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

dornase alfa 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
enzymes	5135	143831-71-4

Description:

Molecule

Description

Synonyms: dornase alfa dornase alfa (genetical recombination) desoxyribonuclease pulmozyme recombinant deoxyribonuclease

A recombinant human deoxyribonuclease I (rhDNAse) with selective DNA cleaving activity. Upon intrapleural administration, dornase alfa catalyzes the degradation of extracellular DNA in airway secretions, which can reduce their viscosity. Thus, dornase alfa may both promote the clearing of airway mucus and improve pulmonary function. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
2.50	mg	Inhal.solution

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
Dec. 30, 1993	FDA	GENENTECH

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
Infective pulmonary exacerbation of cystic fibrosis	4233.43	26.11	793	11981	9486	90606187
Hospitalisation	1006.34	26.11	445	12329	127655	90488018
Cystic fibrosis	879.79	26.11	183	12591	3758	90611915
Pulmonary function test decreased	432.67	26.11	105	12669	4389	90611284
Haemoptysis	317.04	26.11	133	12641	33187	90582486
Bacterial disease carrier	299.10	26.11	66	12708	1800	90613873
Cystic fibrosis respiratory infection suppression	288.60	26.11	49	12725	306	90615367
Bronchial secretion retention	265.47	26.11	68	12706	3547	90612126
Superinfection	245.56	26.11	62	12712	3050	90612623
Sinus operation	189.31	26.11	50	12724	2941	90612732
Pneumonia	182.07	26.11	323	12451	637736	89977937
Bronchospasm	181.41	26.11	78	12696	20631	90595042
Pseudomonas infection	177.90	26.11	70	12704	14795	90600878
Scoliosis	173.40	26.11	60	12714	8847	90606826
Cough	159.24	26.11	226	12548	368736	90246937
Treatment noncompliance	148.81	26.11	92	12682	51635	90564038
Atelectasis	144.52	26.11	70	12704	24339	90591334
Infection	137.67	26.11	209	12565	361885	90253788
Aggression	127.04	26.11	66	12708	26602	90589071
Distal intestinal obstruction syndrome	120.76	26.11	25	12749	498	90615175
Nonspecific reaction	117.84	26.11	34	12740	2775	90612898
Eosinophilia	114.50	26.11	63	12711	28470	90587203
Rib fracture	110.59	26.11	60	12714	26375	90589298
Productive cough	105.11	26.11	87	12687	76976	90538697
Disease complication	103.81	26.11	33	12741	3739	90611934
Sputum increased	103.04	26.11	31	12743	2926	90612747
Forced expiratory volume decreased	101.08	26.11	36	12738	5772	90609901
Illness	98.40	26.11	86	12688	81883	90533790
No adverse event	95.32	26.11	78	12696	67904	90547769
Sleep disorder due to a general medical condition	88.44	26.11	63	12711	44675	90570998
Anxiety	81.73	26.11	152	12622	309620	90306053
Influenza	79.45	26.11	98	12676	139166	90476507
Drug ineffective	79.25	26.11	49	12725	1384249	89231424
Cystic fibrosis lung	71.59	26.11	13	12761	125	90615548
Viral infection	67.64	26.11	52	12722	41362	90574311
Lung transplant	64.68	26.11	23	12751	3669	90612004
Sinus disorder	64.62	26.11	47	12727	34400	90581273
Dyspnoea	63.96	26.11	269	12505	880686	89734987
Emergency care	61.20	26.11	18	12756	1571	90614102
Heart rate increased	58.89	26.11	76	12698	112826	90502847
Staphylococcal infection	56.45	26.11	50	12724	48389	90567284
Amniotic fluid index increased	54.27	26.11	10	12764	105	90615568
Pancreatic failure	53.53	26.11	16	12758	1476	90614197
Cystic fibrosis related diabetes	53.02	26.11	9	12765	56	90615617
Rhinovirus infection	50.68	26.11	22	12752	5941	90609732
Pneumonia pseudomonal	48.81	26.11	18	12756	3185	90612488
Pseudomonas test positive	47.09	26.11	13	12761	903	90614770
Infusion related reaction	46.94	26.11	3	12771	416777	90198896
Impaired quality of life	46.66	26.11	33	12741	23111	90592562
Wheezing	46.26	26.11	103	12671	237977	90377696
Confusional state	42.84	26.11	3	12771	386202	90229471
Loss of personal independence in daily activities	42.52	26.11	72	12702	136033	90479640
Pulmonary haemorrhage	41.52	26.11	21	12753	7992	90607681
Bronchiectasis	40.81	26.11	30	12744	22300	90593373
Foetal macrosomia	40.68	26.11	9	12765	248	90615425
Left-to-right cardiac shunt	39.85	26.11	9	12765	273	90615400
Palpitations	39.66	26.11	70	12704	136658	90479015
Myalgia	38.88	26.11	80	12694	175045	90440628
Steatorrhoea	38.36	26.11	10	12764	558	90615115
Pneumothorax	37.88	26.11	27	12747	19140	90596533
Lung disorder	37.51	26.11	72	12702	149811	90465862
Asthma	36.52	26.11	95	12679	242065	90373608
Infective exacerbation of bronchiectasis	35.20	26.11	9	12765	465	90615208
Contraindicated product administered	34.06	26.11	3	12771	320136	90295537
Respiration abnormal	33.08	26.11	18	12756	7945	90607728
Arthropathy	32.79	26.11	6	12768	366236	90249437
Wound	31.80	26.11	3	12771	302977	90312696
Atrial fibrillation	30.78	26.11	62	12712	133549	90482124
Chest discomfort	30.45	26.11	63	12711	138302	90477371
Pharyngitis streptococcal	30.01	26.11	20	12754	12722	90602951
Joint swelling	29.77	26.11	17	12757	503283	90112390
Pulmonary function test abnormal	29.63	26.11	12	12762	2727	90612946
Hypertension	29.21	26.11	14	12760	457518	90158155
Bronchopulmonary aspergillosis allergic	29.12	26.11	13	12761	3753	90611920
Peripheral swelling	28.98	26.11	11	12763	413095	90202578
Pain in extremity	28.43	26.11	14	12760	450515	90165158
Swelling	28.03	26.11	12	12762	419046	90196627
Respiratory symptom	27.61	26.11	13	12761	4239	90611434
Mental disorder	27.42	26.11	28	12746	32290	90583383
Toxicity to various agents	27.36	26.11	4	12770	287842	90327831
Weight gain poor	27.15	26.11	9	12765	1163	90614510
Acne cystic	26.26	26.11	8	12766	787	90614886
Musculoskeletal stiffness	26.23	26.11	5	12769	296527	90319146

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
Infective pulmonary exacerbation of cystic fibrosis	2936.24	31.09	605	9193	7213	42604324
Hospitalisation	741.92	31.09	354	9444	73976	42537561
Cystic fibrosis	715.70	31.09	150	9648	1905	42609632
Pulmonary function test decreased	383.07	31.09	111	9687	5621	42605916
Cystic fibrosis respiratory infection suppression	263.91	31.09	47	9751	228	42611309
Infection	200.84	31.09	182	9616	111886	42499651
Sputum increased	196.88	31.09	58	9740	3105	42608432
Disease complication	194.19	31.09	57	9741	3013	42608524
Pneumonia	183.84	31.09	338	9460	421811	42189726
Cough	156.28	31.09	198	9600	177905	42433632
Haemoptysis	146.72	31.09	105	9693	46062	42565475
Pseudomonas infection	111.63	31.09	60	9738	15863	42595674
No adverse event	108.69	31.09	82	9716	38939	42572598
Increased bronchial secretion	107.49	31.09	34	9764	2312	42609225
Spinal muscular atrophy	103.23	31.09	23	9775	393	42611144
Influenza	101.47	31.09	96	9702	62079	42549458
Lung transplant	94.67	31.09	31	9767	2355	42609182
Forced expiratory volume decreased	86.91	31.09	40	9758	7590	42603947
Productive cough	84.84	31.09	80	9718	51487	42560050
Pneumococcal sepsis	78.92	31.09	24	9774	1431	42610106
Respiratory tract infection bacterial	76.53	31.09	25	9773	1884	42609653
Motor neurone disease	71.10	31.09	18	9780	541	42610996
Distal intestinal obstruction syndrome	67.84	31.09	17	9781	490	42611047
Cystic fibrosis related diabetes	66.26	31.09	14	9784	184	42611353
Stoma closure	65.42	31.09	15	9783	293	42611244
Ischaemic cerebral infarction	63.78	31.09	21	9777	1622	42609915
Chest X-ray abnormal	62.10	31.09	27	9771	4481	42607056
Bronchial disorder	58.85	31.09	19	9779	1379	42610158
Condition aggravated	58.54	31.09	161	9637	260593	42350944
Lower respiratory tract infection bacterial	56.41	31.09	15	9783	549	42610988
Pancreatic failure	55.00	31.09	17	9781	1070	42610467
Sputum discoloured	54.22	31.09	32	9766	10100	42601437
Cystic fibrosis lung	53.52	31.09	10	9788	66	42611471
Lymphadenectomy	53.30	31.09	14	9784	488	42611049
Dyspnoea	52.90	31.09	221	9577	442400	42169137
Metabolic disorder	51.10	31.09	24	9774	4764	42606773
Resuscitation	50.10	31.09	18	9780	1807	42609730
Lung consolidation	46.32	31.09	25	9773	6652	42604885
Rubber sensitivity	46.32	31.09	12	9786	396	42611141
Secretion discharge	45.87	31.09	26	9772	7609	42603928
Sinus operation	45.85	31.09	14	9784	846	42610691
Brain injury	45.81	31.09	26	9772	7629	42603908
Sinusitis	43.52	31.09	54	9744	47238	42564299
Chest discomfort	42.30	31.09	62	9736	63554	42547983
Viral infection	41.05	31.09	37	9761	22446	42589091
Nasopharyngitis	40.89	31.09	71	9727	83925	42527612
Scoliosis	40.71	31.09	18	9780	3108	42608429
Cerebral ischaemia	39.93	31.09	23	9775	6936	42604601
Anaemia	39.91	31.09	8	9790	280270	42331267
Respiratory disorder	39.64	31.09	36	9762	22049	42589488
Hypotension	39.63	31.09	6	9792	257625	42353912
Infective exacerbation of bronchiectasis	39.32	31.09	11	9787	488	42611049
Respiration abnormal	39.29	31.09	19	9779	4023	42607514
Motor dysfunction	39.12	31.09	24	9774	8122	42603415
Demyelination	38.62	31.09	18	9780	3511	42608026
Steatorrhoea	37.77	31.09	12	9786	827	42610710
Drug ineffective	36.05	31.09	56	9742	630141	41981396
Neutropenia	34.76	31.09	3	9795	199428	42412109
Intestinal ischaemia	33.60	31.09	23	9775	9365	42602172
Muscle atrophy	33.57	31.09	22	9776	8339	42603198
Rhonchi	33.49	31.09	14	9784	2109	42609428

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
Infective pulmonary exacerbation of cystic fibrosis	5510.76	25.04	1067	16298	13704	110558230
Cystic fibrosis	1218.89	25.04	252	17113	4479	110567455
Hospitalisation	1209.35	25.04	540	16825	141953	110429981
Pulmonary function test decreased	623.35	25.04	164	17201	8536	110563398
Cystic fibrosis respiratory infection suppression	400.47	25.04	69	17296	420	110571514
Haemoptysis	359.97	25.04	190	17175	71164	110500770
Disease complication	296.77	25.04	84	17281	5743	110566191
Pneumonia	281.17	25.04	496	16869	876218	109695716
Bacterial disease carrier	273.89	25.04	65	17300	2204	110569730
Sputum increased	266.40	25.04	77	17288	5674	110566260
Bronchial secretion retention	262.99	25.04	74	17291	4950	110566984
Sinus operation	241.32	25.04	62	17303	2929	110569005
Scoliosis	238.74	25.04	78	17287	8655	110563279
Cough	220.50	25.04	314	17051	461327	110110607
Superinfection	205.33	25.04	63	17302	5700	110566234
Pseudomonas infection	171.76	25.04	85	17280	27768	110544166
Atelectasis	168.82	25.04	92	17273	36620	110535314
Forced expiratory volume decreased	168.19	25.04	67	17298	13109	110558825
Bronchospasm	168.05	25.04	86	17279	30153	110541781
Distal intestinal obstruction syndrome	153.57	25.04	35	17330	990	110570944
No adverse event	147.12	25.04	109	17256	73730	110498204
Productive cough	128.16	25.04	121	17244	114184	110457750
Lung transplant	119.77	25.04	41	17324	5245	110566689
Treatment noncompliance	115.47	25.04	94	17271	72896	110499038
Nonspecific reaction	111.18	25.04	34	17331	3040	110568894
Increased bronchial secretion	110.88	25.04	36	17329	3912	110568022
Dyspnoea	107.03	25.04	398	16967	1106474	109465460
Spinal muscular atrophy	105.54	25.04	22	17343	405	110571529
Influenza	103.36	25.04	130	17235	168971	110402963
Pancreatic failure	93.56	25.04	28	17337	2326	110569608
Rib fracture	90.96	25.04	60	17305	33710	110538224
Cystic fibrosis lung	85.72	25.04	16	17349	161	110571773
Infection	84.70	25.04	180	17185	362020	110209914
Respiratory tract infection bacterial	84.31	25.04	26	17339	2390	110569544
Sleep disorder due to a general medical condition	84.28	25.04	68	17297	52044	110519890
Aggression	82.75	25.04	71	17294	59139	110512795
Cystic fibrosis related diabetes	81.75	25.04	16	17349	211	110571723
Illness	77.18	25.04	79	17286	82092	110489842
Drug ineffective	75.38	25.04	77	17288	1520463	109051471
Infective exacerbation of bronchiectasis	74.78	25.04	19	17346	857	110571077
Pneumococcal sepsis	73.80	25.04	23	17342	2189	110569745
Motor neurone disease	73.29	25.04	18	17347	706	110571228
Condition aggravated	73.06	25.04	267	17098	734569	109837365
Rhinovirus infection	72.72	25.04	36	17329	11753	110560181
Steatorrhoea	71.17	25.04	19	17346	1042	110570892
Eosinophilia	70.04	25.04	64	17301	57872	110514062
Respiration abnormal	66.65	25.04	32	17333	9777	110562157
Stoma closure	66.44	25.04	15	17350	406	110571528
Sinus disorder	62.21	25.04	47	17318	32681	110539253
Staphylococcal infection	61.64	25.04	65	17300	69879	110502055
Lower respiratory tract infection bacterial	61.43	25.04	17	17348	1068	110570866
Bronchial disorder	60.82	25.04	21	17344	2755	110569179
Ischaemic cerebral infarction	59.61	25.04	21	17344	2924	110569010
Viral infection	59.02	25.04	56	17309	53083	110518851
Pneumonia pseudomonal	58.61	25.04	27	17338	7519	110564415
Chest discomfort	58.59	25.04	101	17264	173747	110398187
Bronchiectasis	57.69	25.04	47	17318	36446	110535488
Wheezing	55.21	25.04	123	17242	255107	110316827
Toxicity to various agents	54.41	25.04	6	17359	480549	110091385
Blood alkaline phosphatase increased	53.94	25.04	61	17304	70874	110501060
Sputum discoloured	52.83	25.04	40	17325	27905	110544029
Chest X-ray abnormal	52.59	25.04	26	17339	8461	110563473
Anaemia	52.46	25.04	11	17354	547075	110024859
Alanine aminotransferase increased	50.81	25.04	98	17267	183675	110388259
Confusional state	50.25	25.04	7	17358	468673	110103261
Asthma	50.11	25.04	117	17248	250174	110321760
Resuscitation	48.45	25.04	18	17347	2915	110569019
Anxiety	48.25	25.04	141	17224	344937	110226997
Infusion related reaction	47.97	25.04	3	17362	381159	110190775
Amniotic fluid index increased	47.83	25.04	9	17356	95	110571839
Aspartate aminotransferase increased	47.57	25.04	88	17277	159848	110412086
Cystic fibrosis hepatic disease	45.70	25.04	8	17357	54	110571880
Lung consolidation	44.69	25.04	25	17340	10451	110561483
Pseudomonas test positive	44.66	25.04	16	17349	2338	110569596
Pneumothorax	44.65	25.04	40	17325	35245	110536689
Brain injury	43.88	25.04	27	17338	13449	110558485
Lymphadenectomy	43.10	25.04	14	17351	1522	110570412
Hypotension	41.86	25.04	15	17350	523834	110048100
Secretion discharge	40.54	25.04	30	17335	20214	110551720
Heart rate increased	40.11	25.04	77	17288	143757	110428177
Metabolic disorder	39.26	25.04	23	17342	10487	110561447
Hypertension	36.86	25.04	17	17348	510067	110061867
Rash morbilliform	36.74	25.04	20	17345	7931	110564003
Cerebral ischaemia	36.26	25.04	23	17342	12081	110559853
Asthenia	36.17	25.04	33	17332	688966	109882968
Foetal macrosomia	35.51	25.04	7	17358	96	110571838
Peripheral swelling	35.05	25.04	10	17355	404024	110167910
Product dose omission issue	34.47	25.04	120	17245	321662	110250272
Impaired quality of life	34.03	25.04	32	17333	29985	110541949
Lung disorder	32.61	25.04	81	17284	179966	110391968
Staphylococcus test positive	32.56	25.04	18	17347	7352	110564582
Muscle atrophy	31.97	25.04	22	17343	13232	110558702
Arthropathy	31.50	25.04	4	17361	287518	110284416
Thrombocytopenia	31.45	25.04	8	17357	348877	110223057
Left-to-right cardiac shunt	30.85	25.04	7	17358	194	110571740
Intestinal ischaemia	30.23	25.04	23	17342	16156	110555778
Joint swelling	30.11	25.04	16	17349	442829	110129105
Rubber sensitivity	29.82	25.04	12	17353	2406	110569528
Rhonchi	28.47	25.04	14	17351	4504	110567430
Tachypnoea	28.46	25.04	33	17332	39362	110532572
Demyelination	28.45	25.04	18	17347	9411	110562523
Contraindicated product administered	28.33	25.04	3	17362	248264	110323670
Therapy cessation	28.18	25.04	35	17330	44822	110527112
Palpitations	28.17	25.04	71	17294	159141	110412793
Swelling	28.11	25.04	10	17355	351031	110220903
Neutropenia	27.81	25.04	12	17353	374608	110197326
Therapeutic product effect decreased	27.75	25.04	3	17362	244313	110327621
Bronchopulmonary aspergillosis allergic	27.74	25.04	17	17348	8409	110563525
Pulmonary haemorrhage	27.71	25.04	22	17343	16434	110555500
Loss of personal independence in daily activities	27.70	25.04	68	17297	149952	110421982
Lung infiltration	27.43	25.04	26	17339	24602	110547332
Increased viscosity of bronchial secretion	27.29	25.04	8	17357	618	110571316
Mechanical ventilation	26.21	25.04	12	17353	3295	110568639
Pain in extremity	25.93	25.04	23	17342	487095	110084839
Myalgia	25.61	25.04	85	17280	222296	110349638
Oedema peripheral	25.25	25.04	10	17355	328650	110243284

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	B06AA02	BLOOD AND BLOOD FORMING ORGANS OTHER HEMATOLOGICAL AGENTS OTHER HEMATOLOGICAL AGENTS Enzymes
ATC	B06AA10	BLOOD AND BLOOD FORMING ORGANS OTHER HEMATOLOGICAL AGENTS OTHER HEMATOLOGICAL AGENTS Enzymes
ATC	R05CB13	RESPIRATORY SYSTEM COUGH AND COLD PREPARATIONS EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS Mucolytics
FDA CS	M0006007	Deoxyribonuclease I
FDA CS	M0018641	Recombinant Proteins
FDA PE	N0000008867	Decreased Respiratory Secretion Viscosity
FDA EPC	N0000175958	Recombinant Human Deoxyribonuclease 1
CHEBI has role	CHEBI:22587	antiviral agent
CHEBI has role	CHEBI:35441	antiinfective agent
CHEBI has role	CHEBI:35610	antineoplastic agent
CHEBI has role	CHEBI:51177	antitussive
CHEBI has role	CHEBI:65023	anti-asthmatic agent
CHEBI has role	CHEBI:66981	ophthalmology drug
CHEBI has role	CHEBI:73336	vulnerary

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

Disease	Relation	SNOMED_ID	DOID
Cystic fibrosis	indication	190905008	DOID:1485

🐶 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:

None

External reference:

ID	Source
953A26OA1Y	UNII
D03896	KEGG_DRUG
4018657	VANDF
4020830	VANDF
C1135662	UMLSCUI
CHEBI:749545	CHEBI
CHEMBL1201431	ChEMBL_ID
DB00003	DRUGBANK_ID
CHEMBL1201459	ChEMBL_ID
7167	INN_ID
C568813	MESH_SUPPLEMENTAL_RECORD_UI
DB09551	DRUGBANK_ID
3210	RXNORM
3148	MMSL
4633	MMSL
7401	MMSL
d03173	MMSL
001889	NDDF
004413	NDDF
108630006	SNOMEDCT_US
330151006	SNOMEDCT_US
386882003	SNOMEDCT_US
416394007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Pulmozyme	HUMAN PRESCRIPTION DRUG LABEL	1	50242-100	SOLUTION	1 mg	RESPIRATORY (INHALATION)	BLA	27 sections