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Mavik (Trandolapril) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Mavik (Trandolapril) 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 (43)
Death (11)
Life Threatening Events (3)
Disability (1)

Reports by Reaction Type

Cough (5)Death (4)Fall (3)Pulmonary Oedema (3)Cardiac Failure Congestive (3)Pericardial Drainage (3)Hypotension (3)Cerebrovascular Accident (3)Convulsion (3)Asthenia (3)Lower Limb Fracture (2)Glomerulonephritis Membranous (2)

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

Possible Mavik side effects in male

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

Patient: male

Reactions: Myalgia, Neoplasm Malignant, Rash

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Mavik
    Indication: Product Used FOR Unknown Indication

Pravachol
    Indication: Product Used FOR Unknown Indication

Lipitor
    Indication: Product Used FOR Unknown Indication

Crestor
    Indication: Product Used FOR Unknown Indication

Ticlid
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Tikosyn



Possible Mavik side effects in 70 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-26

Patient: 70 year old female, weighing 71.7 kg (157.7 pounds)

Reactions: Cerebrovascular Accident, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aceon
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Mavik
    Dosage: 2 mg, oral : 4 mg
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Amiloride HCL and Hydrochlorothiazide



Possible Mavik side effects in 25 year old female

Reported by a pharmacist from Canada on 2012-06-26

Patient: 25 year old female

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Escitalopram
    Dosage: daily dose + frequency not reported
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Mavik
    Dosage: daily dose + frequency not reported
    Administration route: Oral
    Indication: Blood Pressure Management
    Start date: 2011-04-01

Amitriptyline HCL
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Docusate Sodium



Possible Mavik side effects in 63 year old male

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

Patient: 63 year old male

Reactions: Fatigue, Pain in Extremity, Blood Pressure Decreased

Drug(s) suspected as cause:
Mavik
    Indication: Product Used FOR Unknown Indication

Xolair
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Nasacort; Spiriva; Prednisone TAB; Ventolin; Symbicort



Possible Mavik side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-06-18

Patient: 25 year old female

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amitriptyline HCL
    Dosage: 10 mg
    Administration route: Oral

Mavik
    Administration route: Oral
    Indication: Blood Pressure Management
    Start date: 2011-04-01

Escitalopram
    Administration route: Oral

Other drugs received by patient: Stool Softeners



Possible Mavik side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-30

Patient: female

Reactions: Pharyngeal Oedema, Angioedema, Swollen Tongue

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mavik
    Indication: Product Used FOR Unknown Indication
    End date: 2011-05-01

Levemir
    Indication: Diabetes Mellitus
    Start date: 2011-05-17
    End date: 2011-05-18

Other drugs received by patient: Hydrochlorothiazide; Prilosec; Furosemide; Oxybutynin; Simvastatin; Atenolol; Isosorbide Mononitrate



Possible Mavik side effects in female

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

Patient: female

Reactions: Cough

Drug(s) suspected as cause:
Mavik



Possible Mavik side effects in 54 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-01-23

Patient: 54 year old female, weighing 77.6 kg (170.6 pounds)

Reactions: Psychotic Disorder, Hallucination, Auditory, Paranoia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Crestor
    Dosage: 20 mg;qd

Alvesco
    Dosage: 400 mcg

Aspirin
    Dosage: qd

Mavik
    Dosage: 2 mg;qd;sc
    Indication: Product Used FOR Unknown Indication

Pantoprazole
    Dosage: 40 mg;qd
    Indication: Product Used FOR Unknown Indication

Detrol LA
    Dosage: 4 mg;qd

Macrobid
    Dosage: 100 mg;qd
    Indication: Product Used FOR Unknown Indication

Plavix
    Dosage: 75 mg;qd
    Indication: Product Used FOR Unknown Indication

Ezetimibe
    Dosage: 10 mg;qd
    Indication: Product Used FOR Unknown Indication

Stelara
    Dosage: sc
    Indication: Product Used FOR Unknown Indication

Desloratadine
    Dosage: 5 mg;qd

Sucralfate
    Dosage: 1000 mg;bid
    Indication: Product Used FOR Unknown Indication

Domperidone (Domperidone)
    Dosage: 10 mg;bid

Imipramine
    Dosage: 25 mg;bid
    Indication: Product Used FOR Unknown Indication

Atenolol
    Dosage: 50 mg;qd

Other drugs received by patient: Singulair



Possible Mavik side effects in 25 year old female

Reported by a pharmacist from Canada on 2012-01-20

Patient: 25 year old female

Reactions: Convulsion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Escitalopram
    Dosage: daily dose + frequency not reported
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Mavik
    Dosage: daily dose + frequency not reported
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Amitriptyline HCL
    Dosage: daily dose + frequency not reported
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Laxatives



Possible Mavik side effects in 54 year old female

Reported by a individual with unspecified qualification from Canada on 2012-01-13

Patient: 54 year old female

Reactions: Psychotic Disorder, Hallucination, Auditory, Paranoia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Imipramine HCL TAB
    Dosage: 25.0 mg/bid po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Plavix
    Dosage: 75.0 mg/daily po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

TAB Domperidone
    Dosage: 10 mg/bid po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Mavik
    Dosage: 2.0 mg/daily po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Pantoprazole
    Dosage: 40.0 mg/daily unk
    Indication: Product Used FOR Unknown Indication

Sucralfate
    Dosage: 1000.0 mg/bid unk

Desloratadine
    Dosage: 5.0 mg/daily unk

Zetia
    Dosage: 10 mg/daily po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Crestor
    Dosage: 20 mg/daily po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Macrobid
    Dosage: 100.0 mg/daily po
    Administration route: Oral

Atenolol
    Dosage: 50 mg/daily po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Detrol LA
    Dosage: 4.0 mg/daily po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Stelara
    Dosage: sc
    Indication: Product Used FOR Unknown Indication

Alvesco
    Dosage: 400 microgm/unk po
    Administration route: Oral

Aspirin
    Dosage: unk po
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Singulair



Possible Mavik side effects in male

Reported by a physician from Canada on 2012-01-13

Patient: male, weighing 82.0 kg (180.4 pounds)

Reactions: Coronary Artery Thrombosis, Chest Pain, Myocardial Infarction

Drug(s) suspected as cause:
Mavik
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 2010-03-10
    End date: 2010-12-01

Mavik
    Dosage: 2 mg

Other drugs received by patient: Pantoprazole EC; Nicotine; Multi-Vitamins; Thiamine HCL



Possible Mavik side effects in female

Reported by a physician from Canada on 2011-12-20

Patient: female, weighing 61.8 kg (136.0 pounds)

Reactions: Lower Limb Fracture, Fall, Mobility Decreased

Drug(s) suspected as cause:
Mavik



Possible Mavik side effects in female

Reported by a physician from Canada on 2011-12-15

Patient: female, weighing 36.0 kg (79.2 pounds)

Reactions: Femur Fracture, Hypothyroidism, Fall

Drug(s) suspected as cause:
Mavik
    Indication: Essential Hypertension
    Start date: 2009-07-27

Mavik
    Dosage: 1 mg 3 tabs
    Start date: 2010-10-22

Other drugs received by patient: Hydrochlorthiazide; Norvasc; Avapro; Hydrochlorothiazide



Possible Mavik side effects in female

Reported by a physician from Canada on 2011-12-08

Patient: female, weighing 61.8 kg (136.0 pounds)

Reactions: Lower Limb Fracture, Fall, Mobility Decreased

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Mavik



Possible Mavik side effects in male

Reported by a physician from Canada on 2011-12-06

Patient: male, weighing 77.2 kg (169.8 pounds)

Reactions: Lung Cancer Metastatic, Terminal State

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Mavik

Other drugs received by patient: Hydrochlorothiazide



Possible Mavik side effects in male

Reported by a physician from Canada on 2011-12-06

Patient: male, weighing 91.0 kg (200.2 pounds)

Reactions: Coronary Artery Occlusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mavik
    Dosage: 2 mg daily
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 2010-06-01

Mavik
    Dosage: prescribed at visit #2-1 mg daily
    Administration route: Oral
    Start date: 2010-10-08

Other drugs received by patient: Metoprolol Tartrate



Possible Mavik side effects in female

Reported by a physician from Canada on 2011-11-22

Patient: female, weighing 71.7 kg (157.8 pounds)

Reactions: Cerebrovascular Accident, Asthenia, Cough, Viith Nerve Paralysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mavik
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 2010-08-03

Mavik
    Start date: 2011-06-21

Perindopril Erbumine
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Moduret



Possible Mavik side effects in female

Reported by a physician from Canada on 2011-11-16

Patient: female, weighing 71.7 kg (157.8 pounds)

Reactions: Asthenia, Cerebrovascular Accident, Cough, Viith Nerve Paralysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mavik
    Start date: 2011-06-21

Perindopril Erbumine
    Indication: Product Used FOR Unknown Indication

Mavik
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 2010-08-03

Other drugs received by patient: Moduret



Possible Mavik side effects in male

Reported by a physician from Canada on 2011-11-11

Patient: male, weighing 64.5 kg (141.8 pounds)

Reactions: Pericardial Drainage, Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mavik
    Indication: Steroid Therapy

Mavik
    Dosage: 1 mg /day die
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-06-30
    End date: 2010-08-06

Other drugs received by patient: Diclofenac Sodium; Prednisone TAB; Methotrexate; Steroids; Ativan; Hydrochlorizide



Possible Mavik side effects in male

Reported by a physician from Canada on 2011-11-08

Patient: male, weighing 64.5 kg (141.8 pounds)

Reactions: Pericardial Drainage, Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mavik
    Dosage: 1 mg /day die
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-06-30
    End date: 2010-08-06

Mavik
    Indication: Steroid Therapy

Other drugs received by patient: Steroids; Ativan; Hydrochlorizide; Diclofenac Sodium; Methotrexate; Prednisone



Possible Mavik side effects in female

Reported by a physician from Canada on 2011-11-07

Patient: female, weighing 42.5 kg (93.5 pounds)

Reactions: Cardiac Failure, Lung Infection, Atrial Fibrillation

Drug(s) suspected as cause:
Mavik

Other drugs received by patient: Monocor; Avapro; Coumadin; Lasix; Cordarone



Possible Mavik side effects in male

Reported by a physician from Canada on 2011-11-07

Patient: male, weighing 74.0 kg (162.8 pounds)

Reactions: Rotator Cuff Repair

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mavik
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 2010-07-01
    End date: 2011-07-04

Mavik
    Administration route: Oral
    Start date: 2011-07-04

Other drugs received by patient: Hydrochlorothiazide



Possible Mavik side effects in female

Reported by a physician from Canada on 2011-11-04

Patient: female, weighing 95.3 kg (209.7 pounds)

Reactions: Complications of Transplanted Liver, Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Mavik
    Administration route: Oral
    Indication: Essential Hypertension
    Start date: 2010-07-06

Mavik
    Dosage: unknown dose

Other drugs received by patient: Furosemide



Possible Mavik side effects in male

Reported by a physician from Canada on 2011-11-03

Patient: male, weighing 64.5 kg (141.8 pounds)

Reactions: Pericardial Drainage, Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mavik
    Dosage: 1 mg /day die
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-06-30
    End date: 2010-08-06

Mavik
    Indication: Steroid Therapy

Other drugs received by patient: Steroids; Methotrexate; Hydrochlorizide; Ativan; Prednisone; Diclofenac Sodium



Possible Mavik side effects in female

Reported by a physician from Canada on 2011-11-02

Patient: female, weighing 72.0 kg (158.4 pounds)

Reactions: Dementia, Cerebral Haematoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mavik
    Dosage: 1 mg daily
    Indication: Essential Hypertension
    Start date: 2010-04-20

Mavik

Other drugs received by patient: Ferrous Sulfate TAB; Crestor; Lamotrigine; Exelon; Escitalopram; Acetaminophen; Seroquel; Vitamin D; Dilantin



Possible Mavik side effects in male

Reported by a physician from Canada on 2011-10-28

Patient: male

Reactions: Lung Neoplasm Malignant

Adverse event resulted in: death

Drug(s) suspected as cause:
Mavik



Possible Mavik side effects in female

Reported by a physician from Canada on 2011-10-28

Patient: female, weighing 158.0 kg (347.6 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mavik



Possible Mavik side effects in male

Reported by a physician from Canada on 2011-10-28

Patient: male, weighing 99.9 kg (219.7 pounds)

Reactions: Oedema Peripheral, Oliguria, Proteinuria, Pulmonary Oedema, Glomerulonephritis Membranous, Cardiac Failure Congestive, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mavik
    Indication: Myocardial Infarction

Mavik
    Dosage: initial dose: 1mg per day
    Indication: Essential Hypertension
    Start date: 2009-06-29

Other drugs received by patient: Furosemide



Possible Mavik side effects in male

Reported by a physician from Canada on 2011-10-26

Patient: male, weighing 99.9 kg (219.7 pounds)

Reactions: Oedema Peripheral, Oliguria, Proteinuria, Pulmonary Oedema, Renal Failure Acute, Cardiac Failure Congestive, Glomerulonephritis Membranous

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mavik
    Dosage: initial dose: 1mg per day
    Indication: Essential Hypertension
    Start date: 2009-06-29

Mavik
    Indication: Myocardial Infarction

Other drugs received by patient: Furosemide



Possible Mavik side effects in female

Reported by a physician from Canada on 2011-10-22

Patient: female, weighing 57.7 kg (126.8 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mavik

Other drugs received by patient: Palafer; Diamcron MR; Rabeprazole Sodium; Actos; Actonel; Norvasc; Metformin HCL; Calcium Carbonate; VIT D

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