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Fexofenadine Side Effects

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Common Fexofenadine Side Effects


The most commonly reported Fexofenadine side effects (click to view or check a box to report):

Dizziness (27)
Dyspnoea (26)
Headache (22)
Nausea (19)
Rash (17)
Product Substitution Issue (17)
Pruritus (16)
Urticaria (14)
Palpitations (13)
Pain (13)
Condition Aggravated (13)
Fatigue (12)
Product Quality Issue (12)
Malaise (12)
Hypersensitivity (11)
Anxiety (10)
Swelling Face (10)
Hypertension (9)
Pulmonary Embolism (9)
Insomnia (9)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Fexofenadine Side Effects Reported to FDA



Fexofenadine Side Effect Report#9938092
Blood Glucose Increased
This is a report of a 73-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: nasopharyngitis, who was treated with Fexofenadine Hcl Otc (dosage: NA, start time:
Feb 22, 2014), combined with:
  • Glimepiride
  • Metformin
  • Welchol
and developed a serious reaction and side effect(s): Blood Glucose Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fexofenadine Hcl Otc treatment in female patients, resulting in Blood Glucose Increased side effect.
Fexofenadine Side Effect Report#9893448
Foreign Body
This report suggests a potential Fexofenadine 180mg Tablets Foreign Body side effect(s) that can have serious consequences. A 13-year-old male patient (weight: NA) from AU was diagnosed with the following symptoms/conditions: rash and used Fexofenadine 180mg Tablets (dosage: NA) starting
Jan 30, 2014. After starting Fexofenadine 180mg Tablets the patient began experiencing various side effects, including: Foreign BodyAdditional drugs used concurrently: NA.The patient was hospitalized. Although Fexofenadine 180mg Tablets demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Foreign Body, may still occur.
Fexofenadine Side Effect Report#9871308
Psychotic Disorder, Hallucination, Thinking Abnormal, Off Label Use, Fatigue, Underdose
This Psychotic Disorder problem was reported by a consumer or non-health professional from US. A 89-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rhinorrhoea. On
Apr 13, 2011 this consumer started treatment with Fexofenadine (dosage: 60 Milligram Daily;). The following drugs were being taken at the same time: NA. When using Fexofenadine, the patient experienced the following unwanted symptoms/side effects: Psychotic Disorder, Hallucination, Thinking Abnormal, Off Label Use, Fatigue, UnderdoseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Psychotic Disorder, may become evident only after a product is in use by the general population.
Fexofenadine Side Effect Report#9856957
Alanine Aminotransferase Increased
This Alanine Aminotransferase Increased side effect was reported by a physician from GB. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fexofenadine (drug dosage: NA), which was initiated on
Jan 09, 2014. Concurrently used drugs:
  • Priadel
  • Omeprazole
  • Fluoxetine
  • Ramipril
  • Ramipril
  • Beclometasone
.After starting to take Fexofenadine the consumer reported adverse symptoms, such as: Alanine Aminotransferase IncreasedThese side effects may potentially be related to Fexofenadine.
Fexofenadine Side Effect Report#9855173
Alanine Aminotransferase Increased
This is a report of a 46-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Fexofenadine (dosage: NA, start time:
Oct 31, 2013), combined with:
  • Beclomethasone
  • Fluoxetine
  • Omeprazole
  • Priadel
  • Ramipril
  • Ramipril
and developed a serious reaction and side effect(s): Alanine Aminotransferase Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fexofenadine treatment in male patients, resulting in Alanine Aminotransferase Increased side effect.
Fexofenadine Side Effect Report#9841266
Alanine Aminotransferase Increased
This report suggests a potential Fexofenadine Hydrochloride Alanine Aminotransferase Increased side effect(s) that can have serious consequences. A 46-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Fexofenadine Hydrochloride (dosage: NA) starting
Jan 09, 2014. After starting Fexofenadine Hydrochloride the patient began experiencing various side effects, including: Alanine Aminotransferase IncreasedAdditional drugs used concurrently:
  • Priadel
  • Omeprazole
  • Fluoxetine
  • Ramipril
  • Ramipril
  • Beclometasone
Although Fexofenadine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Alanine Aminotransferase Increased, may still occur.
Fexofenadine Side Effect Report#9830163
Headache, Blood Pressure Increased
This Headache problem was reported by a consumer or non-health professional from US. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypersensitivity. On
Jan 07, 2014 this consumer started treatment with Fexofenadine Hcl Otc (dosage: NA). The following drugs were being taken at the same time:
  • Azor
When using Fexofenadine Hcl Otc, the patient experienced the following unwanted symptoms/side effects: Headache, Blood Pressure IncreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Headache, may become evident only after a product is in use by the general population.
Fexofenadine Side Effect Report#9829703
Alanine Aminotransferase Increased
This Alanine Aminotransferase Increased side effect was reported by a physician from GB. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fexofenadine (drug dosage: NA), which was initiated on
Dec 10, 2013. Concurrently used drugs:
  • Beclometasone
  • Fluoxetine
  • Omeprazole
  • Priadel
  • Ramipril
  • Ramipril
.After starting to take Fexofenadine the consumer reported adverse symptoms, such as: Alanine Aminotransferase IncreasedThese side effects may potentially be related to Fexofenadine.
Fexofenadine Side Effect Report#9807794
Prescribed Overdose, Grand Mal Convulsion
This is a report of a 18-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: urticaria, who was treated with Fexofenadine (dosage: NA, start time:
Nov 28, 2013), combined with: NA. and developed a serious reaction and side effect(s): Prescribed Overdose, Grand Mal Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fexofenadine treatment in female patients, resulting in Prescribed Overdose side effect. The patient was hospitalized.
Fexofenadine Side Effect Report#9804566
Grand Mal Convulsion, Prescribed Overdose
This report suggests a potential Fexofenadine Grand Mal Convulsion side effect(s) that can have serious consequences. A 18-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: urticaria and used Fexofenadine (dosage: 720 Milligram Daily;) starting
Nov 28, 2013. After starting Fexofenadine the patient began experiencing various side effects, including: Grand Mal Convulsion, Prescribed OverdoseAdditional drugs used concurrently:
  • Ranitidine (300 Milligram Daily;)
The patient was hospitalized. Although Fexofenadine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Grand Mal Convulsion, may still occur.
Fexofenadine Side Effect Report#9795716
Grand Mal Convulsion, Prescribed Overdose
This Grand Mal Convulsion problem was reported by a pharmacist from GB. A 18-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: urticaria. On
Nov 28, 2013 this consumer started treatment with Fexofenadine Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Ranitidine
When using Fexofenadine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Grand Mal Convulsion, Prescribed OverdoseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Grand Mal Convulsion, may become evident only after a product is in use by the general population.
Fexofenadine Side Effect Report#9787934
Prescribed Overdose, Grand Mal Convulsion
This Prescribed Overdose side effect was reported by a pharmacist from GB. A 18-year-old female patient (weight:NA) experienced the following symptoms/conditions: urticaria.The patient was prescribed Fexofenadine (drug dosage: NA), which was initiated on
Nov 28, 2013. Concurrently used drugs:
  • Ranitidine
.After starting to take Fexofenadine the consumer reported adverse symptoms, such as: Prescribed Overdose, Grand Mal ConvulsionThese side effects may potentially be related to Fexofenadine. The patient was hospitalized.
Fexofenadine Side Effect Report#9783178
Grand Mal Convulsion, Overdose
This is a report of a 18-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: urticaria, who was treated with Fexofenadine Hydrochloride (dosage: NA, start time: NS), combined with:
  • Ranitidine Hydrochloride
and developed a serious reaction and side effect(s): Grand Mal Convulsion, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fexofenadine Hydrochloride treatment in female patients, resulting in Grand Mal Convulsion side effect.
Fexofenadine Side Effect Report#9714591
Otitis Externa Bacterial, Otitis Media Acute, Otitis Externa Candida, Headache, Pain, Ear Swelling, Ear Infection Fungal, Ear Infection Bacterial, Insomnia
This report suggests a potential Fexofenadine Otitis Externa Bacterial side effect(s) that can have serious consequences. A 34-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Fexofenadine (dosage: 180 Milligram Daily;) starting
Jan 01, 2011. After starting Fexofenadine the patient began experiencing various side effects, including: Otitis Externa Bacterial, Otitis Media Acute, Otitis Externa Candida, Headache, Pain, Ear Swelling, Ear Infection Fungal, Ear Infection Bacterial, InsomniaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Fexofenadine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Otitis Externa Bacterial, may still occur.
Fexofenadine Side Effect Report#9708970
Condition Aggravated, Ear Infection Bacterial, Ear Infection Fungal, Pseudomonas Infection, Otitis Externa Bacterial, Otitis Externa Candida, Otitis Media Acute
This Condition Aggravated problem was reported by a consumer or non-health professional from GB. A 34-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 2011 this consumer started treatment with Fexofenadine (dosage: NA). The following drugs were being taken at the same time: NA. When using Fexofenadine, the patient experienced the following unwanted symptoms/side effects: Condition Aggravated, Ear Infection Bacterial, Ear Infection Fungal, Pseudomonas Infection, Otitis Externa Bacterial, Otitis Externa Candida, Otitis Media AcuteThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Condition Aggravated, may become evident only after a product is in use by the general population.
Fexofenadine Side Effect Report#9706486
Anaphylactic Shock
This Anaphylactic Shock side effect was reported by a consumer or non-health professional from US. A 65-year-old male patient (weight:NA) experienced the following symptoms/conditions: seasonal allergy.The patient was prescribed Fexofenadine Hcl Otc (drug dosage: NA), which was initiated on
Nov 19, 2013. Concurrently used drugs: NA..After starting to take Fexofenadine Hcl Otc the consumer reported adverse symptoms, such as: Anaphylactic ShockThese side effects may potentially be related to Fexofenadine Hcl Otc.
Fexofenadine Side Effect Report#9704554
Otitis Externa Bacterial, Otitis Media Acute, Otitis Externa Candida, Pain, Ear Swelling, Ear Infection Fungal, Ear Infection Bacterial, Pseudomonas Infection, Condition Aggravated
This is a report of a 34-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Fexofenadine Hydrochloride (dosage: NA, start time:
Jan 01, 2011), combined with: NA. and developed a serious reaction and side effect(s): Otitis Externa Bacterial, Otitis Media Acute, Otitis Externa Candida, Pain, Ear Swelling, Ear Infection Fungal, Ear Infection Bacterial, Pseudomonas Infection, Condition Aggravated after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fexofenadine Hydrochloride treatment in male patients, resulting in Otitis Externa Bacterial side effect. The patient was hospitalized.
Fexofenadine Side Effect Report#9690312
Condition Aggravated, Ear Infection Bacterial, Ear Infection Fungal, Ear Swelling, Headache, Pseudomonas Infection, Otitis Externa Bacterial, Otitis Externa Candida, Otitis Media Acute
This report suggests a potential Fexofenadine Condition Aggravated side effect(s) that can have serious consequences. A 34-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Fexofenadine (dosage: NA) starting
Jan 01, 2011. After starting Fexofenadine the patient began experiencing various side effects, including: Condition Aggravated, Ear Infection Bacterial, Ear Infection Fungal, Ear Swelling, Headache, Pseudomonas Infection, Otitis Externa Bacterial, Otitis Externa Candida, Otitis Media AcuteAdditional drugs used concurrently: NA.The patient was hospitalized. Although Fexofenadine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Condition Aggravated, may still occur.
Fexofenadine Side Effect Report#9682562
Swelling Face, Joint Swelling, Eye Swelling
This Swelling Face problem was reported by a consumer or non-health professional from US. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypersensitivity. On
Sep 26, 2013 this consumer started treatment with Fexofenadine Hcl Otc (dosage: NA). The following drugs were being taken at the same time:
  • Novolog
  • Lantus
When using Fexofenadine Hcl Otc, the patient experienced the following unwanted symptoms/side effects: Swelling Face, Joint Swelling, Eye SwellingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Swelling Face, may become evident only after a product is in use by the general population.
Fexofenadine Side Effect Report#9675984
Heart Rate Increased
This Heart Rate Increased side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: hypersensitivity.The patient was prescribed Fexofenadine (drug dosage: 180 Milligram Daily;), which was initiated on 201303. Concurrently used drugs:
  • Tocopherol
  • Lipid Modifying Agents
  • Fish Oil
  • Venlafaxine
  • Gabapentin
  • Celecoxib
  • Metoprolol
.After starting to take Fexofenadine the consumer reported adverse symptoms, such as: Heart Rate IncreasedThese side effects may potentially be related to Fexofenadine.
Fexofenadine Side Effect Report#9669088
Swelling Face, Lip Swelling
This is a report of a 31-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: rhinitis allergic,asthma, who was treated with Fexofenadine (dosage: NA, start time:
Mar 31, 2012), combined with:
  • Qvar
  • Salbutamol
and developed a serious reaction and side effect(s): Swelling Face, Lip Swelling after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fexofenadine treatment in male patients, resulting in Swelling Face side effect.
Fexofenadine Side Effect Report#9668636
Swelling Face, Lip Swelling
This report suggests a potential Fexofenadine Swelling Face side effect(s) that can have serious consequences. A 31-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: rhinitis allergic,asthma and used Fexofenadine (dosage: NA) starting
Mar 31, 2012. After starting Fexofenadine the patient began experiencing various side effects, including: Swelling Face, Lip SwellingAdditional drugs used concurrently:
  • Qvar
  • Salbutamol
Although Fexofenadine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Swelling Face, may still occur.
Fexofenadine Side Effect Report#9648450
Swelling Face, Lip Swelling
This Swelling Face problem was reported by a health professional from GB. A 31-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: rhinitis allergic,asthma. On
Mar 31, 2012 this consumer started treatment with Fexofenadine Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Salbutamol
  • Qvar
When using Fexofenadine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Swelling Face, Lip SwellingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Swelling Face, may become evident only after a product is in use by the general population.
Fexofenadine Side Effect Report#9594920
Lip Swelling
This Lip Swelling side effect was reported by a physician from GB. A 29-year-old male patient (weight:NA) experienced the following symptoms/conditions: urticaria.The patient was prescribed Fexofenadine Hydrochloride (drug dosage: NA), which was initiated on
Sep 16, 2013. Concurrently used drugs: NA..After starting to take Fexofenadine Hydrochloride the consumer reported adverse symptoms, such as: Lip SwellingThese side effects may potentially be related to Fexofenadine Hydrochloride.
Fexofenadine Side Effect Report#9586408
Loss Of Consciousness, Vertigo, Dyspnoea
This is a report of a 51-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: seasonal allergy, who was treated with Fexofenadine (dosage: NA, start time:
Sep 23, 2013), combined with: NA. and developed a serious reaction and side effect(s): Loss Of Consciousness, Vertigo, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fexofenadine treatment in female patients, resulting in Loss Of Consciousness side effect.


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The appearance of Fexofenadine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Fexofenadine Side Effects for Women?

Women Side EffectsReports
Dizziness 19
Dyspnoea 19
Nausea 16
Headache 15
Product Substitution Issue 13
Palpitations 12
Malaise 11
Pain 11
Pruritus 11
Urticaria 11

What are common Fexofenadine Side Effects for Men?

Men Side EffectsReports
Dizziness 8
Headache 7
Atrial Fibrillation 6
Condition Aggravated 6
Dyspnoea 6
Alanine Aminotransferase Increased 5
Lip Swelling 5
Nervousness 5
Pruritus 5
Rash 5

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Fexofenadine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Fexofenadine Safety Alerts, Active Ingredients, Usage Information

    NDC0179-8325
    TypeHUMAN OTC DRUG
    Proprietary NameFexofenadine Hydrochloride 180
    NameFexofenadine Hydrochloride
    Dosage FormTABLET
    RouteORAL
    On market since20120705
    LabelerKaiser Permanente
    Active Ingredient(s)FEXOFENADINE HYDROCHLORIDE
    Strength(s)180
    Unit(s)mg/1
    Pharma Class

    More About Fexofenadine

    Side Effects reported to FDA: 367

    Fexofenadine safety alerts: No

    Reported deaths: 5

    Reported hospitalizations: 41

    Latest Fexofenadine clinical trials