All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
	4981	116094-23-6

Description:

Molecule	Description
Synonyms: insulin aspart protamine recombinant insulin aspart protamine insulin aspart protamine crystalline insulin aspart insulin aspart recombinant novolog insulin aspart [rDNA origin] novorapid	Insulin that has been modified to contain an ASPARTIC ACID instead of a PROLINE at position 38 of the B-chain. Molecular weight: 5825.60 Formula: C256H381N65O79S6 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: 2345.16 ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
40	U	P
40	U	P
40	U	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Sept. 7, 1999	EMA	NovoRapid
June 7, 2000	FDA	NOVO NORDISK INC
Sept. 20, 2019	PMDA	Novo Nordisk Pharma Ltd.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Diabetic ketoacidosis	1613.15	10.55	620	53527	19885	63414990
Hypoglycaemia	1356.50	10.55	764	53383	59301	63375574
Blood glucose increased	1314.68	10.55	843	53304	82913	63351962
Blood glucose decreased	468.05	10.55	265	53882	20687	63414188
Hyperglycaemia	409.44	10.55	316	53831	41551	63393324
Diabetes mellitus inadequate control	383.55	10.55	208	53939	14918	63419957
Acute kidney injury	232.44	10.55	617	53530	262798	63172077
Glycosylated haemoglobin increased	219.55	10.55	135	54012	12263	63422612
Ketoacidosis	216.27	10.55	95	54052	4283	63430592
Blood glucose fluctuation	202.71	10.55	92	54055	4484	63430391
Diabetic retinopathy	195.81	10.55	74	54073	2253	63432622
Hypoglycaemic unconsciousness	179.92	10.55	53	54094	724	63434151
Hypoglycaemic coma	178.04	10.55	71	54076	2504	63432371
Product leakage	162.96	10.55	50	54097	791	63434084
Diabetic metabolic decompensation	146.14	10.55	55	54092	1655	63433220
Drug intolerance	144.61	10.55	42	54105	308619	63126256
Drug ineffective	141.05	10.55	442	53705	1044323	62390552
Arthropathy	136.80	10.55	19	54128	234773	63200102
Blood glucose abnormal	132.29	10.55	83	54064	7809	63427066
Synovitis	127.69	10.55	8	54139	186910	63247965
Contraindicated product administered	123.57	10.55	19	54128	217629	63217246
Alopecia	115.14	10.55	73	54074	337463	63097412
Glossodynia	112.82	10.55	11	54136	178865	63256010
Treatment failure	111.58	10.55	18	54129	199025	63235850
Joint swelling	106.19	10.55	75	54072	327591	63107284
Systemic lupus erythematosus	102.35	10.55	26	54121	208892	63225983
Lactic acidosis	96.56	10.55	140	54007	38147	63396728
Diabetic neuropathy	96.27	10.55	53	54094	3911	63430964
Infusion related reaction	95.45	10.55	45	54102	245476	63189399
Product quality issue	88.78	10.55	130	54017	35735	63399140
Pericarditis	88.75	10.55	6	54141	131573	63303302
Hypoglycaemia unawareness	85.28	10.55	20	54127	102	63434773
Hyper IgE syndrome	84.91	10.55	27	54120	483	63434392
Arthralgia	82.24	10.55	233	53914	569477	62865398
Wound	80.56	10.55	20	54127	163243	63271632
Liquid product physical issue	79.66	10.55	32	54115	1150	63433725
Pain	78.76	10.55	345	53802	740283	62694592
Discomfort	76.08	10.55	24	54123	167350	63267525
Abdominal discomfort	74.29	10.55	99	54048	320786	63114089
Therapeutic product effect decreased	74.16	10.55	36	54111	193151	63241724
Hypoglycaemic seizure	73.54	10.55	24	54123	468	63434407
Rheumatoid arthritis	72.29	10.55	66	54081	253753	63181122
Exposure during pregnancy	69.70	10.55	290	53857	155257	63279618
Diabetic ketosis	69.08	10.55	20	54127	256	63434619
Anti-insulin antibody positive	67.37	10.55	16	54131	87	63434788
Oesophageal spasm	65.68	10.55	38	54109	3085	63431790
Restrictive pulmonary disease	60.80	10.55	30	54117	1765	63433110
Ketosis	60.80	10.55	22	54125	591	63434284
Heart sounds	60.41	10.55	25	54122	971	63433904
Helicobacter infection	60.38	10.55	5	54142	92780	63342095
Foetal exposure during pregnancy	59.91	10.55	102	54045	31860	63403015
Oesophageal pain	59.72	10.55	38	54109	3663	63431212
Musculoskeletal stiffness	58.76	10.55	43	54104	184575	63250300
Prolonged expiration	58.10	10.55	25	54122	1071	63433804
Dehydration	57.53	10.55	296	53851	173058	63261817
Hyperkalaemia	55.98	10.55	135	54012	54068	63380807
Myocardial infarction	55.14	10.55	199	53948	99694	63335181
Completed suicide	54.60	10.55	28	54119	145645	63289230
Toxicity to various agents	54.47	10.55	79	54068	247171	63187704
Hypoglycaemia neonatal	54.20	10.55	23	54124	952	63433923
Sleep apnoea syndrome	52.02	10.55	91	54056	29042	63405833
Infective pulmonary exacerbation of cystic fibrosis	50.38	10.55	49	54098	8768	63426107
Chronic kidney disease	46.80	10.55	113	54034	45285	63389590
Wrong product administered	46.57	10.55	40	54107	6101	63428774
Renal failure	46.29	10.55	211	53936	117441	63317434
Polyuria	46.07	10.55	46	54101	8496	63426379
Euglycaemic diabetic ketoacidosis	45.50	10.55	32	54115	3642	63431233
Swelling	45.49	10.55	105	54042	275273	63159602
Lipodystrophy acquired	45.44	10.55	23	54124	1429	63433446
Diabetes mellitus	45.29	10.55	127	54020	55683	63379192
Irritable bowel syndrome	44.94	10.55	8	54139	82404	63352471
Hypersensitivity	44.89	10.55	116	54031	292569	63142306
Hydrops foetalis	42.85	10.55	17	54130	591	63434284
Premature baby	42.65	10.55	69	54078	20666	63414209
Ketonuria	41.68	10.55	17	54130	636	63434239
Drug hypersensitivity	41.16	10.55	132	54015	310555	63124320
Insulin resistance	39.99	10.55	18	54129	860	63434015
Hepatic enzyme increased	38.60	10.55	71	54076	202257	63232618
Therapeutic product effect incomplete	37.40	10.55	31	54116	125025	63309850
Respiration abnormal	37.30	10.55	36	54111	6381	63428494
Caesarean section	36.85	10.55	58	54089	16974	63417901
International normalised ratio abnormal	36.84	10.55	27	54120	3277	63431598
Polycystic ovaries	35.70	10.55	30	54117	4441	63430434
Mobility decreased	35.06	10.55	31	54116	121128	63313747
Product physical issue	34.87	10.55	31	54116	4949	63429926
Sinusitis	34.60	10.55	90	54057	226563	63208312
Product use issue	33.33	10.55	88	54059	220432	63214443
Pre-eclampsia	33.25	10.55	40	54107	9093	63425782
Bladder agenesis	33.14	10.55	10	54137	149	63434726
Dyslipidaemia	33.03	10.55	36	54111	7357	63427518
Off label use	32.82	10.55	393	53754	674069	62760806
Genitalia external ambiguous	32.72	10.55	10	54137	156	63434719
Cloacal exstrophy	32.72	10.55	10	54137	156	63434719
Congenital ectopic bladder	32.41	10.55	9	54138	98	63434777
Caudal regression syndrome	32.09	10.55	10	54137	167	63434708
Depressive symptom	31.68	10.55	27	54120	4075	63430800
Gastrointestinal malformation	31.49	10.55	10	54137	178	63434697
Lymphoedema	31.30	10.55	44	54103	11648	63423227
Tethered cord syndrome	31.22	10.55	11	54136	273	63434602
Meconium stain	30.83	10.55	10	54137	191	63434684
Cerebrovascular accident	30.77	10.55	177	53970	107847	63327028
Congenital multiplex arthrogryposis	30.66	10.55	7	54140	31	63434844
Impaired healing	29.95	10.55	26	54121	102516	63332359
Device failure	29.92	10.55	31	54116	5980	63428895
Gastrointestinal disorder congenital	29.77	10.55	9	54138	135	63434740
Lethargy	29.56	10.55	110	54037	55897	63378978
Congenital genital malformation	29.06	10.55	9	54138	147	63434728
Dialysis	29.05	10.55	40	54107	10387	63424488
Blood ketone body	27.96	10.55	7	54140	49	63434826
Hyperhidrosis	27.71	10.55	172	53975	107664	63327211
Hip arthroplasty	27.37	10.55	4	54143	47642	63387233
Pancreatitis	27.28	10.55	98	54049	48957	63385918
Blood cholesterol increased	27.27	10.55	24	54123	94008	63340867
Blister	27.09	10.55	43	54104	129771	63305104
Blood ketone body increased	26.91	10.55	10	54137	290	63434585
Coronavirus test positive	26.88	10.55	13	54134	732	63434143
Neural tube defect	26.78	10.55	9	54138	193	63434682
Diabetic gastroparesis	26.72	10.55	10	54137	296	63434579
Anencephaly	26.69	10.55	10	54137	297	63434578
Appetite disorder	26.54	10.55	32	54115	7289	63427586
Diabetic nephropathy	26.16	10.55	16	54131	1438	63433437
Rash	26.04	10.55	330	53817	560541	62874334
Hospitalisation	25.94	10.55	142	54005	84939	63349936
Nasopharyngitis	25.93	10.55	120	54027	254137	63180738
Ultrasound antenatal screen	25.79	10.55	9	54138	217	63434658
Sepsis neonatal	25.70	10.55	11	54136	465	63434410
Productive cough	25.32	10.55	114	54033	63094	63371781
Abdominal pain	25.06	10.55	370	53777	293086	63141789
Fracture blisters	24.98	10.55	7	54140	79	63434796
Impaired gastric emptying	24.91	10.55	37	54110	10295	63424580
Urosepsis	24.58	10.55	51	54096	18473	63416402
Knee arthroplasty	24.21	10.55	8	54139	54198	63380677
Anal atresia	24.17	10.55	10	54137	388	63434487
Flank pain	23.94	10.55	47	54100	16363	63418512
Vomiting	23.53	10.55	634	53513	558983	62875892
Abscess	23.43	10.55	47	54100	16621	63418254
Type 1 diabetes mellitus	23.43	10.55	22	54125	3768	63431107
Restless legs syndrome	23.40	10.55	50	54097	18481	63416394
Dyspnoea	23.38	10.55	733	53414	660580	62774295
Product use in unapproved indication	23.05	10.55	77	54070	179003	63255872
Accidental underdose	23.05	10.55	12	54135	791	63434084
Diabetic ketoacidotic hyperglycaemic coma	22.84	10.55	6	54141	52	63434823
Neonatal respiratory distress syndrome	22.69	10.55	19	54128	2799	63432076
Bicuspid aortic valve	22.62	10.55	7	54140	114	63434761
Gastrointestinal disorder	22.49	10.55	49	54098	131190	63303685
Fatigue	22.37	10.55	582	53565	887446	62547429
Cystic fibrosis	22.06	10.55	20	54127	3276	63431599
Fear-related avoidance of activities	21.77	10.55	7	54140	130	63434745
Bursitis	21.54	10.55	3	54144	37038	63397837
Diabetic hyperosmolar coma	21.47	10.55	9	54138	361	63434514
Acute myocardial infarction	21.23	10.55	68	54079	32056	63402819
Product dispensing error	20.79	10.55	34	54113	10271	63424604
Urinary tract infection	20.77	10.55	329	53818	264355	63170520
Rales	20.54	10.55	38	54109	12659	63422216
Fluid retention	20.52	10.55	103	54044	59583	63375292
Psoriatic arthropathy	20.36	10.55	29	54118	91491	63343384
Angina pectoris	20.18	10.55	64	54083	30014	63404861
Ill-defined disorder	20.15	10.55	24	54123	81731	63353144
Meningomyelocele	19.96	10.55	10	54137	608	63434267
Premature delivery	19.92	10.55	64	54083	30217	63404658
Polyhydramnios	19.72	10.55	16	54131	2255	63432620
Hypervolaemia	19.56	10.55	61	54086	28352	63406523
Large intestine polyp	19.36	10.55	29	54118	8128	63426747
Umbilical cord abnormality	19.29	10.55	10	54137	653	63434222
Therapy non-responder	19.01	10.55	22	54125	75879	63358996
Rhabdomyolysis	18.92	10.55	81	54066	43870	63391005
Headache	18.39	10.55	406	53741	632835	62802040
Hyperglycaemic unconsciousness	18.20	10.55	3	54144	0	63434875
Shoulder dystocia	18.20	10.55	3	54144	0	63434875
Exomphalos	17.95	10.55	9	54138	548	63434327
Device expulsion	17.76	10.55	4	54143	34918	63399957
Decreased insulin requirement	17.66	10.55	6	54141	133	63434742
Carcinoid crisis	17.23	10.55	7	54140	259	63434616
High risk pregnancy	17.06	10.55	6	54141	148	63434727
Intentional overdose	17.03	10.55	115	54032	74037	63360838
Spina bifida	16.87	10.55	10	54137	849	63434026
Device operational issue	16.74	10.55	7	54140	279	63434596
Lymphangiectasia	16.60	10.55	5	54142	74	63434801
Mesenteric arterial occlusion	16.55	10.55	6	54141	162	63434713
Diabetic foot	16.53	10.55	12	54135	1435	63433440
Butterfly rash	16.48	10.55	13	54134	1760	63433115
Congenital anomaly	16.46	10.55	13	54134	1763	63433112
Increased insulin requirement	16.42	10.55	5	54142	77	63434798
Product container issue	16.35	10.55	13	54134	1780	63433095
Therapeutic response decreased	16.32	10.55	17	54130	61508	63373367
Fall	16.31	10.55	444	53703	391890	63042985
Loss of consciousness	16.21	10.55	163	53984	117958	63316917
Hypoglycaemic encephalopathy	16.16	10.55	7	54140	305	63434570
Diabetic hepatopathy	16.13	10.55	3	54144	3	63434872
Hepatic encephalopathy	16.08	10.55	32	54115	11250	63423625
Infection	16.00	10.55	122	54025	229051	63205824
Generalised oedema	15.90	10.55	39	54108	15779	63419096
White blood cell count decreased	15.79	10.55	63	54084	139041	63295834
Maculopathy	15.68	10.55	14	54133	2248	63432627
Red blood cell sedimentation rate increased	15.67	10.55	9	54138	43973	63390902
Acute painful neuropathy of rapid glycaemic control	15.67	10.55	3	54144	4	63434871
Metabolic acidosis	15.65	10.55	78	54069	44991	63389884
Foetal hypokinesia	15.58	10.55	8	54139	512	63434363
Therapeutic drug monitoring analysis incorrectly performed	15.50	10.55	7	54140	337	63434538
Pneumonia	15.49	10.55	504	53643	456263	62978612
Cardiac septal hypertrophy	15.09	10.55	6	54141	210	63434665
Cholestasis	14.86	10.55	57	54090	29377	63405498
Mental status changes	14.80	10.55	70	54077	39529	63395346
Neisseria infection	14.71	10.55	5	54142	111	63434764
Extradural haematoma	14.68	10.55	12	54135	1710	63433165
Resting tremor	14.66	10.55	9	54138	814	63434061
Liver injury	14.66	10.55	18	54129	60502	63374373
Blindness transient	14.62	10.55	17	54130	3727	63431148
Dyspepsia	14.52	10.55	42	54105	102154	63332721
Product administration error	14.43	10.55	47	54100	22350	63412525
Suicide attempt	14.31	10.55	95	54052	60823	63374052
Cellulitis	14.24	10.55	119	54028	81839	63353036
Left ventricular hypertrophy	14.22	10.55	20	54127	5295	63429580
Product storage error	14.11	10.55	36	54111	14920	63419955
Tinnitus	14.07	10.55	64	54083	35564	63399311
Hip fracture	14.00	10.55	56	54091	29418	63405457
Retinopathy	13.61	10.55	15	54132	3104	63431771
Conjoined twins	13.58	10.55	6	54141	274	63434601
Anti-insulin antibody increased	13.49	10.55	4	54143	56	63434819
Contusion	13.46	10.55	74	54073	149970	63284905
Coronary artery disease	13.42	10.55	59	54088	32318	63402557
Immunosuppressant drug level increased	13.35	10.55	16	54131	3622	63431253
Trisomy 18	13.30	10.55	5	54142	150	63434725
Multiple lentigines syndrome	13.20	10.55	5	54142	153	63434722
Pemphigoid	13.18	10.55	23	54124	7321	63427554
Diabetic coma	13.18	10.55	8	54139	709	63434166
Renal hypertension	13.17	10.55	5	54142	154	63434721
Hyperglycaemic hyperosmolar nonketotic syndrome	13.15	10.55	9	54138	980	63433895
Lower respiratory tract infection	13.14	10.55	63	54084	132244	63302631
Blood test abnormal	13.10	10.55	36	54111	15593	63419282
Pulmonary fibrosis	13.01	10.55	9	54138	39800	63395075
Macrosomia	12.99	10.55	4	54143	64	63434811
Malaise	12.84	10.55	454	53693	415500	63019375
Sputum increased	12.82	10.55	13	54134	2446	63432429
Therapeutic drug monitoring analysis not performed	12.76	10.55	10	54137	1342	63433533
Ataxia	12.74	10.55	35	54112	15160	63419715
Sleep disorder	12.73	10.55	32	54115	81534	63353341
Congenital aortic valve stenosis	12.71	10.55	4	54143	69	63434806
Blindness cortical	12.67	10.55	7	54140	520	63434355
Intentional product use issue	12.65	10.55	61	54086	127831	63307044
Hepatotoxicity	12.61	10.55	8	54139	37033	63397842
Diabetic retinal oedema	12.61	10.55	6	54141	326	63434549
Incorrect dose administered by device	12.60	10.55	17	54130	4331	63430544
Abortion spontaneous	12.57	10.55	76	54071	47119	63387756
Intraventricular haemorrhage neonatal	12.54	10.55	5	54142	176	63434699
Blood insulin decreased	12.53	10.55	3	54144	17	63434858
Night sweats	12.38	10.55	14	54133	48800	63386075
Splenic thrombosis	12.38	10.55	3	54144	18	63434857
Dyspnoea exertional	12.37	10.55	91	54056	60211	63374664
Foetal macrosomia	12.35	10.55	4	54143	76	63434799
Hepatocellular injury	12.20	10.55	51	54096	27330	63407545
Pancreas transplant	12.11	10.55	3	54144	20	63434855
Pyoderma	12.10	10.55	6	54141	357	63434518
Sopor	12.08	10.55	44	54103	22120	63412755
End stage renal disease	12.07	10.55	21	54126	6672	63428203
Oedema peripheral	11.77	10.55	227	53920	189284	63245591
Vision blurred	11.73	10.55	125	54022	91799	63343076
Haemodialysis complication	11.65	10.55	5	54142	213	63434662
Polymorphic light eruption	11.52	10.55	3	54144	25	63434850
Suspected product quality issue	11.49	10.55	5	54142	220	63434655
Neutrophil count decreased	11.46	10.55	19	54128	56387	63378488
Febrile neutropenia	11.42	10.55	57	54090	118392	63316483
Unresponsive to stimuli	11.37	10.55	58	54089	33758	63401117
Neutropenia	11.36	10.55	95	54052	174910	63259965
Hypernatraemia	11.35	10.55	22	54125	7587	63427288
Jaundice neonatal	11.32	10.55	8	54139	917	63433958
C-reactive protein increased	11.32	10.55	42	54105	94665	63340210
Leukocytosis	11.31	10.55	48	54099	25887	63408988
Pancreatic carcinoma	11.31	10.55	22	54125	7606	63427269
Glucose-6-phosphate dehydrogenase deficiency	11.24	10.55	5	54142	232	63434643
Psychotic disorder	11.13	10.55	4	54143	25708	63409167
Hypothermia	11.11	10.55	31	54116	13550	63421325
Loss of personal independence in daily activities	11.08	10.55	44	54103	97246	63337629
Basal cell carcinoma	11.06	10.55	5	54142	27986	63406889
Ventricular septal defect	11.02	10.55	16	54131	4362	63430513
Foot deformity	10.97	10.55	5	54142	27848	63407027
Selective eating disorder	10.88	10.55	11	54136	2061	63432814
Pancreatitis acute	10.88	10.55	49	54098	27117	63407758
Accidental overdose	10.84	10.55	44	54103	23265	63411610
Respiratory tract haemorrhage	10.81	10.55	6	54141	450	63434425
Expired product administered	10.63	10.55	19	54128	6162	63428713
Eczema	10.59	10.55	55	54092	32236	63402639
Cardiac failure congestive	10.57	10.55	123	54024	92310	63342565

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
Hypoglycaemia	1153.21	10.92	804	49217	53836	34853074
Blood glucose increased	664.70	10.92	634	49387	66084	34840826
Diabetic ketoacidosis	644.98	10.92	371	49650	17661	34889249
Blood glucose decreased	356.15	10.92	227	49794	13010	34893900
Diabetes mellitus inadequate control	294.64	10.92	203	49818	13261	34893649
Hyperglycaemia	268.09	10.92	306	49715	39174	34867736
Appendicolith	220.21	10.92	143	49878	8458	34898452
Hypoglycaemic unconsciousness	211.09	10.92	68	49953	730	34906180
Hypoglycaemic coma	206.34	10.92	90	49931	2341	34904569
Blood glucose fluctuation	199.44	10.92	103	49918	3941	34902969
Appendicitis	159.09	10.92	147	49874	14660	34892250
Drug abuse	110.98	10.92	8	50013	99088	34807822
Cardiogenic shock	110.77	10.92	162	49859	26456	34880454
Toxicity to various agents	105.02	10.92	80	49941	200282	34706628
Stress	102.87	10.92	168	49853	30179	34876731
Ascites	100.20	10.92	212	49809	46359	34860551
Ketoacidosis	99.98	10.92	67	49954	4176	34902734
Blood phosphorus increased	89.48	10.92	80	49941	7641	34899269
Glycosylated haemoglobin increased	89.04	10.92	95	49926	11265	34895645
Abdominal distension	88.45	10.92	232	49789	58260	34848650
Diabetic retinopathy	85.92	10.92	45	49976	1772	34905138
Drug ineffective	79.16	10.92	361	49660	456390	34450520
Ventricular fibrillation	79.04	10.92	128	49893	22826	34884084
Blood glucose abnormal	75.65	10.92	65	49956	5887	34901023
Acute kidney injury	71.24	10.92	707	49314	304281	34602629
Hypoglycaemic seizure	70.41	10.92	24	49997	311	34906599
Product quality issue	68.44	10.92	102	49919	16933	34889977
Diabetic metabolic decompensation	67.54	10.92	38	49983	1728	34905182
Completed suicide	65.84	10.92	29	49992	98139	34808771
Product leakage	61.82	10.92	25	49996	535	34906375
Trisomy 18	57.27	10.92	26	49995	745	34906165
Diabetic foot	56.21	10.92	40	49981	2748	34904162
Hydrops foetalis	54.35	10.92	26	49995	841	34906069
Cleft lip and palate	53.10	10.92	26	49995	886	34906024
Anti-insulin antibody positive	52.89	10.92	17	50004	181	34906729
Hyponatraemia	52.54	10.92	246	49775	82445	34824465
Hyperkalaemia	49.76	10.92	214	49807	69175	34837735
Vomiting	48.79	10.92	555	49466	247066	34659844
Ultrasound antenatal screen	45.29	10.92	20	50001	536	34906374
Hypoglycaemia neonatal	44.74	10.92	30	49991	1871	34905039
Myasthenia gravis	39.16	10.92	49	49972	6891	34900019
Sepsis	39.15	10.92	387	49634	166174	34740736
General physical health deterioration	38.86	10.92	315	49706	127954	34778956
Chronic kidney disease	37.52	10.92	137	49884	41073	34865837
Diabetic neuropathy	34.48	10.92	36	49985	4161	34902749
Disease progression	34.27	10.92	64	49957	108013	34798897
Wrong product administered	33.90	10.92	40	49981	5294	34901616
Dry mouth	33.34	10.92	107	49914	30058	34876852
Insulin resistance	33.13	10.92	17	50004	641	34906269
Device malfunction	33.03	10.92	56	49965	10365	34896545
Abortion spontaneous	31.33	10.92	14	50007	386	34906524
Liquid product physical issue	31.30	10.92	15	50006	487	34906423
Multiple organ dysfunction syndrome	29.41	10.92	199	49822	76367	34830543
Febrile neutropenia	29.39	10.92	99	49922	136750	34770160
Pulmonary valve stenosis congenital	29.17	10.92	10	50011	132	34906778
Hypoglycaemia unawareness	28.83	10.92	10	50011	137	34906773
Diabetic nephropathy	28.60	10.92	24	49997	2104	34904806
Periodontitis	28.29	10.92	23	49998	1929	34904981
Constipation	27.79	10.92	309	49712	136673	34770237
Foetal exposure during pregnancy	27.67	10.92	118	49903	37983	34868927
Blood ketone body increased	26.91	10.92	13	50008	430	34906480
Cutaneous amyloidosis	26.36	10.92	7	50014	35	34906875
Infective pulmonary exacerbation of cystic fibrosis	26.28	10.92	40	49981	6761	34900149
Insulin autoimmune syndrome	25.25	10.92	11	50010	285	34906625
Abdominal pain	24.99	10.92	350	49671	163268	34743642
Diabetic ketoacidotic hyperglycaemic coma	24.50	10.92	9	50012	147	34906763
Drug therapy	24.47	10.92	17	50004	1124	34905786
Diabetic complication	24.10	10.92	14	50007	677	34906233
Treatment failure	23.95	10.92	19	50002	46678	34860232
Lymphangitis	23.92	10.92	13	50008	552	34906358
Product use in unapproved indication	23.23	10.92	88	49933	117411	34789499
Hyperphosphataemia	22.94	10.92	30	49991	4407	34902503
Diabetic macroangiopathy	22.62	10.92	5	50016	9	34906901
Vitreous haemorrhage	22.51	10.92	22	49999	2351	34904559
Gallbladder neoplasm	22.44	10.92	6	50015	31	34906879
Loss of consciousness	22.35	10.92	198	49823	82469	34824441
Bronchopneumopathy	22.29	10.92	12	50009	500	34906410
Blood uric acid increased	22.06	10.92	45	49976	9579	34897331
Nausea	22.01	10.92	639	49382	339269	34567641
Hypoglycaemic encephalopathy	21.94	10.92	10	50011	289	34906621
Analgesic therapy	21.71	10.92	15	50006	983	34905927
Toe amputation	21.37	10.92	22	49999	2502	34904408
Infusion related reaction	21.03	10.92	27	49994	53030	34853880
Cystic fibrosis	20.85	10.92	18	50003	1640	34905270
Pulmonary vasculitis	20.53	10.92	12	50009	587	34906323
Pemphigoid	20.44	10.92	41	49980	8625	34898285
Aggression	19.80	10.92	16	50005	38948	34867962
Hallucination	19.60	10.92	27	49994	51471	34855439
Congenital bladder anomaly	19.32	10.92	9	50012	274	34906636
Sleep disorder therapy	19.08	10.92	14	50007	1009	34905901
Congenital cystic kidney disease	18.86	10.92	10	50011	404	34906506
Hepatotoxicity	18.59	10.92	4	50017	21481	34885429
Anti-insulin antibody	18.51	10.92	5	50016	27	34906883
Diabetic coma	18.13	10.92	13	50008	904	34906006
Overdose	18.12	10.92	68	49953	90991	34815919
Diabetic ketosis	18.03	10.92	7	50014	134	34906776
Neuritis	17.91	10.92	13	50008	921	34905989
Skin ulcer	17.86	10.92	71	49950	22145	34884765
Genitalia external ambiguous	17.82	10.92	8	50013	223	34906687
Product physical issue	17.74	10.92	20	50001	2521	34904389
Dysmetria	17.71	10.92	11	50010	601	34906309
Varicose vein	17.55	10.92	15	50006	1348	34905562
Osteitis	17.37	10.92	16	50005	1588	34905322
Impaired gastric emptying	17.32	10.92	23	49998	3430	34903480
Diabetes mellitus	16.33	10.92	119	49902	46754	34860156
Haemolytic anaemia	16.26	10.92	42	49979	10437	34896473
Gingival hypertrophy	15.65	10.92	16	50005	1805	34905105
Cold sweat	15.47	10.92	40	49981	9947	34896963
Renal aplasia	15.47	10.92	11	50010	755	34906155
Adenocarcinoma pancreas	15.45	10.92	14	50007	1360	34905550
Therapeutic drug monitoring analysis incorrectly performed	15.16	10.92	8	50013	320	34906590
Vitamin B12 increased	14.73	10.92	8	50013	339	34906571
Polycythaemia neonatorum	14.58	10.92	3	50018	3	34906907
Peripheral artery haematoma	14.31	10.92	5	50016	70	34906840
Wrong technique in device usage process	14.31	10.92	14	50007	1498	34905412
Diabetic foot infection	14.29	10.92	10	50011	669	34906241
Therapeutic product effect incomplete	14.25	10.92	32	49989	50509	34856401
Insulin-requiring type 2 diabetes mellitus	14.16	10.92	6	50015	145	34906765
Hyperinsulinaemic hypoglycaemia	14.12	10.92	5	50016	73	34906837
Diabetic gangrene	14.07	10.92	7	50014	247	34906663
Drug resistance	14.00	10.92	10	50011	25917	34880993
Fine motor skill dysfunction	13.99	10.92	15	50006	1787	34905123
Foetal hypokinesia	13.98	10.92	8	50013	376	34906534
Euglycaemic diabetic ketoacidosis	13.96	10.92	20	50001	3202	34903708
Truncus arteriosus persistent	13.93	10.92	4	50017	28	34906882
Cardiac output decreased	13.88	10.92	11	50010	889	34906021
Pancreatitis	13.70	10.92	99	49922	38792	34868118
Eye haemorrhage	13.46	10.92	23	49998	4282	34902628
Blood pressure fluctuation	13.29	10.92	10	50011	25239	34881671
Neonatal respiratory depression	13.22	10.92	8	50013	417	34906493
Incorrect route of product administration	13.21	10.92	49	49972	14796	34892114
Pain	13.09	10.92	210	49811	204465	34702445
Mucosal inflammation	13.01	10.92	22	49999	38600	34868310
Dry gangrene	12.98	10.92	8	50013	431	34906479
Herpes zoster reactivation	12.91	10.92	7	50014	296	34906614
Sedation	12.86	10.92	7	50014	20999	34885911
Haematochezia	12.68	10.92	30	49991	46504	34860406
Treatment noncompliance	12.61	10.92	76	49945	28024	34878886
Hepatocellular carcinoma	12.60	10.92	31	49990	7478	34899432
Therapy non-responder	12.55	10.92	23	49998	39123	34867787
Anxiety	12.51	10.92	87	49934	99341	34807569
Spermatic cord disorder	12.51	10.92	3	50018	9	34906901
Myelosuppression	12.42	10.92	6	50015	19259	34887651
Gangrene	12.41	10.92	23	49998	4563	34902347
Increased insulin requirement	12.41	10.92	5	50016	106	34906804
Device failure	12.18	10.92	16	50005	2360	34904550
Product administration error	12.16	10.92	51	49970	16293	34890617
Hepatic cirrhosis	12.09	10.92	53	49968	17261	34889649
Ketosis	12.06	10.92	8	50013	490	34906420
Product storage error	12.04	10.92	32	49989	8090	34898820
Basophil count abnormal	11.84	10.92	3	50018	12	34906898
Headache	11.80	10.92	209	49812	200426	34706484
Microalbuminuria	11.74	10.92	9	50012	693	34906217
Product complaint	11.72	10.92	26	49995	5864	34901046
Serotonin syndrome	11.69	10.92	7	50014	19926	34886984
Death	11.63	10.92	459	49562	397590	34509320
Neutrophil count decreased	11.63	10.92	36	49985	51068	34855842
Off label use	11.57	10.92	487	49534	419037	34487873
Heart disease congenital	11.56	10.92	12	50009	1378	34905532
Hunger	11.51	10.92	13	50008	1641	34905269
Postprandial hypoglycaemia	11.47	10.92	3	50018	14	34906896
Funguria	11.45	10.92	4	50017	56	34906854
Incorrect dose administered	11.44	10.92	98	49923	40417	34866493
Hypospadias	11.22	10.92	18	50003	3183	34903727
Nasopharyngitis	11.03	10.92	57	49964	69911	34836999
Heart rate increased	11.01	10.92	32	49989	46311	34860599
Stenosis	10.98	10.92	12	50009	1461	34905449
Haemorrhagic stroke	10.97	10.92	27	49994	6512	34900398

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
Hypoglycaemia	2272.85	9.92	1408	86842	100186	79555952
Diabetic ketoacidosis	1888.49	9.92	866	87384	33256	79622882
Blood glucose increased	1508.24	9.92	1147	87103	113828	79542310
Blood glucose decreased	689.57	9.92	404	87846	25830	79630308
Hyperglycaemia	614.35	9.92	555	87695	69780	79586358
Diabetes mellitus inadequate control	581.25	9.92	352	87898	23912	79632226
Hypoglycaemic coma	371.20	9.92	154	88096	4606	79651532
Hypoglycaemic unconsciousness	348.00	9.92	103	88147	1080	79655058
Blood glucose fluctuation	324.13	9.92	155	88095	6527	79649611
Acute kidney injury	277.61	9.92	1223	87027	518181	79137957
Ketoacidosis	274.70	9.92	146	88104	7708	79648430
Appendicolith	252.16	9.92	142	88108	8409	79647729
Diabetic retinopathy	237.17	9.92	99	88151	3007	79653131
Glycosylated haemoglobin increased	231.93	9.92	183	88067	19077	79637061
Product leakage	198.73	9.92	64	88186	906	79655232
Diabetic metabolic decompensation	194.90	9.92	88	88162	3244	79652894
Appendicitis	169.52	9.92	158	88092	20636	79635502
Drug ineffective	164.74	9.92	629	87621	1080284	78575854
Product quality issue	162.23	9.92	194	88056	33746	79622392
Blood glucose abnormal	150.56	9.92	111	88139	10455	79645683
Toxicity to various agents	149.17	9.92	148	88102	421392	79234746
Completed suicide	132.58	9.92	53	88197	245714	79410424
Synovitis	128.81	9.92	10	88240	150724	79505414
Arthropathy	121.77	9.92	24	88226	177087	79479051
Hypoglycaemic seizure	119.78	9.92	42	88208	782	79655356
Infusion related reaction	111.17	9.92	58	88192	230179	79425959
Joint swelling	105.92	9.92	98	88152	288548	79367590
Anti-insulin antibody positive	105.85	9.92	30	88220	266	79655872
Hand deformity	101.14	9.92	3	88247	103916	79552222
Drug intolerance	100.10	9.92	87	88163	264032	79392106
Hyperkalaemia	99.85	9.92	316	87934	114082	79542056
Cardiogenic shock	97.27	9.92	170	88080	41744	79614394
Liquid product physical issue	94.98	9.92	39	88211	1135	79655003
Treatment failure	94.84	9.92	35	88215	170451	79485687
Arthralgia	92.45	9.92	324	87926	571479	79084659
Diabetic neuropathy	92.41	9.92	67	88183	6149	79649989
Alopecia	91.62	9.92	73	88177	231282	79424856
Blood phosphorus increased	90.91	9.92	82	88168	10265	79645873
Abdominal distension	89.73	9.92	314	87936	119336	79536802
Hypoglycaemia unawareness	89.09	9.92	25	88225	213	79655925
Contraindicated product administered	88.21	9.92	32	88218	157506	79498632
Pain	87.11	9.92	442	87808	703360	78952778
Ascites	80.45	9.92	224	88026	75338	79580800
Glossodynia	80.05	9.92	10	88240	103327	79552811
Stress	77.01	9.92	228	88022	79384	79576754
Rheumatoid arthritis	76.18	9.92	71	88179	208399	79447739
Infective pulmonary exacerbation of cystic fibrosis	75.91	9.92	82	88168	12769	79643369
Drug abuse	75.57	9.92	43	88207	162648	79493490
Therapeutic product effect decreased	75.14	9.92	44	88206	163819	79492319
Hyper IgE syndrome	75.02	9.92	27	88223	544	79655594
Ventricular fibrillation	74.74	9.92	130	88120	31796	79624342
Diabetic ketosis	74.65	9.92	26	88224	474	79655664
Hydrops foetalis	73.86	9.92	29	88221	749	79655389
Chronic kidney disease	73.29	9.92	199	88051	65955	79590183
Systemic lupus erythematosus	72.38	9.92	22	88228	121127	79535011
Lactic acidosis	70.44	9.92	204	88046	70155	79585983
Ultrasound antenatal screen	69.92	9.92	27	88223	666	79655472
Diabetic foot	67.73	9.92	45	88205	3587	79652551
Wrong product administered	66.83	9.92	65	88185	8947	79647191
Oesophageal spasm	64.88	9.92	43	88207	3413	79652725
Pericarditis	63.97	9.92	18	88232	104218	79551920
Insulin resistance	63.88	9.92	31	88219	1348	79654790
Ketosis	63.52	9.92	29	88221	1097	79655041
Vomiting	62.54	9.92	1059	87191	664769	78991369
Trisomy 18	62.42	9.92	24	88226	585	79655553
Cleft lip and palate	59.25	9.92	24	88226	674	79655464
Helicobacter infection	58.49	9.92	5	88245	69699	79586439
Abdominal pain	57.73	9.92	672	87578	388897	79267241
Exposure during pregnancy	56.64	9.92	242	88008	100890	79555248
Oesophageal pain	54.41	9.92	42	88208	4237	79651901
Sinusitis	53.93	9.92	83	88167	195418	79460720
Euglycaemic diabetic ketoacidosis	53.85	9.92	51	88199	6793	79649345
Abdominal discomfort	52.13	9.92	126	88124	250601	79405537
Heart sounds	51.74	9.92	24	88226	942	79655196
Blood ketone body increased	51.74	9.92	22	88228	700	79655438
Diabetic nephropathy	51.33	9.92	35	88215	2912	79653226
Irritable bowel syndrome	50.79	9.92	5	88245	62236	79593902
Sepsis	49.32	9.92	485	87765	268943	79387195
Product physical issue	48.74	9.92	39	88211	4146	79651992
Musculoskeletal stiffness	48.56	9.92	74	88176	174934	79481204
Discomfort	48.01	9.92	41	88209	125576	79530562
Diabetic ketoacidotic hyperglycaemic coma	46.47	9.92	15	88235	214	79655924
Prolonged expiration	45.50	9.92	24	88226	1247	79654891
Folliculitis	43.77	9.92	5	88245	55375	79600763
Restrictive pulmonary disease	43.26	9.92	30	88220	2565	79653573
Therapeutic product effect incomplete	43.17	9.92	56	88194	141589	79514549
Dehydration	42.16	9.92	440	87810	247747	79408391
Ketonuria	40.96	9.92	22	88228	1186	79654952
Nasopharyngitis	40.82	9.92	144	88106	253737	79402401
Muscle injury	39.36	9.92	4	88246	48557	79607581
Product use in unapproved indication	38.93	9.92	144	88106	250215	79405923
Hyponatraemia	37.99	9.92	331	87919	177517	79478621
Myasthenia gravis	37.94	9.92	52	88198	10347	79645791
Multiple organ dysfunction syndrome	37.68	9.92	245	88005	120001	79536137
Mobility decreased	37.54	9.92	48	88202	122127	79534011
C-reactive protein abnormal	36.69	9.92	5	88245	48362	79607776
Cystic fibrosis	36.57	9.92	32	88218	3848	79652290
Headache	36.13	9.92	508	87742	653264	79002874
Drug hypersensitivity	36.12	9.92	189	88061	298727	79357411
Diabetes mellitus	36.02	9.92	177	88073	78213	79577925
Pemphigoid	35.37	9.92	62	88188	15253	79640885
Hyperhidrosis	35.02	9.92	287	87963	151205	79504933
Dyslipidaemia	34.88	9.92	53	88197	11580	79644558
Hypoglycaemic encephalopathy	34.10	9.92	16	88234	645	79655493
Loss of consciousness	34.03	9.92	309	87941	167634	79488504
Hepatic enzyme increased	33.95	9.92	97	88153	182513	79473625
Device malfunction	33.89	9.92	74	88176	21374	79634764
Pancreatitis	33.79	9.92	158	88092	68417	79587721
Insulin autoimmune syndrome	33.76	9.92	14	88236	418	79655720
Polycystic ovaries	33.30	9.92	30	88220	3749	79652389
Off label use	32.45	9.92	761	87489	906454	78749684
Cutaneous amyloidosis	31.69	9.92	8	88242	43	79656095
Hypersensitivity	31.57	9.92	166	88084	262073	79394065
Febrile neutropenia	30.82	9.92	141	88109	230858	79425280
Pre-eclampsia	30.01	9.92	38	88212	7003	79649135
Therapeutic drug monitoring analysis incorrectly performed	29.91	9.92	15	88235	701	79655437
Vitreous haemorrhage	29.85	9.92	28	88222	3685	79652453
Wound	29.53	9.92	52	88198	116127	79540011
Hospitalisation	29.52	9.92	192	88058	94044	79562094
Hip arthroplasty	28.84	9.92	3	88247	35753	79620385
Product administration error	28.71	9.92	89	88161	31757	79624381
Respiration abnormal	28.50	9.92	39	88211	7749	79648389
Sleep apnoea syndrome	28.42	9.92	97	88153	36381	79619757
Caesarean section	27.99	9.92	50	88200	12485	79643653
Drug therapy	27.66	9.92	17	88233	1184	79654954
Hepatic encephalopathy	27.06	9.92	73	88177	24093	79632045
Myocardial infarction	26.93	9.92	317	87933	183812	79472326
Impaired gastric emptying	26.67	9.92	44	88206	10309	79645829
Polyuria	26.27	9.92	54	88196	14960	79641178
Hepatotoxicity	26.18	9.92	12	88238	51340	79604798
Lymphoedema	25.80	9.92	48	88202	12365	79643773
Cold sweat	25.65	9.92	61	88189	18638	79637500
Diabetic hepatopathy	25.58	9.92	5	88245	5	79656133
Increased insulin requirement	25.16	9.92	9	88241	178	79655960
Analgesic therapy	25.08	9.92	15	88235	994	79655144
Device operational issue	25.00	9.92	11	88239	381	79655757
Hyperphosphataemia	24.97	9.92	33	88217	6343	79649795
Renal failure	24.70	9.92	335	87915	200633	79455505
Dyspnoea	24.35	9.92	1170	87080	855855	78800283
Gastrointestinal disorder	24.14	9.92	63	88187	122142	79533996
Hepatocellular carcinoma	24.13	9.92	39	88211	8982	79647156
Dialysis	24.01	9.92	59	88191	18403	79637735
Device failure	23.89	9.92	32	88218	6229	79649909
Disease progression	23.72	9.92	114	88136	184248	79471890
Fluid retention	23.58	9.92	145	88105	69664	79586474
Coronavirus test positive	23.53	9.92	15	88235	1114	79655024
Blood ketone body	23.49	9.92	8	88242	136	79656002
Lethargy	23.28	9.92	162	88088	81130	79575008
Fracture blisters	23.18	9.92	7	88243	79	79656059
Red blood cell sedimentation rate increased	23.01	9.92	11	88239	45931	79610207
Bronchopneumopathy	22.92	9.92	13	88237	780	79655358
Therapy non-responder	22.84	9.92	42	88208	92263	79563875
Psoriatic arthropathy	22.58	9.92	32	88218	77967	79578171
Diabetic gastroparesis	22.58	9.92	10	88240	352	79655786
Sleep disorder therapy	22.33	9.92	14	88236	1010	79655128
Ill-defined disorder	22.25	9.92	24	88226	65851	79590287
Blood uric acid increased	22.15	9.92	47	88203	13313	79642825
Product use issue	21.93	9.92	139	88111	209683	79446455
Impaired healing	21.59	9.92	40	88210	87615	79568523
Fear-related avoidance of activities	21.55	9.92	7	88243	102	79656036
Rash	21.50	9.92	482	87768	577876	79078262
Neutrophil count decreased	21.31	9.92	45	88205	93914	79562224
Drug resistance	21.31	9.92	10	88240	42203	79613935
International normalised ratio abnormal	21.28	9.92	29	88221	5739	79650399
Myelosuppression	21.20	9.92	9	88241	40287	79615851
Blood pressure fluctuation	21.02	9.92	26	88224	67119	79589019
Rales	20.99	9.92	59	88191	19942	79636196
Incorrect dose administered	20.95	9.92	151	88099	76479	79579659
Intentional product use issue	20.79	9.92	92	88158	152020	79504118
Pulmonary vasculitis	20.72	9.92	12	88238	749	79655389
Treatment noncompliance	20.53	9.92	113	88137	52155	79603983
Lymphangitis	20.53	9.92	15	88235	1393	79654745
Constipation	20.51	9.92	433	87817	282617	79373521
Lower respiratory tract infection	20.28	9.92	74	88176	129146	79526992
Type 1 diabetes mellitus	20.01	9.92	31	88219	6888	79649250
Pancreatitis acute	20.00	9.92	108	88142	49496	79606642
Hyperglycaemic hyperosmolar nonketotic syndrome	19.74	9.92	18	88232	2285	79653853
Swelling	19.48	9.92	150	88100	216561	79439577
Decreased insulin requirement	19.31	9.92	7	88243	144	79655994
Diabetic macroangiopathy	19.27	9.92	7	88243	145	79655993
Foetal macrosomia	19.19	9.92	4	88246	7	79656131
C-reactive protein increased	18.89	9.92	76	88174	128951	79527187
Bursitis	18.86	9.92	8	88242	35836	79620302
Insulin-requiring type 2 diabetes mellitus	18.75	9.92	7	88243	157	79655981
Appetite disorder	18.75	9.92	32	88218	7707	79648431
Gallbladder neoplasm	18.63	9.92	6	88244	85	79656053
Urosepsis	18.53	9.92	68	88182	26427	79629711
Cellulitis	18.33	9.92	193	88057	108867	79547271
Heart rate decreased	18.30	9.92	31	88219	70285	79585853
Polyhydramnios	17.87	9.92	15	88235	1705	79654433
Infection	17.87	9.92	176	88074	241536	79414602
Adenocarcinoma pancreas	17.64	9.92	16	88234	2017	79654121
Neuritis	17.58	9.92	15	88235	1743	79654395
Adverse drug reaction	17.53	9.92	29	88221	66363	79589775
Hyperglycaemic unconsciousness	17.42	9.92	3	88247	0	79656138
Haemorrhagic stroke	17.33	9.92	38	88212	11008	79645130
Hypervolaemia	17.24	9.92	93	88157	42597	79613541
Dyspepsia	17.21	9.92	62	88188	108625	79547513
Periodontitis	17.19	9.92	23	88227	4473	79651665
Product container issue	17.14	9.92	13	88237	1278	79654860
White blood cell count decreased	17.07	9.92	130	88120	188158	79467980
Anti-insulin antibody increased	16.85	9.92	6	88244	117	79656021
Product dispensing error	16.84	9.92	42	88208	13221	79642917
Device expulsion	16.75	9.92	4	88246	25857	79630281
Knee arthroplasty	16.66	9.92	14	88236	43234	79612904
Arthritis	16.60	9.92	68	88182	114812	79541326
Gangrene	16.59	9.92	33	88217	8931	79647207
Angina pectoris	16.56	9.92	106	88144	51626	79604512
Toe amputation	16.50	9.92	21	88229	3890	79652248
Blood insulin increased	16.40	9.92	8	88242	352	79655786
Foetal hypokinesia	16.31	9.92	8	88242	356	79655782
General physical health deterioration	16.20	9.92	409	87841	274829	79381309
Poisoning	16.19	9.92	4	88246	25268	79630870
Adverse event	16.18	9.92	26	88224	60188	79595950
Depressive symptom	16.15	9.92	27	88223	6396	79649742
Subgaleal haematoma	16.14	9.92	6	88244	133	79656005
Wrong technique in device usage process	16.01	9.92	21	88229	4007	79652131
Cerebrovascular accident	15.97	9.92	251	87999	155041	79501097
End stage renal disease	15.83	9.92	39	88211	12181	79643957
Metabolic acidosis	15.77	9.92	150	88100	82379	79573759
Hypothermia	15.59	9.92	58	88192	22688	79633450
Hypernatraemia	15.53	9.92	43	88207	14408	79641730
Anti-insulin antibody	15.45	9.92	5	88245	72	79656066
Suspected product tampering	15.35	9.92	3	88247	3	79656135
Hyperglycaemic seizure	15.35	9.92	3	88247	3	79656135
Injection site reaction	15.34	9.92	23	88227	54762	79601376
Respiratory arrest	15.32	9.92	25	88225	57525	79598613
Contusion	15.31	9.92	99	88151	148677	79507461
Diabetic coma	15.30	9.92	12	88238	1239	79654899
Product storage error	15.23	9.92	46	88204	16180	79639958
Diabetic hyperosmolar coma	15.16	9.92	10	88240	787	79655351
Hyperinsulinaemic hypoglycaemia	15.10	9.92	6	88244	160	79655978
Fatigue	15.04	9.92	859	87391	928868	78727270
Neutropenia	14.98	9.92	226	88024	287484	79368654
Acute painful neuropathy of rapid glycaemic control	14.89	9.92	3	88247	4	79656134
Immunodeficiency	14.84	9.92	3	88247	21765	79634373
Rhabdomyolysis	14.82	9.92	177	88073	102954	79553184
Erythema	14.71	9.92	167	88083	223123	79433015
Inflammation	14.50	9.92	54	88196	93699	79562439
Suspected product quality issue	14.31	9.92	7	88243	310	79655828
Cholestatic liver injury	14.10	9.92	22	88228	4919	79651219
Blood ketone body present	14.07	9.92	5	88245	97	79656041
Oedema peripheral	14.00	9.92	372	87878	251916	79404222
Abortion spontaneous	13.82	9.92	67	88183	29440	79626698
Sputum increased	13.81	9.92	21	88229	4592	79651546
Premature delivery	13.78	9.92	57	88193	23410	79632728
Fall	13.64	9.92	665	87585	486964	79169174
Blister	13.61	9.92	77	88173	119399	79536739
Eye haemorrhage	13.57	9.92	32	88218	9725	79646413
Diabetic gangrene	13.55	9.92	6	88244	211	79655927
Lymphangiectasia	13.53	9.92	5	88245	109	79656029
Coronary artery disease	13.52	9.92	121	88129	65353	79590785
Glucose-6-phosphate dehydrogenase deficiency	13.50	9.92	7	88243	351	79655787
Diabetic retinal oedema	13.48	9.92	7	88243	352	79655786
Generalised oedema	13.47	9.92	57	88193	23652	79632486
Gingival hypertrophy	13.46	9.92	17	88233	3125	79653013
Somnolence	13.44	9.92	353	87897	238628	79417510
Dry gangrene	13.22	9.92	10	88240	979	79655159
Hepatocellular injury	13.13	9.92	94	88156	47499	79608639
Oral herpes	13.11	9.92	7	88243	27447	79628691
Flank pain	13.10	9.92	50	88200	19794	79636344
Peritonitis bacterial	12.89	9.92	31	88219	9536	79646602
Leg amputation	12.88	9.92	18	88232	3648	79652490
Loss of personal independence in daily activities	12.86	9.92	64	88186	102516	79553622
Peripheral artery haematoma	12.85	9.92	5	88245	126	79656012
Fine motor skill dysfunction	12.78	9.92	22	88228	5335	79650803
Drug clearance decreased	12.69	9.92	17	88233	3310	79652828
Product complaint	12.68	9.92	38	88212	13311	79642827
Mesenteric arterial occlusion	12.67	9.92	6	88244	247	79655891
Hypoaesthesia	12.67	9.92	132	88118	179220	79476918
Night sweats	12.63	9.92	24	88226	52071	79604067
Incorrect dose administered by device	12.58	9.92	21	88229	4968	79651170
Product odour abnormal	12.50	9.92	11	88239	1333	79654805
Osteoarthritis	12.42	9.92	52	88198	87257	79568881
Intentional overdose	12.35	9.92	175	88075	105785	79550353
Swollen tongue	12.28	9.92	85	88165	42485	79613653
Suicide attempt	12.21	9.92	143	88107	82789	79573349
Sleep disorder due to a general medical condition	12.04	9.92	39	88211	14238	79641900
Dialysis device insertion	12.03	9.92	4	88246	63	79656075
Blood potassium increased	11.97	9.92	64	88186	29211	79626927
Mental status changes	11.96	9.92	120	88130	66839	79589299
Nonreassuring foetal heart rate pattern	11.90	9.92	3	88247	16	79656122
Cardiac failure	11.90	9.92	239	88011	154603	79501535
Acute myocardial infarction	11.86	9.92	134	88116	76902	79579236
Progressive multifocal leukoencephalopathy	11.84	9.92	4	88246	20596	79635542
Suicidal ideation	11.79	9.92	44	88206	76296	79579842
Pyoderma	11.77	9.92	7	88243	459	79655679
Nightmare	11.77	9.92	7	88243	25854	79630284
Foot deformity	11.70	9.92	6	88244	24068	79632070
Glomerular filtration rate decreased	11.69	9.92	53	88197	22649	79633489
Microalbuminuria	11.65	9.92	9	88241	909	79655229
Anaemia	11.64	9.92	603	87647	444412	79211726
Hypokalaemia	11.63	9.92	224	88026	143816	79512322
Multiple use of single-use product	11.60	9.92	9	88241	915	79655223
Neisseria infection	11.48	9.92	5	88245	169	79655969
Retrograde ejaculation	11.42	9.92	6	88244	309	79655829
Abscess	11.39	9.92	53	88197	22898	79633240
Haematochezia	11.38	9.92	54	88196	87591	79568547
Therapeutic response decreased	11.35	9.92	37	88213	66816	79589322
Grip strength decreased	11.32	9.92	5	88245	21864	79634274
Foot amputation	11.23	9.92	9	88241	959	79655179
Vision blurred	11.20	9.92	172	88078	105726	79550412
Subdural haemorrhage	11.13	9.92	22	88228	5926	79650212
Carcinoid crisis	11.03	9.92	7	88243	516	79655622
Postprandial hypoglycaemia	11.00	9.92	4	88246	83	79656055
Large intestine polyp	10.98	9.92	35	88215	12673	79643465
Acetonaemia	10.96	9.92	6	88244	336	79655802
Dystonia	10.91	9.92	5	88245	21394	79634744
Mydriasis	10.91	9.92	3	88247	17640	79638498
Multiple lentigines syndrome	10.81	9.92	5	88245	195	79655943
Lack of application site rotation	10.79	9.92	4	88246	88	79656050
Productive cough	10.74	9.92	147	88103	88184	79567954
Acute myeloid leukaemia	10.71	9.92	11	88239	30874	79625264
Troponin increased	10.71	9.92	46	88204	19209	79636929
Neoplasm progression	10.70	9.92	26	88224	51656	79604482
Therapy partial responder	10.68	9.92	3	88247	17394	79638744
Septic necrosis	10.66	9.92	4	88246	91	79656047
Polymorphic light eruption	10.65	9.92	3	88247	26	79656112
Blindness transient	10.60	9.92	19	88231	4757	79651381
Drug dependence	10.58	9.92	18	88232	40751	79615387
Blood pressure diastolic abnormal	10.57	9.92	4	88246	19198	79636940
Vascular purpura	10.57	9.92	15	88235	3083	79653055
High risk pregnancy	10.54	9.92	4	88246	94	79656044
Osteitis	10.48	9.92	17	88233	3926	79652212
Diabetic foot infection	10.43	9.92	8	88242	799	79655339
Basophil count abnormal	10.35	9.92	3	88247	29	79656109
Renal impairment	10.34	9.92	238	88012	157545	79498593
Butterfly rash	10.33	9.92	11	88239	1685	79654453
Conjunctivitis	10.31	9.92	8	88242	25707	79630431
Hot flush	10.30	9.92	29	88221	54848	79601290
Cystic fibrosis related diabetes	10.23	9.92	5	88245	221	79655917
Hepatic cytolysis	10.20	9.92	58	88192	27093	79629045
Basal cell carcinoma	10.17	9.92	16	88234	37359	79618779
Psychomotor hyperactivity	10.17	9.92	3	88247	16846	79639292
Maculopathy	10.12	9.92	14	88236	2811	79653327
Psychotic disorder	10.10	9.92	19	88231	41383	79614755
Sedation	10.06	9.92	27	88223	51868	79604270
Pregnancy	9.97	9.92	9	88241	26842	79629296
Accidental underdose	9.97	9.92	8	88242	854	79655284
Medication error	9.95	9.92	118	88132	68524	79587614
Drug reaction with eosinophilia and systemic symptoms	9.94	9.92	37	88213	64207	79591931

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A10AB05	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES INSULINS AND ANALOGUES Insulins and analogues for injection, fast-acting
ATC	A10AD05	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES INSULINS AND ANALOGUES Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting
ATC	A10AD06	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES INSULINS AND ANALOGUES Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting
FDA CS	M0011417	Insulin
FDA EPC	N0000175453	Insulin Analog
CHEBI has role	CHEBI:35526	antidiabetic
FDA EPC	N0000175944	Insulin
MeSH PA	D007004	Hypoglycemic Agents

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

Disease	Relation	SNOMED_ID	DOID
Diabetes mellitus	indication	73211009	DOID:9351

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Insulin receptor	Kinase	P06213	INSR_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
D04475	KEGG_DRUG
4021226	VUID
N0000148670	NUI
4017559	VANDF
4017569	VANDF
4019786	VANDF
4021226	VANDF
4021394	VANDF
CHEBI:5931	CHEBI
CHEMBL1201496	ChEMBL_ID
CHEMBL1201664	ChEMBL_ID
DB01306	DRUGBANK_ID
DB00030	DRUGBANK_ID
253182	RXNORM
15636	MMSL
17095	MMSL
327602	MMSL
37703	MMSL
4885	MMSL
4886	MMSL
d00262	MMSL
d04369	MMSL
d04697	MMSL
d04838	MMSL
000869	NDDF
000870	NDDF
006518	NDDF
007992	NDDF
009607	NDDF
126210001	SNOMEDCT_US
325072002	SNOMEDCT_US
388452006	SNOMEDCT_US
417423002	SNOMEDCT_US
420609005	SNOMEDCT_US
427292001	SNOMEDCT_US
96367001	SNOMEDCT_US
D061267	MESH_DESCRIPTOR_UI
C1708521	UMLSCUI
C0795635	UMLSCUI
7541	INN_ID
16132418	PUBCHEM_CID
5186	INN_ID
118984375	PUBCHEM_CID
D933668QVX	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
NOVOLOG	HUMAN PRESCRIPTION DRUG LABEL	1	0169-2100	INJECTION, SOLUTION	100 [iU]	INTRAVENOUS	BLA	29 sections
NOVOLOG	HUMAN PRESCRIPTION DRUG LABEL	1	0169-2100	INJECTION, SOLUTION	100 [iU]	INTRAVENOUS	BLA	29 sections
NOVOLOG	HUMAN PRESCRIPTION DRUG LABEL	1	0169-2101	INJECTION, SOLUTION	100 [iU]	INTRAVENOUS	BLA	29 sections
NOVOLOG	HUMAN PRESCRIPTION DRUG LABEL	1	0169-2101	INJECTION, SOLUTION	100 [iU]	INTRAVENOUS	BLA	29 sections
NovoLog Mix 70/30	HUMAN PRESCRIPTION DRUG LABEL	1	0169-2200	INJECTION, SUSPENSION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
NovoLog Mix 70/30	HUMAN PRESCRIPTION DRUG LABEL	1	0169-2200	INJECTION, SUSPENSION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
NovoLog Mix 70/30	HUMAN PRESCRIPTION DRUG LABEL	1	0169-2201	INJECTION, SUSPENSION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
NovoLog Mix 70/30	HUMAN PRESCRIPTION DRUG LABEL	1	0169-2201	INJECTION, SUSPENSION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3201	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3201	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3201	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3201	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3204	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3204	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3204	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3204	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3205	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3205	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3205	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3205	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
Fiasp	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3206	INJECTION, SOLUTION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
NOVOLOG	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3303	INJECTION, SOLUTION	100 [iU]	INTRAVENOUS	BLA	29 sections
NOVOLOG	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3303	INJECTION, SOLUTION	100 [iU]	INTRAVENOUS	BLA	29 sections
NovoLog Mix 70/30	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3685	INJECTION, SUSPENSION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
NovoLog Mix 70/30	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3685	INJECTION, SUSPENSION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
NovoLog Mix 70/30	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3696	INJECTION, SUSPENSION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
NovoLog Mix 70/30	HUMAN PRESCRIPTION DRUG LABEL	1	0169-3696	INJECTION, SUSPENSION	100 [iU]	SUBCUTANEOUS	BLA	27 sections
NOVOLOG	HUMAN PRESCRIPTION DRUG LABEL	1	0169-6338	INJECTION, SOLUTION	100 [iU]	INTRAVENOUS	BLA	29 sections
NOVOLOG	HUMAN PRESCRIPTION DRUG LABEL	1	0169-6338	INJECTION, SOLUTION	100 [iU]	INTRAVENOUS	BLA	29 sections
NOVOLOG	HUMAN PRESCRIPTION DRUG LABEL	1	0169-6339	INJECTION, SOLUTION	100 [iU]	INTRAVENOUS	BLA	29 sections