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 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 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 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 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 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 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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