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Fexofenadine Side Effects

The most commonly reported side effects of fexofenadine include headache, fatigue, and nausea, based on 88,231 FDA adverse event reports from 2004 to 2025. 13.1% of reports found the drug to be ineffective.

Fexofenadine side effects

Percentages show how often each reaction appears relative to total reports for fexofenadine.

1
Drug Ineffective13.1%11,521
2
Headache4.2%3,702
3
Fatigue4.2%3,699
4
Nausea3.8%3,385
5
Diarrhoea3.2%2,851
6
Dizziness3.2%2,822
7
Pruritus3.1%2,739
8
Dyspnoea3.0%2,639
9
Insomnia2.8%2,446
10
Rash2.7%2,420
11
Off Label Use2.7%2,401
12
Pain2.6%2,277
13
Somnolence2.3%1,992
14
Malaise2.2%1,969
15
Extra Dose Administered2.2%1,967

These are voluntary reports and do not establish that fexofenadine caused these reactions.

Report severity

44.4%Serious39,163 reports
18.0%Hospitalizations15,875 reports
3.6%Fatal3,133 reports

Seriousness is determined by the reporter, not by OpenClaim.

Fexofenadine drug interactions

Other drugs that appear in adverse event reports alongside fexofenadine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dupilumab3.6%3,174
2
Sodium-oxybate3.4%2,961
3
Adalimumab2.6%2,261
4
Omalizumab2.4%2,137
5
Lenalidomide2.4%2,119
6
Fluticasone1.5%1,329
7
Omeprazole1.3%1,167
8
Cetirizine-hydrochloride1.3%1,126
9
Esomeprazole1.2%1,076
10
Ethinyl-estradiol1.2%1,074
11
Montelukast-sodium1.1%1,006
12
Drospirenone1.0%847
13
Salmeterol-xinafoate0.8%716
14
Etanercept0.8%715
15
Lansoprazole0.8%665

Taken alongside

1
Fluticasone13.9%12,295
2
Albuterol13.6%11,987
3
Acetaminophen13.2%11,675
4
Ergocalciferol12.0%10,593
5
Montelukast-sodium11.1%9,809
6
Aspirin10.8%9,548
7
Levothyroxine-sodium9.9%8,714
8
Omeprazole9.8%8,660
9
Atorvastatin-calcium7.1%6,243
10
Amlodipine6.3%5,527
11
Gabapentin6.2%5,489
12
Prednisone6.2%5,433
13
Furosemide6.0%5,304
14
Ibuprofen5.6%4,900
15
Calcium5.5%4,830

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports fexofenadine side effects

59.6% of fexofenadine adverse event reports involve female patients and 26.3% involve male patients. The largest age group is adult at 65%. These figures reflect who reports side effects, not underlying risk.

Sex

Female59.6%
Male26.3%
Unknown14.1%

Age group

< 20.2%
2–112.0%
12–172.3%
18–6464.8%
65+30.7%

What is fexofenadine used for

Conditions and purposes for which patients were taking fexofenadine when the adverse event was reported.

11-beta-hydroxylase DeficiencyAbdominal DiscomfortAbdominal DistensionAbdominal PainAbdominal Pain UpperAcarodermatitisAccidental Exposure To ProductAccidental Exposure To Product By ChildAcneAcute Graft Versus Host DiseaseAcute SinusitisAdjuvant TherapyAdverse Drug ReactionAdverse EventAdverse Reaction

Showing 15 of 905 indications

Fexofenadine brand names and reporting trend

Fexofenadine is sold under the brand name Fexofenadine Hcl; Pseudoephedrine Hcl.

Brand names

Fexofenadine Hcl; Pseudoephedrine Hcl76

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking fexofenadine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.