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Azor (Amlodipine / Olmesartan) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Azor (Amlodipine / Olmesartan) 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 (27)
Death (2)
Disability (1)

Reports by Reaction Type

Diarrhoea (6)Dyspnoea (5)Oedema Peripheral (4)Dehydration (4)Hypersensitivity (3)Pruritus (3)Abdominal Discomfort (3)Dizziness (3)Blood Pressure Increased (3)Weight Decreased (2)Headache (2)Weight Increased (2)

Possible Azor side effects in 68 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 68 year old female

Reactions: Drug Hypersensitivity

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azor

Nexium
    Administration route: Oral

Exedrin



Possible Azor side effects in 74 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-02

Patient: 74 year old female

Reactions: Cataract

Drug(s) suspected as cause:
Azor



Possible Azor side effects in 67 year old male

Reported by a individual with unspecified qualification from United States on 2012-07-20

Patient: 67 year old male, weighing 108.6 kg (238.9 pounds)

Reactions: Cardiac Valve Disease, Dyspnoea, Chest Discomfort, Hypotension, Dizziness, Headache, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azor

Other drugs received by patient: Metformin HCL; Levoxyl (Levothyroxine Sodium) (Levothyroxine Sodium); Lotrel (Amlodipine, Benazepril Hydrochloride) (Amlodipine, Benazepril



Possible Azor side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: male

Reactions: Hypertension

Drug(s) suspected as cause:
Norvasc
    Dosage: unk

Azor
    Dosage: unk



Possible Azor side effects in 58 year old female

Reported by a physician from United States on 2012-06-20

Patient: 58 year old female, weighing 78.9 kg (173.6 pounds)

Reactions: Renal Tubular Disorder, Gastrointestinal Haemorrhage, Escherichia Urinary Tract Infection, Diverticulitis, Metastatic Gastric Cancer, Pericardial Effusion, Cardiomegaly, Gastric Cancer Stage 0, Incision Site Pain, Iron Deficiency Anaemia, Blood Pressure Inadequately Controlled, Blood Uric Acid Increased, Pleural Effusion, Renal Failure Acute, Metabolic Acidosis, Anaemia, Urinary Tract Infection, Condition Aggravated, Renal Cyst, Diverticulum, Diarrhoea, Ejection Fraction Decreased, Gastric Polyps, Sinus Tachycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vegf Trap-EYE (Ingredients Unspecified)
    Dosage: intravitreal
    Indication: Diabetic Retinal Oedema
    Start date: 2011-10-06
    End date: 2011-10-06

Azor
    Dosage: 5/20 mg (qd), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-09

Other drugs received by patient: Novolog (Insulin Aspart) (Insulin Aspart); Sulfam + TRI (Bactrim) (Sulfamethoxazole, Trimethoprim) (Sulfamethoxaz; Onglyza (Saxagliptin) (Saxagliptin); Levemir; Extra-Strength Tylenol (Paracetamol) (Paracetamol); Vitamin B12 (Cyanocobalamin) (Cyanocobalamin)



Possible Azor side effects in female

Reported by a pharmacist from United States on 2012-06-19

Patient: female

Reactions: Burning Sensation, Hypersensitivity, Pruritus, Hypopnoea

Drug(s) suspected as cause:
Catapres
    Dosage: 0.2 mg

Motrin

Hydrochlorothiazide

Irbesartan
    Indication: Hypertension
    Start date: 2012-04-05
    End date: 2012-04-05

Toprol-XL
    Dosage: 25 mg

Azor

Benicar HCT

Micardis
    Dosage: 40 mg

Tekturna HCT

Atacand HCT

Amlodipine Besylate

Bystolic

Atenolol
    Dosage: 50 mg

Lisinopril
    Dosage: 10 mg

Other drugs received by patient: Xyzal; Diovan HCT



Possible Azor side effects in 73 year old male

Reported by a individual with unspecified qualification from United States on 2012-06-13

Patient: 73 year old male, weighing 109.8 kg (241.5 pounds)

Reactions: Neuropathy Peripheral, Chest Discomfort, Pain in Extremity, Diarrhoea, Muscle Spasms, Venous Occlusion, Arrhythmia

Drug(s) suspected as cause:
Welchol
    Dosage: per oral
    Administration route: Oral
    Indication: Bile Acid Malabsorption

Azor
    Dosage: 5/40mg (qd), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-03-01

Tribenzor
    Dosage: per oral
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-03-01

Other drugs received by patient: Simvastatin; Benicar



Possible Azor side effects in 66 year old male

Reported by a consumer/non-health professional from United States on 2012-05-02

Patient: 66 year old male, weighing 93.0 kg (204.6 pounds)

Reactions: Gout, Oedema Peripheral, Dehydration, Blood Pressure Inadequately Controlled, Coronary Artery Disease, Condition Aggravated, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Benicar
    Dosage: 40 mg (40 mg, qd), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2002-01-01
    End date: 2012-01-01

Unspecified Diuretic (Diuretics)
    Dosage: per oral
    Administration route: Oral
    Indication: Hypertension
    End date: 2009-01-01

Azor
    Dosage: 5/40mg (qd), per oral; 10/40 mg (qd), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-01
    End date: 2012-04-08

Azor
    Dosage: 5/40mg (qd), per oral; 10/40 mg (qd), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-04-09

Other drugs received by patient: Plavix; Crestor; Aspirin; Metoprolol Succinate; Allopurinol; Coq10 (Ubidecarenone) (Ubidecarenone)



Possible Azor side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2012-04-30

Patient: 50 year old male, weighing 134.7 kg (296.4 pounds)

Reactions: Weight Increased

Drug(s) suspected as cause:
Azor
    Indication: Hypertension

Azor
    Indication: Hypertension
    Start date: 2007-01-01
    End date: 2012-01-01



Possible Azor side effects in female

Reported by a physician from United States on 2012-04-26

Patient: female

Reactions: Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azor



Possible Azor side effects in 50 year old female

Reported by a individual with unspecified qualification from United States on 2012-04-20

Patient: 50 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Pain in Extremity, Bone Pain, Abasia, Conduction Disorder, Hypoaesthesia, Paraesthesia, Myalgia, Arthralgia, Alopecia, Oedema Peripheral, Oedema, Asthenia, Back Disorder, Muscle Spasms

Drug(s) suspected as cause:
Azor

Other drugs received by patient: Hormone Replacement (Ingredients Unspecified)



Possible Azor side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-02

Patient: female

Reactions: Balance Disorder, Drug Interaction, Muscular Weakness, Blood Magnesium Decreased, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simvastatin
    Dosage: 20 mg (20 mg,qd),per oral
    Administration route: Oral
    Indication: Hyperlipidaemia

Azor
    Dosage: 10/40mg (qd),per oral ; 5/mg (qd),per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-01

Azor
    Dosage: 10/40mg (qd),per oral ; 5/mg (qd),per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01
    End date: 2012-01-01

Other drugs received by patient: Aspirin; Metformin HCL



Possible Azor side effects in 67 year old male

Reported by a individual with unspecified qualification from United States on 2012-03-23

Patient: 67 year old male, weighing 64.4 kg (141.7 pounds)

Reactions: Bedridden, Product Quality Issue, Weight Decreased, Vomiting, Diarrhoea, Nausea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azor
    Dosage: 10/40mg (qd),per oral ; 10/40mg (qd),per oral ; 10/40mg (qd),per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-03-05
    End date: 2012-03-05

Azor
    Dosage: 10/40mg (qd),per oral ; 10/40mg (qd),per oral ; 10/40mg (qd),per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-01-01
    End date: 2012-02-20

Azor
    Dosage: 10/40mg (qd),per oral ; 10/40mg (qd),per oral ; 10/40mg (qd),per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-02-28
    End date: 2012-02-28



Possible Azor side effects in

Reported by a consumer/non-health professional from United States on 2012-03-21

Patient:

Reactions: Blood Pressure Increased, Ear Disorder, Pyrexia, Erythema, Flushing, Abdominal Discomfort, Oedema Peripheral, Feeling Abnormal, Sinusitis

Drug(s) suspected as cause:
Tektamlo (Aliskiren, Amlodipine) Unknown
    Start date: 2011-02-18

Norvasc

Azor

Other drugs received by patient: Antihypertensive Drugs (NO Ingredients / Substances)



Possible Azor side effects in 60 year old male

Reported by a consumer/non-health professional from United States on 2012-03-16

Patient: 60 year old male

Reactions: Abdominal Discomfort, Hypersensitivity, Dyspnoea, Pruritus, Sedation, Rash, Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sular

Atenolol

Coreg

Azor

Tekturna
    Dosage: 150 mg, once daily, oral
    Administration route: Oral

Bystolic

Hydrochlorothiazide
    Dosage: oral
    Administration route: Oral

Labetalol HCL

Caduap

Enalapril Maleate

Lisinopril

Clonidine

Amlodipine

Aciphex

Micardis



Possible Azor side effects in 60 year old male

Reported by a consumer/non-health professional from United States on 2012-03-16

Patient: 60 year old male

Reactions: Abdominal Discomfort, Hypersensitivity, Pruritus, Dyspnoea, Sedation, Rash, Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Coreg

Lisinopril

Sular

Clonidine

Tekturna
    Dosage: 150 mg, once daily, oral
    Administration route: Oral

Labetalol HCL

Enalapril Maleate

Caduap

Aciphex

Azor

Bystolic

Hydrochlorothiazide
    Dosage: oral
    Administration route: Oral

Atenolol

Micardis

Amlodipine



Possible Azor side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-16

Patient: male

Reactions: Hypertension

Drug(s) suspected as cause:
Tekturna

Azor
    Dosage: 40 mg, oral
    Administration route: Oral



Possible Azor side effects in 67 year old male

Reported by a individual with unspecified qualification from United States on 2012-03-12

Patient: 67 year old male, weighing 64.4 kg (141.7 pounds)

Reactions: Product Quality Issue, Weight Decreased, Malaise, Nausea, Diarrhoea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azor
    Dosage: 10/40mg (qd),per oral ; 10/40mg (qd),per oral ; 10/40mg (qd),per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-01-01
    End date: 2012-02-20

Azor
    Dosage: 10/40mg (qd),per oral ; 10/40mg (qd),per oral ; 10/40mg (qd),per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-02-28
    End date: 2012-02-28

Azor
    Dosage: 10/40mg (qd),per oral ; 10/40mg (qd),per oral ; 10/40mg (qd),per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-03-05
    End date: 2012-03-05



Possible Azor side effects in

Reported by a consumer/non-health professional from United States on 2012-03-08

Patient:

Reactions: Microalbuminuria

Adverse event resulted in: death

Drug(s) suspected as cause:
Azor

Other drugs received by patient: Januvia; Metformin (Metformin)(tablet) (Metformin)



Possible Azor side effects in 67 year old male

Reported by a pharmacist from United States on 2012-03-06

Patient: 67 year old male, weighing 68.0 kg (149.7 pounds)

Reactions: Diarrhoea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azor



Possible Azor side effects in female

Reported by a pharmacist from United States on 2012-03-06

Patient: female, weighing 91.8 kg (202.0 pounds)

Reactions: Tubulointerstitial Nephritis, Vomiting, Dialysis, Renal Failure Acute, Tremor, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azor

Other drugs received by patient: Tricor; Flaxseed OIL; Lisinopril; Hydrochlorothiazide; Citalopram Hydrobromide



Possible Azor side effects in 69 year old female

Reported by a physician from United States on 2012-03-02

Patient: 69 year old female, weighing 73.9 kg (162.7 pounds)

Reactions: Dyspnoea, Incorrect Dose Administered, Diarrhoea, Tension Headache, Oedema Peripheral, Gastrointestinal Disorder, Dizziness, Gait Disturbance, Asthenia, Decreased Appetite, Influenza

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Azor



Possible Azor side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-24

Patient: male, weighing 121.9 kg (268.2 pounds)

Reactions: Blood Pressure Increased, Back Pain, Weight Increased, Dyspnoea, Loss of Employment, Pain, non-Cardiac Chest Pain

Drug(s) suspected as cause:
Nitroglycerin
    Dosage: 50 mg, 2x/day

Amiodarone HCL
    Dosage: 200 mg, 2x/day

Azor

Metoprolol Tartrate
    Dosage: 50 mg, 2x/day

Acetylsalicylic Acid SRT

Lipitor

Digoxin
    Dosage: 0.25 ug, 1x/day

Atenolol

Carvedilol

Altace
    Dosage: 10 mg, 1x/day
    Administration route: Oral

Norvasc
    Dosage: 5 mg, 1x/day

Zoloft
    Dosage: 100 mg, 1x/day



Possible Azor side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-02-08

Patient: 55 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Blood Pressure Increased, Catheter Placement, NO Therapeutic Response, Headache

Drug(s) suspected as cause:
Azor
    Dosage: 5/20mg (qd), per oral 10/40mg ((5/20mg tablets) bid), per oral 10/40mg (qd), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-11-01
    End date: 2012-01-01

Azor
    Dosage: 5/20mg (qd), per oral 10/40mg ((5/20mg tablets) bid), per oral 10/40mg (qd), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-01
    End date: 2012-01-01

Azor
    Dosage: 5/20mg (qd), per oral 10/40mg ((5/20mg tablets) bid), per oral 10/40mg (qd), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-01

Other drugs received by patient: Zemplar (Paricalcitol) (Paricalcitol)



Possible Azor side effects in 58 year old male

Reported by a consumer/non-health professional from United States on 2012-01-17

Patient: 58 year old male, weighing 86.2 kg (189.6 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Azor

Other drugs received by patient: Metformin HCL



Possible Azor side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2011-12-27

Patient: 81 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Protein Urine Present, Renal Disorder, Haemorrhage, Stent Placement, Blood Potassium Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azor

Other drugs received by patient: Amlodipine (Amlodipine) (5 Mililgram) (Amlodipine); Hydrochlorothiazide (Hydrochlorothiazide) (25 Milligram) (Hydrochlorot



Possible Azor side effects in 57 year old male

Reported by a consumer/non-health professional from United States on 2011-10-31

Patient: 57 year old male, weighing 74.8 kg (164.7 pounds)

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Azor

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