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fexofenadine + pseudoephedrine

✓ Approved

RVL Pharmaceuticals · HRH1 · Small Molecule

What is fexofenadine + pseudoephedrine?

fexofenadine + pseudoephedrine is a small molecule developed by RVL Pharmaceuticals. It is approved for therapeutic indications via oral (po).

Drug Profile

CompanyRVL Pharmaceuticals
Drug ClassSmall Molecule
Molecular TargetHRH1
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, RVL Pharmaceuticals

Mechanism of Action

Molecular Targets

fexofenadine + pseudoephedrine acts on 1 molecular target:

HRH1histamine receptor H1 (HH1R, H1R)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

fexofenadine + pseudoephedrine is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Skin and subcutaneous tissue disordersUrticaria✓ Approved
Immune system disordersSeasonal allergy✓ Approved

Related Research Articles

PubMedThe Journal of allergy and clinical immunology2026-10-16

Comparative efficacy and safety of antihistamines, increased antihistamine dosing, and antihistamine adjuncts for chronic urticaria: a systematic review, dose-response, and network meta-analysis of randomized trials.

Chu Alexandro W L AWL, Zhao Irene X IX, Rayner Daniel G DG, Guyatt Gordon H GH et al.

Chronic urticaria is a common immune-mediated condition characterized by wheals (itch and hives), angioedema, or both, lasting for greater than six weeks. It is managed with H1 antihistamines as the first-line therapy. Fundamental unresolved questions remain regarding the comparative benefits and harms of antihistamines and their adjuncts, and of H1 antihistamine dose-escalation. To analyze the comparative benefits and harms of antihistamines and their adjuncts (H2 blockers or montelukast), and of H1 antihistamine dose-escalation. As part of updating the American Academy of Allergy, Asthma & Immunology and American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters Chronic Urticaria guidelines, we searched MEDLINE, EMBASE, CENTRAL, and regulatory databases from inception to March 17, 2025, for randomized trials addressing antihistamines or their adjuncts for chronic urticaria. Paired reviewers independently screened records, extracted data, and assessed risk of bias. Random effects network and dose-response meta-analyses addressed urticaria activity (composed of itch and wheal scores), angioedema activity, urticaria-related quality of life, and harms including sedation. The GRADE approach informed certainty of evidence ratings. CRD42022367280. 211 trials (22,187 participants) evaluated 55 unique treatments. Bilastine, desloratadine, fexofenadine, and levocetirizine are among the most effective in improving overall urticaria activity, urticaria-related quality of life, and sleep disturbance. Cetirizine and loratadine are among the most effective in reducing overall urticaria activity and its subcomponents, with cetirizine also among the most effective in improving urticaria-related quality of life. Escalating from a single to quadruple daily dose may yield diminishing additional benefit. Second-generation agents as a class may be more effective than first-generation agents in improving urticaria activity and sleep disturbance. Sedation risk likely increases with higher doses, with first-generation agents (e.g., diphenhydramine, hydroxyzine) and doxepin among the most sedating; cetirizine, ketotifen, levocetirizine, and rupatadine among the intermediate sedating; and bepotastine, bilastine, desloratadine, ebastine, fexofenadine, and loratadine among the least sedating. Adding montelukast (moderate certainty) or an H2 blocker (very low certainty) to a second-generation agent may further reduce urticaria activity. For chronic urticaria, second-generation agents differ in their efficacy and safety. First-generation agents are less beneficial and more harmful. Escalating to higher daily doses may provide additional benefits but likely increases sedation.

PMID 42887704
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PubMedThe American Journal of dermatopathology2026-10-15

Neutrophilic Fixed Drug Eruption Mimicking Neutrophilic Dermatosis: Two Cases, Including Sequential Biopsies Demonstrating Time-Dependent Histopathology.

Chamninawakul Padol P, Lim Ziying Vanessa ZV, Khoo Lawrence Shih Wee LSW, Lee Joyce Siong See JSS

Fixed drug eruption (FDE) is classically a lymphocyte-predominant interface dermatitis, but an early lesion may show a prominent neutrophilic infiltrate that closely simulates a primary neutrophilic dermatosis. We report 2 cases. The first, a 42-year-old woman, developed a multifocal eruption approximately 45 minutes after re-exposure to etoricoxib, recurring at previously affected and new sites. A punch biopsy performed 21 hours after ingestion of the drug showed a basketweave stratum corneum, intense papillary dermal edema with pseudovesiculation, and a superficial and deep infiltrate rich in neutrophils with karyorrhexis, closely resembling Sweet syndrome. Only occasional apoptotic keratinocytes were present within the epidermis, and the marked edema obscured any interface dermatitis, although admixed eosinophils were noted. Clinicopathologic correlation ultimately established the diagnosis of neutrophilic FDE. The second, a 55-year-old man, had an eruption recurring at the same sites after pseudoephedrine. A biopsy of an established lesion 2-3 weeks after ingestion showed classic interface dermatitis with numerous eosinophils and pigment incontinence, whereas one taken from the same region within 24 hours of re-exposure showed a neutrophil-predominant infiltrate with prominent karyorrhexis and only focal interface change. These cases, biopsied at documented time points, support the concept that the neutrophil-rich appearance of FDE represents an early phase in its histopathologic evolution, demonstrate how it can be mistaken for a neutrophilic dermatosis in the absence of adequate clinical history, and show that clinicopathologic correlation and a high index of suspicion are necessary to reliably arrive at the correct diagnosis.

PMID 42878618
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PubMedNaunyn-Schmiedeberg's archives of pharmacology2026-09-28

Pseudoephedrine intoxication: sex-specific differences in clinical symptoms.

Gezgin Funda F, Seifert Roland R

Pseudoephedrine (PSE) is an indirectly acting sympathomimetic agent used worldwide to treat cold and flu symptoms, as well as allergic rhinitis. In Germany, PSE is available exclusively as a combination product with other active ingredients such as acetylsalicylic acid, paracetamol, ibuprofen, and first- and second-generation H1 receptor antagonists. Despite the widespread availability and frequent use of PSE, the active ingredient has repeatedly been linked to serious adverse drug reactions (ADRs). Most recently, in 2024, a red-hand letter was circulated after a link was established between PSE use and the occurrence of cerebral hypoperfusion. Furthermore, the drug is not always used in accordance with guidelines for treating specific symptoms but is also misused due to its indirect sympathomimetic effect. This study includes an analysis of published PSE intoxication cases from the literature. To this end, a systematic literature search was conducted in PubMed, from which 118 patient cases were extracted from a total of 81 case reports. The individual cases were then analyzed with regard to various aspects. The United States was the leading country in terms of case reports, followed by the United Kingdom. The analyzed patient cases show differences in terms sex and symptoms. Cardiovascular events occurred predominantly in men, while gastroenterological and dermatological symptoms occurred predominantly in women. To reduce the risk of PSE poisoning, increased educational efforts by physicians and pharmacists are necessary. Furthermore, checking for contraindications could reduce the risk. Education about PSE could also be provided through reputable online platforms. This study highlights the clinical relevance of PSE poisoning and the wide range of symptoms.

PMID 42803967
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PubMedJournal of pharmaceutical and biomedical analysis2026-09-27

A CotB1p-mediated one-step immobilization strategy for constructing GPCR affinity chromatography to screen multi-target natural product ligands.

Zhu Huiting H, Zhang Zilong Z, Ou Yuanyuan Y, Weng Shiyao S et al.

G protein-coupled receptors (GPCRs) are critical targets for drug discovery, yet the screening of GPCR-binding ligands from complex natural products remains challenging due to the lack of mild and universal immobilization strategies for these fragile membrane proteins. Here, we reported CotB1p-mediated one-step immobilization strategy for the construction of GPCR affinity chromatography columns to screen natural product ligands. Three asthma-related GPCRs β2-adrenergic receptor (β2AR), muscarinic M3 receptor (M3R), and cysteinyl leukotriene receptor 1 (CysLT1R) were genetically fused with the silica-binding peptide CotB1p. These fusion proteins were then directly immobilized onto macroporous silica via simple affinity adsorption, a process that avoids harsh chemical crosslinking and preserves receptor binding activity. The prepared affinity columns showed good specificity, stability, and repeatability, with retention time RSDs of 1.56%, 0.98%, and 1.68% for the β2AR, M3R, and CysLT1R columns, respectively. The three affinity columns were applied to screen ligands from a representative natural product prescription, followed by LC-MS/MS identification. Amygdalin, ephedrine/pseudoephedrine, scopolamine, atropine, forsythoside A, and phillyrin were identified as receptor-binding constituents selectively retained by different GPCR columns. Nonlinear chromatography enabled the evaluation of ligand-receptor interactions, with association constants ranging from 4.33 × 104-5.08 × 105 M⁻¹ .Molecular docking and molecular dynamics simulations further supported the possible binding modes and relative conformational stability of the ligand-receptor complexes. In addition, cellular assays in human airway smooth muscle cells indicated that the screened compounds could reduce TNF-α-induced inflammatory cytokine production. Overall, this CotB1p-mediated one-step immobilization strategy provides a mild and efficient approach for preparing functional GPCR affinity stationary phases, offering a useful analytical platform for target-resolved screening of natural product ligands against multiple GPCRs.

PMID 42800465
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PubMedACS environmental Au2026-09-25

Environmental Contaminants in Surface Snow Samples Made from Reclaimed Water at a Ski Resort: A Mass Spectrometry Analysis.

Yazzie Marquis T MT, Zhao Haoqi Nina HN, Antoninka Anita J AJ, Abrell Leif L et al.

Artificial snowmaking is used by winter recreation resorts to elongate the ski season in areas that lack sufficient snow, yet the occurrence of contaminants in artificial snow remains largely uncharacterized. Contaminants in artificial snow can lead to the introduction of pollutants into surrounding ecosystems (e.g., plants, water streams, soils) or create pathways for human exposure. Using the Arizona Snowbowl Ski Resort in Flagstaff, Arizona, as a case study, we characterized the chemical (organic and inorganic) profile of snow made from reclaimed water samples as compared to natural snow samples. Pharmaceuticals and anthropogenic compounds were identified in snowmaking from reclaimed water samples using nontargeted mass spectrometry paired with molecular networking, and identities of selected compounds were confirmed and quantified using targeted mass spectrometry alongside authentic chemical standards. Nineteen pharmaceuticals were found to be increased in high artificial snowmaking samples as compared to natural snow, including carbamazepine, fexofenadine, flecainide, and lamotrigine, which were present at low ng/L concentrations in one set of high artificial snowmaking samples. A suite of inorganic contaminants was also assessed and quantified using inductively coupled plasma mass spectrometry to reveal that nine metalssodium, phosphorus, potassium, chromium, manganese, iron, zinc, arsenic, and bariumwere increased in abundance in high artificial snowmaking samples compared to levels in normal snow. Taken together, this study suggests that snow made from reclaimed water may contain anthropogenic organic and inorganic analytes, warranting further study on their environmental and human health effects.

PMID 42787932
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PubMedPakistan journal of pharmaceutical sciences2026-09-08

Formulation, evaluation and characterization of fexofenadine IR and paracetamol SR multiparticulate drug delivery system.

Nawaz Muhammad Sajid MS, Zaman Muhammad M, Hameed Huma H, Siddique Waqar W et al.

Multiparticulate Drug Delivery (MDD) system are particularly considered as well suited systems for controlling oral preparations that have low risk of dose-dumping. The current research work was aimed to prepare Fexofenadine HCl immediate release (IR) and Paracetamol sustained release (SR) pellets in a single dosage unit for the treatment of Allergic Rhinitis. Extrusion-spheronization was used to fabricate pellets. The formulations were analyzed for several parameters, including micromeritic studies, Friability, Weight variation test, Swelling, X-Ray Diffraction (XRD), Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy (SEM), in-vitro release and stability studies. The results showed that the formulated pellets have an excellent flowability (23.01° to 25.23°), bulk density falls in the range of 1.23 g cm -3 to 1.42 g cm -3 , tapped density ranges 1.43 g/cm 3 1.58 g/cm 3 , carr's compressibility index lie between 10.31 % to 15.17 %, Hausner's ratio ranges 1.11 to 1.18 which concluded pellets had good flow properties. Friability was less than 1%; the T6 formulation showed the maximum swelling of 99.28%. No interaction between excipient and drug was found. T6 showed a drug release of 99.08% in 24 hours. The research effectively demonstrated that preparing a single-unit dosage form of paracetamol and fexofenadine is a safe, simple and promising technique for SR of Paracetamol, thereby increasing patient compliance by reducing the dosage frequency.

PMID 42708772
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