This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Avalide (Irbesartan / Hydrochlorothiazide) 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 (316)
Death (2)
Life Threatening Events (1)
Disability (1)
Reports by Reaction Type
Drug Ineffective (45),
Blood Pressure Increased (40),
Hypertension (36),
Dizziness (28),
Headache (23),
Medication Error (16),
Blood Pressure Inadequately Controlled (11),
Oedema Peripheral (11),
Back Pain (10),
Nausea (10),
Blood Pressure Fluctuation (10),
Fatigue (9)
Below are a few examples of reports where side effects / adverse reactions may be related to Avalide (Irbesartan / Hydrochlorothiazide). For a complete list or a specific selection of reports, please use the links above.
Possible Avalide side effects in 64 year old female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: 64 year old female, weighing 90.7 kg (199.6 pounds)
Reactions: Blood Pressure Increased, Nausea, Dizziness, Feeling Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Avalide
Possible Avalide side effects in 54 year old male
Reported by a physician from United States on 2012-08-03
Patient: 54 year old male, weighing 102.0 kg (224.4 pounds)
Reactions: Cyst, Lower Limb Fracture, Prostatic Disorder, Fall, Loss of Consciousness, Foot Fracture, Osteonecrosis, Syncope, Arthropathy, Carpal Tunnel Syndrome
Drug(s) suspected as cause:
Lyrica
Indication: Fibromyalgia
Cimzia
Indication: Depression
Lortab
Dosage: 1df:10/500 units nos
Indication: Pain
Avalide
Dosage: 1df = 300/12.5 mg
Administration route: Oral
Indication: Hypertension
Start date: 2011-07-05
Other drugs received by patient: Synthroid; Crestor; Zanaflex
Possible Avalide side effects in 65 year old male
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: 65 year old male, weighing 109.0 kg (239.8 pounds)
Reactions: Weight Increased, Cataract, Lung Disorder, Swelling, Arthritis
Drug(s) suspected as cause:
Avapro
Dosage: inter jun-2012.
Avalide
Dosage: 1df:300/12.5 mg, inter on an unspecified date and restarted again in jun2012.
Other drugs received by patient: Hydrochlorothiazide; Lasix
Possible Avalide side effects in 54 year old female
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: 54 year old female, weighing 73.0 kg (160.6 pounds)
Reactions: Weight Decreased, Vertigo, Renal Failure Chronic
Drug(s) suspected as cause:
Avalide
Indication: Hypertension
Start date: 2000-01-01
Avapro
Possible Avalide side effects in 54 year old male
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: 54 year old male, weighing 102.0 kg (224.4 pounds)
Reactions: Cyst, Lower Limb Fracture, Prostatic Disorder, Fall, Loss of Consciousness, Foot Fracture, Arthropathy, Osteonecrosis, Carpal Tunnel Syndrome
Drug(s) suspected as cause:
Avalide
Possible Avalide side effects in 51 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-18
Patient: 51 year old female, weighing 66.7 kg (146.7 pounds)
Reactions: Eye Haemorrhage, Back Pain, Increased Tendency To Bruise
Drug(s) suspected as cause:
Avalide
Dosage: daily oral
Administration route: Oral
Indication: Hypertension
Start date: 2006-01-01
End date: 2012-01-01
Hydrochlorothiazide
Possible Avalide side effects in 79 year old female
Reported by a consumer/non-health professional from United States on 2012-07-06
Patient: 79 year old female, weighing 82.0 kg (180.4 pounds)
Reactions: Chest Discomfort, Hypersensitivity, Drug Ineffective, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Norvasc
Avalide
Dosage: 1df=300/25mg for 9 months. also 300/12.5 pills. exp date:08sep12,8mar13
Administration route: Oral
Indication: Hypertension
Start date: 2011-09-09
Other drugs received by patient: Multi-Vitamins; Crestor
Possible Avalide side effects in 63 year old male
Reported by a consumer/non-health professional from Mexico on 2012-07-06
Patient: 63 year old male
Reactions: Myocardial Infarction
Adverse event resulted in: death
Drug(s) suspected as cause:
Avalide
Other drugs received by patient: Isosorbide; Clopidogrel Bisulfate
Possible Avalide side effects in 40 year old female
Reported by a consumer/non-health professional from Mexico on 2012-07-05
Patient: 40 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: Type 2 Diabetes Mellitus
Drug(s) suspected as cause:
Avalide
Possible Avalide side effects in 54 year old female
Reported by a consumer/non-health professional from United States on 2012-06-25
Patient: 54 year old female, weighing 58.0 kg (127.6 pounds)
Reactions: Pharyngeal Oedema, Cough
Drug(s) suspected as cause:
Avalide
Dosage: 1df=150/12.5 mg
Indication: Hypertension
Avapro
Indication: Hypertension
Monopril
Possible Avalide side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-11
Patient: male
Reactions: Coronary Artery Occlusion, Condition Aggravated, Myocardial Infarction
Drug(s) suspected as cause:
Plavix
Indication: Vascular Occlusion
Start date: 2005-01-01
End date: 2011-01-01
Avalide
Possible Avalide side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: female
Reactions: Angle Closure Glaucoma
Drug(s) suspected as cause:
Avalide
Possible Avalide side effects in 74 year old male
Reported by a consumer/non-health professional from Canada on 2012-05-25
Patient: 74 year old male
Reactions: Prostate Cancer
Drug(s) suspected as cause:
Alfuzosin HCL
Dosage: at bedtime
Administration route: Oral
Indication: Urinary Tract Disorder
Start date: 2007-01-01
End date: 2012-05-15
Testim
Administration route: Topical
Start date: 2011-07-01
End date: 2011-12-12
Lantus
Dosage: 36iu in morning, 38iu at bedtime
Indication: Diabetes Mellitus
Start date: 2007-01-01
Altace
Administration route: Oral
Indication: Hypertension
Start date: 2009-01-01
Avalide
Dosage: 1 df= 300/12.5mg
Administration route: Oral
Indication: Hypertension
Start date: 2009-01-01
Other drugs received by patient: Clonidine; Novorapid; Avodart; Atenolol; Amlodipine Besylate
Possible Avalide side effects in 74 year old male
Reported by a consumer/non-health professional from Canada on 2012-05-24
Patient: 74 year old male
Reactions: Prostate Cancer, Drug Administration Error
Drug(s) suspected as cause:
Alfuzosin HCL
Dosage: 10 mg, at bedtime
Administration route: Oral
Indication: Urinary Tract Disorder
Start date: 2007-01-01
End date: 2012-05-15
Lantus
Dosage: 74 iu daily, (36 iu in the morning and 38 iu at bedtime)
Indication: Diabetes Mellitus
Start date: 2007-01-01
Altace
Dosage: 10 mg, daily
Administration route: Oral
Indication: Hypertension
Start date: 2009-01-01
Avalide
Dosage: 24 mg, daily
Administration route: Oral
Indication: Hypertension
Start date: 2009-01-01
Testim
Dosage: unk
Administration route: Topical
Indication: Hormone Replacement Therapy
Start date: 2011-07-01
End date: 2011-12-12
Other drugs received by patient: Novorapid; Avodart; Clonidine; Atenolol; Amlodipine
Possible Avalide side effects in 74 year old male
Reported by a consumer/non-health professional from Canada on 2012-05-21
Patient: 74 year old male
Reactions: Prostate Cancer, Drug Administration Error
Drug(s) suspected as cause:
Alfuzosin HCL
Administration route: Oral
Indication: Urinary Tract Disorder
Start date: 2007-01-01
End date: 2012-05-15
Lantus
Dosage: dose- 36 iu in the morning and 38 iu at bedtime
Start date: 2007-01-01
Altace
Administration route: Oral
Indication: Hypertension
Start date: 2009-01-01
Avalide
Administration route: Oral
Indication: Hypertension
Start date: 2009-01-01
Testim
Administration route: Topical
Indication: Hormone Replacement Therapy
Start date: 2011-07-01
End date: 2011-12-12
Other drugs received by patient: Avodart; Atenolol; Clonidine; Amlodipine Besylate; Novorapid
Possible Avalide side effects in 79 year old female
Reported by a consumer/non-health professional from United States on 2012-05-07
Patient: 79 year old female, weighing 82.0 kg (180.4 pounds)
Reactions: Chest Discomfort, Hypersensitivity, Drug Ineffective, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Avalide
Dosage: 1df=300/25mg for 9 months. also 300/12.5 pills. exp date:08sep12,8mar13
Administration route: Oral
Indication: Hypertension
Start date: 2011-09-09
Norvasc
Other drugs received by patient: Multi-Vitamins; Crestor
Possible Avalide side effects in
Reported by a consumer/non-health professional from United States on 2012-04-17
Patient:
Reactions: Incorrect Storage of Drug
Drug(s) suspected as cause:
Avapro
Plavix
Reyataz
Hydrea
Avalide
Sustiva
Sprycel
Zerit
Coumadin
Videx
Glucovance
Onglyza
Azactam
Dosage: powdered vial
Abilify
Kombiglyze XR
Kenalog-40
Possible Avalide side effects in female
Reported by a physician from United States on 2012-04-05
Patient: female, weighing 93.9 kg (206.5 pounds)
Reactions: Road Traffic Accident, Fatigue, Syncope, Post-Traumatic Pain, Clavicle Fracture, Vision Blurred, Dizziness
Drug(s) suspected as cause:
Tekturna
Dosage: 300 mg, qd
Administration route: Oral
Indication: Hypertension
Start date: 2008-03-03
End date: 2012-01-18
Tekturna
End date: 2012-01-19
Avalide
Dosage: 1 df, (300/25) qd
End date: 2011-01-01
Losartan Potassium and Hydrochlorothiazide
Dosage: 1 df (25/100 mg), qd
Indication: Hypertension
Other drugs received by patient: Simvastatin; Fluoxetine; Multi-Vitamins; Aspirin; Clonidine HCL; Hyzaar; Caltrate +D; Fish OIL
Possible Avalide side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-31
Patient: female, weighing 93.9 kg (206.5 pounds)
Reactions: Syncope, Fatigue, Road Traffic Accident, Clavicle Fracture, Post-Traumatic Pain, Dizziness, Vision Blurred
Drug(s) suspected as cause:
Tekturna
End date: 2012-01-19
Losartan Potassium and Hydrochlorothiazide
Dosage: 1 df (25/100 mg), qd
Indication: Hypertension
Avalide
Dosage: 1 df, (300/25) qd
End date: 2011-01-01
Tekturna
Dosage: 300 mg, qd
Administration route: Oral
Indication: Hypertension
Start date: 2008-03-03
End date: 2012-01-18
Other drugs received by patient: Aspirin; Multi-Vitamins; Clonidine HCL; Fluoxetine; Hyzaar; Simvastatin; Fish OIL; Caltrate +D
Possible Avalide side effects in 79 year old female
Reported by a consumer/non-health professional from United States on 2012-03-29
Patient: 79 year old female, weighing 82.0 kg (180.4 pounds)
Reactions: Hypersensitivity, Chest Discomfort, Drug Ineffective, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Norvasc
Avalide
Dosage: 300/25 for 9 months. also 300/12.5 pills. exp date:08sep12,8mar13
Administration route: Oral
Indication: Hypertension
Start date: 2011-09-09
Other drugs received by patient: Multi-Vitamins; Crestor
Possible Avalide side effects in 80 year old male
Reported by a consumer/non-health professional from Mexico on 2012-03-21
Patient: 80 year old male, weighing 120.0 kg (264.0 pounds)
Reactions: Myocardial Infarction
Adverse event resulted in: death
Drug(s) suspected as cause:
Lantus
Indication: Type 2 Diabetes Mellitus
Start date: 2007-01-01
End date: 2012-02-06
Avalide
Dosage: 1df= 1 tab for 24 hrs
Administration route: Oral
Indication: Hypertension
Start date: 2003-01-01
End date: 2012-02-06
Plavix
Dosage: 1df= 1 tab for 24 hrs
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2006-01-01
End date: 2012-02-06
Other drugs received by patient: Aldactone; Adalat
Possible Avalide side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-21
Patient: male
Reactions: Medication Error, Coronary Artery Occlusion, Appendicitis, Blood Pressure Fluctuation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Avalide
Dosage: 150mg avapro and 25mg hydrochlorothiazide
Avapro
Possible Avalide side effects in 64 year old male
Reported by a consumer/non-health professional from Canada on 2012-03-09
Patient: 64 year old male, weighing 95.0 kg (209.0 pounds)
Reactions: Blood Pressure Increased, Bladder Discomfort, Expired Drug Administered, Erectile Dysfunction, Road Traffic Accident, Breast Swelling, Skin Discolouration, Feeling Abnormal
Drug(s) suspected as cause:
Avalide
Dosage: 1 df = 300mg/12.5mg
Administration route: Oral
Indication: Hypertension
Start date: 2012-02-13
End date: 2012-02-16
Avalide
Dosage: 1df:150/12.5mg;09fb12-12fb,
Administration route: Oral
Indication: Hypertension
Start date: 2012-02-09
End date: 2012-02-12
Other drugs received by patient: Indomethacin; Ibuprofen; Acetaminophen
Possible Avalide side effects in 51 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-05
Patient: 51 year old male, weighing 100.0 kg (220.0 pounds)
Reactions: Pain, Osteopenia, Allergy To Arthropod Sting, Hypercalcaemia
Drug(s) suspected as cause:
Avalide
Indication: Hypertension
Diltiazem
Possible Avalide side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: female, weighing 93.9 kg (206.5 pounds)
Reactions: Fatigue, Syncope, Road Traffic Accident, Post-Traumatic Pain, Clavicle Fracture, Vision Blurred, Dizziness
Drug(s) suspected as cause:
Tekturna
End date: 2012-01-19
Tekturna
Dosage: 300 mg, qd
Administration route: Oral
Indication: Hypertension
Start date: 2008-03-03
End date: 2012-01-18
Avalide
Dosage: 1 df, (300/25) qd
End date: 2011-01-01
Losartan Potassium and Hydrochlorothiazide
Dosage: 1 df (25/100 mg), qd
Indication: Hypertension
Other drugs received by patient: Fluoxetine; Fish OIL; Aspirin; Simvastatin; Caltrate +D; Clonidine HCL; Hyzaar; Multi-Vitamins
Possible Avalide side effects in 76 year old female
Reported by a consumer/non-health professional from United States on 2012-02-24
Patient: 76 year old female, weighing 82.0 kg (180.4 pounds)
Reactions: Back Pain, Bladder Pain, Urinary Retention, Renal Pain
Drug(s) suspected as cause:
Avalide
Other drugs received by patient: Vitamin B6; Allopurinol; Calcium; Aspirin; Vitamin B-12; Vitamin D; Folic Acid
Possible Avalide side effects in 51 year old male
Reported by a consumer/non-health professional from United States on 2012-02-23
Patient: 51 year old male, weighing 100.0 kg (220.0 pounds)
Reactions: Pain, Osteopenia, Hypercalcaemia, Allergy To Arthropod Sting
Drug(s) suspected as cause:
Avalide
Indication: Hypertension
Diltiazem
Possible Avalide side effects in 52 year old male
Reported by a consumer/non-health professional from United States on 2012-02-20
Patient: 52 year old male, weighing 98.0 kg (215.6 pounds)
Reactions: Stomatitis, Hypotension, Dehydration, Febrile Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Erbitux
Indication: Head and Neck Cancer
Start date: 2008-02-11
End date: 2008-02-18
Cisplatin
Indication: Head and Neck Cancer
Start date: 2008-02-11
End date: 2008-02-11
Avalide
Possible Avalide side effects in 63 year old female
Reported by a consumer/non-health professional from United States on 2012-02-17
Patient: 63 year old female
Reactions: Coeliac Disease
Drug(s) suspected as cause:
Avalide
Other drugs received by patient: Dicyclomine; Prednisone; Diltiazem; Amitriptyline HCL; Evista
Possible Avalide side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-30
Patient: male
Reactions: Retinal Artery Embolism, Vitreous Haemorrhage, Hypertension
Drug(s) suspected as cause:
Avalide
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