Over-the-counter medication · Second-Generation Antihistamine
fexofenadine
Also sold as Allegra. This medicine treats hives and itching caused by hives.
Data updated 2026-05-15
- 19,831
- FDA reportsModerately reported
- 1
- InteractionFew interactions
- $0.23
- Generic price (NADAC)
What the data shows
fexofenadine (Allegra) is an over-the-counter Second-Generation Antihistamine, reported at a middle-of-the-pack volume (19,831 FDA reports), with 1 documented drug interaction.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
fexofenadine (Allegra) is an over-the-counter Second-Generation Antihistamine. This medicine treats hives and itching caused by hives.
Fexofenadine (Allegra) is an antihistamine medicine. It helps reduce hives and relieve itching.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.23/unit
Generic Available
Yes (19 manufacturers)
Pricing data from NADAC (CMS), effective December 25, 2024. Compare all drug costs →
NADAC price trail: FEXOFENADINE HCL 180 MG TABLET
Same CMS presentation as the headline generic unit price above (3 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: 0% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| June 19, 2024 | $0.2752/EA | - | 1 |
| December 18, 2024 | $0.2320/EA | -15.7% | 10 |
| December 25, 2024 | $0.2320/EA | 0% | 1 |
What it does
This medicine treats hives and itching caused by hives.
Common side effects
Headache, Fatigue, Nausea
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
The sections below are summarized in plain English from fexofenadine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Fexofenadine blocks histamine in your body. Histamine is a natural substance that causes allergy symptoms. By blocking histamine, fexofenadine reduces itching and hives.
Side Effects (from patient reports)
Based on 19,831 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for fexofenadine, by number of reports
- Headache
Headache
878 reports
- Fatigue
Fatigue
858 reports
- Nausea
Nausea
778 reports
- Pruritus
Pruritus
765 reports
- Extra Dose Administered
Extra Dose Administered
700 reports
- Diarrhoea
Diarrhoea
693 reports
- Dizziness
Dizziness
648 reports
- Rash
Rash
605 reports
- Somnolence
Somnolence
597 reports
- Dyspnoea
Dyspnoea
589 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for fexofenadine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where fexofenadine sits
fexofenadine has more FDA adverse-event reports than 54% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is fexofenadine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 19,831 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
19,831
Reports Mentioning Death
549
2.8% of reports — not proof of cause
Hospitalization Reports
2,701
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | HEADACHE | 878 |
| 3 | FATIGUE | 858 |
| 4 | NAUSEA | 778 |
| 5 | PRURITUS | 765 |
| 6 | EXTRA DOSE ADMINISTERED | 700 |
| 7 | DIARRHOEA | 693 |
| 9 | DIZZINESS | 648 |
| 10 | RASH | 605 |
| 11 | SOMNOLENCE | 597 |
| 12 | DYSPNOEA | 589 |
| 13 | COUGH | 555 |
| 14 | INSOMNIA | 530 |
| 15 | PAIN | 488 |
| 16 | FEELING ABNORMAL | 485 |
| 18 | MALAISE | 451 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
Additionally, no dosage adjustment for substrates of CYP2D6 (e.g., dextromethorphan), CYP3A4 (e.g., lovastatin), CYP2B6 (e.g., bupropion), BCRP (e.g., rosuvastatin), or P-gp (e.g., fexofenadine) is required when administered concomitantly with REXULTI.
Mechanism: Brexpiprazole does not affect the transport protein responsible for moving fexofenadine through your body.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What should I do if the foil seal under the cap is broken?
Can children under 12 take this medicine?
Can I take more than one tablet a day?
What if I have kidney problems?
Can older adults take this medicine?
Will this medicine prevent allergic skin reactions?
How often should I take this medicine?
What is the strength of each tablet?
Should I take this medicine with food?
What do I do if I accidentally take an extra dose?
What are the common side effects of fexofenadine?
Does fexofenadine interact with other medications?
What drug class is fexofenadine?
What pregnancy or breastfeeding source fields are listed for fexofenadine?
Related Medications in Second-Generation Antihistamine
Other drugs grouped near fexofenadine - same-class peers and common alternatives.
azelastine
Astelin, Astepro
Azelastine nasal spray is an antihistamine medicine.
Compare with fexofenadine →
budesonide nasal
Rhinocort
Rhinocort is a nasal spray that helps relieve allergy symptoms.
Compare with fexofenadine →
cetirizine
Zyrtec
Cetirizine (Zyrtec) is an antihistamine medicine.
Compare with fexofenadine →
chlorpheniramine
Chlor-Trimeton
Chlorpheniramine is an antihistamine medicine.
Compare with fexofenadine →
ciclesonide nasal
Omnaris, Zetonna
Omnaris Nasal Spray is a medicine that helps treat allergy symptoms in your nose.
Compare with fexofenadine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for fexofenadine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 19,831.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 2.77%.
- etanercept Δ 0.02 pts · 591,578 reports · TNF-Alpha Inhibitor (Biologic) 2.79%death share
- lurasidone Δ 0.02 pts · 20,544 reports · Atypical Antipsychotic 2.75%death share
- inclisiran Δ 0.05 pts · 6,989 reports · PCSK9 siRNA 2.72%death share
- bimatoprost Δ 0.06 pts · 28,128 reports · Prostaglandin Analog (Ophthalmic) 2.71%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for fexofenadine
The FDA label for fexofenadine (sold under brand names such as Allegra) classifies it as an over-the-counter product in the Second-Generation Antihistamine class. This medicine treats hives and itching caused by hives. Official labeling lists 3 commonly reported side effects, including Headache, Fatigue, Nausea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 19,831 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.23.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: December 19, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages