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Prestarium Side Effects

Common Prestarium Side Effects


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

Acute Myocardial Infarction (2)
Thrombosis (2)
Mucosal Inflammation (2)
Angina Pectoris (2)
Bronchitis (2)
Endocrine Test (1)
Essential Hypertension (1)
Dermatitis Exfoliative (1)
Asthenia (1)
Thrombocytopenic Purpura (1)
Angina Unstable (1)
Adverse Event (1)
Multi-organ Failure (1)
Hyperkalaemia (1)
Hyperaldosteronism (1)
Hypertension (1)
Metabolic Disorder (1)
Pulmonary Embolism (1)
Post Procedural Haemorrhage (1)
Tachycardia (1)

➢ 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.

Prestarium Side Effects Reported to FDA

The following Prestarium 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 Prestarium 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.
Multi-organ Failure, Pulmonary Embolism
This is a report of a 69-year-old female patient (weight: NA) from SLOVAKIA (Slovak Republic), suffering from the following symptoms/conditions: NA, who was treated with Prestarium A (perindopril) (dosage: NA, start time: Oct 20, 2010), combined with:
  • Vitamin B12
  • Agen (amlodipine Besilate) (amlodipine Besilate)
  • Concor Cor (bisoprolol)
  • Prothazin (promethazine Hydrochloride)
  • Helicid (omeprazole)
  • Fragmin (5000 Iu, Single)
  • Perindopril Arginine
  • Ciprofloxacin
and developed a serious reaction and side effect(s). The consumer presented with:
  • Multi-organ Failure
  • Pulmonary Embolism
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prestarium A (perindopril) treatment in female patients, resulting in multi-organ failure side effect. The patient was hospitalized.

Atrial Conduction Time Prolongation
This report suggests a potential Prestarium Atrial Conduction Time Prolongation side effect(s) that can have serious consequences. A 63-year-old female patient (weight: NA) from ITALY was diagnosed with the following symptoms/conditions: NA and used Prestarium (dosage: NA) starting NS. Soon after starting Prestarium the patient began experiencing various side effects, including:
  • Atrial Conduction Time Prolongation
Drugs used concurrently:
  • Amlodipine Besylate
  • Nebivolol (5 Mg)
Although Prestarium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as atrial conduction time prolongation, may still occur.

Acute Myocardial Infarction, Angina Pectoris, Angina Unstable, Post Procedural Haemorrhage
This Acute Myocardial Infarction, Angina Pectoris, Angina Unstable, Post Procedural Haemorrhage problem was reported by a health professional from CZECH REPUBLIC. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension. On Jun 19, 2011 this consumer started treatment with Prestarium Neo Combi (dosage: 10 Mg, Unk). The following drugs were being taken at the same time:
  • Tasigna (800 Mg, Daily)
  • Lokren (10 Mg, Unk)
  • Tasigna (800 Mg, Daily)
  • Tasigna (800 Mg, Daily)
  • Lactulose (As Needed)
  • Tasigna (No Treatment Received)
When commencing Prestarium Neo Combi, the patient experienced the following unwanted symptoms/side effects:
  • Acute Myocardial Infarction
  • Angina Pectoris
  • Angina Unstable
  • Post Procedural Haemorrhage
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 acute myocardial infarction, may become evident only after a product is in use by the general population.

Cerebrovascular Accident, Adverse Event
This is a report of a 80-year-old male patient (weight: NA) from CZECH REPUBLIC. The patient developed the following symptoms/conditions: NA and was treated with Prestarium (dosage: NA) starting Oct 13, 2010. Concurrently used drugs:
  • Oral Antidiabetics
  • Hypotylin
  • Omeprazole
  • Imuran (Unk)
  • Forteo (20 Ug, Qd)
  • Corticosteroid Nos
  • Prednisone (5 Mg, Qd)
  • Tanakan
Soon after that, the consumer experienced the following side effects:
  • Cerebrovascular Accident
  • Adverse Event
The patient was hospitalized. This opens a possibility that Prestarium treatment could cause the above reactions, including cerebrovascular accident, and some male subjects may be more susceptible.


Cholesterol Granuloma
A 52-year-old male patient (weight: NA) from POLAND with the following symptoms/conditions: hypertension,depression,spondylitis started Prestarium treatment (dosage: NA) on Jan 01, 2009. Soon after starting Prestarium treatment, the subject experienced various side effects, including:
  • Cholesterol Granuloma
Concurrently used drugs:
  • Anafranil
  • Cimzia (200 Mg)
  • Chlorprotixen
  • Bisoprolol Fumarate
  • Ketoprofen
  • Depakene
  • Depakene
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Prestarium.

Tachycardia
A 67-year-old female patient from RUSSIAN FEDERATION (weight: NA) experienced symptoms, such as: hypertension and was treated with Prestarium(dosage: Unk). The treatment was initiated on Dec 14, 2011. After that a consumer reported the following side effect(s):
  • Tachycardia
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Prestarium efficacy:
  • Arifon (Unk)
  • Levothyroxine Sodium (Unk)
  • Xalatan (1 Gtt Into Each Eye, 1x/day, Before Night)


Bronchitis, Mucosal Inflammation, Thrombosis
In this report, Prestarium was administered for the following condition: NA.A 60-year-old female consumer from CZECH REPUBLIC (weight: NA) started Prestarium treatment (dosage: NA) on Mar 08, 2011.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Bronchitis
  • Mucosal Inflammation
  • Thrombosis
A possible interaction with other drugs could have contributed to this reaction:
  • Lexaurin
  • Milurit
  • Sutent (50 Mg Daily, 4 Weeks On, 2 Weeks Off)
  • Omeprazole
  • Tolperisone Hydrochloride
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Prestarium treatment could be related to the listed above side effect(s).

Angina Pectoris
This is a report of the following Prestarium side effect(s):
  • Angina Pectoris
A female patient from ROMANIA (weight: NA) presented with the following condition: NA and received a treatment with Prestarium (dosage: NA) starting: Sep 21, 2010.The following concurrently used drugs could have generated interactions:
  • Docetaxel (Dose Level: 100 Mg/m2, Form: Vials, Last Dose Prior To Sae: 02 Nov 2010)
  • Physiotens
  • Trastuzumab (Restarted)
  • Cyclophosphamide (Last Dose Prior To Sae: 4 Jan 2011, Dose Level: 600 Mg/m2, Form: Vials)
  • Trastuzumab
  • Epirubicin (Last Dose Prior To Sae: 04 Jan 2011, Form: Vials, Dose Level 90 Mg/m2)
  • Amlohexal
  • Fluorouracil (Last Dose Prior To Sae: 4 Jan 2011, Form: Vial, Dose Level: 600 Mg/m2)
The patient was hospitalized.This report suggests that a Prestarium treatment could be associated with the listed above side effect(s).

Acute Myocardial Infarction
This Prestarium Neo Combi report was submitted by a male consumer from CZECH REPUBLIC (weight: NA). The patient was diagnosed with: hypertension and Prestarium Neo Combi was administered (dosage: 1 Df, Daily) starting: Jun 21, 2011. The consumer developed a set of symptoms:
  • Acute Myocardial Infarction
Other drugs used simultaneously:
  • Lokren (1 Df, Daily)
  • Lactulose (As Needed)
  • Tasigna (No Treatment Received)
  • Tasigna (400 Mg, Daily)
  • Tasigna (400 Mg, Daily)
The patient was hospitalized.Those unexpected symptoms could be linked to a Prestarium Neo Combi treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Thrombosis, Bronchitis, Mucosal Inflammation
This is a report of a possible correlation between Prestarium use and the following symptoms/side effect(s):
  • Thrombosis
  • Bronchitis
  • Mucosal Inflammation
which could contribute to an assessment of Prestarium risk profile.A 60-year-old female consumer from CZECH REPUBLIC (weight: NA) was suffering from NA and was treated with Prestarium (dosage: NA) starting Mar 08, 2011.Other concurrent medications:
  • Omeprazole
  • Milurit
  • Sutent (50 Mg Daily, 4 Weeks On, 2 Weeks Off)
  • Lexaurin
  • Tolperisone Hydrochloride
The patient was hospitalized.

Dermatitis Exfoliative
A 64-year-old male patient from CZECH REPUBLIC (weight: NA) presented with the following symptoms: NA and after a treatment with Prestarium (dosage: Unk) experienced the following side effect(s):
  • Dermatitis Exfoliative
The treatment was started on Dec 08, 2008. Prestarium was used in combination with the following drugs:
  • Essentiale Forte
  • Godasal (100 Mg, Unk)
  • Atrovent
  • Sunitinib Malate (50 Mg, 1x/day)
The patient was hospitalized.This report could alert potential Prestarium consumers.

Thrombocytopenic Purpura, Vasculitis
In this report, a 46-year-old male patient from RUSSIAN FEDERATION (weight: NA) was affected by a possible Prestarium 2mg side effect.The patient was diagnosed with NA. After a treatment with Prestarium 2mg (dosage: Daily Dose: 2 Milligram(s), start date: Jan 01, 1997), the patient experienced the following side effect(s):
  • Thrombocytopenic Purpura
  • Vasculitis
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Prestarium 2mg treatment.

Blood Potassium Decreased, Endocrine Test, Essential Hypertension, Metabolic Disorder
This is a report of a male patient from SLOVAKIA (Slovak Republic) (weight: NA), who used Prestarium (dosage: Daily Dose: 4 Milligram(s)) for a treatment of ill-defined disorder. After starting a treatment on Mar 01, 2002, the patient experienced the following side effect(s):
  • Blood Potassium Decreased
  • Endocrine Test
  • Essential Hypertension
  • Metabolic Disorder
The following drugs could possibly have interacted with the Prestarium treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Prestarium treatment could be related to side effect(s), such as Blood Potassium Decreased, Endocrine Test, Essential Hypertension, Metabolic Disorder.

Hyperaldosteronism
This hyperaldosteronism side effect was reported by a consumer or non-health professional from SLOVAKIA (Slovak Republic). A male patient (weight:NA) experienced the following symptoms/conditions: ill-defined disorder. The patient was prescribed Prestarium (dosage: Daily Dose: 4 Milligram(s)), which was started on Mar 01, 2002. Concurrently used drugs:
  • Amaryl
  • Glucophage
When starting to take Prestarium the consumer reported the following symptoms:
  • Hyperaldosteronism
The patient was hospitalized. These side effects may potentially be related to Prestarium.

Asthenia, Bradycardia, Hyperkalaemia
This is a Prestarium side effect report of a 67-year-old female patient (weight:NA) from POLAND, suffering from the following symptoms/conditions: hypertension,ill-defined disorder, who was treated with Prestarium (dosage:Daily Dose: 4 Milligram(s), start time: Nov 01, 2005), combined with:
  • Verospiron (Daily Dose: 50 Milligram(s))
  • Kalipoz (Daily Dose: 2 Dosage Form)
  • Concor Cor (Daily Dose: 2.5 Milligram(s))
, and developed a serious reaction and a asthenia side effect. The patient presented with:
  • Asthenia
  • Bradycardia
  • Hyperkalaemia
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Prestarium treatment in female patients suffering from hypertension,ill-defined disorder, resulting in asthenia.

Blood Pressure Increased
This report suggests a potential Prestarium Forte blood pressure increased side effect(s) that can have serious consequences. A 62-year-old female patient from POLAND (weight:NA) was diagnosed with the following health condition(s): hypertension and used Prestarium Forte (dosage: Daily Dose: 8 Milligram(s)) starting Jan 01, 2005. Soon after starting Prestarium Forte the patient began experiencing various side effects, including:
  • Blood Pressure Increased
Drugs used concurrently:NA. Although Prestarium Forte demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as blood pressure increased, may still occur.



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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    More About Prestarium

    Side Effects reported to FDA: 16

    Prestarium safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 9

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