moxifloxacin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antibacterials, nalidixic acid derivatives	1854	151096-09-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: avelox moxifloxacin moxifloxacin hydrochloride avolex moxeza moxifloxacine moxifloxacin HCl	A fluoroquinolone that acts as an inhibitor of DNA TOPOISOMERASE II and is used as a broad-spectrum antibacterial agent. Molecular weight: 401.44 Formula: C21H24FN3O4 CLOGP: -0.08 LIPINSKI: 0 HAC: 7 HDO: 2 TPSA: 82.11 ALOGS: -3.38 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

avelox
moxifloxacin
moxifloxacin hydrochloride
avolex
moxeza
moxifloxacine
moxifloxacin HCl

A fluoroquinolone that acts as an inhibitor of DNA TOPOISOMERASE II and is used as a broad-spectrum antibacterial agent.

Molecular weight: 401.44
Formula: C21H24FN3O4
CLOGP: -0.08
LIPINSKI: 0
HAC: 7
HDO: 2
TPSA: 82.11
ALOGS: -3.38
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.40	g	O
0.40	g	P

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	27.50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	22 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	14.23 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	86 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	1.40 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.60 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	8.20 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Dec. 10, 1999	FDA	BAYER HLTHCARE

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
Anaphylactic reaction	1652.05	32.75	421	5222	9284	2343158
Rash	1256.36	32.75	529	5114	59029	2293413
Hypersensitivity	1008.16	32.75	352	5291	23241	2329201
Urticaria	975.51	32.75	346	5297	23915	2328527
Pruritus	960.30	32.75	400	5243	42940	2309502
Dyspnoea	934.88	32.75	470	5173	78263	2274179
Dizziness	871.90	32.75	409	5234	58256	2294186
Nausea	726.65	32.75	450	5193	111739	2240703
Drug hypersensitivity	724.72	32.75	336	5307	46307	2306135
Vomiting	593.91	32.75	338	5305	71264	2281178
Anaphylactic shock	534.29	32.75	146	5497	4140	2348302
Erythema	506.69	32.75	218	5425	24941	2327501
Electrocardiogram QT prolonged	496.98	32.75	158	5485	7656	2344786
Paraesthesia	443.13	32.75	191	5452	21897	2330545
Tendonitis	407.78	32.75	103	5540	2124	2350318
Anxiety	382.08	32.75	188	5455	29171	2323271
Palpitations	371.92	32.75	155	5488	16301	2336141
Tremor	338.00	32.75	155	5488	20506	2331936
Diarrhoea	313.16	32.75	241	5402	83323	2269119
Arthralgia	301.02	32.75	199	5444	54086	2298356
Toxic anterior segment syndrome	300.63	32.75	56	5587	237	2352205
Neuropathy peripheral	300.16	32.75	120	5523	11312	2341130
Swelling face	289.19	32.75	111	5532	9382	2343060
Hypoaesthesia	258.15	32.75	128	5515	20087	2332355
Loss of consciousness	246.04	32.75	121	5522	18646	2333796
Pain	243.41	32.75	184	5459	61673	2290769
Torsade de pointes	240.45	32.75	68	5575	2178	2350264
Tendon pain	238.44	32.75	53	5590	610	2351832
Tachycardia	236.78	32.75	113	5530	16296	2336146
Pyrexia	220.56	32.75	164	5479	53544	2298898
Lip swelling	219.94	32.75	76	5567	4745	2347697
Asthenia	219.29	32.75	155	5488	46771	2305671
Throat tightness	218.24	32.75	74	5569	4362	2348080
Myalgia	215.63	32.75	119	5524	23214	2329228
Tendon rupture	199.50	32.75	54	5589	1464	2350978
Pain in extremity	197.46	32.75	140	5503	42400	2310042
Oedema peripheral	194.64	32.75	112	5531	23651	2328791
Hypotension	191.63	32.75	124	5519	32312	2320130
Heart rate increased	186.50	32.75	85	5558	11020	2341422
Swollen tongue	186.20	32.75	69	5574	5274	2347168
Drug intolerance	184.27	32.75	90	5553	13627	2338815
Syncope	177.93	32.75	94	5549	16781	2335661
Headache	174.56	32.75	170	5473	80009	2272433
Chest discomfort	164.40	32.75	85	5558	14510	2337932
Mental disorder	162.92	32.75	58	5585	3949	2348493
Vision blurred	155.42	32.75	82	5561	14586	2337856
Burning sensation	154.09	32.75	67	5576	7761	2344681
Insomnia	153.19	32.75	99	5544	25688	2326754
Pharyngeal oedema	151.29	32.75	53	5590	3440	2349002
Ocular hyperaemia	150.97	32.75	55	5588	4001	2348441
Hyperhidrosis	145.99	32.75	80	5563	15342	2337100
Confusional state	145.91	32.75	94	5549	24250	2328192
Rash erythematous	143.78	32.75	59	5584	5917	2346525
Contrast media allergy	142.59	32.75	29	5614	209	2352233
Malaise	142.08	32.75	129	5514	55456	2296986
Swelling	141.62	32.75	80	5563	16270	2336172
Feeling abnormal	141.19	32.75	91	5552	23490	2328952
Abdominal pain	140.80	32.75	105	5538	34269	2318173
Hallucination	138.72	32.75	63	5580	8085	2344357
Muscular weakness	132.01	32.75	74	5569	14823	2337619
Eye pain	130.42	32.75	52	5591	4839	2347603
Joint swelling	126.26	32.75	75	5568	16744	2335698
Nervous system disorder	126.25	32.75	45	5598	3071	2349371
Blood pressure decreased	125.14	32.75	61	5582	9175	2343267
Eye swelling	121.67	32.75	48	5595	4342	2348100
Hypopyon	121.38	32.75	24	5619	147	2352295
Nervousness	120.63	32.75	50	5593	5139	2347303
Disorientation	120.37	32.75	53	5590	6319	2346123
Treatment failure	120.15	32.75	55	5588	7184	2345258
Chest pain	119.75	32.75	88	5555	28049	2324393
Speech disorder	119.64	32.75	53	5590	6411	2346031
Visual impairment	119.62	32.75	64	5579	11691	2340751
Iris transillumination defect	117.42	32.75	17	5626	2	2352440
Angioedema	115.38	32.75	56	5587	8340	2344102
Cardiac arrest	113.15	32.75	67	5576	14863	2337579
Ventricular tachycardia	112.66	32.75	41	5602	2970	2349472
Stevens-Johnson syndrome	112.56	32.75	45	5598	4214	2348228
Musculoskeletal injury	111.09	32.75	18	5625	24	2352418
Drug resistance	110.49	32.75	39	5604	2585	2349857
Thrombocytopenia	109.96	32.75	72	5571	19059	2333383
Corneal oedema	109.47	32.75	25	5618	327	2352115
Drug ineffective	107.96	32.75	149	5494	101475	2250967
Corneal epithelium defect	107.43	32.75	20	5623	84	2352358
Fatigue	106.37	32.75	135	5508	84738	2267704
Visual acuity reduced	106.35	32.75	46	5597	5252	2347190
Drug reaction with eosinophilia and systemic symptoms	104.55	32.75	46	5597	5472	2346970
Pneumonia	104.04	32.75	103	5540	49193	2303249
Photophobia	103.98	32.75	36	5607	2253	2350189
Endophthalmitis	103.45	32.75	28	5615	757	2351685
Tendon disorder	102.38	32.75	28	5615	788	2351654
Wheezing	101.23	32.75	47	5596	6337	2346105
Abdominal discomfort	101.04	32.75	66	5577	17390	2335052
Flushing	99.80	32.75	57	5586	11814	2340628
Seizure	96.19	32.75	73	5570	24393	2328049
Clostridium difficile colitis	95.60	32.75	33	5610	2046	2350396
Corneal infiltrates	95.03	32.75	17	5626	54	2352388
Ulcerative keratitis	92.53	32.75	24	5619	548	2351894
Bronchitis	89.64	32.75	56	5587	13658	2338784
Hepatitis	89.25	32.75	43	5600	6294	2346148
Eye irritation	85.54	32.75	35	5608	3477	2348965
Rash macular	85.36	32.75	35	5608	3496	2348946
Cough	84.66	32.75	77	5566	33040	2319402
Delirium	84.50	32.75	39	5604	5184	2347258
Arrhythmia	82.17	32.75	40	5603	5988	2346454
Muscle spasms	81.79	32.75	63	5580	21503	2330939
Hypertension	80.68	32.75	69	5574	27292	2325150
Feeling hot	79.78	32.75	41	5602	6887	2345555
Gait disturbance	79.31	32.75	63	5580	22482	2329960
Tinnitus	78.90	32.75	37	5606	5098	2347344
Toxic epidermal necrolysis	78.85	32.75	32	5611	3112	2349330
Chills	78.44	32.75	54	5589	15498	2336944
Abdominal pain upper	78.26	32.75	62	5581	22038	2330404
Panic attack	78.24	32.75	34	5609	3922	2348520
Dysphagia	77.96	32.75	50	5593	12755	2339687
International normalised ratio increased	77.57	32.75	41	5602	7295	2345147
Cardiovascular disorder	76.81	32.75	29	5614	2326	2350116
Eye pruritus	74.78	32.75	29	5614	2502	2349940
Dysgeusia	72.09	32.75	41	5602	8418	2344024
Skin injury	71.71	32.75	17	5626	264	2352178
Hepatic enzyme increased	71.63	32.75	43	5600	9759	2342683
Injury	70.76	32.75	36	5607	5918	2346524
Dry mouth	70.33	32.75	40	5603	8213	2344229
Anterior chamber cell	69.00	32.75	13	5630	59	2352383
Hypoaesthesia oral	67.98	32.75	26	5617	2160	2350282
Off label use	67.77	32.75	101	5542	73497	2278945
Decreased appetite	67.66	32.75	64	5579	28827	2323615
Paraesthesia oral	66.77	32.75	26	5617	2268	2350174
Vertigo	65.56	32.75	40	5603	9344	2343098
Upper respiratory tract infection	65.12	32.75	39	5604	8812	2343630
Aspartate aminotransferase increased	64.07	32.75	44	5599	12568	2339874
Punctate keratitis	63.94	32.75	14	5629	149	2352293
Depression	63.37	32.75	61	5582	28071	2324371
Emotional distress	63.07	32.75	30	5613	4265	2348177
Hepatotoxicity	62.64	32.75	28	5615	3453	2348989
Vitritis	62.25	32.75	14	5629	170	2352272
Weight decreased	61.06	32.75	60	5583	28311	2324131
Hallucination, visual	60.20	32.75	26	5617	2953	2349489
Restlessness	58.36	32.75	29	5614	4534	2347908
Obliterative bronchiolitis	58.03	32.75	14	5629	235	2352207
Alanine aminotransferase increased	57.59	32.75	43	5600	13989	2338453
Obstructive airways disorder	56.24	32.75	20	5623	1353	2351089
Face oedema	56.21	32.75	27	5616	3921	2348521
Jaundice	56.00	32.75	30	5613	5478	2346964
Cyanosis	55.33	32.75	25	5618	3160	2349282
Liver function test abnormal	55.08	32.75	33	5610	7457	2344985
Hyperventilation	54.53	32.75	19	5624	1210	2351232
Conjunctival hyperaemia	54.42	32.75	16	5627	587	2351855
Vasculitis	52.71	32.75	22	5621	2296	2350146
Suicidal ideation	52.37	32.75	37	5606	11050	2341392
Disturbance in attention	52.35	32.75	29	5614	5656	2346786
Respiratory distress	52.32	32.75	28	5615	5101	2347341
Multiple organ dysfunction syndrome	51.91	32.75	32	5611	7609	2344833
Cold sweat	51.79	32.75	21	5622	2036	2350406
White blood cell count increased	51.57	32.75	31	5612	7047	2345395
Hypokalaemia	51.36	32.75	36	5607	10618	2341824
Pulse absent	51.07	32.75	17	5626	942	2351500
Serum sickness	50.97	32.75	15	5628	552	2351890
Acute kidney injury	50.56	32.75	54	5589	28068	2324374
Aphasia	50.55	32.75	27	5616	4901	2347541
Bronchospasm	50.21	32.75	23	5620	3001	2349441
Eyelid oedema	50.06	32.75	22	5621	2604	2349838
Sinusitis	49.32	32.75	42	5601	16484	2335958
Pathogen resistance	49.13	32.75	16	5627	827	2351615
Musculoskeletal pain	48.53	32.75	35	5608	10795	2341647
Blood pressure increased	48.31	32.75	42	5601	16944	2335498
Anaphylactoid reaction	47.21	32.75	16	5627	937	2351505
Oxygen saturation decreased	47.08	32.75	30	5613	7556	2344886
Ventricular fibrillation	47.07	32.75	20	5623	2181	2350261
Purpura senile	47.03	32.75	8	5635	17	2352425
Infusion related reaction	46.98	32.75	33	5610	9763	2342679
Skin lesion	46.84	32.75	24	5619	4001	2348441
Intentional product use issue	46.38	32.75	23	5620	3579	2348863
Anaemia	46.00	32.75	57	5586	34735	2317707
Blood potassium decreased	45.96	32.75	26	5617	5279	2347163
Clostridial infection	45.81	32.75	15	5628	789	2351653
Dyskinesia	45.66	32.75	25	5618	4764	2347678
Crying	44.84	32.75	24	5619	4372	2348070
Mydriasis	43.63	32.75	19	5624	2200	2350242
Acute hepatic failure	43.56	32.75	20	5623	2622	2349820
Palmar erythema	43.09	32.75	11	5632	235	2352207
Feeling jittery	42.80	32.75	18	5625	1914	2350528
Asthma	42.72	32.75	33	5610	11281	2341161
Tarsal tunnel syndrome	42.70	32.75	8	5635	35	2352407
Blister	42.57	32.75	27	5616	6744	2345698
Ventricular extrasystoles	42.49	32.75	18	5625	1948	2350494
Skin reaction	42.22	32.75	18	5625	1979	2350463
Ototoxicity	42.08	32.75	11	5632	259	2352183
Heart rate irregular	42.00	32.75	19	5624	2408	2350034
Neck pain	41.80	32.75	28	5615	7669	2344773
Eosinophilic pneumonia acute	41.52	32.75	9	5634	91	2352351
Agitation	41.22	32.75	32	5611	11019	2341423
Foreign body sensation in eyes	41.13	32.75	12	5631	428	2352014
Drug interaction	40.52	32.75	49	5594	29114	2323328
Intra-abdominal haematoma	40.40	32.75	11	5632	304	2352138
Incoherent	40.03	32.75	14	5629	901	2351541
Adverse drug reaction	39.94	32.75	28	5615	8255	2344187
Circulatory collapse	39.89	32.75	21	5622	3699	2348743
Renal failure	39.75	32.75	38	5605	17311	2335131
Throat irritation	39.16	32.75	23	5620	5007	2347435
Ear pruritus	38.70	32.75	11	5632	357	2352085
No adverse event	38.64	32.75	29	5614	9499	2342943
Diplopia	38.41	32.75	20	5623	3445	2348997
Mobility decreased	38.39	32.75	28	5615	8782	2343660
Glaucoma	38.16	32.75	17	5626	2078	2350364
Herpes zoster	38.11	32.75	29	5614	9696	2342746
Gait inability	38.07	32.75	24	5619	5931	2346511
Respiratory failure	37.55	32.75	33	5610	13495	2338947
Hypoglycaemia	37.27	32.75	27	5616	8380	2344062
Rash maculo-papular	37.26	32.75	21	5622	4231	2348211
Adverse event	37.18	32.75	26	5617	7633	2344809
Peripheral nerve injury	36.80	32.75	8	5635	82	2352360
Dysphonia	36.61	32.75	24	5619	6340	2346102
Anterior chamber disorder	36.43	32.75	7	5636	36	2352406
Musculoskeletal stiffness	36.27	32.75	31	5612	12216	2340226
Thinking abnormal	36.14	32.75	16	5627	1926	2350516
Paradoxical drug reaction	35.98	32.75	11	5632	462	2351980
Physical disability	35.91	32.75	9	5634	178	2352264
Corneal opacity	34.88	32.75	9	5634	201	2352241
Respiratory arrest	34.81	32.75	23	5620	6155	2346287
Hepatic failure	34.06	32.75	22	5621	5667	2346775
Oedema mouth	34.03	32.75	12	5631	791	2351651
Lymphadenopathy	34.03	32.75	22	5621	5676	2346766
Sleep disorder	33.79	32.75	23	5620	6466	2345976
Balance disorder	33.71	32.75	27	5616	9720	2342722
Skin exfoliation	33.71	32.75	22	5621	5768	2346674
Discomfort	33.50	32.75	21	5622	5138	2347304
Tongue discolouration	33.37	32.75	11	5632	591	2351851
Loss of employment	33.29	32.75	8	5635	132	2352310
Lacrimation increased	33.29	32.75	17	5626	2813	2349629
Dry eye	33.22	32.75	19	5624	3937	2348505
Limb discomfort	33.21	32.75	18	5625	3361	2349081
Anosmia	33.07	32.75	12	5631	860	2351582
Rheumatoid arthritis	33.05	32.75	36	5607	19104	2333338
Mycobacterium avium complex infection	32.84	32.75	10	5633	414	2352028
Psychotic disorder	32.80	32.75	20	5623	4659	2347783

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
Anaphylactic reaction	844.35	34.52	228	3415	5885	1737253
Pruritus	495.39	34.52	213	3430	23009	1720129
Rash	448.87	34.52	233	3410	38460	1704678
Hypersensitivity	427.94	34.52	154	3489	10290	1732848
Urticaria	414.98	34.52	157	3486	12084	1731054
Dyspnoea	378.96	34.52	231	3412	51828	1691310
Electrocardiogram QT prolonged	373.92	34.52	119	3524	5426	1737712
Tendonitis	306.40	34.52	76	3567	1357	1741781
Tendon rupture	295.21	34.52	77	3566	1695	1741443
Anaphylactic shock	249.03	34.52	75	3568	2824	1740314
Neuropathy peripheral	240.05	34.52	98	3545	9155	1733983
Erythema	224.20	34.52	106	3537	14082	1729056
Dizziness	222.12	34.52	142	3501	34219	1708919
Arthralgia	187.15	34.52	111	3532	23333	1719805
Mental disorder	187.06	34.52	60	3583	2783	1740355
Tendon pain	171.68	34.52	39	3604	465	1742673
Swelling face	171.34	34.52	63	3580	4420	1738718
Delirium	149.94	34.52	63	3580	6299	1736839
Paraesthesia	143.43	34.52	71	3572	10380	1732758
Pyrexia	137.09	34.52	120	3523	46280	1696858
Toxic anterior segment syndrome	135.03	34.52	27	3616	164	1742974
Drug hypersensitivity	134.66	34.52	77	3566	15058	1728080
Pain in extremity	133.08	34.52	82	3561	18390	1724748
Vomiting	131.36	34.52	108	3535	38207	1704931
Confusional state	129.75	34.52	85	3558	21193	1721945
Loss of consciousness	127.84	34.52	74	3569	14801	1728337
Hypotension	126.18	34.52	95	3548	29559	1713579
Hepatotoxicity	123.93	34.52	45	3598	3039	1740099
Pain	121.44	34.52	89	3554	26568	1716570
Lip swelling	120.64	34.52	43	3600	2752	1740386
Visual acuity reduced	117.30	34.52	46	3597	3842	1739296
Hypoaesthesia	115.02	34.52	60	3583	9775	1733363
Tendon disorder	113.34	34.52	28	3615	488	1742650
Blood pressure decreased	110.97	34.52	54	3589	7592	1735546
Swelling	109.37	34.52	52	3591	6944	1736194
Nausea	108.13	34.52	110	3533	51086	1692052
Diarrhoea	107.06	34.52	112	3531	53740	1689398
Torsade de pointes	103.92	34.52	32	3611	1292	1741846
Oedema peripheral	101.77	34.52	65	3578	15485	1727653
Hallucination	101.72	34.52	52	3591	8118	1735020
Musculoskeletal injury	99.69	34.52	16	3627	17	1743121
Drug resistance	96.65	34.52	38	3605	3192	1739946
Hyperhidrosis	96.39	34.52	58	3585	12430	1730708
Tremor	93.70	34.52	58	3585	13073	1730065
Asthenia	92.87	34.52	85	3558	34585	1708553
Swollen tongue	90.97	34.52	35	3608	2773	1740365
Ulcerative keratitis	90.39	34.52	22	3621	359	1742779
Clostridium difficile colitis	89.85	34.52	30	3613	1574	1741564
Jaundice	88.48	34.52	43	3600	6019	1737119
Condition aggravated	88.11	34.52	67	3576	21083	1722055
Anxiety	87.20	34.52	59	3584	15468	1727670
Product use in unapproved indication	86.53	34.52	49	3594	9373	1733765
Skin injury	86.46	34.52	19	3624	192	1742946
Eye pain	86.17	34.52	32	3611	2299	1740839
Burning sensation	86.17	34.52	35	3608	3200	1739938
Nervous system disorder	84.57	34.52	32	3611	2422	1740716
Flushing	84.08	34.52	42	3601	6237	1736901
Corneal oedema	82.95	34.52	20	3623	313	1742825
Myalgia	82.01	34.52	57	3586	15601	1727537
Iris transillumination defect	81.59	34.52	12	3631	2	1743136
Endophthalmitis	81.13	34.52	23	3620	693	1742445
Multiple-drug resistance	79.18	34.52	19	3624	291	1742847
Aspartate aminotransferase increased	77.94	34.52	48	3595	10708	1732430
Off label use	76.04	34.52	80	3563	38491	1704647
Angioedema	74.82	34.52	45	3598	9619	1733519
Chest discomfort	72.39	34.52	40	3603	7291	1735847
Intraocular pressure increased	69.78	34.52	23	3620	1158	1741980
Palpitations	69.54	34.52	38	3605	6776	1736362
Arrhythmia	68.25	34.52	36	3607	5980	1737158
Pneumonia	67.51	34.52	82	3561	46100	1697038
Alanine aminotransferase increased	67.33	34.52	46	3597	12232	1730906
Emotional distress	66.55	34.52	25	3618	1853	1741285
Seizure	66.40	34.52	56	3587	20385	1722753
Insomnia	64.30	34.52	50	3593	16226	1726912
Intentional product use issue	64.21	34.52	27	3616	2692	1740446
Mycobacterial infection	64.20	34.52	16	3627	289	1742849
Abdominal pain	63.97	34.52	56	3587	21434	1721704
Vision blurred	59.50	34.52	37	3606	8386	1734752
Throat tightness	59.22	34.52	22	3621	1580	1741558
Cardiac arrest	58.75	34.52	47	3596	15883	1727255
Pharyngeal oedema	58.55	34.52	22	3621	1631	1741507
Hepatic failure	57.68	34.52	32	3611	5871	1737267
Syncope	56.97	34.52	44	3599	14125	1729013
Corneal infiltrates	56.63	34.52	11	3632	56	1743082
Uveitis	56.24	34.52	19	3624	1032	1742106
Stevens-Johnson syndrome	55.62	34.52	26	3617	3331	1739807
Injury	55.55	34.52	25	3618	2935	1740203
Hypopyon	55.45	34.52	12	3631	112	1743026
Chills	50.74	34.52	38	3605	11649	1731489
Cardiovascular disorder	49.27	34.52	22	3621	2535	1740603
Muscular weakness	48.26	34.52	35	3608	10214	1732924
Decreased appetite	47.79	34.52	50	3593	23821	1719317
Ocular hyperaemia	47.58	34.52	20	3623	1990	1741148
Wheezing	47.50	34.52	25	3618	4128	1739010
Bradycardia	47.40	34.52	35	3608	10499	1732639
Drug ineffective	47.11	34.52	82	3561	63719	1679419
Iridocyclitis	46.44	34.52	13	3630	373	1742765
Chest pain	45.86	34.52	45	3598	19869	1723269
Photophobia	45.80	34.52	17	3626	1217	1741921
Renal failure	45.66	34.52	45	3598	19972	1723166
Tuberculosis	45.62	34.52	19	3624	1847	1741291
Dysphoria	45.51	34.52	15	3628	754	1742384
Hypoglycaemia	44.77	34.52	31	3612	8407	1734731
Deafness	44.67	34.52	19	3624	1947	1741191
Acute kidney injury	44.51	34.52	58	3585	34886	1708252
Drug-induced liver injury	44.32	34.52	22	3621	3215	1739923
Pathogen resistance	44.11	34.52	16	3627	1073	1742065
Keratitis fungal	43.17	34.52	8	3635	30	1743108
Liver function test abnormal	42.57	34.52	26	3617	5700	1737438
Malaise	42.28	34.52	52	3591	29513	1713625
Coma	41.65	34.52	28	3615	7234	1735904
Tinnitus	41.64	34.52	21	3622	3174	1739964
Hepatic enzyme increased	41.54	34.52	27	3616	6594	1736544
Conjunctival hyperaemia	41.49	34.52	13	3630	555	1742583
Conjunctivitis	41.22	34.52	17	3626	1612	1741526
Ventricular tachycardia	41.00	34.52	22	3621	3776	1739362
Corneal opacity	40.74	34.52	10	3633	169	1742969
Drug eruption	40.39	34.52	20	3623	2906	1740232
Respiratory distress	39.83	34.52	24	3619	5133	1738005
Choroiditis	39.26	34.52	8	3635	54	1743084
Cyanosis	39.07	34.52	19	3624	2655	1740483
Clostridial infection	38.65	34.52	13	3630	696	1742442
Restlessness	38.34	34.52	22	3621	4299	1738839
Eye swelling	38.28	34.52	17	3626	1932	1741206
International normalised ratio increased	38.28	34.52	28	3615	8271	1734867
Abdominal discomfort	38.23	34.52	29	3614	9052	1734086
Thrombocytopenia	38.09	34.52	42	3601	21207	1721931
Tachycardia	37.70	34.52	33	3610	12595	1730543
Tubulointerstitial nephritis	37.25	34.52	19	3624	2939	1740199
Rhabdomyolysis	37.22	34.52	31	3612	11059	1732079
Atrial fibrillation	36.37	34.52	35	3608	15076	1728062
Diastasis recti abdominis	36.22	34.52	6	3637	9	1743129
Clostridium test positive	36.09	34.52	10	3633	276	1742862
Visual impairment	35.72	34.52	24	3619	6194	1736944
Hepatitis	35.55	34.52	22	3621	4933	1738205
Dysgeusia	35.17	34.52	22	3621	5027	1738111
Infusion site erythema	34.77	34.52	10	3633	317	1742821
Urethritis mycoplasmal	34.76	34.52	5	3638	0	1743138
Headache	34.66	34.52	51	3592	34325	1708813

Pharmacologic Action:

Source	Code	Description
ATC	J01MA14	ANTIINFECTIVES FOR SYSTEMIC USE ANTIBACTERIALS FOR SYSTEMIC USE QUINOLONE ANTIBACTERIALS Fluoroquinolones
ATC	S01AE07	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFECTIVES Fluoroquinolones
FDA EPC	N0000175937	Quinolone Antimicrobial
FDA Chemical/Ingredient	N0000007606	Quinolones
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D004791	Enzyme Inhibitors
CHEBI has role	CHEBI:36047	antibacterial drug
MeSH PA	D059005	Topoisomerase II Inhibitors

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Septicemic plague	indication	9012003	DOID:3481
Infection of skin AND/OR subcutaneous tissue	indication	19824006
Staphylococcal pneumonia	indication	22754005
Pneumonia due to Streptococcus	indication	34020007
Pneumonic plague	indication	38976008	DOID:10398
Pneumonia due to Mycoplasma pneumoniae	indication	46970008
Peritonitis	indication	48661000
Bacterial pneumonia	indication	53084003	DOID:874
Pneumonia due to Klebsiella pneumoniae	indication	64479007
Haemophilus influenzae pneumonia	indication	70036007
Rhinoscleroma	indication	72409005	DOID:11336
Abdominal abscess	indication	75100008
Acute bacterial sinusitis	indication	75498004
Infectious disease of abdomen	indication	128070006
Bacterial conjunctivitis	indication	128350005	DOID:9700
Infection due to Enterobacteriaceae	indication	128945009
Bacterial infection due to Klebsiella pneumoniae	indication	186435004
Pneumococcal pneumonia	indication	233607000
Chlamydial pneumonia	indication	233609002
Streptococcus pyogenes infection	indication	302809008
Infection due to Staphylococcus aureus	indication	406602003
Acute exacerbation of chronic bronchitis	indication	425748003
Complicated Skin and Skin Structure E. Coli Infection	indication
Complicated Skin and Skin Structure Infection	indication
Haemophilus Influenzae Chronic Bronchitis	indication
Complicated Skin and Skin Structure Staphylococcus Aureus Infection	indication
Haemophilus Parainfluenzae Chronic Bronchitis	indication
Streptococcus Pneumoniae Chronic Bronchitis	indication
Moraxella Catarrhalis Pneumonia	indication
Staphylococcus Chronic Bronchitis	indication
Klebsiella Pneumoniae Chronic Bronchitis	indication
Moraxella Catarrhalis Chronic Bronchitis	indication
Acute tuberculosis	off-label use	25629007
Pulmonary tuberculosis	off-label use	154283005	DOID:2957
Cirrhosis of liver	contraindication	19943007	DOID:5082
Torsades de pointes	contraindication	31722008
Transplantation of heart	contraindication	32413006
Tendinitis	contraindication	34840004	DOID:971
Hypokalemia	contraindication	43339004
Conduction disorder of the heart	contraindication	44808001
Bradycardia	contraindication	48867003
Transplant of kidney	contraindication	70536003
Epilepsy	contraindication	84757009	DOID:1826
Transplant of lung	contraindication	88039007
Myasthenia gravis	contraindication	91637004	DOID:437
Prolonged QT interval	contraindication	111975006
Liver function tests abnormal	contraindication	166603001
Drug-induced hepatitis	contraindication	235876009
Peripheral nerve disease	contraindication	302226006
Pseudomembranous enterocolitis	contraindication	397683000
Myocardial ischemia	contraindication	414795007	DOID:3393
Traumatic rupture of tendon	contraindication	415749005
Congenital long QT syndrome	contraindication	442917000
Severe Cerebral Arteriosclerosis	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	6.23	acidic
pKa2	8.54	Basic
pKa3	2.92	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
400MG/250ML (1.6MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	BAYER HLTHCARE	N021277	Nov. 30, 2001	DISCN	SOLUTION	INTRAVENOUS	6548079	July 25, 2020	METHOD OF COMBATING BACTERIA IN A PATIENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
DNA gyrase	Enzyme	GYRA_ECOLI GYRB_ECOLI	INHIBITOR	IC50	6.52	CHEMBL	CHEMBL
Topoisomerase IV	Enzyme	PARC_ECOLI PARE_ECOLI	INHIBITOR			CHEMBL	CHEMBL
DNA topoisomerase 4 subunit A	Enzyme	PARC_STAAU		IC50	6.10	CHEMBL
DNA gyrase subunit A	Enzyme	GYRA_MYCTU		IC50	5.04	CHEMBL

External reference:

ID	Source
D000077266	MESH_DESCRIPTOR_UI
C0875968	UMLSCUI
D00874	KEGG_DRUG
371296007	SNOMEDCT_US
007927	NDDF
d04500	MMSL
139462	RXNORM
4021185	VANDF
412439003	SNOMEDCT_US
C53598599T	UNII
186826-86-8	SECONDARY_CAS_RN
CHEMBL32	ChEMBL_ID
DB00218	DRUGBANK_ID
CHEMBL1200735	ChEMBL_ID
7659	INN_ID
MFX	PDB_CHEM_ID
CHEBI:63611	CHEBI
152946	PUBCHEM_CID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
MOXEZA	HUMAN PRESCRIPTION DRUG LABEL	1	0065-0006	SOLUTION	5 mg	OPHTHALMIC	NDA	14 sections
VIGAMOX	HUMAN PRESCRIPTION DRUG LABEL	1	0065-4013	SOLUTION/ DROPS	5 mg	OPHTHALMIC	NDA	15 sections
Moxifloxacin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7387	TABLET, FILM COATED	400 mg	ORAL	ANDA	19 sections
Moxifloxacin Ophthalmic Solution	HUMAN PRESCRIPTION DRUG LABEL	1	0781-7135	SOLUTION/ DROPS	5 mg	OPHTHALMIC	NDA authorized generic	15 sections
Moxifloxacin	HUMAN PRESCRIPTION DRUG LABEL	1	0904-6406	TABLET, FILM COATED	400 mg	ORAL	ANDA	20 sections
moxifloxacin hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	13668-201	TABLET	400 mg	ORAL	ANDA	20 sections
Avelox ABC Pack	HUMAN PRESCRIPTION DRUG LABEL	1	16590-881	TABLET, FILM COATED	400 mg	ORAL	NDA	17 sections
Moxifloxacin	HUMAN PRESCRIPTION DRUG LABEL	1	17478-519	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	15 sections
VIGAMOX	HUMAN PRESCRIPTION DRUG LABEL	1	21695-968	SOLUTION	5 mg	OPHTHALMIC	NDA	13 sections
Moxifloxacin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	40032-034	TABLET	400 mg	ORAL	ANDA	20 sections
Moxifloxacin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	47781-268	TABLET, FILM COATED	400 mg	ORAL	NDA authorized generic	20 sections
Moxifloxacin	HUMAN PRESCRIPTION DRUG LABEL	1	48792-7823	TABLET, FILM COATED	400 mg	ORAL	ANDA	18 sections
VIGAMOX	HUMAN PRESCRIPTION DRUG LABEL	1	50090-0859	SOLUTION/ DROPS	5 mg	OPHTHALMIC	NDA	15 sections
Moxifloxacin	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3147	TABLET, FILM COATED	400 mg	ORAL	ANDA	20 sections
Moxifloxacin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4058	TABLET	400 mg	ORAL	ANDA	20 sections
Moxifloxacin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4100	TABLET	400 mg	ORAL	ANDA	20 sections
Moxifloxacin ophthalmic solution	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4781	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	15 sections
Moxifloxacin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	50268-576	TABLET, FILM COATED	400 mg	ORAL	ANDA	21 sections
Avelox	HUMAN PRESCRIPTION DRUG LABEL	1	50419-530	TABLET, FILM COATED	400 mg	ORAL	NDA	20 sections
Avelox	HUMAN PRESCRIPTION DRUG LABEL	1	50419-537	INJECTION, SOLUTION	400 mg	INTRAVENOUS	NDA	20 sections
Moxifloxacin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	51991-943	TABLET	400 mg	ORAL	ANDA	20 sections
Avelox	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4367	TABLET, FILM COATED	400 mg	ORAL	NDA	21 sections
VIGAMOX	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4798	SOLUTION	5 mg	OPHTHALMIC	NDA	15 sections
Moxifloxacin	HUMAN PRESCRIPTION DRUG LABEL	1	55111-112	TABLET, FILM COATED	400 mg	ORAL	ANDA	20 sections
Moxifloxacin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	57237-156	TABLET, FILM COATED	400 mg	ORAL	ANDA	19 sections
Moxifloxacin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	60429-893	TABLET	400 mg	ORAL	ANDA	20 sections
Moxifloxacin ophthalmic solution	HUMAN PRESCRIPTION DRUG LABEL	1	62332-505	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	15 sections
Moxifloxacin	HUMAN PRESCRIPTION DRUG LABEL	1	63323-850	INJECTION, SOLUTION	400 mg	INTRAVENOUS	NDA	19 sections
MOXIFLOXACIN HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	65862-603	TABLET, FILM COATED	400 mg	ORAL	ANDA	19 sections
MOXIFLOXACIN	HUMAN PRESCRIPTION DRUG LABEL	1	65862-840	SOLUTION/ DROPS	5 mg	OPHTHALMIC	ANDA	15 sections