Side Effects of fexofenadine: A Synthesis of Findings from 29 Studies

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Original Abstract of the Article

Major Research Findings

Fexofenadine is a medication used to treat allergic symptoms, such as allergic rhinitis. 16 found that a combination of fexofenadine and montelukast was effective in treating patients with prurigo nodularis or pemphigoid nodularis who had not responded to conventional therapy. 5 suggests that increasing the dosage of fexofenadine to four times the recommended dose may be effective for chronic spontaneous urticaria. Another study, 1 found that a combination of naproxen and fexofenadine may be effective in preventing side effects of influenza vaccination. These findings suggest that fexofenadine is a promising treatment for allergic conditions, however, it is important to be aware of potential side effects and interactions with other medications.

Reasons for Side Effects

Side effects of fexofenadine are associated with its histamine H1 receptor antagonist properties. Histamine is a neurotransmitter involved in allergic and inflammatory responses. It binds to H1 receptors, triggering various symptoms. Fexofenadine inhibits the action of histamine by binding to H1 receptors, but this action can lead to side effects. 14

Common Side Effects

Drowsiness

Fexofenadine may cause drowsiness, particularly in elderly patients and those with liver impairment. 14 , 18 , 28 , 12 , 20

Gastrointestinal Symptoms

Fexofenadine may cause gastrointestinal symptoms, such as nausea, vomiting, abdominal pain, constipation, and diarrhea. 25 , 11 , 3

Liver Impairment

Fexofenadine may lead to liver impairment. Symptoms of liver impairment include jaundice, abdominal pain, and loss of appetite. 22

Allergic Reactions

Fexofenadine can cause allergic reactions. Symptoms of allergic reactions include rash, itching, and difficulty breathing. 21

Other

Other possible side effects of fexofenadine include headache, dizziness, palpitations, fever, muscle aches, joint pain, and fatigue. 17 , 10

Managing Side Effects

Drowsiness

To minimize drowsiness, adjusting the time of fexofenadine administration is crucial. Taking it before bedtime may lead to excessive sleepiness. Therefore, taking it in the morning or afternoon is recommended. When taking fexofenadine, avoid activities requiring alertness, such as driving or operating machinery. 14

Gastrointestinal Symptoms

Eating a balanced diet and staying hydrated can help alleviate gastrointestinal symptoms. Avoid fatty foods and stimulants. 25

Liver Impairment

If you experience symptoms of liver impairment, consult your doctor immediately. 22

Allergic Reactions

If you experience symptoms of an allergic reaction, seek medical attention immediately. 21

Other

Consult your doctor if you experience any other side effects. 17 , 10

Comparison Across Studies

Commonalities

While these studies suggest fexofenadine's effectiveness in treating allergic conditions, information on side effects varies and doesn't always align. 16 , 5 , 1

Differences

The frequency and severity of specific side effects vary across studies. For example, 16 reported no side effects from the combined therapy of fexofenadine and montelukast. However, 5 observed drowsiness and other side effects when fexofenadine was administered at four times the regular dose. These discrepancies may arise from differences in patient populations and research methodologies. 14

Practical Implications and Precautions

Fexofenadine is an effective medication for treating allergic symptoms, but it's crucial to be aware of potential side effects and interactions with other medications. 16 , 5 , 1

Always follow your doctor's instructions when taking fexofenadine. Do not stop or change the dosage without consulting your doctor. 17

Fexofenadine may interact with other medications. If you are taking other medications, consult your doctor or pharmacist. 24 , 22 , 13

Avoid taking fexofenadine if you are pregnant or breastfeeding. 4

Fexofenadine can affect driving and operating machinery. Use caution when performing such activities. 12 , 26

Limitations of Current Research

The research on fexofenadine side effects is still limited. 28 , 10

More research is needed to understand the long-term effects of taking fexofenadine, particularly in specific patient groups. 19

Future Research Directions

Further research is essential to investigate the long-term effects of fexofenadine and its potential side effects in specific patient groups. 28 , 10

In addition, more detailed studies on the interactions of fexofenadine with other medications are needed. 24 , 22 , 13

Conclusion

Fexofenadine is an effective medication for treating allergic symptoms, but there are associated side effects. 16 , 5 , 1

When taking fexofenadine, follow your doctor's instructions carefully and promptly report any side effects to your doctor. 17

Literature analysis of 29 papers
Positive Content
22
Neutral Content
4
Negative Content
3
Article Type
3
1
2
6
27
3.

Diphenhydramine: Time to Move on?

Author: WolfsonAnna R, WongDennis, AbramsElissa M, WasermanSusan, SussmanGordon L

Antihistamine effect
Sedation
Toxicity

This article argues that diphenhydramine, a widely used antihistamine, should be replaced with newer, safer alternatives like second-generation antihistamines, due to its undesirable side effects and availability of more favorable options.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

4.

Fexofenadine: review of safety, efficacy and unmet needs in children with allergic rhinitis.

Author: MeltzerEli O, RosarioNelson Augusto, Van BeverHugo, LucioLuiz

AR symptom relief
conjunctivitis relief
quality of life improvement

Fexofenadine, a second-generation antihistamine, effectively alleviates allergic rhinitis (AR) symptoms in children, is non-sedating, and is devoid of cardiovascular side effects. This review aimed to evaluate and compare the safety and efficacy of fexofenadine with other available first- and second-generation antihistamines in children with AR.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Efficacy and Safety of Up-dosing Antihistamines in Chronic Spontaneous Urticaria: A Systematic Review of the Literature.

Author: Iriarte SotésP, ArmisénM, Usero-BárcenaT, Rodriguez FernándezA, Otero RivasM M, GonzalezM T, Meijide CalderónA, VeleiroB,

Urticaria treatment

This study reviews the clinical evidence on the efficacy and safety of higher-than-licensed dosage of second-generation oral antihistamines in the treatment of chronic spontaneous urticaria (CSU).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

7.

Antihistamine effects and safety of fexofenadine: a systematic review and Meta-analysis of randomized controlled trials.

Author: HuangCheng-Zhi, JiangZhi-Hui, WangJian, LuoYue, PengHua

Allergic disease treatment

This systematic review evaluated the antihistamine effects and safety of fexofenadine.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

8.

Effects of a Novel Barley-Based Formulation on Allergic Rhinitis: A Randomized Controlled Trial.

Author: DerakhshanAlireza, KhodadoostMahmood, GhaneiMostafa, GachkarLatif, HajimahdipourHoma, TaghipourAli, YousefiJaleh, KhoshkhuiMaryam, AzadFarahzad J

Reduced AR symptoms

A natural formulation based on Hordeum vulgare (Ma-al-Shaeer) may be an effective treatment for allergic rhinitis (AR). It showed comparable effectiveness to fexofenadine in reducing symptoms and improving rhinitis control. Further research is needed to confirm its therapeutic potential.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

9.

The Efficacy of a Two-Fold Increase of H1-Antihistamine in the Treatment of Chronic Urticaria - the Vietnamese Experience.

Author: ThiHuyen Tran, ThiLan Pham, VanThuong Nguyen, MinhPhuong Pham Thi, TrongHao Nguyen, VanTro Chau, HuuSau Nguyen, MinhTrang Trinh, HuuNghi Dinh, VanTam Hoang, CamVan Tran, HuyenMy Le, HauKhang Tran, ThanhThuy Nguyen, ThiPhuong Hoang, ThuyLinh Nguyen, GandolfiMarco, SatolliFrancesca, FelicianiClaudio, TirantMichael, VojvodicAleksandra, LottiTorello

Chronic urticaria treatment

Chronic urticaria, a common and debilitating condition, often requires increased doses of H1-antihistamines beyond the recommended dose to achieve satisfactory relief.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

10.

Use of a trigger tool to detect adverse drug reactions in an emergency department.

Author: de AlmeidaSilvana Maria, RomualdoAruana, de Abreu FerraresiAndressa, ZelezogloGiovana Roberta, MarraAlexandre R, EdmondMichael B

ADR detection

This study aimed to estimate the prevalence of adverse drug reactions in patients seeking care in the emergency department.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

Comparative Efficacy and Safety of Ebastine 20 mg, Ebastine 10 mg and Levocetirizine 5 mg in Acute Urticaria.

Author: GoyalVippan, GuptaAnu, GuptaOnam, LalDhruvendra, GillManharan

Urticaria treatment

Second-generation non-sedating H1 antihistamines are often used as first-line treatment for acute and chronic urticaria.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

12.

A simulated car-driving study on the effects of acute administration of levocetirizine, fexofenadine, and diphenhydramine in healthy Japanese volunteers.

Author: InamiAkie, MatsudaRin, GroboschThomas, KomamuraHiroshi, TakedaKazuko, YamadaYusuke, MiyakeMasayasu, HiraokaKotaro, MaurerMarcus, YanaiKazuhiko, TashiroManabu

No sedative effects

This study evaluated the sedative effects of levocetirizine, a new-generation antihistamine, in healthy Japanese subjects.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

13.

Effect of diosmin on the intestinal absorption and pharmacokinetics of fexofenadine in rats.

Author: NeeratiPrasad, BedadaSatish Kumar

Altered bioavailability

Diosmin is a potent P-glycoprotein (P-gp) inhibitor in cultured cells. This study investigated the effect of diosmin on the intestinal absorption and pharmacokinetics of fexofenadine, a P-gp substrate in rats.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Brain histamine H1 receptor occupancy measured by PET after oral administration of levocetirizine, a non-sedating antihistamine.

Author: HiraokaKotaro, TashiroManabu, GroboschThomas, MaurerMarcus, OdaKeiichi, ToyoharaJun, IshiiKenji, IshiwataKiichi, YanaiKazuhiko

Non-sedating antihistamine

Levocetirizine, a second-generation antihistamine, showed less brain H1R occupancy and subjective sleepiness compared to fexofenadine, suggesting a better non-sedating profile.

Controlled Clinical TrialA clinical trial that evaluates the effectiveness of a treatment by comparing a group that receives the intervention with a group that receives a placebo or standard treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Combination therapy of fexofenadine and montelukast is effective in prurigo nodularis and pemphigoid nodularis.

Author: ShintaniTakako, OhataChika, KogaHiroshi, OhyamaBungo, HamadaTakahiro, NakamaTakekuni, FurumuraMinao, TsurutaDaisuke, IshiiNorito, HashimotoTakashi

Prurigo nodularis treatment

Combination therapy of fexofenadine and montelukast was effective for some patients with conventional therapy-resistant prurigo nodularis and pemphigoid nodularis. 11 of 15 cases (73.3%) improved with this therapy.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

Characterization of anti-inflammatory properties and evidence for no sedation liability for the novel antihistamine SUN-1334H.

Author: MandhaneSanjay N, ShahJigar H, BahekarPrashant C, MehetreSameer V, PawarChandrashekhar A, BagadAshish S, ChidrewarGajanan U, RaoChitturi Trinadha, RajamannarThennati

Anti-inflammatory effects
CNS side effects

This study compared the anti-inflammatory effects, sedation potential, and interaction with alcohol of SUN-1334H, a new potential antihistamine, with other antihistamines.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

20.

Evaluation of the efficacy and safety of olopatadine and fexofenadine compared with placebo in Japanese cedar pollinosis using an environmental exposure unit.

Author: EnomotoT, LuH Q, YinM, SakodaT, DakeY, EnomotoK, IdeT, ChengL

Activity improvement
Nasal symptom relief
Fexofenadine ineffective

Olopatadine is more effective than placebo and fexofenadine in improving nasal symptoms of Japanese cedar pollinosis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

21.

[Antipruritic efficacy of a high-dosage antihistamine therapy. Results of a retrospectively analysed case series].

Author: SchulzS, MetzM, SiepmannD, LugerT A, MaurerM, StänderS

Symptom relief
Not effective at standard doses

High-dosage antihistamines can be effective and safe for treating chronic pruritus of different origins.

Controlled Clinical TrialA clinical trial that evaluates the effectiveness of a treatment by comparing a group that receives the intervention with a group that receives a placebo or standard treatment.
English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : German

23.

Detecting signals of drug-drug interactions in a spontaneous reports database.

Author: ThakrarBharat T, GrundschoberSabine Borel, DoesseggerLucette

Drug-drug interactions

This study investigates a method for detecting signals of adverse drug reactions (ADRs) associated with drug-drug interactions (DDIs) in a spontaneous reports database. Two different statistical assumptions for detecting these signals were investigated.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

24.

Grapefruit juice and drug interactions. Exploring mechanisms of this interaction and potential toxicity for certain drugs.

Author: BresslerRubin

Adverse clinical effects

Grapefruit juice can significantly alter the plasma concentrations of numerous drugs by inhibiting CYP3A4 and OATP enzymes, leading to potentially adverse clinical effects. It is essential to advise patients about potential interactions with grapefruit juice and certain medications.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

25.

The proarrhythmic antihistaminic drug terfenadine increases spontaneous calcium release in human atrial myocytes.

Author: Hove-MadsenLeif, LlachAnna, MolinaCristina E, Prat-VidalCristina, FarréJordi, RouraSantiago, CincaJuan

Arrhythmogenic potential

This study examined the effects of the antihistamine drug terfenadine on intracellular calcium handling in isolated human atrial myocytes. Terfenadine was shown to inhibit L-type calcium current and increase spontaneous calcium release, potentially contributing to its proarrhythmic effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

27.

Antimuscarinic actions of antihistamines on the heart.

Author: LiuHuiling, ZhengQi, FarleyJerry M

Antihistamine treatment
Dry mouth
Sedation
Tachycardia
Thickening of mucus

This study examined the interaction of four antihistamines with muscarinic receptors. Fexofenadine and cetirizine had little or no interaction with muscarinic receptors.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

28.

Review of H1 antihistamines in the treatment of chronic idiopathic urticaria.

Author: MonroeEugene

CIU treatment efficacy

Newer-generation H1 antihistamines like fexofenadine, loratadine, and desloratadine are preferred over older-generation antihistamines for treating chronic idiopathic urticaria due to their nonsedating properties.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

29.

Chiral cardiovascular drugs: an overview.

Author: RanadeVasant V, SombergJohn C

Cardiovascular drug development

Chirality, or the ability of a molecule to exist in two mirror-image forms, is becoming increasingly important in drug research and development. Different stereoisomers of a drug can have different therapeutic activity, side effects, and toxicity. This review discusses chirality in cardiovascular drugs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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