Allergic symptoms/rhinitis: Product-specific dosing:
Twice-daily formulations (eg, oral suspension, oral disintegrating tablet, regular tablet):
Oral suspension:
Infants ≥6 months and Children <2 years: Limited data available (Ref):
<10.5 kg: Oral: 15 mg every 12 hours.
≥10.5 kg: Oral: 30 mg every 12 hours.
Dosing based on a safety and tolerability study on patients with allergic rhinitis receiving fexofenadine 15 mg twice daily (weight <10.5 kg, n=85) and fexofenadine 30 mg twice daily (weight ≥10.5 kg, n=108) compared to placebo (n=199); adverse events were similar between fexofenadine and placebo (Ref).
Children ≥2 to <12 years: Oral: 30 mg every 12 hours; maximum daily dose: 60 mg/day.
Children ≥12 years and Adolescents: Oral: 60 mg every 12 hours; maximum daily dose: 120 mg/day.
Orally-disintegrating tablet (ODT):
Children ≥6 years to <12 years: Oral: 30 mg every 12 hours; maximum daily dose: 60 mg/day.
Children ≥12 years and Adolescents: Oral: 60 mg every 12 hours; maximum daily dose: 120 mg/day.
12-hour tablet: Children ≥12 years and Adolescents: Oral: 60 mg every 12 hours; maximum daily dose: 120 mg/day.
Once-daily formulation:
Children ≥12 years and Adolescents: Oral: 180 mg once daily.
Urticaria, acute: Limited data available (Ref):
Children ≥6 to 11 years: Twice-daily formulations (eg, oral suspension, oral disintegrating tablet, regular tablet): Oral: 30 mg every 12 hours.
Children ≥12 years and Adolescents: Twice-daily formulations (eg, oral suspension, oral disintegrating tablet, regular tablet): Oral: 60 mg every 12 hours.
Urticaria, chronic spontaneous: Limited data available: Note: Considered first-line therapy for management of chronic urticaria; if response inadequate after 2 to 4 weeks of therapy or symptoms intolerable, consider increasing the dose of fexofenadine (as age and weight permits) as second-line treatment rather than changing therapy (Ref).
Infants ≥6 months to Children <2 years: Twice-daily formulations (eg, oral suspension): Oral: 15 mg every 12 hours (Ref).
Children ≥2 to <12 years: Twice-daily formulations (eg, oral suspension, orally-disintegrating tablet, regular tablet): Oral: 30 mg twice daily (Ref).
Children ≥12 years and Adolescents:
Twice-daily formulations (eg, oral suspension, orally-disintegrating tablet, regular tablet): Oral: 60 mg every 12 hours (Ref).
Once-daily formulation: Oral: 180 mg once daily (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Twice-daily formulations (eg, oral suspension, oral disintegrating tablet, regular tablet):
There are no dosage adjustments provided in the OTC manufacturer's labeling; previous prescribing information (Ref) suggested the following
Infants ≥6 months to Children <2 years: Any degree of kidney impairment: Initial: 15 mg once daily.
Children 2 to 11 years: Any degree of kidney impairment: 30 mg once daily.
Children ≥12 years and Adolescents: Any degree of kidney impairment: 60 mg once daily.
Others have suggested the following: Children ≥12 years and Adolescents (Ref):
CrCl 10 to 50 mL/minute: 60 mg once daily.
CrCl <10 mL/minute: 30 mg once daily.
Hemodialysis: Not effectively removed by hemodialysis: 30 mg once daily.
Peritoneal dialysis: 30 mg once daily.
Once-daily formulation: There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in manufacturer's labeling.
(For additional information see "Fexofenadine: Drug information")
Upper respiratory allergies:
Twice-daily formulations: Oral: 60 mg every 12 hours (maximum: 120 mg/day).
Once-daily formulations: Oral: 180 mg once daily (maximum: 180 mg/day).
Urticaria, new onset and chronic spontaneous (off-label use):
New onset: Oral: Initial: 180 mg once daily. If symptom control is inadequate, may immediately increase to 180 mg twice daily (Ref).
Chronic spontaneous: Oral: 180 mg once daily (Ref). If symptom control is inadequate, add a different second-generation antihistamine; higher doses of fexofenadine have not been shown to be more effective in controlling urticaria symptoms in most patients (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Note: Use of the once-daily formulation is not recommended in patients with eGFR <50 mL/minute/1.73 m2 or on renal replacement therapies (Ref).
Altered kidney function (Ref):
eGFR ≥50 mL/minute/1.73 m2: Oral: No dosage adjustment necessary.
eGFR 10 to <50 mL/minute/1.73 m2: Oral: 60 mg every 12 to 24 hours.
eGFR <10 mL/minute/1.73 m2: Oral: 60 mg every 24 hours. Note: Results of a pharmacokinetic study suggest that nonrenal clearance of fexofenadine is impaired in patients with end-stage kidney disease (ESKD) (Ref); monitor patients for signs and symptoms of drug accumulation and toxicity.
Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2):
Note: Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Younger patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).
Oral: No dosage adjustment necessary (Ref).
Hemodialysis, intermittent (thrice weekly): Not dialyzable (Ref):
Oral: 60 mg every 24 hours (Ref).
Note: Results of a pharmacokinetic study suggest that nonrenal clearance of fexofenadine is impaired in patients with ESKD (Ref); monitor patients for signs and symptoms of drug accumulation and toxicity.
Peritoneal dialysis: Significant removal unlikely (large Vd) (Ref):
Oral: 60 mg every 24 hours (Ref).
Note: Results of a pharmacokinetic study suggest that nonrenal clearance of fexofenadine is impaired in patients with ESKD (Ref); monitor patients for signs and symptoms of drug accumulation and toxicity.
CRRT:
Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) and minimal residual kidney function unless otherwise noted. Close monitoring of response and adverse reactions (eg, excess sedation) due to drug accumulation is important.
Oral: 60 mg every 24 hours (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration):
Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Close monitoring of response and adverse reactions (eg, excess sedation) due to drug accumulation is important.
Oral: 60 mg every 24 hours (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Gastrointestinal: Vomiting (infants and children: 12%)
1% to 10%:
Gastrointestinal: Diarrhea (infants and children: 4%), stomach discomfort (adolescents and adults: 2%)
Genitourinary: Dysmenorrhea (adolescents and adults: 2%)
Nervous system: Dizziness (adolescents and adults: 2%), drowsiness (infants and children: ≤3%), fatigue (infants and children: ≤3%), headache (adolescents and adults: 5% to 10%)
Neuromuscular & skeletal: Back pain (adolescents and adults: 2% to 3%), limb pain (adolescents and adults: 2%)
Respiratory: Cough (children: 4%), rhinorrhea (infants and children: 2%), upper respiratory tract infection (children: 3%)
Miscellaneous: Fever (children: 2%)
Postmarketing (any population):
Dermatologic: Skin rash (Wahn 2003), Stevens-Johnson syndrome (Teo 2017), toxic epidermal necrolysis (Teo 2017)
Gastrointestinal: Dyspepsia (Meltzer 2004), nausea (Wahn 2003)
Hypersensitivity reaction: Anaphylaxis, angioedema, hypersensitivity reaction
Nervous system: Insomnia, nervousness, nightmares, sleep disorder
Respiratory: Epistaxis (Wahn 2003)
OTC labeling: When used for self-medication do not use if you ever had an allergic reaction to fexofenadine or any component of the formulation.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment may be recommended.
Dosage form specific issues:
• Orally disintegrating tablet: Some products may contain phenylalanine.
Other warnings/precautions:
• OTC labeling: When used for self-medication (OTC), do not exceed recommended dosage or administer at the same time with aluminum or magnesium antacids or with fruit juices.
Safety and efficacy for the use of cough and cold products in pediatric patients <4 years of age is limited; the AAP warns against the use of these products for respiratory illnesses in young children. Serious adverse effects including death have been reported. Many of these products contain multiple active ingredients, increasing the risk of accidental overdose when used with other products. The FDA does not recommend OTC uses for these products in pediatric patients <2 years of age and recommends to use with caution in pediatric patients ≥2 years of age. Health care providers are reminded to ask caregivers about the use of OTC cough and cold products in order to avoid exposure to multiple medications containing the same ingredient (AAP 2018; CDC 2007; FDA 2017; FDA 2018).
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension, Oral, as hydrochloride:
Allegra Allergy Childrens: 30 mg/5 mL (240 mL) [alcohol free, dye free; contains butylparaben, edetate (edta) disodium, propylene glycol, propylparaben; berry flavor]
Allegra Allergy Childrens: 30 mg/5 mL (120 mL) [alcohol free, dye free; contains butylparaben, edetate (edta) disodium, propylene glycol, propylparaben; raspberry creme flavor]
Allergy Childrens: 30 mg/5 mL (118 mL, 237 mL [DSC]) [alcohol free, dye free; contains butylparaben, edetate (edta) disodium, propylene glycol, propylparaben; berry flavor]
Tablet, Oral, as hydrochloride:
Allegra Allergy: 60 mg, 180 mg
Allegra Allergy: 180 mg [contains fd&c blue #1 (brilliant blue)]
Allegra Hives 24HR: 180 mg
Allergy 24-HR: 180 mg
Allergy Relief: 60 mg [contains corn starch]
Allergy Relief: 180 mg
Allergy Relief: 180 mg [contains corn starch]
Allergy Relief/Indoor/Outdoor: 180 mg [contains corn starch]
FT Allergy Relief: 180 mg
FT Allergy Relief 12 Hour: 60 mg [contains corn starch, fd&c red #40 (allura red ac dye)]
FT Allergy Relief 24 Hour: 180 mg
FT Allergy Relief 24 Hour: 180 mg [contains corn starch, fd&c red #40 (allura red ac dye)]
Generic: 60 mg, 180 mg
Tablet Disintegrating, Oral, as hydrochloride:
Allegra Allergy Childrens: 30 mg [dye free; contains aspartame; orange cream flavor]
May be product dependent
Suspension (Allegra Allergy Childrens Oral)
30 mg/5 mL (per mL): $0.13
Tablet, orally-disintegrating (Allegra Allergy Childrens Oral)
30 mg (per each): $1.26
Tablets (Allegra Allergy Oral)
60 mg (per each): $1.17
180 mg (per each): $0.95
Tablets (Allegra Hives 24HR Oral)
180 mg (per each): $1.88
Tablets (Fexofenadine HCl Oral)
60 mg (per each): $0.12 - $0.22
180 mg (per each): $0.27 - $0.59
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral:
Twice-daily formulations:
Suspension, regular tablet: May administer without respect to food. Take with water; avoid administration with fruit juices; shake suspension well before use. Administer suspension with an accurate measuring device; do not use a household teaspoon.
Orally-disintegrating tablet: Administer on an empty stomach. Do not remove from blister pack until ready to administer. Using dry hands, place immediately on tongue. Tablet will dissolve within seconds and may be swallowed with or without liquid; avoid administering with fruit juices.
Once-daily formulation: Swallow whole with water; do not take with fruit juices.
Orally disintegrating tablet: Administer on an empty stomach. Remove tablet from individual blister and place immediately on tongue; tablet will disintegrate with or without water (do not administer with fruit juices).
Oral suspension, tablet: Administer with water only; do not administer with fruit juices. Shake suspension well before use. Use suspension only with enclosed dosing cup.
Store at 20°C to 25°C (68°F to 77°F). Use orally disintegrating tablet immediately after opening individual blister.
Relief of symptoms due to hayfever or upper respiratory allergies (OTC products: Oral suspension: FDA approved in ages ≥2 years and adults; Meltable tablets: FDA approved in ages ≥6 years and adults; Tablets [12 or 24 hours]: FDA approved in ages ≥12 years and adults); has also been used to treat uncomplicated skin manifestations of urticaria. Note: Approved ages and uses for generic products may vary; consult labeling for specific information.
Allegra may be confused with Allegra Anti-Itch Cream (diphenhydramine/allantoin), Viagra
Fexofenadine may be confused with fesoterodine
Mucinex Allergy may be confused with Mucinex
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (pediatric liquid medications requiring measurement) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).
Allegra [US, Canada, and multiple international markets] may be confused with Allegro brand name for fluticasone [Israel] and frovatriptan [Germany]
Substrate of CYP3A4 (Minor), MATE1/2-K, OAT1/3, OATP1B1/1B3, P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Amezinium: Antihistamines may increase stimulatory effects of Amezinium. Risk C: Monitor
Antacids: May decrease serum concentration of Fexofenadine. Management: Separate the administration of fexofenadine and aluminum- or magnesium-containing antacids. Risk D: Consider Therapy Modification
Benzylpenicilloyl Polylysine: Coadministration of Antihistamines and Benzylpenicilloyl Polylysine may alter diagnostic results. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider Therapy Modification
Betahistine: Antihistamines may decrease therapeutic effects of Betahistine. Betahistine may decrease therapeutic effects of Antihistamines. Risk C: Monitor
Certoparin: Antihistamines may increase therapeutic effects of Certoparin. Risk C: Monitor
Grapefruit Juice: May decrease serum concentration of Fexofenadine. Risk C: Monitor
Hyaluronidase: Antihistamines may decrease therapeutic effects of Hyaluronidase. Risk C: Monitor
P-glycoprotein/ABCB1 Inducers: May decrease serum concentration of Fexofenadine. Risk C: Monitor
Pitolisant: Antihistamines may decrease therapeutic effects of Pitolisant. Risk X: Avoid
RifAMPin: May decrease serum concentration of Fexofenadine. RifAMPin may increase serum concentration of Fexofenadine. Risk C: Monitor
High-fat meals decrease the bioavailability of fexofenadine by ~50%. Fruit juice (apple, grapefruit, orange) may decrease bioavailability of fexofenadine by ~36%. Management: Separating fexofenadine administration and fruit juice consumption by at least 4 hours may decrease the significance of this possible interaction.
Some products may contain phenylalanine and/or sodium. Take suspension and tablets preferably with water; separate administration with grapefruit or other fruit juices by at least 4 hours.
Fexofenadine crosses the placenta (Pinto 2020).
Outcome data following maternal use of fexofenadine during pregnancy are available (Andersson 2020, Craig-McFeely 2001, Gilboa 2009, Hansen 2020, Kocatürk 2022). Based on the limitations of available data, second-generation antihistamines are considered acceptable for use during pregnancy, with preference given to agents with more study (EAACI [Zuberbier 2022]).
Algorithms are available for the treatment of acute rhinitis and urticaria. When treatment with a second-generation oral antihistamine is recommended, agents other than fexofenadine may be preferred for use during pregnancy (AAAAI/ACAAI [Dykewicz 2020], Andersson 2020, EAACI [Zuberbier 2022]).
Improvement in signs and symptoms of allergic rhinitis and chronic idiopathic urticaria
Fexofenadine is an active metabolite of terfenadine and like terfenadine it competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels and respiratory tract; it appears that fexofenadine does not cross the blood-brain barrier to any appreciable degree, resulting in a reduced potential for sedation
Onset of action: 2 hours (Simons 2004)
Duration of action: 24 hours (Simons 2004)
Absorption: Rapid
Protein binding: 60% to 70% (Markham 1998); primarily albumin and alpha1-acid glycoprotein
Metabolism: Minimal (Hepatic: ~5%); 3.6% transformed into methylester metabolite found only in feces
Bioavailability: ~33%
Half-life elimination: 14.4 hours (59% longer in patients with mild to moderate renal impairment [CrCl 41 to 80 mL/minute]; 72% longer in patients with severe renal impairment [CrCl 11 to 40 mL/minute]) (Markham 1998; Simons 2004)
Time to peak, serum: ODT: 2 hours (4 hours with high-fat meal); Tablet: ~2.6 hours (Simons 2004); Suspension: ~1 hour
Excretion: Feces (80%) and urine (12%) as unchanged drug (Simons 2004)
Altered kidney function: Mild to moderate impairment with CrCl 41 to 80 mL/minute has an 87% increase in Cmax. Severe impairment with CrCl 11 to 40 mL/minute has a 111% increase in Cmax.
Older adult: Cmax is increased 99%.