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Micardis (Telmisartan) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Micardis (Telmisartan) 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 (379)
Death (34)
Life Threatening Events (18)
Disability (6)

Reports by Reaction Type

Dizziness (27)Interstitial Lung Disease (23)Blood Pressure Increased (17)Renal Impairment (17)Hypertension (17)Drug Ineffective (14)Malaise (13)Nausea (13)Headache (12)Dyspepsia (12)Renal Failure Acute (12)Dyspnoea (12)

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

Possible Micardis side effects in 90 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 90 year old female

Reactions: Blood Pressure Increased

Drug(s) suspected as cause:
Micardis

Other drugs received by patient: Xanax; Beta Blocker; Multaq



Possible Micardis side effects in 76 year old male

Reported by a pharmacist from Japan on 2012-08-27

Patient: 76 year old male

Reactions: Rhabdomyolysis, Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Micardis



Possible Micardis side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-24

Patient:

Reactions: Tubulointerstitial Nephritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actos
    Dosage: 7.5 mg, qd
    Administration route: Oral
    Indication: Blood Glucose Increased
    Start date: 2011-01-01
    End date: 2011-03-01

Candesartan Cilexetil
    Dosage: 8 mg, qd
    Administration route: Oral
    Indication: Blood Pressure Increased
    Start date: 2010-06-01
    End date: 2011-04-01

Januvia
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: Blood Glucose Increased
    Start date: 2010-09-01
    End date: 2011-03-01

Metformin HCL
    Dosage: 500 mg, qd
    Administration route: Oral
    Indication: Blood Glucose Increased
    Start date: 2010-11-01
    End date: 2011-01-01

Micardis
    Dosage: 80 mg, qd
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-06-01



Possible Micardis side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 79 year old female

Reactions: Abdominal Pain, Agitation, Pruritus, Restless Legs Syndrome, Orthostatic Hypotension, Disorientation, Pharyngeal Oedema, Dyspepsia, Palpitations, Feeling of Body Temperature Change, Muscle Spasms, Blood Pressure Increased, Nightmare, Nausea, Hypotension, Blood Creatine Increased, Tremor, Anxiety, Heart Rate Decreased, Arthralgia, Diarrhoea

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

Cartia XT
    Dosage: unk

Celebrex
    Dosage: unk

Ciprofloxacin HCL
    Dosage: unk

Cymbalta
    Dosage: unk

Diltiazem
    Dosage: unk

Diovan
    Dosage: unk

Fentanyl
    Dosage: unk

Levaquin

Macrobid
    Dosage: unk

Micardis
    Dosage: unk

Mirtazapine
    Dosage: unk

Naproxen Sodium
    Dosage: unk

Norvasc
    Dosage: unk

Paxil
    Dosage: unk

Prozac
    Dosage: unk

Tekturna
    Dosage: unk

Tiazac
    Dosage: unk

Toprol-XL

Vasotec
    Dosage: unk

Wellbutrin XL
    Dosage: unk

Zoloft
    Dosage: unk

Other drugs received by patient: Effexor XR; Protonix



Possible Micardis side effects in male

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

Patient: male

Reactions: Renal Disorder, Blood Glucose Increased

Drug(s) suspected as cause:
Micardis

Other drugs received by patient: Calcium; Fish OIL; Lipitor; Vitamin B-12; Ranitidine; Osteo BI Flex



Possible Micardis side effects in

Reported by a physician from United States on 2012-08-21

Patient:

Reactions: Blood Pressure Systolic Increased

Drug(s) suspected as cause:
Micardis



Possible Micardis side effects in 50 year old male

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

Patient: 50 year old male

Reactions: Tooth Fracture

Drug(s) suspected as cause:
Micardis
    Dosage: 80 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2006-01-01

Spiriva
    Dosage: 18 mcg
    Indication: Chronic Obstructive Pulmonary Disease
    Start date: 2006-01-01

Other drugs received by patient: Gabapentin; Nexium; Proventil-HFA; Buspar; Cymbalta; Lunesta



Possible Micardis side effects in female

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

Patient: female

Reactions: Knee Operation

Drug(s) suspected as cause:
Micardis



Possible Micardis side effects in 32 year old male

Reported by a physician from Japan on 2012-08-17

Patient: 32 year old male, weighing 57.0 kg (125.4 pounds)

Reactions: Upper Respiratory Tract Inflammation, Herpes Zoster, Renal Impairment, Oral Candidiasis, Neoplasm Skin, Bronchitis, White Blood Cell Count Increased, Influenza

Drug(s) suspected as cause:
Micardis
    Dosage: 40 mg
    Administration route: Oral
    Start date: 2007-06-24
    End date: 2007-08-01

Micardis
    Dosage: 80 mg
    Administration route: Oral
    Start date: 2007-08-02

Micardis
    Dosage: 20 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2007-06-08
    End date: 2007-06-23

Prednisolone
    Dosage: 50 mg
    Administration route: Oral
    Indication: Lupus Nephritis
    Start date: 2007-05-31

Prograf
    Dosage: 1.5 mg
    Administration route: Oral
    Indication: Lupus Nephritis
    Start date: 2007-05-31
    End date: 2007-06-11

Prograf
    Dosage: 2 mg
    Administration route: Oral
    Start date: 2007-06-12

Other drugs received by patient: Pravastatin; Zantac; Alfarol; Bonalon 5MG; Warfarin Sodium; Vitamin B12



Possible Micardis side effects in 81 year old female

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

Patient: 81 year old female

Reactions: Blood Urine Present, Skin Cancer, Inguinal Hernia

Drug(s) suspected as cause:
Micardis
    Indication: Hypertension
    Start date: 2007-01-01

Pradaxa
    Dosage: 300 mg
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-08-01

Other drugs received by patient: Coreg; Spironolactone; Tekturna; Hydrochlorothiazide



Possible Micardis side effects in female

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

Patient: female

Reactions: Endometrial Cancer, Cough

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 df, daily

Lisinopril
    Dosage: 1 df, daily (10 mg)

Micardis
    Dosage: 1 df, daily

Other drugs received by patient: Glimepiride; Amlodipine; Metformin HCL; Fish OIL



Possible Micardis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female

Reactions: Endometrial Cancer, Cough

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 1 df, daily

Lisinopril
    Dosage: 1 df, daily (10 mg)

Micardis
    Dosage: 1 df, daily

Other drugs received by patient: Glimepiride; Metformin HCL; Fish OIL; Amlodipine



Possible Micardis side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-08-13

Patient: female

Reactions: Breast Cancer Metastatic, Respiratory Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Micardis

Other drugs received by patient: Atenolol; Omeprazole; Tapazol



Possible Micardis side effects in 78 year old female

Reported by a physician from China on 2012-08-10

Patient: 78 year old female, weighing 58.0 kg (127.6 pounds)

Reactions: Asthma, Respiratory Failure

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Micardis

Other drugs received by patient: Adalat; Amlodipine; Nifedipine



Possible Micardis side effects in 64 year old male

Reported by a consumer/non-health professional from Germany on 2012-08-09

Patient: 64 year old male, weighing 99.0 kg (217.8 pounds)

Reactions: Oedema, Hypertensive Crisis

Drug(s) suspected as cause:
Amlodipine

Micardis
    Dosage: 1 anz
    Start date: 2004-01-01

Mobic



Possible Micardis side effects in 82 year old female

Reported by a physician from France on 2012-08-08

Patient: 82 year old female

Reactions: Carotid Artery Stenosis, Microcytic Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Micardis

Other drugs received by patient: Medication NOT Further Specified



Possible Micardis side effects in female

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

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Micardis



Possible Micardis side effects in 49 year old female

Reported by a consumer/non-health professional from France on 2012-08-07

Patient: 49 year old female, weighing 139.0 kg (305.8 pounds)

Reactions: Hyperlipasaemia, Blood Glucose Fluctuation, Enterocolitis Infectious

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Glucophage
    Administration route: Oral
    End date: 2012-05-19

Glyburide
    Administration route: Oral
    End date: 2012-05-20

Insulatard NPH Human
    Dosage: evening

Micardis
    Administration route: Oral
    End date: 2012-05-19

Onglyza
    Administration route: Oral
    Indication: Type 2 Diabetes Mellitus
    Start date: 2011-09-01
    End date: 2012-05-19



Possible Micardis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female, weighing 67.0 kg (147.4 pounds)

Reactions: Drug Ineffective, Dizziness, Hypertension

Drug(s) suspected as cause:
Micardis

Other drugs received by patient: Metoprolol Tartrate; Aspirin



Possible Micardis side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male, weighing 86.0 kg (189.2 pounds)

Reactions: Heart Rate Decreased, Head Injury, Hypotension, Dehydration, Fall, Loss of Consciousness

Drug(s) suspected as cause:
Micardis

Other drugs received by patient: Hydrochlorothiazde TAB; Toporol



Possible Micardis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female

Reactions: Swelling Face, Diarrhoea

Drug(s) suspected as cause:
Micardis



Possible Micardis side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female, weighing 57.0 kg (125.4 pounds)

Reactions: Oesophageal Pain, Increased Upper Airway Secretion, Musculoskeletal Chest Pain, Oropharyngeal Pain, Dental Discomfort, Abdominal Pain Upper, Oropharyngeal Discomfort, Abdominal Discomfort, Dysgeusia, Throat Irritation, Sensory Disturbance, Chest Pain, Radiculopathy, Pain in JAW, Neuralgia

Drug(s) suspected as cause:
Micardis



Possible Micardis side effects in female

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

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Mixed Connective Tissue Disease, Musculoskeletal Pain, Raynaud's Phenomenon

Drug(s) suspected as cause:
Micardis



Possible Micardis side effects in male

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

Patient: male

Reactions: Dizziness Postural, Arthritis

Drug(s) suspected as cause:
Flomax
    Dosage: 0.4 mg
    Administration route: Oral
    Indication: Prostatic Disorder
    Start date: 2009-01-01

Micardis
    Dosage: 40 mg
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-05-01



Possible Micardis side effects in female

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

Patient: female

Reactions: Respiratory Failure, Lung Cancer Metastatic

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Micardis

Other drugs received by patient: Atenolol; Tapazol; Omeprazole



Possible Micardis side effects in female

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

Patient: female

Reactions: Speech Disorder, Dysphagia, Diplegia

Drug(s) suspected as cause:
Micardis



Possible Micardis side effects in female

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

Patient: female

Reactions: Speech Disorder, Dysphagia, Diplegia

Drug(s) suspected as cause:
Micardis



Possible Micardis side effects in male

Reported by a consumer/non-health professional from France on 2012-07-27

Patient: male

Reactions: Arthralgia, Yellow Skin, Lung Neoplasm Malignant, Bronchitis, Eczema, Erythema, Bowen's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Micardis

Other drugs received by patient: Nicardipine HCL



Possible Micardis side effects in 84 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 84 year old female

Reactions: Back Pain, Joint Swelling, Constipation, Sinus Congestion

Drug(s) suspected as cause:
Micardis

Other drugs received by patient: Ciproflaxacin; Crestor



Possible Micardis side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: male

Reactions: Weight Increased

Drug(s) suspected as cause:
Micardis

Other drugs received by patient: Aspirin; Lipitor; Nexium

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