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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
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 dANDA2025-06-19
12 hour nasal decongestantANDA2024-05-20
acticonC2002632025-07-08
acticon pediatricC2002632025-07-17
actinelC2002632025-07-08
actinel pediatricC2002632025-07-08
actispec pseC2002632025-07-17
advil allergy sinusNew Drug Application2024-06-20
advil cold and sinusNew Drug Application2025-09-11
alavertANDA2021-12-07
Show 197 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
cough—D003371R05
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
302 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypotensionD007022EFO_0005251I95269163767
RhinitisD012220EFO_0008521J3125135732
Allergic rhinitisD065631—J30.92594828
Cesarean sectionD002585———1161018
Spinal anesthesiaD000775———117918
Allergic rhinitis seasonalD006255EFO_0003956J301252313
AnesthesiaD000758————22913
Common coldD003139EFO_0007214J001—72212
Nasal obstructionD015508——1—1349
SinusitisD012852EFO_0007486J32—1—269
Show 36 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.9111—58
PharyngitisD010612—R07.0——1—23
Postoperative nausea and vomitingD020250EFO_0004888———1—23
Allergic rhinitis perennialD012221EFO_1001417J30.89——2—13
Vasomotor rhinitisD012223EFO_0007533J30.0——2—13
InflammationD007249MP_0001845———2—13
Postoperative cognitive complicationsD000079690———11—23
Communicable diseasesD003141————1—12
Obstetrical anesthesiaD000773———11——2
Cognitive dysfunctionD060825—G31.84—11—12
Show 14 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
VomitingD014839—R11.1—1——23
Hiv infectionsD015658EFO_0000764B20—1——12
Intratracheal intubationD007442———1——12
Hemostatic disordersD020141———1———1
Lacrimal duct obstructionD007767——11———1
PainD010146EFO_0003843R5211———1
Lambert-eaton myasthenic syndromeD015624EFO_0020094G70.8011———1
Congenital myasthenic syndromesD020294Orphanet_590G70.211———1
NauseaD009325—R11.0—1———1
Urinary incontinenceD014549—R32—1———1
Show 3 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———16———723
MalnutritionD044342EFO_0008572E40-E466———28
Pure autonomic failureD054970——3————3
HypersensitivityD006967EFO_0003785T78.402————2
HypertensionD006973EFO_0000537I101———12
Shy-drager syndromeD012791EFO_1001050—2————2
Multiple system atrophyD019578——2————2
Orthostatic hypotensionD007024—I95.11————1
Ear diseasesD004427EFO_1001455H93.91————1
FeverD005334—R50.91————1
Show 5 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postoperative painD010149—G89.18————88
Acute kidney injuryD058186—N17————33
HysterectomyD007044EFO_0003881—————33
Breast neoplasmsD001943EFO_0003869C50————33
Carotid stenosisD016893——————22
Hip fracturesD006620EFO_0003964S72.00————22
Pregnancy rateD018873——————22
Renal insufficiencyD051437—N19————22
Cardio-renal syndromeD059347——————22
EpistaxisD004844EFO_0003895R04.0————22
Show 82 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
+
Brompheniramine
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Pseudoephedrine
+
Pentoxyverine
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Pseudoephedrine
+
Carbinoxamine
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Pseudoephedrine
+
Cetirizine
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Pseudoephedrine
+
Chlorpheniramine
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Pseudoephedrine
+
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
+
Doxylamine
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Pseudoephedrine
+
Fexofenadine
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Pseudoephedrine
+
Guaifenesin
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Pseudoephedrine
+
Hydrocodone
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Pseudoephedrine
+
Ibuprofen
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Pseudoephedrine
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Loratadine
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Pseudoephedrine
+
Methscopolamine
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Pseudoephedrine
+
Naproxen
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Triprolidine
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Additional graphs summarizing 3,727 documents
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Black-box warning for: Triacin-c
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31,190 adverse events reported
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