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Edarbi (Azilsartan) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Edarbi (Azilsartan) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (41)
Life Threatening Events (1)
Disability (2)

Reports by Reaction Type

Hypotension (9)Dizziness (7)Renal Impairment (7)Fatigue (5)Muscle Spasms (4)Renal Failure (4)Syncope (4)Loss of Consciousness (3)Oedema Peripheral (3)Angioedema (3)Confusional State (2)Dermatitis Allergic (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Edarbi (Azilsartan). For a complete list or a specific selection of reports, please use the links above.

Possible Edarbi side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-06

Patient: 68 year old female

Reactions: Dyspnoea Exertional, Oedema Peripheral

Drug(s) suspected as cause:
Edarbi

Other drugs received by patient: Bisoprolol Fumarate; Phenpro (Phenprocoumon); Losartan Potassium



Possible Edarbi side effects in female

Reported by a physician from United States on 2012-08-02

Patient: female

Reactions: Fall

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in male

Reported by a physician from United States on 2012-07-25

Patient: male

Reactions: Angioedema

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in 65 year old male

Reported by a physician from United States on 2012-07-19

Patient: 65 year old male

Reactions: Blood Pressure Decreased, Muscle Spasms, Oxygen Saturation Decreased

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: 58 year old female, weighing 127.0 kg (279.4 pounds)

Reactions: Hyperacusis, Drug Ineffective, Palpitations, Heart Rate Increased, Dizziness, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Edarbi
    Dosage: 80 mg, 1 in 1 d, per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-06-01
    End date: 2012-06-01

Edarbyclor
    Dosage: 1 in 1 d, per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-06-06
    End date: 2012-06-10

Edarbyclor
    Dosage: 1 in 1 d, per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-05-30
    End date: 2012-06-05

Other drugs received by patient: Hydrochlorothiazide



Possible Edarbi side effects in male

Reported by a physician from United States on 2012-06-07

Patient: male

Reactions: Weight Decreased, Hypotension, Loss of Consciousness

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in 64 year old female

Reported by a physician from United States on 2012-06-05

Patient: 64 year old female, weighing 117.0 kg (257.5 pounds)

Reactions: Muscle Spasms

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in 70 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-05

Patient: 70 year old female

Reactions: Oedema Peripheral, Rash Pruritic

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Edarbi

Other drugs received by patient: HMG COA Reductase Inhibitors; Platelet Aggregation Inhibitors; Oral Anticoagulants (Vit K Antagonists)



Possible Edarbi side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-25

Patient: female

Reactions: Dermatitis Allergic

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-22

Patient:

Reactions: Hypertensive Crisis

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-09

Patient: female

Reactions: Dermatitis Allergic

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-12

Patient: 60 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Myalgia, Fatigue, Renal Failure, Diarrhoea, Nausea, Muscle Spasms

Drug(s) suspected as cause:
Edarbi

Other drugs received by patient: Lipitor



Possible Edarbi side effects in male

Reported by a physician from United States on 2012-03-28

Patient: male

Reactions: Weight Decreased, Hypotension, Loss of Consciousness

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-27

Patient: 59 year old female

Reactions: Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Edarbi

Other drugs received by patient: Metoprolol Tartrate



Possible Edarbi side effects in 60 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-27

Patient: 60 year old male, weighing 70.3 kg (154.7 pounds)

Reactions: Myalgia, Fatigue, Renal Failure, Nausea, Diarrhoea, Muscle Spasms

Drug(s) suspected as cause:
Edarbi

Other drugs received by patient: Lipitor



Possible Edarbi side effects in 70 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-19

Patient: 70 year old female

Reactions: Oedema Peripheral, Rash Pruritic

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Edarbi

Other drugs received by patient: Platelet Aggregation Inhibitors (Platelet Aggregation Inhibitors); Oral Anticoagulants (Vit K Antagonists); HMG COA Reductase Inhibitors (Hmg COA Reductase Inhibitors)



Possible Edarbi side effects in 59 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-16

Patient: 59 year old female

Reactions: Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Edarbi

Other drugs received by patient: Metoprolol Tartrate



Possible Edarbi side effects in female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-08

Patient: female

Reactions: Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Edarbi

Other drugs received by patient: Metoprolol Tartrate



Possible Edarbi side effects in 39 year old female

Reported by a physician from United States on 2012-02-29

Patient: 39 year old female

Reactions: Anaphylactic Reaction

Drug(s) suspected as cause:
Edarbi

Other drugs received by patient: Zantac



Possible Edarbi side effects in male

Reported by a individual with unspecified qualification from United States on 2012-02-16

Patient: male

Reactions: Blood Pressure Increased, Liver Function Test Abnormal, Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norvasc
    Dosage: 5 mg, qd

Gilenya
    Dosage: 0.5 mg, qd
    Start date: 2011-05-10

Diovan
    Dosage: 80mg in the morning and 160mg at bedtime daily
    End date: 2011-08-19

Diovan
    Dosage: 80 mg, qd

Ampyra
    End date: 2011-08-02

Keppra
    Dosage: 750 mg, bid

Aricept
    End date: 2011-08-02

Norvasc
    Dosage: 2.5 mg, qhs
    Start date: 2011-08-30

Imuran

Avapro
    Dosage: 150 mg, qd

Edarbi
    Dosage: 80 mg, unk

Other drugs received by patient: Aspirin; Niacin; Aspirin; Calcium; Baclofen; Lipitor; Flonase; Tizanidine HCL



Possible Edarbi side effects in male

Reported by a physician from United States on 2012-02-15

Patient: male, weighing 140.0 kg (308.0 pounds)

Reactions: Fatigue, Syncope, Renal Impairment, Hypotension, Dizziness

Drug(s) suspected as cause:
Norvasc
    Dosage: 5 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-16
    End date: 2011-10-11

Edarbi
    Dosage: 80 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-16
    End date: 2011-10-11

Catapres
    Dosage: 0.3 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-01-01



Possible Edarbi side effects in male

Reported by a physician from United States on 2012-02-02

Patient: male, weighing 140.0 kg (308.0 pounds)

Reactions: Renal Impairment, Fatigue, Syncope, Hypotension, Dizziness

Drug(s) suspected as cause:
Edarbi
    Dosage: 80 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-16
    End date: 2011-10-11

Norvasc
    Dosage: 5 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-16
    End date: 2011-10-11

Catapres
    Dosage: 0.3 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-01-01



Possible Edarbi side effects in male

Reported by a physician from United States on 2012-02-01

Patient: male, weighing 63.5 kg (139.7 pounds)

Reactions: Renal Impairment, Hypotension

Drug(s) suspected as cause:
Edarbi
    Dosage: 80 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-16
    End date: 2011-10-11

Norvasc
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-16
    End date: 2011-10-11

Catapres
    Dosage: 0.3 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-01-01



Possible Edarbi side effects in male

Reported by a physician from United States on 2012-01-27

Patient: male

Reactions: Renal Impairment, Syncope, Hypotension

Drug(s) suspected as cause:
Norvasc
    Dosage: 0.5 mg, daily
    Indication: Hypertension
    Start date: 2011-08-16
    End date: 2011-10-11

Catapres
    Dosage: unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-01-01

Edarbi
    Dosage: 80 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-16
    End date: 2011-10-11



Possible Edarbi side effects in 57 year old male

Reported by a physician from United States on 2012-01-26

Patient: 57 year old male, weighing 63.5 kg (139.7 pounds)

Reactions: Fatigue, Renal Impairment, Syncope, Hypotension, Dizziness

Drug(s) suspected as cause:
Norvasc
    Dosage: 5 mg, 1 in 1 d, oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-16
    End date: 2011-10-11

Catapres
    Dosage: 0.3 mg, 1 in 1 d, oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-01-01

Edarbi
    Dosage: 80 mg, 1 in 1 d, oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-16
    End date: 2011-10-11



Possible Edarbi side effects in 68 year old male

Reported by a pharmacist from United States on 2012-01-26

Patient: 68 year old male, weighing 121.6 kg (267.4 pounds)

Reactions: Hyperkalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-12

Patient: 49 year old female

Reactions: Glomerular Filtration Rate Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-22

Patient:

Reactions: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Edarbi



Possible Edarbi side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-09

Patient: female

Reactions: Confusional State, Chills, Rhinorrhoea, Oropharyngeal Pain, Eye Pain, Eye Haemorrhage, Visual Impairment, Dizziness, DRY Eye

Drug(s) suspected as cause:
Tradjenta
    Dosage: 5 mg
    Administration route: Oral
    Indication: Blood Glucose Increased
    Start date: 2011-12-02

Tradjenta
    Indication: Type 2 Diabetes Mellitus

Edarbi
    Dosage: 80 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-11-01

Other drugs received by patient: Pepcid AC; Calcium Magnesium Zinc; Acetaminophen



Possible Edarbi side effects in 80 year old female

Reported by a consumer/non-health professional from United States on 2011-12-07

Patient: 80 year old female

Reactions: Eye Haemorrhage, Confusional State, Chills, Visual Impairment, Rhinorrhoea, Dizziness, Oropharyngeal Pain

Drug(s) suspected as cause:
Tradjenta
    Dosage: 5 mg
    Administration route: Oral
    Indication: Blood Glucose Increased
    Start date: 2011-12-02
    End date: 2011-12-04

Tradjenta
    Indication: Type 2 Diabetes Mellitus

Edarbi
    Dosage: 80 mg
    Administration route: Oral
    Indication: Hypertension

Other drugs received by patient: Calcium Magnesium Zinc; Pepcid AC; Acetaminophen

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