infection	50.48	16.86	16	28821	456	53319773
Neutropenic sepsis	50.09	16.86	50	28787	14599	53305630
Coagulopathy	49.32	16.86	57	28780	19641	53300588
Sinusitis	49.15	16.86	15	28822	168549	53151680
Linear IgA disease	48.57	16.86	21	28816	1449	53318780
Nocardiosis	48.56	16.86	23	28814	1964	53318265
Neutropenic colitis	48.44	16.86	25	28812	2568	53317661
Therapeutic product effect decreased	47.43	16.86	6	28831	125649	53194580
Acute respiratory failure	46.44	16.86	70	28767	31188	53289041
Platelet count decreased	46.27	16.86	146	28691	107953	53212276
Brain abscess	46.00	16.86	22	28815	1919	53318310
Gait disturbance	44.78	16.86	15	28822	158827	53161402
Malaise	44.75	16.86	78	28759	357539	52962690
Haemodynamic instability	44.44	16.86	37	28800	8557	53311672
Enterocolitis	44.23	16.86	34	28803	7018	53313211
Asthma	44.20	16.86	4	28833	108968	53211261
Hyperbilirubinaemia	43.91	16.86	41	28796	11028	53309201
Systemic inflammatory response syndrome	43.86	16.86	31	28806	5629	53314600
Peritonitis	43.33	16.86	56	28781	21631	53298598
Weight decreased	43.29	16.86	38	28799	234910	53085319
Acute hepatic failure	42.90	16.86	49	28788	16671	53303558
Pneumonia bacterial	42.76	16.86	35	28802	7905	53312324
Cardiac arrest	42.39	16.86	129	28708	93538	53226691
Drug ineffective for unapproved indication	42.18	16.86	54	28783	20666	53299563
Fungal infection	42.04	16.86	68	28769	32178	53288051
Meningitis candida	41.82	16.86	9	28828	50	53320179
Anuria	41.69	16.86	42	28795	12398	53307831
Procalcitonin increased	41.29	16.86	16	28821	833	53319396
Insomnia	41.28	16.86	25	28812	187047	53133182
Systemic lupus erythematosus	40.68	16.86	9	28828	125405	53194824
Oliguria	40.12	16.86	36	28801	9202	53311027
C-reactive protein increased	40.08	16.86	103	28734	67783	53252446
Enterococcal sepsis	39.88	16.86	18	28819	1376	53318853
Musculoskeletal stiffness	39.72	16.86	9	28828	123359	53196870
Alopecia	39.64	16.86	41	28796	234542	53085687
Graft versus host disease	39.63	16.86	32	28805	7090	53313139
Blood bilirubin increased	39.50	16.86	70	28767	35660	53284569
Staphylococcal infection	39.41	16.86	73	28764	38475	53281754
Hyperlactacidaemia	38.96	16.86	22	28815	2703	53317526
Anticonvulsant drug level decreased	38.64	16.86	17	28820	1223	53319006
Acute myeloid leukaemia	37.45	16.86	46	28791	16886	53303343
Anxiety	37.22	16.86	31	28806	196673	53123556
Weissella infection	37.05	16.86	7	28830	17	53320212
Excessive eye blinking	36.94	16.86	15	28822	884	53319345
Hyperchloraemia	36.00	16.86	14	28823	736	53319493
Perinephric abscess	35.58	16.86	10	28827	186	53320043
Eosinophilic pneumonia acute	35.56	16.86	12	28825	418	53319811
Multiple-drug resistance	35.46	16.86	22	28815	3213	53317016
Nausea	35.27	16.86	252	28585	755839	52564390
Factor V inhibition	35.24	16.86	10	28827	193	53320036
Fungal sepsis	35.01	16.86	16	28821	1259	53318970
Guillain-Barre syndrome	34.76	16.86	23	28814	3752	53316477
Drug interaction	34.75	16.86	220	28617	219109	53101120
Feeling abnormal	34.43	16.86	15	28822	135286	53184943
Blood lactate dehydrogenase increased	34.11	16.86	50	28787	21731	53298498
Mucosal inflammation	34.08	16.86	73	28764	42711	53277518
Hepatic infarction	34.05	16.86	13	28824	650	53319579
Leukopenia	34.00	16.86	102	28735	73361	53246868
Pleural effusion	33.73	16.86	115	28722	88464	53231765
Product use in unapproved indication	33.71	16.86	135	28702	112154	53208075
Bone marrow failure	33.29	16.86	59	28778	30056	53290173
Alanine aminotransferase increased	33.22	16.86	120	28717	94975	53225254
Wound	33.06	16.86	5	28832	91552	53228677
Metabolic acidosis	32.42	16.86	71	28766	42171	53278058
Umbilical erythema	32.11	16.86	8	28829	91	53320138
Transaminases increased	31.98	16.86	58	28779	30074	53290155
Trichosporon infection	31.89	16.86	10	28827	275	53319954
Toxic encephalopathy	31.65	16.86	26	28811	5901	53314328
Rhinocerebral mucormycosis	31.32	16.86	9	28828	182	53320047
Clostridium difficile infection	31.28	16.86	55	28782	27838	53292391
Neurotoxicity	31.24	16.86	40	28797	15309	53304920
Product deposit	30.91	16.86	9	28828	191	53320038
Injection site erythema	30.88	16.86	3	28834	77246	53242983
Encephalopathy	30.71	16.86	64	28773	36744	53283485
Nephropathy toxic	30.68	16.86	30	28807	8542	53311687
Blood pressure increased	30.67	16.86	19	28818	140460	53179769
Emphysematous pyelonephritis	30.47	16.86	9	28828	201	53320028
Renal abscess	29.88	16.86	12	28825	687	53319542
Scedosporium infection	29.50	16.86	11	28826	515	53319714
Pneumothorax	29.36	16.86	39	28798	15468	53304761
Pyelonephritis fungal	29.25	16.86	8	28829	134	53320095
Mixed liver injury	29.23	16.86	21	28816	3912	53316317
Anaemia	29.21	16.86	252	28585	276466	53043763
Haemorrhage intracranial	29.09	16.86	36	28801	13316	53306913
Haemostasis	28.93	16.86	9	28828	241	53319988
Arthritis	28.84	16.86	6	28831	87292	53232937
Brain oedema	28.65	16.86	36	28801	13522	53306707
Contusion	28.61	16.86	12	28825	110720	53209509
Abscess neck	28.58	16.86	11	28826	562	53319667
Hepatic failure	28.41	16.86	61	28776	35745	53284484
Central nervous system injury	28.41	16.86	8	28829	150	53320079
Adjusted calcium decreased	28.36	16.86	8	28829	151	53320078
Hypoxia	28.35	16.86	80	28757	55600	53264629
Posterior reversible encephalopathy syndrome	28.10	16.86	39	28798	16121	53304108
Drug hypersensitivity	27.86	16.86	64	28773	265178	53055051
Cholestasis	27.66	16.86	53	28784	28642	53291587
Cytopenia	27.20	16.86	29	28808	9141	53311088
Escherichia infection	27.07	16.86	33	28804	12017	53308212
Discomfort	26.92	16.86	9	28828	95463	53224766
Mycobacterium abscessus infection	26.83	16.86	11	28826	664	53319565
Hypotension	26.61	16.86	231	28606	253845	53066384
Seizure	26.43	16.86	139	28698	129370	53190859
Drug ineffective	26.22	16.86	601	28236	816644	52503585
Hypernatraemia	26.01	16.86	25	28812	6972	53313257
Aspartate aminotransferase increased	26.00	16.86	102	28735	83927	53236302
Blood alkaline phosphatase increased	25.70	16.86	64	28773	41298	53278931
Migraine	25.61	16.86	6	28831	80411	53239818
Disease progression	25.53	16.86	116	28721	101804	53218425
Hyperchlorhydria	25.48	16.86	14	28823	1632	53318597
Escherichia bacteraemia	25.36	16.86	18	28819	3290	53316939
Hyperoxaluria	25.33	16.86	7	28830	122	53320107
Gamma-glutamyltransferase increased	25.30	16.86	56	28781	33499	53286730
Myocardial infarction	25.29	16.86	11	28826	99343	53220886
Splenic injury	25.24	16.86	8	28829	228	53320001
Liver abscess	25.23	16.86	17	28820	2858	53317371
Globulins decreased	25.14	16.86	8	28829	231	53319998
Respiratory distress	24.99	16.86	56	28781	33771	53286458
Cross sensitivity reaction	24.94	16.86	15	28822	2072	53318157
Cytomegalovirus test positive	24.91	16.86	17	28820	2918	53317311
Noninfectious peritonitis	24.85	16.86	8	28829	240	53319989
Haemorrhagic disorder	24.75	16.86	11	28826	811	53319418
Diabetic macroangiopathy	24.67	16.86	7	28830	135	53320094
Hypoalbuminaemia	24.65	16.86	30	28807	10906	53309323
Tubulointerstitial nephritis	24.57	16.86	37	28800	16467	53303762
Death neonatal	24.54	16.86	8	28829	250	53319979
Pericarditis	24.48	16.86	3	28834	64403	53255826
Pseudomonal sepsis	24.35	16.86	15	28822	2164	53318065
Abdominal pain upper	23.88	16.86	33	28804	166258	53153971
Type IV hypersensitivity reaction	23.82	16.86	16	28821	2676	53317553
Cerebral mass effect	23.65	16.86	11	28826	901	53319328
Herpes simplex viraemia	23.34	16.86	7	28830	165	53320064
Toxic skin eruption	23.28	16.86	32	28805	13107	53307122
Acute graft versus host disease in skin	23.18	16.86	17	28820	3269	53316960
Hypochromasia	22.95	16.86	8	28829	308	53319921
Hyperhidrosis	22.68	16.86	12	28825	96781	53223448
Osteomyelitis bacterial	22.66	16.86	7	28830	183	53320046
Hypotonia	22.59	16.86	26	28811	8915	53311314
Venoocclusive disease	22.59	16.86	14	28823	2041	53318188
Klebsiella bacteraemia	22.57	16.86	12	28825	1310	53318919
Bacterial sepsis	22.47	16.86	18	28819	3944	53316285
Vulvovaginitis	22.47	16.86	8	28829	328	53319901
Colitis	22.43	16.86	61	28776	41491	53278738
Somnolence	22.41	16.86	35	28802	167699	53152530
Lung abscess	22.39	16.86	13	28824	1684	53318545
Infusion related reaction	22.34	16.86	31	28806	155926	53164303
Folate deficiency	22.29	16.86	14	28823	2090	53318139
Herpes simplex hepatitis	22.28	16.86	8	28829	336	53319893
Hypertransaminasaemia	22.25	16.86	18	28819	3998	53316231
Metabolic alkalosis	22.16	16.86	16	28821	3003	53317226
Dry mouth	22.09	16.86	3	28834	59547	53260682
Relapsing fever	21.97	16.86	7	28830	203	53320026
Diffuse large B-cell lymphoma refractory	21.92	16.86	11	28826	1065	53319164
Overgrowth fungal	21.91	16.86	6	28831	101	53320128
Morganella infection	21.47	16.86	9	28828	575	53319654
Intentional overdose	21.43	16.86	5	28832	67200	53253029
Hyperaemia	21.24	16.86	14	28823	2269	53317960
Hyperamylasaemia	21.20	16.86	8	28829	387	53319842
Endocarditis	21.15	16.86	20	28817	5464	53314765
Status epilepticus	21.14	16.86	33	28804	15151	53305078
Rash morbilliform	21.05	16.86	16	28821	3247	53316982
Candida endophthalmitis	21.03	16.86	5	28832	46	53320183
Anisocytosis	20.98	16.86	9	28828	609	53319620
Exfoliative rash	20.90	16.86	15	28822	2789	53317440
Cytomegalovirus viraemia	20.79	16.86	19	28818	4972	53315257
Neutrophil count decreased	20.69	16.86	66	28771	49032	53271197
Cerebrovascular accident	20.59	16.86	16	28821	105158	53215071
Hypersensitivity	20.40	16.86	53	28784	210612	53109617
Suicidal ideation	20.32	16.86	4	28833	60507	53259722
Hyperkalaemia	20.25	16.86	70	28767	54186	53266043
Venoocclusive liver disease	20.22	16.86	18	28819	4554	53315675
Acid base balance abnormal	20.22	16.86	7	28830	264	53319965
Hydrocephalus	20.01	16.86	19	28818	5217	53315012
Cytomegalovirus infection	19.96	16.86	37	28800	19502	53300727
Liver disorder	19.76	16.86	57	28780	40098	53280131
Cardiac failure congestive	19.61	16.86	13	28824	92744	53227485
Hepatitis fulminant	19.59	16.86	16	28821	3603	53316626
Delayed graft function	19.56	16.86	10	28827	1007	53319222
Bronchitis	19.51	16.86	19	28818	111880	53208349
Antibiotic level above therapeutic	19.47	16.86	7	28830	295	53319934
Serum sickness	19.43	16.86	14	28823	2619	53317610
Epilepsy	19.42	16.86	43	28794	25724	53294505
Acute graft versus host disease in intestine	19.40	16.86	12	28825	1744	53318485
Coagulation test abnormal	19.22	16.86	9	28828	749	53319480
Low cardiac output syndrome	19.16	16.86	7	28830	309	53319920
Blood fibrinogen decreased	19.15	16.86	9	28828	755	53319474
Abdominal sepsis	19.09	16.86	11	28826	1405	53318824
Chest pain	19.07	16.86	47	28790	190138	53130091
Pulmonary haemorrhage	18.95	16.86	21	28816	6912	53313317
Systemic mycosis	18.89	16.86	10	28827	1082	53319147
Septal panniculitis	18.73	16.86	5	28832	76	53320153
Herpes simplex	18.73	16.86	22	28815	7707	53312522
Pulmonary sepsis	18.53	16.86	11	28826	1484	53318745
Clostridium test positive	18.53	16.86	13	28824	2333	53317896
Thrombotic microangiopathy	18.48	16.86	24	28813	9313	53310916
Acute myeloid leukaemia recurrent	18.41	16.86	11	28826	1502	53318727
Hyperammonaemia	18.39	16.86	18	28819	5131	53315098
Encephalitis	18.24	16.86	22	28815	7922	53312307
Dermatitis exfoliative generalised	18.12	16.86	15	28822	3440	53316789
Vision blurred	18.10	16.86	12	28825	85592	53234637
Musculoskeletal pain	18.10	16.86	9	28828	75191	53245038
Influenza	18.06	16.86	15	28822	95364	53224865
Injection site reaction	18.00	16.86	3	28834	51163	53269066
Kussmaul respiration	17.98	16.86	6	28831	202	53320027
Inappropriate schedule of product administration	17.96	16.86	9	28828	74869	53245360
Liver injury	17.93	16.86	38	28799	22065	53298164
Hospitalisation	17.86	16.86	8	28829	71004	53249225
CNS ventriculitis	17.84	16.86	5	28832	92	53320137
Fusarium infection	17.73	16.86	8	28829	611	53319618
Pulseless electrical activity	17.70	16.86	21	28816	7433	53312796
Sepsis syndrome	17.59	16.86	9	28828	908	53319321
Serratia infection	17.49	16.86	9	28828	919	53319310
Abdominal compartment syndrome	17.49	16.86	8	28829	631	53319598
Cardiomyopathy acute	17.44	16.86	6	28831	222	53320007
Oedema peripheral	17.28	16.86	42	28795	170745	53149484
Leukocytosis	17.22	16.86	40	28797	24694	53295535
Clostridial sepsis	17.12	16.86	7	28830	420	53319809
Calcification of muscle	17.11	16.86	4	28833	34	53320195
Pneumonia cytomegaloviral	17.07	16.86	12	28825	2160	53318069
Rhinorrhoea	17.05	16.86	4	28833	53574	53266655
Nosocomial infection	17.05	16.86	11	28826	1720	53318509
Blast cell count increased	17.02	16.86	7	28830	426	53319803
Gastrooesophageal reflux disease	16.93	16.86	12	28825	82651	53237578
Wound haemorrhage	16.90	16.86	12	28825	2195	53318034
Clostridial infection	16.87	16.86	16	28821	4386	53315843

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	475.79	14.64	495	37984	69359	32405688
Septic shock	461.13	14.64	484	37995	68505	32406542
Drug resistance	341.52	14.64	254	38225	22711	32452336
Pathogen resistance	333.39	14.64	181	38298	9329	32465718
Drug reaction with eosinophilia and systemic symptoms	287.63	14.64	266	38213	32219	32442828
Bronchopulmonary aspergillosis	220.62	14.64	159	38320	13528	32461519
Sepsis	220.50	14.64	541	37938	158293	32316754
Drug ineffective	201.41	14.64	940	37539	382537	32092510
Fatigue	181.31	14.64	95	38384	350606	32124441
Enterococcal infection	179.65	14.64	120	38359	9027	32466020
Pyrexia	165.91	14.64	782	37697	319186	32155861
Off label use	164.93	14.64	757	37722	305563	32169484
Respiratory failure	164.62	14.64	380	38099	106802	32368245
Candida infection	163.16	14.64	145	38334	16658	32458389
Disseminated intravascular coagulation	153.38	14.64	162	38317	23014	32452033
Hepatic function abnormal	142.03	14.64	217	38262	44623	32430424
Eosinophilia	141.78	14.64	161	38318	24797	32450250
Dizziness	137.49	14.64	39	38440	209579	32265468
Haemophagocytic lymphohistiocytosis	137.10	14.64	111	38368	11224	32463823
Fall	127.74	14.64	37	38442	196164	32278883
Klebsiella infection	126.63	14.64	92	38387	7920	32467127
Febrile neutropenia	120.17	14.64	362	38117	119204	32355843
Rash maculo-papular	111.24	14.64	151	38328	27871	32447176
Systemic candida	104.45	14.64	57	38422	2964	32472083
Product dose omission issue	100.62	14.64	5	38474	102570	32372477
Toxic epidermal necrolysis	100.61	14.64	123	38356	20470	32454577
Pseudomonas infection	99.46	14.64	95	38384	11961	32463086
Death	96.91	14.64	192	38287	382325	32092722
Aspergillus infection	95.10	14.64	91	38388	11483	32463564
Pancytopenia	92.32	14.64	277	38202	90958	32384089
Myocardial infarction	90.86	14.64	19	38460	125657	32349390
Thrombocytopenia	87.28	14.64	377	38102	147922	32327125
Geotrichum infection	79.26	14.64	28	38451	497	32474550
Drug ineffective for unapproved indication	76.03	14.64	88	38391	13824	32461223
Drug abuse	75.35	14.64	5	38474	80238	32394809
Herpes simplex oesophagitis	73.89	14.64	20	38459	136	32474911
Pain	73.83	14.64	68	38411	187488	32287559
Headache	72.76	14.64	75	38404	196122	32278925
Bone marrow failure	71.80	14.64	129	38350	30275	32444772
Dysbiosis	71.33	14.64	25	38454	433	32474614
Depression	65.51	14.64	17	38462	97043	32378004
Acute respiratory distress syndrome	64.62	14.64	111	38368	25142	32449905
Asthenia	61.68	14.64	116	38363	235828	32239219
Mucormycosis	61.34	14.64	52	38427	5602	32469445
Anxiety	60.76	14.64	19	38460	95986	32379061
Arthralgia	60.58	14.64	52	38427	148396	32326651
Renal impairment	59.64	14.64	241	38238	91731	32383316
Stenotrophomonas infection	59.23	14.64	33	38446	1787	32473260
Fungaemia	58.92	14.64	37	38442	2502	32472545
Pseudomembranous colitis	57.19	14.64	39	38440	3033	32472014
Clostridium difficile infection	54.71	14.64	85	38394	17711	32457336
Trichosporon infection	54.68	14.64	24	38455	771	32474276
Hyphaema	54.47	14.64	21	38458	481	32474566
Drug-induced liver injury	54.15	14.64	100	38379	23963	32451084
Weight decreased	53.53	14.64	70	38409	164748	32310299
Pneumonia bacterial	52.31	14.64	64	38415	10652	32464395
Cholestasis	51.85	14.64	105	38374	26928	32448119
Back pain	51.58	14.64	34	38445	111019	32364028
Product use in unapproved indication	50.67	14.64	221	38258	86983	32388064
Clostridium difficile colitis	50.55	14.64	73	38406	14258	32460789
Pain in extremity	50.53	14.64	40	38439	118861	32356186
Inflammatory marker increased	50.41	14.64	39	38440	3690	32471357
Hepatomegaly	50.32	14.64	62	38417	10395	32464652
Brain abscess	49.35	14.64	35	38444	2899	32472148
Nausea	47.52	14.64	207	38272	320642	32154405
Agranulocytosis	47.20	14.64	93	38386	23384	32451663
Liver injury	47.19	14.64	70	38409	14004	32461043
Blood pressure increased	46.25	14.64	18	38461	79336	32395711
Feeling abnormal	46.04	14.64	8	38471	60415	32414632
Pulmonary haemorrhage	45.12	14.64	57	38422	9800	32465247
Liver abscess	44.66	14.64	36	38443	3615	32471432
Spinal muscular atrophy	43.94	14.64	16	38463	311	32474736
Systemic mycosis	43.89	14.64	25	38454	1413	32473634
Joint swelling	43.74	14.64	5	38474	51730	32423317
Cardiac failure congestive	43.60	14.64	23	38456	84829	32390218
Inappropriate schedule of product administration	42.58	14.64	3	38476	45822	32429225
Pneumonia	42.58	14.64	622	37857	354630	32120417
Gait disturbance	42.50	14.64	21	38458	80387	32394660
Myalgia	41.76	14.64	22	38457	81208	32393839
Fungal infection	41.60	14.64	69	38410	15186	32459861
Rheumatoid arthritis	41.15	14.64	3	38476	44541	32430506
Muscle spasms	40.99	14.64	16	38463	70402	32404645
Tachypnoea	40.62	14.64	72	38407	16711	32458336
Coagulopathy	39.89	14.64	78	38401	19499	32455548
Pneumococcal sepsis	39.87	14.64	20	38459	873	32474174
Nocardiosis	39.83	14.64	34	38445	3697	32471350
Pneumothorax	39.50	14.64	73	38406	17497	32457550
Coronary artery disease	39.17	14.64	6	38473	49700	32425347
Syncope	38.68	14.64	30	38449	90094	32384953
Drug eruption	38.61	14.64	76	38403	19090	32455957
Hypoalbuminaemia	38.49	14.64	58	38421	11764	32463283
Bacteraemia	38.07	14.64	72	38407	17561	32457486
Chest pain	37.99	14.64	55	38424	124082	32350965
Hypofibrinogenaemia	37.31	14.64	24	38455	1692	32473355
Aeromonas infection	37.14	14.64	14	38465	301	32474746
Enterococcus test positive	36.94	14.64	19	38460	875	32474172
C-reactive protein increased	36.86	14.64	133	38346	47969	32427078
Hepatic failure	36.65	14.64	109	38370	35571	32439476
Cough	36.42	14.64	68	38411	138749	32336298
Nasopharyngitis	36.30	14.64	15	38464	63772	32411275
Ototoxicity	36.17	14.64	23	38456	1589	32473458
Aplastic anaemia	35.93	14.64	44	38435	7329	32467718
Hyperhidrosis	35.52	14.64	20	38459	71148	32403899
Leukopenia	35.38	14.64	153	38326	59969	32415078
Neutropenia	35.23	14.64	288	38191	141887	32333160
Dyspnoea	34.58	14.64	269	38210	361776	32113271
Enterocolitis	34.48	14.64	43	38436	7297	32467750
Weight increased	34.47	14.64	29	38450	83634	32391413
Abdominal discomfort	34.02	14.64	10	38469	52614	32422433
Serum sickness-like reaction	33.11	14.64	10	38469	105	32474942
Dehydration	33.10	14.64	64	38415	128894	32346153
Acute generalised exanthematous pustulosis	33.10	14.64	40	38439	6573	32468474
Hepatotoxicity	32.30	14.64	71	38408	19266	32455781
Myelosuppression	32.09	14.64	53	38426	11623	32463424
Vomiting	31.83	14.64	157	38322	235400	32239647
Hypoxia	31.70	14.64	134	38345	51998	32423049
Platelet count decreased	31.61	14.64	238	38241	114353	32360694
Respiratory gas exchange disorder	31.35	14.64	14	38465	469	32474578
Cytomegalovirus infection	31.26	14.64	83	38396	25381	32449666
Cross sensitivity reaction	30.71	14.64	20	38459	1440	32473607
Rectal haemorrhage	30.69	14.64	4	38475	37419	32437628
Intentional overdose	30.63	14.64	6	38473	41595	32433452
Respiratory tract infection bacterial	30.48	14.64	15	38464	628	32474419
Hospitalisation	30.42	14.64	10	38469	48961	32426086
Portal fibrosis	30.36	14.64	13	38466	393	32474654
Cytokine release syndrome	30.13	14.64	56	38423	13479	32461568
Hyperferritinaemia	30.02	14.64	13	38466	404	32474643
Acinetobacter infection	29.99	14.64	18	38461	1122	32473925
Tubulointerstitial nephritis	29.50	14.64	69	38410	19508	32455539
Vision blurred	29.30	14.64	8	38471	44178	32430869
Encephalopathy	29.08	14.64	98	38381	34159	32440888
Shock	29.00	14.64	78	38401	24036	32451011
Clostridium test positive	28.66	14.64	23	38456	2294	32472753
Staphylococcal sepsis	28.60	14.64	46	38433	9867	32465180
Neutropenic colitis	28.50	14.64	24	38455	2561	32472486
Epidermolysis bullosa	28.41	14.64	9	38470	112	32474935
Rash morbilliform	28.35	14.64	25	38454	2839	32472208
Insomnia	28.26	14.64	47	38432	100301	32374746
Pneumonia fungal	28.24	14.64	36	38443	6244	32468803
Incorrect dose administered	28.12	14.64	4	38475	35024	32440023
Respiratory paralysis	28.10	14.64	8	38471	67	32474980
Acute myeloid leukaemia recurrent	27.88	14.64	21	38458	1909	32473138
Sputum increased	27.87	14.64	22	38457	2143	32472904
Wound dehiscence	27.79	14.64	27	38452	3469	32471578
Cerebrovascular accident	27.64	14.64	37	38442	86283	32388764
Liver disorder	27.27	14.64	91	38388	31563	32443484
Dermatitis bullous	27.03	14.64	36	38443	6517	32468530
Endocarditis	26.98	14.64	36	38443	6528	32468519
Venoocclusive liver disease	26.68	14.64	38	38441	7327	32467720
Eosinophilic pneumonia	26.61	14.64	25	38454	3081	32471966
Constipation	26.50	14.64	70	38409	126303	32348744
Balance disorder	26.44	14.64	7	38472	39452	32435595
Aggression	26.36	14.64	7	38472	39382	32435665
Musculoskeletal stiffness	26.24	14.64	7	38472	39257	32435790
Therapeutic product effect decreased	26.21	14.64	3	38476	31014	32444033
Multiple-drug resistance	26.05	14.64	27	38452	3748	32471299
Wrong technique in product usage process	25.93	14.64	5	38474	35054	32439993
Oedema peripheral	25.63	14.64	61	38418	114030	32361017
Nosocomial infection	25.56	14.64	17	38462	1268	32473779
Condition aggravated	25.50	14.64	289	38190	155372	32319675
Hypertension	25.39	14.64	76	38403	131674	32343373
Chronic obstructive pulmonary disease	25.35	14.64	13	38466	48740	32426307
Tumour lysis syndrome	24.96	14.64	54	38425	14493	32460554
Hepatic cytolysis	24.49	14.64	39	38440	8294	32466753
Pneumonia klebsiella	24.29	14.64	23	38456	2862	32472185
Contusion	24.28	14.64	5	38474	33463	32441584
Vascular pseudoaneurysm thrombosis	24.24	14.64	7	38472	62	32474985
Treatment failure	24.06	14.64	101	38378	39062	32435985
Blood glucose increased	24.06	14.64	25	38454	65216	32409831
Acute myeloid leukaemia	24.04	14.64	63	38416	19111	32455936
Cardiac valve vegetation	23.96	14.64	12	38467	522	32474525
Factor V inhibition	23.81	14.64	9	38470	195	32474852
Abscess bacterial	23.55	14.64	9	38470	201	32474846
Granulocyte count decreased	23.48	14.64	13	38466	695	32474352
Acute graft versus host disease in skin	23.22	14.64	29	38450	4928	32470119
Increased bronchial secretion	22.90	14.64	18	38461	1743	32473304
Neurotoxicity	22.58	14.64	53	38426	15017	32460030
Asthma	22.54	14.64	12	38467	44053	32430994
Interleukin-2 receptor increased	22.39	14.64	8	38471	147	32474900
Haemorrhagic pneumonia	22.34	14.64	8	38471	148	32474899
Blood alkaline phosphatase increased	22.24	14.64	86	38393	32046	32443001
Peripheral swelling	22.17	14.64	29	38450	68316	32406731
Renal failure	22.16	14.64	250	38229	134228	32340819
CNS ventriculitis	22.00	14.64	9	38470	242	32474805
Deep vein thrombosis	21.75	14.64	26	38453	63687	32411360
Gastrooesophageal reflux disease	21.73	14.64	7	38472	34731	32440316
Alanine aminotransferase increased	21.62	14.64	163	38316	78316	32396731
Transaminases increased	21.60	14.64	72	38407	24956	32450091
Meningitis bacterial	21.59	14.64	15	38464	1202	32473845
Leukocytosis	21.59	14.64	69	38410	23398	32451649
Suicidal ideation	21.59	14.64	9	38470	38074	32436973
Enterococcal sepsis	21.54	14.64	17	38462	1656	32473391
Drug level decreased	21.52	14.64	32	38447	6414	32468633
Candida sepsis	21.35	14.64	15	38464	1224	32473823
Intentional product misuse	21.29	14.64	8	38471	36043	32439004
Chest X-ray abnormal	21.28	14.64	25	38454	3988	32471059
Loss of consciousness	21.25	14.64	41	38438	82666	32392381
Drug intolerance	21.19	14.64	17	38462	50218	32424829
Shock haemorrhagic	21.18	14.64	42	38437	10603	32464444
Procalcitonin increased	21.18	14.64	17	38462	1696	32473351
Mobility decreased	21.12	14.64	4	38475	28405	32446642
Toxicity to various agents	21.06	14.64	124	38355	177917	32297130
Stevens-Johnson syndrome	20.98	14.64	59	38420	18650	32456397
Eosinophilic pneumonia acute	20.92	14.64	11	38468	530	32474517
Necrotising fasciitis	20.85	14.64	24	38455	3745	32471302
Dyspnoea exertional	20.84	14.64	10	38469	38951	32436096
Enterobacter infection	20.84	14.64	19	38460	2254	32472793
COVID-19	20.79	14.64	84	38395	31931	32443116
Scedosporium infection	20.63	14.64	13	38466	884	32474163
Transient ischaemic attack	20.58	14.64	3	38476	25791	32449256
Radiation fibrosis - lung	20.48	14.64	5	38474	21	32475026
Urinary tract infection fungal	20.34	14.64	10	38469	418	32474629
Immune effector cell-associated neurotoxicity syndrome	20.33	14.64	16	38463	1552	32473495
Nephrogenic diabetes insipidus	20.31	14.64	15	38464	1323	32473724
Angina pectoris	20.26	14.64	6	38473	31420	32443627
Dysarthria	20.23	14.64	7	38472	33194	32441853
Paraesthesia	20.18	14.64	24	38455	58920	32416127
Dyspepsia	20.09	14.64	7	38472	33048	32441999
Nephrolithiasis	20.02	14.64	4	38475	27350	32447697
Dermatitis exfoliative generalised	19.94	14.64	22	38457	3279	32471768
Candida test positive	19.92	14.64	10	38469	437	32474610
Hepatic necrosis	19.82	14.64	24	38455	3951	32471096
Septic embolus	19.66	14.64	14	38465	1167	32473880
Sleep disorder	19.40	14.64	4	38475	26748	32448299
Blood bilirubin increased	19.31	14.64	94	38385	38690	32436357
Graft versus host disease in gastrointestinal tract	19.19	14.64	22	38457	3419	32471628
Acute respiratory failure	19.16	14.64	76	38403	28652	32446395
Acute kidney injury	19.08	14.64	468	38011	293000	32182047
Hypokalaemia	19.06	14.64	121	38358	54973	32420074
Antinuclear antibody negative	19.01	14.64	5	38474	30	32475017
Intra-abdominal fluid collection	18.92	14.64	14	38465	1239	32473808
Strongyloidiasis	18.91	14.64	19	38460	2542	32472505
Acute hepatic failure	18.76	14.64	45	38434	12924	32462123
Device related infection	18.61	14.64	55	38424	17878	32457169
Chimerism	18.58	14.64	8	38471	245	32474802
Faeces pale	18.54	14.64	15	38464	1514	32473533
Lung consolidation	18.29	14.64	27	38452	5376	32469671
Type IV hypersensitivity reaction	18.19	14.64	14	38465	1314	32473733
Myasthenia gravis crisis	18.14	14.64	10	38469	530	32474517
Myocardial calcification	18.11	14.64	5	38474	37	32475010
Mediastinitis	18.02	14.64	11	38468	707	32474340
Decreased appetite	17.97	14.64	114	38365	160699	32314348
Tremor	17.81	14.64	44	38435	81233	32393814
Vascular pseudoaneurysm	17.81	14.64	17	38462	2137	32472910
Heart rate decreased	17.80	14.64	4	38475	25196	32449851
Epilepsy	17.67	14.64	62	38417	22047	32453000
Coagulation time prolonged	17.64	14.64	14	38465	1374	32473673
Flavobacterium infection	17.50	14.64	6	38473	97	32474950
Arthritis	17.38	14.64	5	38474	26687	32448360
Fungal sepsis	17.31	14.64	12	38467	958	32474089
Blood lactate dehydrogenase increased	17.30	14.64	61	38418	21744	32453303
Graft versus host disease	17.28	14.64	39	38440	10767	32464280
Staphylococcal infection	17.15	14.64	80	38399	32359	32442688
Malaise	17.13	14.64	131	38348	177007	32298040
Gamma-glutamyltransferase increased	17.08	14.64	77	38402	30705	32444342
Hypernatraemia	17.01	14.64	33	38446	8200	32466847
Overdose	16.93	14.64	50	38429	87027	32388020
Potentiating drug interaction	16.92	14.64	25	38454	4983	32470064
Injection site pain	16.91	14.64	9	38470	33049	32441998
ADAMTS13 activity decreased	16.85	14.64	6	38473	109	32474938
Metabolic disorder	16.74	14.64	22	38457	3931	32471116
Hypoaesthesia	16.73	14.64	27	38452	58326	32416721
Dry mouth	16.69	14.64	4	38475	24115	32450932
Drug level increased	16.65	14.64	57	38422	20023	32455024
Chest discomfort	16.61	14.64	21	38458	50209	32424838
Macule	16.41	14.64	12	38467	1043	32474004
Soft tissue necrosis	16.39	14.64	8	38471	329	32474718
Muscular weakness	16.31	14.64	35	38444	67894	32407153
Acute graft versus host disease	16.28	14.64	28	38451	6342	32468705
Hyperbilirubinaemia	16.19	14.64	52	38427	17678	32457369
Respiratory distress	15.84	14.64	83	38396	35163	32439884
Hepatitis cholestatic	15.82	14.64	32	38447	8193	32466854
Circulatory collapse	15.82	14.64	58	38421	21067	32453980
Intestinal pseudo-obstruction	15.76	14.64	13	38466	1348	32473699
Amnesia	15.74	14.64	5	38474	25031	32450016
Staphylococcus test positive	15.60	14.64	19	38460	3146	32471901
Splenomegaly	15.60	14.64	45	38434	14432	32460615
Cytomegalovirus test positive	15.60	14.64	21	38458	3841	32471206
Cholangitis	15.47	14.64	32	38447	8326	32466721
Infective aneurysm	15.46	14.64	9	38470	530	32474517
Haemodynamic instability	15.45	14.64	33	38446	8778	32466269
Blood culture positive	15.36	14.64	24	38455	5021	32470026
Acoustic neuroma	15.34	14.64	6	38473	143	32474904
Bladder irrigation	15.31	14.64	5	38474	69	32474978
Plasma cell myeloma	15.29	14.64	28	38451	57586	32417461
Cholangiolitis	15.21	14.64	4	38475	24	32475023
Listeriosis	15.18	14.64	11	38468	942	32474105
Escherichia infection	15.16	14.64	29	38450	7131	32467916
Ependymitis	15.15	14.64	3	38476	3	32475044
Cystitis haemorrhagic	15.12	14.64	24	38455	5090	32469957
Linear IgA disease	15.12	14.64	14	38465	1694	32473353
Medication error	15.09	14.64	4	38475	22531	32452516
Dermatitis exfoliative	15.02	14.64	30	38449	7614	32467433
Hypoproteinaemia	14.93	14.64	15	38464	2006	32473041
Catheter site pain	14.93	14.64	12	38467	1200	32473847
Red blood cell sedimentation rate decreased	14.81	14.64	5	38474	77	32474970
Drug withdrawal syndrome	14.72	14.64	3	38476	20228	32454819
Retinopathy hypertensive	14.71	14.64	7	38472	272	32474775
Purpura non-thrombocytopenic	14.69	14.64	5	38474	79	32474968
Alveolitis necrotising	14.68	14.64	4	38475	28	32475019

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	antibacterials
CHEBI has role	CHEBI:88188	allergenic drug

Drug Use (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

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	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	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
119478-56-7	SECONDARY_CAS_RN
FV9J3JU8B1	UNII
29561	RXNORM
173661	MMSL
5055	MMSL
6047	MMSL
d04027	MMSL
005166	NDDF
387540000	SNOMEDCT_US
725669004	SNOMEDCT_US
96062004	SNOMEDCT_US

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	0781-3098	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
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1453	INJECTION, POWDER, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	26 sections
Meropenem	HUMAN PRESCRIPTION DRUG LABEL	1	70121-1454	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	26 sections