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Prestarium Side Effects

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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.

Prestarium Side Effects Reported to FDA



Prestarium Side Effect Report#8446993-7
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 health 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): Multi-organ Failure, Pulmonary Embolism 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.
Prestarium Side Effect Report#8371524-X
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. After starting Prestarium the patient began experiencing various side effects, including: Atrial Conduction Time ProlongationAdditional 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.
Prestarium Side Effect Report#8227278-0
Acute Myocardial Infarction, Angina Pectoris, Angina Unstable, Post Procedural Haemorrhage
This Acute Myocardial Infarction 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 using Prestarium Neo Combi, the patient experienced the following unwanted symptoms/side effects: Acute Myocardial Infarction, Angina Pectoris, Angina Unstable, Post Procedural HaemorrhageThe 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.
Prestarium Side Effect Report#8155488-X
Cerebrovascular Accident, Adverse Event
This Cerebrovascular Accident side effect was reported by a physician from Czech Republic. A 80-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Prestarium (drug dosage: NA), which was initiated on
Oct 13, 2010. Concurrently used drugs:
  • Oral Antidiabetics
  • Hypotylin
  • Omeprazole
  • Imuran (Unk)
  • Forteo (20 Ug, Qd)
  • Corticosteroid Nos
  • Prednisone (5 Mg, Qd)
  • Tanakan
.After starting to take Prestarium the consumer reported adverse symptoms, such as: Cerebrovascular Accident, Adverse EventThese side effects may potentially be related to Prestarium. The patient was hospitalized.
Prestarium Side Effect Report#8103500-6
Cholesterol Granuloma
This is a report of a 52-year-old male patient (weight: NA) from Poland, suffering from the following health symptoms/conditions: hypertension,depression,spondylitis, who was treated with Prestarium (dosage: NA, start time:
Jan 01, 2009), combined with:
  • Anafranil
  • Cimzia (200 Mg)
  • Chlorprotixen
  • Bisoprolol Fumarate
  • Ketoprofen
  • Depakene
  • Depakene
and developed a serious reaction and side effect(s): Cholesterol Granuloma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prestarium treatment in male patients, resulting in Cholesterol Granuloma side effect. The patient was hospitalized.
Prestarium Side Effect Report#7998467-5
Tachycardia
This report suggests a potential Prestarium Tachycardia side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from Russian Federation was diagnosed with the following symptoms/conditions: hypertension and used Prestarium (dosage: Unk) starting
Dec 14, 2011. After starting Prestarium the patient began experiencing various side effects, including: TachycardiaAdditional drugs used concurrently:
  • Arifon (Unk)
  • Levothyroxine Sodium (Unk)
  • Xalatan (1 Gtt Into Each Eye, 1x/day, Before Night)
Although Prestarium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tachycardia, may still occur.
Prestarium Side Effect Report#7659059-0
Bronchitis, Mucosal Inflammation, Thrombosis
This Bronchitis problem was reported by a consumer or non-health professional from Czech Republic. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 08, 2011 this consumer started treatment with Prestarium (dosage: NA). The following drugs were being taken at the same time:
  • Lexaurin
  • Milurit
  • Sutent (50 Mg Daily, 4 Weeks On, 2 Weeks Off)
  • Omeprazole
  • Tolperisone Hydrochloride
When using Prestarium, the patient experienced the following unwanted symptoms/side effects: Bronchitis, Mucosal Inflammation, ThrombosisThe 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 Bronchitis, may become evident only after a product is in use by the general population.
Prestarium Side Effect Report#7626487-9
Angina Pectoris
This Angina Pectoris side effect was reported by a physician from Romania. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Prestarium (drug dosage: NA), which was initiated on
Sep 21, 2010. Concurrently used drugs:
  • 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)
.After starting to take Prestarium the consumer reported adverse symptoms, such as: Angina PectorisThese side effects may potentially be related to Prestarium. The patient was hospitalized.
Prestarium Side Effect Report#7617317-X
Acute Myocardial Infarction
This is a report of a male patient (weight: NA) from Czech Republic, suffering from the following health symptoms/conditions: hypertension, who was treated with Prestarium Neo Combi (dosage: 1 Df, Daily, start time:
Jun 21, 2011), combined with:
  • Lokren (1 Df, Daily)
  • Lactulose (As Needed)
  • Tasigna (No Treatment Received)
  • Tasigna (400 Mg, Daily)
  • Tasigna (400 Mg, Daily)
and developed a serious reaction and side effect(s): Acute Myocardial Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prestarium Neo Combi treatment in male patients, resulting in Acute Myocardial Infarction side effect. The patient was hospitalized.
Prestarium Side Effect Report#7462371-1
Thrombosis, Bronchitis, Mucosal Inflammation
This report suggests a potential Prestarium Thrombosis side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from Czech Republic was diagnosed with the following symptoms/conditions: NA and used Prestarium (dosage: NA) starting
Mar 08, 2011. After starting Prestarium the patient began experiencing various side effects, including: Thrombosis, Bronchitis, Mucosal InflammationAdditional drugs used concurrently:
  • Omeprazole
  • Milurit
  • Sutent (50 Mg Daily, 4 Weeks On, 2 Weeks Off)
  • Lexaurin
  • Tolperisone Hydrochloride
The patient was hospitalized. Although Prestarium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Thrombosis, may still occur.
Prestarium Side Effect Report#7302372-7
Dermatitis Exfoliative
This Dermatitis Exfoliative problem was reported by a physician from Czech Republic. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 08, 2008 this consumer started treatment with Prestarium (dosage: Unk). The following drugs were being taken at the same time:
  • Essentiale Forte
  • Godasal (100 Mg, Unk)
  • Atrovent
  • Sunitinib Malate (50 Mg, 1x/day)
When using Prestarium, the patient experienced the following unwanted symptoms/side effects: Dermatitis ExfoliativeThe 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 Dermatitis Exfoliative, may become evident only after a product is in use by the general population.
Prestarium Side Effect Report#6356040-9
Thrombocytopenic Purpura, Vasculitis
This Thrombocytopenic Purpura side effect was reported by a physician from Russian Federation. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Prestarium 2mg (drug dosage: Daily Dose: 2 Milligram(s)), which was initiated on
Jan 01, 1997. Concurrently used drugs: NA..After starting to take Prestarium 2mg the consumer reported adverse symptoms, such as: Thrombocytopenic Purpura, VasculitisThese side effects may potentially be related to Prestarium 2mg.
Prestarium Side Effect Report#5064269-5
Blood Potassium Decreased, Endocrine Test, Essential Hypertension, Hypertension, Metabolic Disorder
This is a report of a male patient (weight: NA) from Slovakia (slovak Republic), suffering from the following health symptoms/conditions: ill-defined disorder, who was treated with Prestarium (dosage: Daily Dose: 4 Milligram(s), start time:
Mar 01, 2002), combined with: NA. and developed a serious reaction and side effect(s): Blood Potassium Decreased, Endocrine Test, Essential Hypertension, Hypertension, Metabolic Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prestarium treatment in male patients, resulting in Blood Potassium Decreased side effect. The patient was hospitalized.
Prestarium Side Effect Report#5008726-6
Hyperaldosteronism
This report suggests a potential Prestarium Hyperaldosteronism side effect(s) that can have serious consequences. A male patient (weight: NA) from Slovakia (slovak Republic) was diagnosed with the following symptoms/conditions: ill-defined disorder and used Prestarium (dosage: Daily Dose: 4 Milligram(s)) starting
Mar 01, 2002. After starting Prestarium the patient began experiencing various side effects, including: HyperaldosteronismAdditional drugs used concurrently:
  • Amaryl
  • Glucophage
The patient was hospitalized. Although Prestarium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyperaldosteronism, may still occur.
Prestarium Side Effect Report#4997221-6
Asthenia, Bradycardia, Hyperkalaemia
This Asthenia problem was reported by a health professional from Poland. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypertension,ill-defined disorder. On
Nov 01, 2005 this consumer started treatment with Prestarium (dosage: Daily Dose: 4 Milligram(s)). The following drugs were being taken at the same time:
  • Verospiron (Daily Dose: 50 Milligram(s))
  • Kalipoz (Daily Dose: 2 Dosage Form)
  • Concor Cor (Daily Dose: 2.5 Milligram(s))
When using Prestarium, the patient experienced the following unwanted symptoms/side effects: Asthenia, Bradycardia, HyperkalaemiaThe 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 Asthenia, may become evident only after a product is in use by the general population.
Prestarium Side Effect Report#4898786-5
Blood Pressure Increased
This Blood Pressure Increased side effect was reported by a health professional from Poland. A 62-year-old female patient (weight:NA) experienced the following symptoms/conditions: hypertension.The patient was prescribed Prestarium Forte (drug dosage: Daily Dose: 8 Milligram(s)), which was initiated on
Jan 01, 2005. Concurrently used drugs: NA..After starting to take Prestarium Forte the consumer reported adverse symptoms, such as: Blood Pressure IncreasedThese side effects may potentially be related to Prestarium Forte.



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.


Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

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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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