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Drug ReportsPseudoephedrine
Sudafed 12 hour, Aerinaze(pseudoephedrine)
/ / Pseudoephedrine, / Pseudoephedrine, Actahist, Actifed, Advil, Aerinaze, Afrinol, Allegr, Allerfed, Benylin, Bromfed-dm, Brompheril, Chlor-trimeton, Clarinex, Claritin, Codimal-l.a, Corphed, Disobrom, Disophrol, Drixoral, Histafed, Hycofenix, Ibuprohm, Isoclor, Motrin, Mucinex D, Myfed, Pseudoephedrine, Resporal, Rezira, Semprex, Sine-aid, Sudafed, Tavist, Triacin-c, Trilitron, Trinalin, Triphed, Zyrtec (pseudoephedrine) is a small molecule pharmaceutical. Pseudoephedrine was first approved as Chlor-trimeton on 1982-01-01. It is used to treat allergic rhinitis perennial, asthma, common cold, and sinusitis in the USA. It has been approved in Europe to treat allergic rhinitis seasonal.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
immune system diseasesD007154
Trade Name
FDA
EMA
Pseudoephedrine, Sudafed (discontinued: Afrinol, Novafed, Pseudo, Sudafed)
Combinations
Advil, Allegr, Bromfed-dm, Brompheniramine maleate, pseudoephedrine dextromethorphan, Cetirizine pseudoephedrine, Clarinex, Claritin, Desloratadine pseudoephedrine, Fexofenadine pseudoephedrine, Guaifenesin pseudoephedrine, Hydrocodone bitartrate, chlorpheniramine pseudoephedrine, Ibuprofen pseudoephedrine, Loratadine pseudoephedrine, Motrin, Mucinex d, Naproxen pseudoephedrine, Sine-aid, Zyrtec (discontinued: Actifed, Aleve, Allerfed, Benylin, Bromanate, Bromfed-dm, Brompheniramine maleate, pseudoephedrine dextromethorphan, Brompheril, Cetirizine pseudoephedrine, Chlor-trimeton, Clarinex d, Codimal-l.a., Corphed, Dimetane-dx, Disobrom, Disophrol, Drixoral, Efidac 24 pseudoephedrine hydrochloride/brompheniramine, Fexofenadine pseudoephedrine, Guaifenesin pseudoephedrine, Hycofenix, Hydrocodone bitartrate, chlorpheniramine pseudoephedrine, Hydrocodone pseudoephedrine, Ibuprofen pseudoephedrine, Isoclor, Pseudoephedrine chlorpheniramine, Pseudoephedrine triprolidine, Rezira, Semprex, Tavist, Trinalin, Triphed, Triprolidine hydrochloride, pseudoephedrine codeine, Triprolidine pseudoephedrine, Triprolidine pseudoephedrine hydrochlorides, Zutripro)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ibuprofen
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL COLD AND SINUSGSKN-019771 OTC1989-09-19
1 products, RLD, RS
CHILDREN'S ADVIL COLDGSKN-021373 OTC2002-04-18
1 products
ADVIL COLD AND SINUSGSKN-021374 OTC2002-05-30
1 products, RLD, RS
CHILDREN'S MOTRIN COLDJohnson & JohnsonN-021128 OTC2000-08-01
1 products, RLD, RS
SINE-AID IBJohnson & JohnsonN-019899 OTC1992-12-31
1 products
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
SUDAFED 24 HOURJohnson & JohnsonN-020021 OTC1992-12-15
1 products, RLD, RS
Show 2 discontinued
Cetirizine hydrochloride
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ZYRTEC-D 12 HOURJohnson & JohnsonN-021150 OTC2007-11-09
1 products, RLD, RS
Codeine phosphate
+
Pseudoephedrine hydrochloride
+
Triprolidine hydrochloride
Tradename
Company
Number
Date
Products
ACTIFED W/ CODEINEGSKN-012575 DISCN1984-04-04
1 products
Hide discontinued
Pseudoephedrine hydrochloride
+
Triprolidine hydrochloride
Tradename
Company
Number
Date
Products
ACTIFEDGSKN-018996 DISCN1985-06-17
1 products
Hide discontinued
Chlorpheniramine maleate
+
Ibuprofen
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL ALLERGY SINUSGSKN-021441 OTC2002-12-19
1 products, RLD, RS
CHILDREN'S ADVIL ALLERGY SINUSGSKN-021587 OTC2004-02-24
1 products, RLD, RS
Desloratadine
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
CLARINEX-D 12 HOUROrganonN-021313 RX2006-02-01
1 products, RLD, RS
Show 1 discontinued
Acetaminophen
+
Clemastine fumarate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
TAVIST ALLERGY/SINUS/HEADACHENovartisN-021082 DISCN2001-03-01
1 products
Hide discontinued
Fexofenadine hydrochloride
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONSanofiN-020786 OTC2011-01-24
1 products, RLD, RS
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTIONSanofiN-021704 OTC2011-01-24
1 products, RLD, RS
Pseudoephedrine polistirex
Tradename
Company
Number
Date
Products
PSEUDO-12UCBN-019401 DISCN1987-06-19
1 products
Hide discontinued
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
AFRINOLMerck & CoN-018191 DISCN1982-01-01
1 products, RLD
Hide discontinued
Dexbrompheniramine maleate
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
DISOPHROLMerck & CoN-012394 DISCN1982-01-01
1 products
DRIXORALMerck & CoN-013483 DISCN1982-09-13
1 products, RLD
DISOPHROLMerck & CoN-013483 DISCN1982-09-13
1 products
Hide discontinued
Acetaminophen
+
Dexbrompheniramine maleate
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
DRIXORAL PLUSMerck & CoN-019453 DISCN1987-05-22
1 products
Hide discontinued
Azatadine maleate
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
TRINALINMerck & CoN-018506 DISCN1982-03-23
1 products
Hide discontinued
Naproxen sodium
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ALEVE-D SINUS & COLDBayerN-021076 DISCN1999-11-29
1 products, RLD
Hide discontinued
Chlorpheniramine maleate
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
CHLOR-TRIMETONBayerN-018397 DISCN1982-01-01
1 products, RLD
Hide discontinued
Loratadine
+
Pseudoephedrine sulfate
Tradename
Company
Number
Date
Products
CLARITIN-DBayerN-019670 OTC2002-11-27
1 products, RLD, RS
CLARITIN-D 24 HOURBayerN-020470 OTC2002-11-27
1 products, RLD, RS
Diphenhydramine hydrochloride
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
BENYLINPfizerN-019014 DISCN1985-06-11
1 products
Hide discontinued
Guaifenesin
+
Hydrocodone bitartrate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
HYCOFENIXChartwell PharmaceuticalsN-022279 DISCN2015-05-14
1 products, RLD
Hide discontinued
Chlorpheniramine maleate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATECentral PharmaceuticalsN-019428 DISCN1988-08-02
1 products
ISOCLORFisonsN-018747 DISCN1986-03-06
1 products
CODIMAL-L.A. 12Schwarz PharmaN-018935 DISCN1985-04-15
1 products
Hide discontinued
Acrivastine
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
SEMPREX-DEndoN-019806 DISCN1994-03-25
1 products, RLD
Hide discontinued
Brompheniramine maleate
+
Dextromethorphan hydrobromide
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
DIMETANE-DXA.H. Robins CompanyN-019279 DISCN1984-08-24
1 products, RLD
Hide discontinued
Brompheniramine maleate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATEAlzaN-019672 DISCN1996-03-29
1 products
Hide discontinued
Hydrocodone bitartrate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
REZIRAPersion PharmaceuticalsN-022442 DISCN2011-06-08
1 products, RLD
Hide discontinued
Chlorpheniramine maleate
+
Hydrocodone bitartrate
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
ZUTRIPROPersion PharmaceuticalsN-022439 DISCN2011-06-08
1 products, RLD
Hide discontinued
Guaifenesin
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
MUCINEX DRB HealthN-021585 OTC2004-06-22
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
12 hour allergy dANDA2020-09-03
12 hour nasal decongestantANDA2024-05-20
12hr allergy and congestion reliefANDA2024-10-29
abatuss dmxOTC monograph final2022-10-28
acticonC2002632024-06-28
actifedC2002632024-10-04
actinelC2002632024-06-27
actinel pediatricC2002632024-06-28
advilNew Drug Application2025-01-14
advil allergy and congestion reliefNew Drug Application2024-06-20
Show 287 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sinusitisEFO_0007486D012852J32
asthmaEFO_0000270D001249J45
common coldEFO_0007214D003139J00
allergic rhinitis perennialEFO_1001417D012221J30.89
urticariaEFO_0005531D014581L50
atopic dermatitisEFO_0000274D003876L20
rhinitisEFO_0008521D012220J31
allergic conjunctivitisEFO_0007141D003233H10.44
coughHP_0012735D003371R05
vasomotor rhinitisEFO_0007533D012223J30.0
Show 30 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Chlorpheniramine Maleate / Ibuprofen / Pseudoephedrine Hydrochloride, Advil Allergy Sinus, Haleon Us Holdings
78632872027-02-28DP
Chlorpheniramine Maleate / Ibuprofen / Pseudoephedrine Hydrochloride, Children'S Advil Allergy Sinus, Haleon Us Holdings
102386402024-05-25DP
ATC Codes
R: Respiratory system drugs
— R01: Nasal preparations
— R01B: Nasal decongestants for systemic use
— R01BA: Sympathomimetics
— R01BA02: Pseudoephedrine
— R01BA52: Pseudoephedrine, combinations
HCPCS
No data
Clinical
Clinical Trials
2152 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePseudoephedrine
INNpseudoephedrine
Description
Pseudoephedrine is a member of the class of the class of phenylethanolamines that is (1S)-2-(methylamino)-1-phenylethan-1-ol in which the pro-S hydrogen at position 2 is replaced by a methyl group. It has a role as a sympathomimetic agent, an anti-asthmatic drug, a bronchodilator agent, a vasoconstrictor agent, a central nervous system drug, a nasal decongestant, a xenobiotic and a plant metabolite. It is a secondary alcohol, a secondary amino compound and a member of phenylethanolamines. It is a conjugate base of a pseudoephedrine(1+).
Classification
Small molecule
Drug classsympathomimetics
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN[C@@H](C)[C@@H](O)c1ccccc1
Identifiers
PDB—
CAS-ID90-82-4
RxCUI—
ChEMBL IDCHEMBL1590
ChEBI ID51209
PubChem CID7028
DrugBankDB00852
UNII ID7CUC9DDI9F (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Clarinex – Organon
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Estimated US medical usage
Pseudoephedrine
+
Acetaminophen
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Pseudoephedrine
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Acrivastine
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Pseudoephedrine
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Azatadine
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Pseudoephedrine
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Brompheniramine
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Pseudoephedrine
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Carbetapentane
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Pseudoephedrine
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Carbinoxamine
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Pseudoephedrine
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Cetirizine
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Pseudoephedrine
+
Chlorpheniramine
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Pseudoephedrine
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Codeine
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Pseudoephedrine
+
Desloratadine
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Pseudoephedrine
+
Dexbrompheniramine
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Pseudoephedrine
+
Dexchlorpheniramine
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Pseudoephedrine
+
Dextromethorphan
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Pseudoephedrine
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Doxylamine
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Pseudoephedrine
+
Fexofenadine
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Pseudoephedrine
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Guaifenesin
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Pseudoephedrine
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Hydrocodone
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Pseudoephedrine
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Ibuprofen
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Pseudoephedrine
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Loratadine
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Pseudoephedrine
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Methscopolamine
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Pseudoephedrine
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Naproxen
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Pseudoephedrine
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Pseudoephedrine
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Terfenadine
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Pseudoephedrine
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Triprolidine
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,515 documents
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Safety
Black-box Warning
Black-box warning for: Triacin-c
Adverse Events
Top Adverse Reactions
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208,105 adverse events reported
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