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Gastrointestinal Increase (6)
Diarrhea (4)
Tired (4)
Coughing (4)
Could Faint (1)
Gastritis (1)
Gastrointestinal Increase, Tired, Could Faint (1)
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Vastarel Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Cardiomegaly, Arteriosclerosis Coronary Artery, Aortic Arteriosclerosis (8462108-3)
on Jun 25, 2012 Male from FRANCE , 43 years of age, was treated with Vastarel. Directly after, patient experienced the unwanted or unexpected Vastarel side effects: cardiomegaly, arteriosclerosis coronary artery, aortic arteriosclerosis. Vastarel dosage: Unk.
Associated medications used:
  • Viagra (25 Mg, 1x/day)
  • Viagra
  • Lexomil
  • Nitroglycerin
  • Yohimbine (Unk)
  • Verapamil Hcl (Unk)


Pulmonary Embolism, Chest Pain (8413552-1)
Patient was taking Vastarel. Patient felt the following Vastarel side effects: pulmonary embolism, chest pain on May 24, 2012 from FRANCE Additional patient health information: Female , 85 years of age, weighting 136.7 lb, . Vastarel dosage: 35mg Twice Per Day.
Multiple prescriptions taken:
  • Lexomil (6mg Per Day)
  • Arixtra (7.5mg Per Day)
  • Trimeprazine Tartrate (20drop Per Day)
  • Zolpidem (10mg Twice Per Day)


Haematuria, Prostatitis, Bladder Transitional Cell Carcinoma Recurrent, Neoplasm Malignant, Metastasis (8359758-1)
Adverse event was reported on May 07, 2012 by a Male taking Vastarel (Dosage: Unk Ukn, Unk) was diagnosed with
  • hypertension
  • hypercholesterolaemia
and. Location: FRANCE , weighting 187.4 lb, After Vastarel was administered, patient encountered several Vastarel side effects: haematuria, prostatitis, bladder transitional cell carcinoma recurrent, neoplasm malignant, metastasis.
Multiple concurrent drugs taken:
  • Zocor (40 Mg, Daily)
  • Aspirin (75 Mg, Daily)
  • Gleevec (400 Mg, Daily)
  • Lorazepam (Unk Ukn, Unk)
  • Cozaar (Unk Ukn, Unk)
  • Gleevec (300 Mg, Daily)
  • Serc (8 Mg, Daily)


Hyperhidrosis (8304965-7)
on Apr 12, 2012 Male from FRANCE , 67 years of age, was diagnosed with
  • congestive cardiomyopathy
and was treated with Vastarel. Directly after, patient experienced the unwanted or unexpected Vastarel side effects: hyperhidrosis. Vastarel dosage: N/A.
Associated medications used:
  • Molsidomine
  • Crestor
  • Bisoprolol Fumarate
  • Amlodipine Besylate
  • Aspirin
  • Valsartan
  • Molsidomine
  • Pantoprazole Sodium



Haemoptysis, Anaemia, Dyspnoea, Occult Blood Positive, Melaena, Cerebrovascular Accident, Overdose (8301118-3)
on Apr 14, 2012 Male from SINGAPORE , 69 years of age, weighting 132.3 lb, was treated with Vastarel. Patient felt the following Vastarel side effects: haemoptysis, anaemia, dyspnoea, occult blood positive, melaena, cerebrovascular accident, overdose. Vastarel dosage: 20 Mg, Unk.
Multiple prescriptions taken:
  • Proton Pump Inhibitors
  • Isosorbide Dinitrate
  • Amiodarone Hcl (200 Mg, Unk)
  • Xarelto (20 Mg, Qd)
  • Enalapril Maleate (5 Mg, Unk)
  • Xarelto (15 Mg, Qd)
  • Digoxin (62.5 ?g, Unk)
  • Atorvastatin (20 Mg, Unk)
Patient was hospitalized.

Deep Vein Thrombosis, Pulmonary Embolism, Fall, Cerebral Haematoma (8300845-1)
Patient was taking Vastarel. After Vastarel was administered, patient encountered several Vastarel side effects: deep vein thrombosis, pulmonary embolism, fall, cerebral haematoma on Apr 16, 2012 from FRANCE Additional patient health information: Female , weighting 154.3 lb, was diagnosed with
  • poor peripheral circulation
  • glaucoma
  • pain
  • hip arthroplasty
and. Vastarel dosage: 40 Mcg.
Multiple concurrent drugs taken:
  • Xalatan (One Drop)
  • Acetaminophen (2 G)
  • Pradaxa (75 Mg)
  • Pradaxa (150 Mg)
Patient was hospitalized.

Coronary Artery Disease, Chest Pain, Coronary Artery Occlusion, Fatigue, Off Label Use (8256263-8)
Adverse event was reported on Mar 26, 2012 by a Male taking Vastarel (Dosage: N/A) . Location: BRAZIL , 58 years of age, weighting 216.1 lb, Directly after, patient experienced the unwanted or unexpected Vastarel side effects: coronary artery disease, chest pain, coronary artery occlusion, fatigue, off label use.
Associated medications used:
  • Atacand Hct (16+12.5 Mg Daily)
  • Aldactone
  • Brilinta
  • Lipitor
  • Enalapril
Patient was hospitalized.

Hyperkalaemia (8218605-9)
on Mar 07, 2012 Male from FRANCE , 83 years of age, was treated with Vastarel. Patient felt the following Vastarel side effects: hyperkalaemia. Vastarel dosage: 70 Mg, Qd.
Multiple prescriptions taken:
  • Valsartan And Hydrochlorothiazide (Unk)
  • Repaglinide (1 Tab, Qd)
  • Metformin Hydrochloride (Unk)
Patient was hospitalized.

Dry Mouth, Nausea, Neck Pain (8187325-1)
on Feb 20, 2012 Female from FRANCE , 81 years of age, was treated with Vastarel. After Vastarel was administered, patient encountered several Vastarel side effects: dry mouth, nausea, neck pain. Vastarel dosage: N/A.
Multiple concurrent drugs taken:
  • Actonel
  • Panos
  • Diltiazem Hcl
  • Potassium Chloride
  • Voltaren
  • Lyrica
  • Delursan
  • Mirtazapine (15 Mg; Qd; Po)
Patient was hospitalized.

Infarction (8010635-5)
Patient was taking Vastarel. Directly after, patient experienced the unwanted or unexpected Vastarel side effects: infarction on Dec 26, 2011 from EL SALVADOR Additional patient health information: Male , 79 years of age, . Vastarel dosage: N/A.
Associated medications used:
  • Voltaren (75 Mg, Prn)
  • Prostamen


Tremor, Blood Glucose Decreased, Hallucination, Speech Disorder, Disorientation (7904354-0)
Adverse event was reported on Nov 07, 2011 by a Female taking Vastarel (Dosage: 35 Mg, 2x/day) was diagnosed with
  • cardiac disorder
  • hyperlipidaemia
  • back pain
and. Location: THAILAND , 85 years of age, Patient felt the following Vastarel side effects: tremor, blood glucose decreased, hallucination, speech disorder, disorientation.
Multiple prescriptions taken:
  • Fenofibrate (100 Mg, 2x/day)
  • Acetaminophen And Codeine Phosphate (1 Tablet, 2 Times Daily)
  • Aspirin (81 Mg, 1x/day)
  • Celebrex (200 Mg, 1x/day)
  • Folic Acid (5 Mg, 1x/day)
  • Orphenadrine Citrate (100 Mg, 3x/day)
  • Vitamin B 1-6-12 (1 Tablet, Once Daily)
  • Lyrica (75 Mg, 1x/day)
Patient was hospitalized.

Hyperhidrosis, Vomiting, Cardiac Arrest (7777271-7)
on Sep 20, 2011 Male from COSTA RICA , 92 years of age, was treated with Vastarel. After Vastarel was administered, patient encountered several Vastarel side effects: hyperhidrosis, vomiting, cardiac arrest. Vastarel dosage: Unk.
Multiple concurrent drugs taken:
  • Diovan Hct (1 Df, (valsartan 160, Hydrochlorothiazide 12.5 Mg), Daily)


Injection Site Pain, Injection Site Nodule, Eye Haemorrhage, Injection Site Haematoma, Vision Blurred (7768048-7)
on Sep 15, 2011 Female from BRAZIL , 61 years of age, weighting 172.0 lb, was treated with Vastarel ^biopharma^. Directly after, patient experienced the unwanted or unexpected Vastarel side effects: injection site pain, injection site nodule, eye haemorrhage, injection site haematoma, vision blurred. Vastarel ^biopharma^ dosage: N/A.
Associated medications used:
  • Simvastatin
  • Apidra
  • Sustrate
  • Omeprazole


Aortic Valve Disease (7735696-X)
Patient was taking Vastarel. Patient felt the following Vastarel side effects: aortic valve disease on Aug 29, 2011 from GERMANY Additional patient health information: Female , 66 years of age, was diagnosed with
  • vertigo
  • type 2 diabetes mellitus
  • hypertension
and. Vastarel dosage: Vastarel 35mg Tabs.
Multiple prescriptions taken:
  • Glucophage (Glucophage 1000mg)
  • Hyperium (Hyperium 1mg Tabs)
  • Bicirkan
  • Mediator (Tabs)
  • Fenofibrate
  • Bisoprolol Fumarate


Lung Disorder (7732548-6)
Adverse event was reported on Mar 21, 2011 by a Male taking Vastarel (Dosage: N/A) . Location: FRANCE , 75 years of age, After Vastarel was administered, patient encountered several Vastarel side effects: lung disorder.
Multiple concurrent drugs taken:
  • Crestor
  • Nicardipine Hcl
  • Arixtra
Patient was hospitalized.

Pulmonary Embolism, Deep Vein Thrombosis (7685974-8)
on Aug 12, 2011 Female from FRANCE , weighting 154.3 lb, was diagnosed with
  • poor peripheral circulation
  • glaucoma
  • hip arthroplasty
and was treated with Vastarel. Directly after, patient experienced the unwanted or unexpected Vastarel side effects: pulmonary embolism, deep vein thrombosis. Vastarel dosage: 40 Mcg.
Associated medications used:
  • Xalatan (One Drop)
  • Pradaxa (75 Mg)
  • Pradaxa (150 Mg)
  • Acetaminophen (2 G)
Patient was hospitalized.

Thrombophlebitis, Pulmonary Embolism, Vomiting, Malaise, Nausea (7482456-3)
on May 11, 2011 Female from FRANCE , 63 years of age, was treated with Vastarel. Patient felt the following Vastarel side effects: thrombophlebitis, pulmonary embolism, vomiting, malaise, nausea. Vastarel dosage: N/A.
Multiple prescriptions taken:
  • Temazepam
  • Temerit
  • Fenofibrate
  • Humira
  • Prednisone Tab (1 Df Daily)
  • Amlodipine Besylate
  • Methotrexate (2.5 Mg Daily)
  • Folic Acid
Patient was hospitalized.

Altered State Of Consciousness, Disorientation, Fall (7455013-2)
Patient was taking Vastarel. After Vastarel was administered, patient encountered several Vastarel side effects: altered state of consciousness, disorientation, fall on Apr 27, 2011 from FRANCE Additional patient health information: Female , 74 years of age, . Vastarel dosage: N/A.
Multiple concurrent drugs taken:
  • Xanax (Unk)
  • Tahor (10 Mg, Unk)
  • Amlodipine Besylate (5 Mg, Unk)
  • Fludex
  • Trileptal (1 Df, 1x/day)
Patient was hospitalized.

Venous Thrombosis, Thrombophlebitis Superficial (7388438-4)
Adverse event was reported on Mar 22, 2011 by a Female taking Vastarel (Dosage: 70 Mg) . Location: FRANCE , weighting 119.0 lb, Directly after, patient experienced the unwanted or unexpected Vastarel side effects: venous thrombosis, thrombophlebitis superficial.
Associated medications used:
  • Pradaxa (150 Mg)
  • Alepsal (115 Mg)
  • Celectol (200 Mg)


Phlebitis (7386267-9)
on Mar 23, 2011 Female from FRANCE , 87 years of age, was diagnosed with
  • hearing impaired
  • hypertension
and was treated with Vastarel. Patient felt the following Vastarel side effects: phlebitis. Vastarel dosage: 70 Mg.
Multiple prescriptions taken:
  • Irbesartan (75 Mg)
  • Inipomp (20 Mg)
  • Fumafer (400 Mg)
  • Lercanidipine
  • Dafalgan (4000 Mg)
  • Pradaxa (150 Mg)
Patient was hospitalized.

Toxic Skin Eruption (7376906-0)
on Mar 18, 2011 Female from FRANCE , 72 years of age, was treated with Vastarel. After Vastarel was administered, patient encountered several Vastarel side effects: toxic skin eruption. Vastarel dosage: N/A.
Multiple concurrent drugs taken:
  • Ossopan
  • Colecalciferol
  • Lipanthyl (Interrupted And Restarted.)
  • Irbesartan
  • Travatan
  • Kardegic
Patient was hospitalized.

Muscular Weakness, Malaise, Fall, Supraventricular Tachycardia, Blood Pressure Systolic Increased, Visual Impairment (7336322-4)
Patient was taking Vastarel (trimetazidine Hydrochloride). Directly after, patient experienced the unwanted or unexpected Vastarel side effects: muscular weakness, malaise, fall, supraventricular tachycardia, blood pressure systolic increased, visual impairment on Feb 14, 2011 from FRANCE Additional patient health information: Male , 54 years of age, was diagnosed with
  • hypertension
and. Vastarel (trimetazidine Hydrochloride) dosage: 70 Mg (35 Mg, 2 In 1 D) Oral.
Associated medications used:
  • Atorvastatin Calcium
  • Amlodipine Besylate (10 Mg (5 Mg, 2 In 1 D) Oral)
  • Tramadol Hcl (2 Df (1 Df, 2 In 1 D) Oral)
  • Kardegic (acetylsalicylate Lysine)
  • Victoza (0.6 Mg (1 In 1 D) Subcutaneous, 1.2 Mg (1 In 1 D) Subcutaneous, 1.8 Mg (1 In 1 D) Subcutaneous)
  • Victoza (0.6 Mg (1 In 1 D) Subcutaneous, 1.2 Mg (1 In 1 D) Subcutaneous, 1.8 Mg (1 In 1 D) Subcutaneous)
  • Victoza (0.6 Mg (1 In 1 D) Subcutaneous, 1.2 Mg (1 In 1 D) Subcutaneous, 1.8 Mg (1 In 1 D) Subcutaneous)
  • Bisoprolol Fumarate (20 Mg Oral)
Patient was hospitalized.

Autonomic Nervous System Imbalance (7285802-9)
Adverse event was reported on Feb 02, 2011 by a Male taking Vastarel (Dosage: N/A) . Location: FRANCE , 59 years of age, Patient felt the following Vastarel side effects: autonomic nervous system imbalance.
Multiple prescriptions taken:
  • Crestor
  • Plavix
  • Lansoprazole
  • Permixon
  • Fenofibrate
Patient was hospitalized.

Venous Thrombosis Limb, Pulmonary Embolism (7236876-2)
on Jan 12, 2011 Male from FRANCE , weighting 154.3 lb, was treated with Vastarel. After Vastarel was administered, patient encountered several Vastarel side effects: venous thrombosis limb, pulmonary embolism. Vastarel dosage: N/A.
Multiple concurrent drugs taken:
  • Prednisone (1 Mg/kg, Unk)
  • Nexium (Unk)
  • Speciafoldine (5 Mg, Unk)
  • Actonel (Unk)
  • Mabthera (650 Mg, 1/week)
  • Discotrine
  • Nexium (Unk)
  • Prednisone (Unk)
Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Vastarel Information

More About Vastarel

Side Effects reported to FDA: 24. View Vastarel Adverse Reports

Vastarel safety alerts: No

Reported deaths: 3

Reported hospitalizations: 14

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