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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
This is a report of a 73-year-old female patient (weight: NA) from DE, suffering from the following symptoms/conditions: NA, who was treated with Provas (dosage: 80 Mg, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Red Blood Cell Count Decreased
  • Protein Urine
  • Erythema
  • Alopecia
  • Muscle Spasms
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Provas treatment in female patients, resulting in red blood cell count decreased side effect.

Arthritis, Myositis, Tendonitis, Tendon Rupture
This report suggests a potential Provas Arthritis, Myositis, Tendonitis, Tendon Rupture side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: hypertension and used Provas (dosage: 160 Mg, 0.5 Df Twice Daily) starting 2009. Soon after starting Provas the patient began experiencing various side effects, including:
  • Arthritis
  • Myositis
  • Tendonitis
  • Tendon Rupture
Drugs used concurrently:
  • Atacand (16 Mg, 2 Df Eevryday)
Although Provas demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as arthritis, may still occur.

Cerebrovascular Accident, Cerebral Infarction
This Cerebrovascular Accident, Cerebral Infarction problem was reported by a consumer or non-health professional from GERMANY. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension,diabetes mellitus,rectal cancer. On Aug 15, 2011 this consumer started treatment with Provas (germany) (dosage: NA). The following drugs were being taken at the same time:
  • Glimepiride
  • Xeloda
  • Amlodipine
  • Tim-ophtal (Dose: 0.1)
When commencing Provas (germany), the patient experienced the following unwanted symptoms/side effects:
  • Cerebrovascular Accident
  • Cerebral Infarction
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as cerebrovascular accident, may become evident only after a product is in use by the general population.

Dyspnoea, Fatigue, Pruritus, Musculoskeletal Stiffness, Diverticulitis
This is a report of a 59-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: blood cholesterol increased and was treated with Provastatin Dont Have With Me At The Moment Dont Have With Me At The M (dosage: Once A Day Once A Day Po) starting Apr 14, 2010. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Dyspnoea
  • Fatigue
  • Pruritus
  • Musculoskeletal Stiffness
  • Diverticulitis
This opens a possibility that Provastatin Dont Have With Me At The Moment Dont Have With Me At The M treatment could cause the above reactions, including dyspnoea, and some female subjects may be more susceptible.


Autoimmune Disorder, C-reactive Protein Increased, Cervicobrachial Syndrome, Polymyalgia Rheumatica, Red Blood Cell Sedimentation Rate Increased, Vasculitis
A 67-year-old female patient (weight: NA) from GERMANY with the following symptoms/conditions: hypertension started Provas Comp treatment (dosage: 1 Df, Qd) on Oct 01, 2009. Soon after starting Provas Comp treatment, the subject experienced various side effects, including:
  • Autoimmune Disorder
  • C-reactive Protein Increased
  • Cervicobrachial Syndrome
  • Polymyalgia Rheumatica
  • Red Blood Cell Sedimentation Rate Increased
  • Vasculitis
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Provas Comp.

Prothrombin Time Prolonged
A 80-year-old male patient from GERMANY (weight: NA) experienced symptoms, such as: NA and was treated with Provastatin /00501501/ (prostavasin 20)(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Prothrombin Time Prolonged
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Provastatin /00501501/ (prostavasin 20) efficacy: NA.

C-reactive Protein Increased, Polymyalgia Rheumatica, Red Blood Cell Sedimentation Rate Increased
In this report, Provas Comp was administered for the following condition: NA.A 67-year-old female consumer from GERMANY (weight: NA) started Provas Comp treatment (dosage: Unk) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • C-reactive Protein Increased
  • Polymyalgia Rheumatica
  • Red Blood Cell Sedimentation Rate Increased
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Provas Comp treatment could be related to the listed above side effect(s).

Cough, Dyspnoea
This is a report of the following Provas side effect(s):
  • Cough
  • Dyspnoea
A 61-year-old female patient from GERMANY (weight: NA) presented with the following condition: hypertension and received a treatment with Provas (dosage: 80 Mg, Unk) starting: Jun 12, 2009.The following concurrently used drugs could have generated interactions:
  • Vitamin B Complex Cap
  • Ameu
This report suggests that a Provas treatment could be associated with the listed above side effect(s).

Cardiac Disorder, Cardiospasm, Myalgia
This Provas report was submitted by a 69-year-old female consumer from GERMANY (weight: NA). The patient was diagnosed with: NA and Provas was administered (dosage: 160 Mg) starting: NS. The consumer developed a set of symptoms:
  • Cardiac Disorder
  • Cardiospasm
  • Myalgia
Other drugs used simultaneously:
  • Metoprolol Succinate (95 Mg)
  • Torsemide
Those unexpected symptoms could be linked to a Provas treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Atrial Fibrillation
This is a report of a possible correlation between Provas use and the following symptoms/side effect(s):
  • Atrial Fibrillation
which could contribute to an assessment of Provas risk profile.A male consumer from GERMANY (weight: NA) was suffering from hypertension and was treated with Provas (dosage: 160 Mg, Qd) starting Nov 01, 2005.Other concurrent medications:
  • 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
A 69-year-old female patient from GERMANY (weight: NA) presented with the following symptoms: NA and after a treatment with Provas (dosage: 160 Mg) experienced the following side effect(s):
  • Cardiac Disorder
  • Cardiospasm
  • Myalgia
The treatment was started on NS. Provas was used in combination with the following drugs:
  • Beloc Zok
  • Torsemide
This report could alert potential Provas consumers.

Retinal Oedema, Stent Placement, Visual Impairment
In this report, a male patient from GERMANY (weight: NA) was affected by a possible Provas Comp side effect.The patient was diagnosed with NA. After a treatment with Provas Comp (dosage: 1 Df, Qd, start date: NS), the patient experienced the following side effect(s):
  • Retinal Oedema
  • Stent Placement
  • Visual Impairment
The following simultaneously used drugs could have led to this reaction:
  • Aspirin (100 Mg, Qd)
The findings here stress that side effects should be taken into consideration when evaluating a Provas Comp treatment.

Blood Pressure Inadequately Controlled, Blood Pressure Increased
This is a report of a 65-year-old male patient from GERMANY (weight: NA), who used Provas Maxx (dosage: NA) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Blood Pressure Inadequately Controlled
  • Blood Pressure Increased
The following drugs could possibly have interacted with the Provas Maxx treatment NA.Taken together, these observations suggest that a Provas Maxx treatment could be related to side effect(s), such as Blood Pressure Inadequately Controlled, Blood Pressure Increased.

Angiodysplasia, Asthenia, Blood Alkaline Phosphatase Increased, Blood Creatinine Increased, C-reactive Protein Increased, Faeces Discoloured, Gastrointestinal Haemorrhage, Haematocrit Decreased, Haemoglobin Decreased
This angiodysplasia side effect was reported by a health professional from GERMANY. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: hypertension,osteoporosis,embolism,hyperuricaemia,anaemia. The patient was prescribed Provas Comp (dosage: 160 Mg), which was started on Nov 01, 2008. Concurrently used drugs:
  • 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)
When starting to take Provas Comp the consumer reported the following symptoms:
  • Angiodysplasia
  • Asthenia
  • Blood Alkaline Phosphatase Increased
  • Blood Creatinine Increased
  • C-reactive Protein Increased
  • Faeces Discoloured
  • Gastrointestinal Haemorrhage
  • Haematocrit Decreased
  • Haemoglobin Decreased
The patient was hospitalized. These side effects may potentially be related to Provas Comp.

Polyneuropathy
This is a Provas Comp side effect report of a 77-year-old male patient (weight:NA) from GERMANY, suffering from the following symptoms/conditions: NA, who was treated with Provas Comp (dosage:160/12.5 Mg, start time: NS), combined with: NA., and developed a serious reaction and a polyneuropathy side effect. The patient presented with:
  • Polyneuropathy
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Provas Comp treatment in male patients suffering from NA, resulting in polyneuropathy.

Suicide Attempt
This report suggests a potential Provas suicide attempt side effect(s) that can have serious consequences. A female patient from GERMANY (weight:NA) was diagnosed with the following health condition(s): NA and used Provas (dosage: 3 X 0.5 Tablets (320 Mg)) starting NS. Soon after starting Provas the patient began experiencing various side effects, including:
  • Suicide Attempt
Drugs used concurrently:
  • Aspirin (3 Tablets (300 Mg))
  • Amlodipine (10 Mg)
  • Novonorm (3 Tablets (1.5 Mg))
The patient was hospitalized. Although Provas demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as suicide attempt, may still occur.

Suicide Attempt
This suicide attempt problem was reported by a consumer or non-health professional from GERMANY. A female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On NS a consumer started treatment with Provas (dosage: 3 X 0.5 Tablets (320 Mg)). The following drugs/medications were being taken at the same time:
  • Aspirin (3 Tablets (300 Mg))
  • Amlodipine (3 X 0.5 Tablets (7.5 Mg))
  • Novonorm (3 Tablets (1.5 Mg))
When commencing Provas, the patient experienced the following unwanted symptoms /side effects:
  • Suicide Attempt
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as suicide attempt, may become evident only after a product is in use by the general population.

Cardiospasm, Myalgia
This is a Provas side effect report of a 69-year-old female patient (weight: NA) from GERMANY. The patient developed the following symptoms/conditions: NA and was treated with Provas (dosage: NA) starting NS. Concurrently used drugs:
  • Beloc Zok
  • Torsemide
Soon after that, the consumer experienced the following of symptoms:
  • Cardiospasm
  • Myalgia
This opens a possibility that Provas could cause cardiospasm and that some female patients may be more susceptible.

Ileus Paralytic, Somnolence, Suicide Attempt
A female patient (weight: NA) from GERMANY with the following symptoms: NA started Provas Maxx treatment (dosage: 40 Tablets At Once) on NS. Soon after starting Provas Maxx treatment, the consumer experienced several side effects, including:
  • Ileus Paralytic
  • Somnolence
  • Suicide Attempt
. Concurrently used drugs:
  • Dexamethasone (3 Tablets (24 Mg) Once)
  • Moxonidine (40 Tablets (12 Mg) Once)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Provas Maxx side effects, such as ileus paralytic.

Abdominal Pain, Bacterial Infection, Blister, Blood Cholesterol Increased, Candidiasis, Conjunctivitis, Dandruff, Eczema Nummular, Eosinophil Count Increased
This abdominal pain side effect was reported by a consumer or non-health professional from GERMANY. A female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Provas Maxx (dosage: 1 Df, Qd), which was started on Feb 01, 2002. Concurrently used drugs:
  • Bisoprolol (1 Df, Qd)
  • Atmadisc
  • Aspirin (100 Mg Per Day)
.When starting to take Provas Maxx the consumer reported symptoms, such as:
  • Abdominal Pain
  • Bacterial Infection
  • Blister
  • Blood Cholesterol Increased
  • Candidiasis
  • Conjunctivitis
  • Dandruff
  • Eczema Nummular
  • Eosinophil Count Increased
These side effects may potentially be related to Provas Maxx. The patient was hospitalized.

Blood Pressure Inadequately Controlled, Epistaxis
This is a report of a 68-year-old female patient (weight: NA) from GERMANY, suffering from the following symptoms/conditions: NA, who was treated with Provas (dosage: 1 Df (160mg), Qd, start time: Mar 02, 2009), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Blood Pressure Inadequately Controlled
  • Epistaxis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Provas treatment in female patients, resulting in blood pressure inadequately controlled side effect.

Blood Creatine Phosphokinase Increased
This report suggests a potential Provas Comp Blood Creatine Phosphokinase Increased side effect(s) that can have serious consequences. A 69-year-old male patient (weight: NA) from GERMANY was diagnosed with the following symptoms/conditions: NA and used Provas Comp (dosage: 80/12.5 Mg) starting NS. Soon after starting Provas Comp the patient began experiencing various side effects, including:
  • Blood Creatine Phosphokinase Increased
Drugs used concurrently: NA. Although Provas Comp demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as blood creatine phosphokinase increased, may still occur.

Angiodysplasia, Asthenia, Blood Alkaline Phosphatase Increased, Blood Creatinine Increased, C-reactive Protein Increased, Faeces Discoloured, Gastrointestinal Haemorrhage, Haematocrit Decreased, Haemoglobin Decreased
This Angiodysplasia, Asthenia, Blood Alkaline Phosphatase Increased, Blood Creatinine Increased, C-reactive Protein Increased, Faeces Discoloured, Gastrointestinal Haemorrhage, Haematocrit Decreased, Haemoglobin Decreased problem was reported by a health professional from GERMANY. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension,osteoporosis,embolism,hyperuricaemia,anaemia. On Nov 01, 2008 this consumer started treatment with Provas Comp (dosage: 160 Mg). The following drugs were being taken at the same time:
  • 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)
When commencing Provas Comp, the patient experienced the following unwanted symptoms/side effects:
  • Angiodysplasia
  • Asthenia
  • Blood Alkaline Phosphatase Increased
  • Blood Creatinine Increased
  • C-reactive Protein Increased
  • Faeces Discoloured
  • Gastrointestinal Haemorrhage
  • Haematocrit Decreased
  • Haemoglobin Decreased
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as angiodysplasia, may become evident only after a product is in use by the general population.

Blood Pressure Inadequately Controlled, Epistaxis
This is a report of a 68-year-old female patient (weight: NA) from GERMANY. The patient developed the following symptoms/conditions: NA and was treated with Provas (dosage: 0.5 Df, Qd) starting May 19, 2009. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Blood Pressure Inadequately Controlled
  • Epistaxis
This opens a possibility that Provas treatment could cause the above reactions, including blood pressure inadequately controlled, and some female subjects may be more susceptible.

Blood Gases Abnormal, Pulmonary Congestion, Pulmonary Fibrosis, Pulmonary Hypertension, Tricuspid Valve Incompetence
A female patient (weight: NA) from GERMANY with the following symptoms/conditions: hypertension,coronary artery disease,chronic obstructive pulmonary disease started Provas treatment (dosage: 80 Mg, Qd) on May 01, 2006. Soon after starting Provas treatment, the subject experienced various side effects, including:
  • Blood Gases Abnormal
  • Pulmonary Congestion
  • Pulmonary Fibrosis
  • Pulmonary Hypertension
  • Tricuspid Valve Incompetence
Concurrently used drugs:
  • Ass ^ct-arzneimittel^ (100 Mg, Qd)
  • Berodual (3 Df, Qd)
The patient was hospitalized and became disabled. This finding indicates that some female patients could be more vulnerable to Provas.

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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

    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.


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    Provas Safety Alerts, Active Ingredients, Usage Information

    More About Provas

    Side Effects reported to FDA: 81

    Provas safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 10

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