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Micardis HCT (Telmisartan / Hydrochlorothiazide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Micardis HCT (Telmisartan / 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 (110)
Death (7)
Life Threatening Events (11)
Disability (7)

Reports by Reaction Type

Blood Pressure Increased (9)Dyspnoea (9)Hyponatraemia (9)Haematoma (8)Pollakiuria (8)Renal Failure Acute (7)Hypertension (7)Drug Ineffective (6)Injection Site Haemorrhage (6)Rales (6)Oedema (6)Dizziness (6)

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

Possible Micardis HCT side effects in 89 year old female

Reported by a consumer/non-health professional from Peru on 2012-08-21

Patient: 89 year old female

Reactions: Sepsis, Urinary Tract Infection

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Micardis HCT
    Dosage: strength:80+12.5mg; daily dose:80+12.5mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-01-01
    End date: 2012-07-01

Spiriva
    Dosage: 18 mcg
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2010-01-01
    End date: 2012-07-01



Possible Micardis HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Muscle Spasms

Drug(s) suspected as cause:
Micardis HCT
    Indication: Oedema Peripheral

Micardis HCT
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-02-01



Possible Micardis HCT side effects in 64 year old female

Reported by a consumer/non-health professional from Peru on 2012-08-20

Patient: 64 year old female

Reactions: Cerebrovascular Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Micardis HCT



Possible Micardis HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: LIP Swelling, Uvulitis

Drug(s) suspected as cause:
Micardis HCT



Possible Micardis HCT side effects in male

Reported by a physician from Singapore on 2012-08-15

Patient: male

Reactions: Asthma, Hyponatraemia, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apixaban
    Dosage: 10 mg
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2011-01-13
    End date: 2012-06-05

Micardis HCT
    Dosage: 1 dosage form
    Start date: 2011-05-30

Other drugs received by patient: Budesonide; Digoxin; Isosorbide Dinitrate; Albuterol Sulate; Simvastatin; Nitroglycerin; Tolbutamide; Senna-Mint WAF; Nifedipine; Omeprazole



Possible Micardis HCT side effects in 71 year old male

Reported by a physician from Italy on 2012-08-14

Patient: 71 year old male

Reactions: Hypotension, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cardura
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-06-19
    End date: 2012-07-10

Furosemide
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01

Micardis HCT
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-06-19

Norvasc
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-01

Other drugs received by patient: Potassium Chloride; Clonazepam; Aspirin



Possible Micardis HCT side effects in 58 year old female

Reported by a pharmacist from United States on 2012-08-13

Patient: 58 year old female

Reactions: Nasal Dryness, Epistaxis

Drug(s) suspected as cause:
Micardis HCT



Possible Micardis HCT side effects in female

Reported by a physician from Mexico on 2012-08-13

Patient: female

Reactions: Platelet Count Decreased, Upper Gastrointestinal Haemorrhage

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Dabigatran Etexilate
    Dosage: 110 mg
    Administration route: Oral
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2012-06-01
    End date: 2012-07-01

Micardis HCT
    Dosage: strength: 80/12.5mg daily dose: one tablet daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-04-01
    End date: 2012-07-01



Possible Micardis HCT side effects in female

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

Patient: female

Reactions: Chest Discomfort, Asthenia

Drug(s) suspected as cause:
Micardis HCT
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-05-01
    End date: 2012-07-08

Micardis HCT
    Indication: Blood Pressure Abnormal

Other drugs received by patient: Singulair; Fish OIL; Singulair; Cinnamon; Cinnamon; Aspirin; Levemir; Novolog



Possible Micardis HCT side effects in male

Reported by a physician from Mexico on 2012-08-03

Patient: male, weighing 95.0 kg (209.0 pounds)

Reactions: Blood Pressure Increased, Cerebral Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dabigatran Etexilate
    Dosage: 450 mg
    Administration route: Oral
    Start date: 2012-02-13
    End date: 2012-02-13

Dabigatran Etexilate
    Dosage: 300 mg
    Administration route: Oral
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2012-02-10
    End date: 2012-02-12

Micardis HCT
    Dosage: strength: 80/12.5mg daily dose: 1 tablet daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-02-05

Tamsulosin HCL
    Dosage: 0.4 mg
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia

Other drugs received by patient: Amlodipino; Dabex; Tenormin



Possible Micardis HCT side effects in 71 year old male

Reported by a physician from Italy on 2012-08-03

Patient: 71 year old male

Reactions: Hypotension, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cardura
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-06-19
    End date: 2012-07-10

Micardis HCT
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-06-19

Norvasc
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-01

Spirofur
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01

Other drugs received by patient: Potassium Chloride; Aspirin; Rivotril



Possible Micardis HCT side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-02

Patient: female

Reactions: Hyponatraemia, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Micardis HCT

Other drugs received by patient: Nebivolol HCL; Lasix



Possible Micardis HCT side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-31

Patient: female

Reactions: Nausea, Abdominal Distension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bisoprolol Fumarate
    Dosage: 1.25 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-01
    End date: 2012-07-06

Micardis HCT
    Dosage: strength: 40mg + 12.5 mg; one posologic unit daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-01
    End date: 2012-07-06

Vasexten
    Dosage: 10 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-01
    End date: 2012-07-05

Other drugs received by patient: Lexotan



Possible Micardis HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Respiratory Disorder, Sinusitis, Cough

Drug(s) suspected as cause:
Micardis HCT

Other drugs received by patient: Aspirin; Synthroid; Lipitor



Possible Micardis HCT side effects in male

Reported by a physician from Australia on 2012-07-27

Patient: male

Reactions: Hypovolaemic Shock, Dyspnoea, Angioedema, Anaphylactic Reaction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Micardis HCT
    Dosage: 80/12.5 mg mane
    Indication: Hypertension
    Start date: 2011-01-01
    End date: 2012-05-23

Perindopril Erbumine
    Dosage: 5 mg
    Start date: 2010-01-01
    End date: 2012-05-23

Other drugs received by patient: Atenolol



Possible Micardis HCT side effects in female

Reported by a physician from United States on 2012-07-24

Patient: female

Reactions: Hypertension

Drug(s) suspected as cause:
Micardis
    Administration route: Oral

Micardis
    Administration route: Oral
    Indication: Hypertension

Micardis HCT
    Administration route: Oral
    Indication: Hypertension



Possible Micardis HCT side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-07-23

Patient: female

Reactions: Product Quality Issue, Chest Pain, Abdominal Distension, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Micardis HCT

Other drugs received by patient: Lercanidipine



Possible Micardis HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: female

Reactions: Muscle Spasms

Drug(s) suspected as cause:
Micardis HCT
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-02-01

Micardis HCT
    Indication: Oedema Peripheral



Possible Micardis HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: female

Reactions: Chest Discomfort, Asthenia

Drug(s) suspected as cause:
Micardis HCT

Other drugs received by patient: Novolog; Levemir; Singulair



Possible Micardis HCT side effects in female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-12

Patient: female

Reactions: Hyponatraemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Micardis HCT

Other drugs received by patient: Lasix; Nebivolol HCL



Possible Micardis HCT side effects in 74 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-09

Patient: 74 year old female, weighing 69.9 kg (153.8 pounds)

Reactions: Joint Instability, Fatigue, Incontinence, Arthralgia, Haematuria, Rash

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Micardis HCT



Possible Micardis HCT side effects in 83 year old male

Reported by a consumer/non-health professional from Canada on 2012-07-09

Patient: 83 year old male, weighing 69.0 kg (151.7 pounds)

Reactions: Blood Pressure Increased, Pain in Extremity, Intermittent Claudication, Arterial Occlusive Disease

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Micardis HCT

Other drugs received by patient: Garlic; Adalat XL - SRT; Glucosamine



Possible Micardis HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-26

Patient: female

Reactions: Sensation of Heaviness, Pollakiuria

Drug(s) suspected as cause:
Micardis HCT

Other drugs received by patient: Hydrocodone; Omeprazole; Glucosamine; Atenolol; Fish OIL; Lipitor; Mirtazapine; Amlodipine; Aspirin; Citalopram Hydrobromide; Diclofenac Sodium; Timolol Maleate



Possible Micardis HCT side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: male

Reactions: Hypertension

Drug(s) suspected as cause:
Micardis HCT



Possible Micardis HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-31

Patient: female

Reactions: Joint Swelling

Drug(s) suspected as cause:
Micardis
    Dosage: 80 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-05-07

Micardis HCT
    Administration route: Oral
    Indication: Hypertension



Possible Micardis HCT side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-05-15

Patient: female, weighing 46.0 kg (101.2 pounds)

Reactions: Renal Disorder, Urinary Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Micardis HCT

Other drugs received by patient: Trayenta; Manivasc; Xalatan



Possible Micardis HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-07

Patient: female

Reactions: Back Pain, Pruritus, Renal Disorder, Dysuria, Skin Disorder, Cystitis

Drug(s) suspected as cause:
Micardis HCT

Other drugs received by patient: Levothyroxine Sodium; Xanax; Albuterol



Possible Micardis HCT side effects in male

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

Patient: male

Reactions: Accidental Exposure

Drug(s) suspected as cause:
Micardis HCT



Possible Micardis HCT side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-26

Patient: female

Reactions: Dyspnoea, Pneumonia, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Micardis HCT
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01
    End date: 2012-04-15

Proair HFA
    Dosage: 4 puf
    Indication: Asthma
    Start date: 2010-01-01

Proair HFA
    Start date: 2011-01-01

Qvar 40
    Start date: 2011-01-01

Qvar 40
    Dosage: 4 puf
    Indication: Asthma
    Start date: 2010-01-01

Other drugs received by patient: Flexeril; Aspirin; Furosemide; Hydrocodone; Spiriva



Possible Micardis HCT side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-25

Patient: male

Reactions: Bronchitis, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Micardis HCT

Other drugs received by patient: Norvasc

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