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Provas Side Effects

Common Provas Side Effects

The most commonly reported Provas side effects (click to view or check a box to report):

Alanine Aminotransferase Increased (9)
Blood Cholesterol Increased (8)
Blood Bilirubin Increased (7)
Gamma-glutamyltransferase Increased (6)
Blood Pressure Inadequately Controlled (6)
Aspartate Aminotransferase Increased (5)
Asthenia (5)
Dyspnoea (5)
Blood Pressure Increased (4)
C-reactive Protein Increased (4)
Cutaneous Vasculitis (4)
Cardiac Disorder (4)
Ultrasound Liver Abnormal (4)
Fatigue (3)
Myalgia (3)
Epistaxis (3)
Depression (3)
Cerebrovascular Accident (3)
Cough (3)
Dry Eye (3)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Provas Side Effects Reported to FDA

The following Provas reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Provas on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Red Blood Cell Count Decreased, Protein Urine, Erythema, Alopecia, Muscle Spasms
on Jul 15, 2013 Female from DE , 73 years of age, was treated with Provas. Directly after, patient experienced the unwanted or unexpected Provas side effects: red blood cell count decreased, protein urine, erythema, alopecia, muscle spasms. Provas dosage: 80 Mg, Unk.

Arthritis, Myositis, Tendonitis, Tendon Rupture
Patient was taking Provas. Patient felt the following Provas side effects: arthritis, myositis, tendonitis, tendon rupture on Dec 04, 2012 from DE Additional patient health information: Male , 61 years of age, weighting 187.4 lb, was diagnosed with and. Provas dosage: 160 Mg, 0.5 Df Twice Daily.
Multiple prescriptions taken:
  • Atacand (16 Mg, 2 Df Eevryday)


Cerebrovascular Accident, Cerebral Infarction
Adverse event was reported on Oct 03, 2011 by a Male taking Provas (germany) (Dosage: N/A) was diagnosed with and. Location: GERMANY , weighting 163.1 lb, After Provas was administered, patient encountered several Provas side effects: cerebrovascular accident, cerebral infarction.
Multiple concurrent drugs taken:
  • Glimepiride
  • Xeloda
  • Amlodipine
  • Tim-ophtal (Dose: 0.1)
Patient was hospitalized.

Dyspnoea, Fatigue, Pruritus, Musculoskeletal Stiffness, Diverticulitis
on Feb 03, 2011 Female from UNITED STATES , 59 years of age, weighting 219.0 lb, was diagnosed with and was treated with Provastatin Dont Have With Me At The Moment Dont Have With Me At The M. Directly after, patient experienced the unwanted or unexpected Provas side effects: dyspnoea, fatigue, pruritus, musculoskeletal stiffness, diverticulitis. Provastatin Dont Have With Me At The Moment Dont Have With Me At The M dosage: Once A Day Once A Day Po.


Autoimmune Disorder, C-reactive Protein Increased, Cervicobrachial Syndrome, Polymyalgia Rheumatica, Red Blood Cell Sedimentation Rate Increased, Vasculitis
on Sep 10, 2010 Female from GERMANY , 67 years of age, was diagnosed with and was treated with Provas Comp. Patient felt the following Provas side effects: autoimmune disorder, c-reactive protein increased, cervicobrachial syndrome, polymyalgia rheumatica, red blood cell sedimentation rate increased, vasculitis. Provas Comp dosage: 1 Df, Qd.

Prothrombin Time Prolonged
Patient was taking Provastatin /00501501/ (prostavasin 20). After Provas was administered, patient encountered several Provas side effects: prothrombin time prolonged on Jul 27, 2010 from GERMANY Additional patient health information: Male , 80 years of age, . Provastatin /00501501/ (prostavasin 20) dosage: N/A.

C-reactive Protein Increased, Polymyalgia Rheumatica, Red Blood Cell Sedimentation Rate Increased
Adverse event was reported on Jul 13, 2010 by a Female taking Provas Comp (Dosage: Unk) . Location: GERMANY , 67 years of age, Directly after, patient experienced the unwanted or unexpected Provas side effects: c-reactive protein increased, polymyalgia rheumatica, red blood cell sedimentation rate increased.

Cough, Dyspnoea
on Jun 10, 2010 Female from GERMANY , 61 years of age, was diagnosed with and was treated with Provas. Patient felt the following Provas side effects: cough, dyspnoea. Provas dosage: 80 Mg, Unk.
Multiple prescriptions taken:
  • Vitamin B Complex Cap
  • Ameu


Cardiac Disorder, Cardiospasm, Myalgia
on Apr 14, 2010 Female from GERMANY , 69 years of age, was treated with Provas. After Provas was administered, patient encountered several Provas side effects: cardiac disorder, cardiospasm, myalgia. Provas dosage: 160 Mg.
Multiple concurrent drugs taken:
  • Metoprolol Succinate (95 Mg)
  • Torsemide


Atrial Fibrillation
Patient was taking Provas. Directly after, patient experienced the unwanted or unexpected Provas side effects: atrial fibrillation on Mar 22, 2010 from GERMANY Additional patient health information: Male , weighting 189.6 lb, was diagnosed with and. Provas dosage: 160 Mg, Qd.
Associated medications used:
  • Doxacor (1 Df, Bid)
  • Pentaerythritol Tetranitrate (80 Mg Per Day)
  • Falithrom (Unk)
  • Torsemide (0.5 Df, Bid)
  • No Treatment Received Nomed


Cardiac Disorder, Cardiospasm, Myalgia
Adverse event was reported on Mar 17, 2010 by a Female taking Provas (Dosage: 160 Mg) . Location: GERMANY , 69 years of age, Patient felt the following Provas side effects: cardiac disorder, cardiospasm, myalgia.
Multiple prescriptions taken:
  • Beloc Zok
  • Torsemide


Retinal Oedema, Stent Placement, Visual Impairment
on Feb 24, 2010 Male from GERMANY , weighting 189.6 lb, was treated with Provas Comp. After Provas was administered, patient encountered several Provas side effects: retinal oedema, stent placement, visual impairment. Provas Comp dosage: 1 Df, Qd.
Multiple concurrent drugs taken:
  • Aspirin (100 Mg, Qd)


Blood Pressure Inadequately Controlled, Blood Pressure Increased
on Feb 02, 2010 Male from GERMANY , 65 years of age, was treated with Provas Maxx. Directly after, patient experienced the unwanted or unexpected Provas side effects: blood pressure inadequately controlled, blood pressure increased. Provas Maxx dosage: N/A.

Angiodysplasia, Asthenia, Blood Alkaline Phosphatase Increased, Blood Creatinine Increased, C-reactive Protein Increased, Faeces Discoloured, Gastrointestinal Haemorrhage, Haematocrit Decreased, Haemoglobin Decreased
Patient was taking Provas Comp. Patient felt the following Provas side effects: angiodysplasia, asthenia, blood alkaline phosphatase increased, blood creatinine increased, c-reactive protein increased, faeces discoloured, gastrointestinal haemorrhage, haematocrit decreased, haemoglobin decreased on Jan 26, 2010 from GERMANY Additional patient health information: Male , 75 years of age, weighting 165.3 lb, was diagnosed with and. Provas Comp dosage: 160 Mg.
Multiple prescriptions taken:
  • Alendronic Acid (70 Mg)
  • Falithrom (3 Mg)
  • Allopurinol (300 Mg)
  • Aranesp (40 Mg)
  • Carmen (10 Mg)
  • Dekristol (20000 Iu)
  • Doxazosin Mesylate (4 Mg)
  • Novaminsulfon (750 Mg)
Patient was hospitalized.

Polyneuropathy
Adverse event was reported on Jan 08, 2010 by a Male taking Provas Comp (Dosage: 160/12.5 Mg) . Location: GERMANY , 77 years of age, After Provas was administered, patient encountered several Provas side effects: polyneuropathy.

Suicide Attempt
on Dec 27, 2009 Female from GERMANY , weighting 209.4 lb, was treated with Provas. Directly after, patient experienced the unwanted or unexpected Provas side effects: suicide attempt. Provas dosage: 3 X 0.5 Tablets (320 Mg).
Associated medications used:
  • Aspirin (3 Tablets (300 Mg))
  • Amlodipine (10 Mg)
  • Novonorm (3 Tablets (1.5 Mg))
Patient was hospitalized.

Suicide Attempt
on Dec 09, 2009 Female from GERMANY , weighting 209.4 lb, was treated with Provas. Patient felt the following Provas side effects: suicide attempt. Provas dosage: 3 X 0.5 Tablets (320 Mg).
Multiple prescriptions taken:
  • Aspirin (3 Tablets (300 Mg))
  • Amlodipine (3 X 0.5 Tablets (7.5 Mg))
  • Novonorm (3 Tablets (1.5 Mg))
Patient was hospitalized.

Cardiospasm, Myalgia
Patient was taking Provas. After Provas was administered, patient encountered several Provas side effects: cardiospasm, myalgia on Nov 30, 2009 from GERMANY Additional patient health information: Female , 69 years of age, . Provas dosage: N/A.
Multiple concurrent drugs taken:
  • Beloc Zok
  • Torsemide


Ileus Paralytic, Somnolence, Suicide Attempt
Adverse event was reported on Nov 24, 2009 by a Female taking Provas Maxx (Dosage: 40 Tablets At Once) . Location: GERMANY , weighting 154.3 lb, Directly after, patient experienced the unwanted or unexpected Provas side effects: ileus paralytic, somnolence, suicide attempt.
Associated medications used:
  • Dexamethasone (3 Tablets (24 Mg) Once)
  • Moxonidine (40 Tablets (12 Mg) Once)
Patient was hospitalized.

Abdominal Pain, Bacterial Infection, Blister, Blood Cholesterol Increased, Candidiasis, Conjunctivitis, Dandruff, Eczema Nummular, Eosinophil Count Increased
on Nov 05, 2009 Female from GERMANY , weighting 143.3 lb, was diagnosed with and was treated with Provas Maxx. Patient felt the following Provas side effects: abdominal pain, bacterial infection, blister, blood cholesterol increased, candidiasis, conjunctivitis, dandruff, eczema nummular, eosinophil count increased. Provas Maxx dosage: 1 Df, Qd.
Multiple prescriptions taken:
  • Bisoprolol (1 Df, Qd)
  • Atmadisc
  • Aspirin (100 Mg Per Day)
Patient was hospitalized.

Blood Pressure Inadequately Controlled, Epistaxis
on Nov 02, 2009 Female from GERMANY , 68 years of age, weighting 172.0 lb, was treated with Provas. After Provas was administered, patient encountered several Provas side effects: blood pressure inadequately controlled, epistaxis. Provas dosage: 1 Df (160mg), Qd.

Blood Creatine Phosphokinase Increased
Patient was taking Provas Comp. Directly after, patient experienced the unwanted or unexpected Provas side effects: blood creatine phosphokinase increased on Aug 25, 2009 from GERMANY Additional patient health information: Male , 69 years of age, . Provas Comp dosage: 80/12.5 Mg.

Angiodysplasia, Asthenia, Blood Alkaline Phosphatase Increased, Blood Creatinine Increased, C-reactive Protein Increased, Faeces Discoloured, Gastrointestinal Haemorrhage, Haematocrit Decreased, Haemoglobin Decreased
Adverse event was reported on Jul 16, 2009 by a Male taking Provas Comp (Dosage: 160 Mg) was diagnosed with and. Location: GERMANY , 75 years of age, Patient felt the following Provas side effects: angiodysplasia, asthenia, blood alkaline phosphatase increased, blood creatinine increased, c-reactive protein increased, faeces discoloured, gastrointestinal haemorrhage, haematocrit decreased, haemoglobin decreased.
Multiple prescriptions taken:
  • Alendronic Acid (70 Mg)
  • Falithrom (3 Mg)
  • Allopurinol (300 Mg)
  • Aranesp (40 Mg)
  • Carmen (10 Mg)
  • Dekristol (20000 Iu)
  • Doxazosin Mesylate (4 Mg)
  • Novaminsulfon (750 Mg)
Patient was hospitalized.

Blood Pressure Inadequately Controlled, Epistaxis
on May 19, 2009 Female from GERMANY , 68 years of age, was treated with Provas. After Provas was administered, patient encountered several Provas side effects: blood pressure inadequately controlled, epistaxis. Provas dosage: 0.5 Df, Qd.

Blood Gases Abnormal, Pulmonary Congestion, Pulmonary Fibrosis, Pulmonary Hypertension, Tricuspid Valve Incompetence
on May 06, 2009 Female from GERMANY , weighting 106.9 lb, was diagnosed with and was treated with Provas. Directly after, patient experienced the unwanted or unexpected Provas side effects: blood gases abnormal, pulmonary congestion, pulmonary fibrosis, pulmonary hypertension, tricuspid valve incompetence. Provas dosage: 80 Mg, Qd.
Associated medications used:
  • Ass ^ct-arzneimittel^ (100 Mg, Qd)
  • Berodual (3 Df, Qd)
Patient was hospitalized and became disabled.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


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  • 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.

    Discuss Provas Side Effects



    Did You Have a Provas Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Provas for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
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    Safety Alerts, Active Ingredients, Usage Information

    Alternative PROVAS Names:DIMETHICO

    Active Ingredient: DIMETHICO

    More About Provas

    Side Effects reported to FDA: 81

    Provas safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 10

    Latest Provas clinical trials