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Fraxodi Side Effects

Common Fraxodi Side Effects


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

Heparin-induced Thrombocytopenia (3)
Deep Vein Thrombosis (3)
Anaemia (3)
Hyponatraemia (3)
Cervix Disorder (3)
Melaena (3)
Renal Infarct (3)
Urine Output Decreased (3)
Pulmonary Embolism (3)
Blood Alkaline Phosphatase Increased (1)
Angioedema (1)
Weight Decreased (1)
Blood Creatinine Increased (1)
Mixed Hepatocellular-cholestatic Injury (1)
Transaminases Increased (1)
Sepsis (1)
Lung Disorder (1)
Cholestasis (1)


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.

Fraxodi Side Effects Reported to FDA

The following Fraxodi 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 Fraxodi 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.
Lung Disorder
This is a report of a female patient (weight: NA) from FRANCE, suffering from the following symptoms/conditions: pulmonary embolism, who was treated with Fraxodi (dosage: NA, start time: Mar 25, 2011), combined with:
  • Acetaminophen
  • Crestor (10mg At Night)
  • Magne B6
  • Allopurinol
  • Ofatumumab (1000mg Per Day)
  • Rabeprazole Sodium (20mg In The Morning)
  • Potassium Chloride
  • Lorazepam (1mg At Night)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Lung Disorder
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fraxodi treatment in female patients, resulting in lung disorder side effect. The patient was hospitalized.

Weight Decreased, Blood Creatinine Increased
This report suggests a potential Fraxodi Weight Decreased, Blood Creatinine Increased side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from GERMANY was diagnosed with the following symptoms/conditions: NA and used Fraxodi (dosage: NA) starting May 20, 2010. Soon after starting Fraxodi the patient began experiencing various side effects, including:
  • Weight Decreased
  • Blood Creatinine Increased
Drugs used concurrently:
  • Polymycin B Sulfate
  • Lysomucil (Lysomucil Effervescent Tab)
  • Pemetrexed Disodium (On Day One Every 21 Days.last Dose On 8jun2010;interr:29jun10)
  • Moviprep
  • Minocycline Hcl
  • Metronidazole (Formulation:cream)
  • Dexamethasone
  • Laxoberon
The patient was hospitalized. Although Fraxodi demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as weight decreased, may still occur.

Angioedema
This Angioedema problem was reported by a consumer or non-health professional from FRANCE. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Fraxodi (dosage: NA). The following drugs were being taken at the same time:
  • Previscan
  • Sintrom
  • Arixtra
When commencing Fraxodi, the patient experienced the following unwanted symptoms/side effects:
  • Angioedema
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as angioedema, may become evident only after a product is in use by the general population.

Sepsis
This is a report of a 65-year-old female patient (weight: NA) from GERMANY. The patient developed the following symptoms/conditions: NA and was treated with Fraxodi (dosage: NA) starting Apr 26, 2010. Concurrently used drugs:
  • Cap Vorinostat (300 Mg/daily Po)
  • Novalgin
Soon after that, the consumer experienced the following side effects:
  • Sepsis
The patient was hospitalized. This opens a possibility that Fraxodi treatment could cause the above reactions, including sepsis, and some female subjects may be more susceptible.


Blood Alkaline Phosphatase Increased, Cholestasis, Mixed Hepatocellular-cholestatic Injury, Transaminases Increased
A 56-year-old male patient (weight: NA) from FRANCE with the following symptoms/conditions: deep vein thrombosis started Fraxodi treatment (dosage: .7ml Per Day) on Sep 12, 2006. Soon after starting Fraxodi treatment, the subject experienced various side effects, including:
  • Blood Alkaline Phosphatase Increased
  • Cholestasis
  • Mixed Hepatocellular-cholestatic Injury
  • Transaminases Increased
Concurrently used drugs:
  • Nicorette (1unit Per Day)
  • Nexium (20mg At Night)
  • Efferalgan Codeine (2unit Three Times Per Day)
  • Previscan (20mg At Night)
  • Solupred (60mg In The Morning)
  • Atarax (100mg Per Day)
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Fraxodi.

Anaemia, Cervix Disorder, Deep Vein Thrombosis, Heparin-induced Thrombocytopenia, Hyponatraemia, Melaena, Pulmonary Embolism, Renal Infarct, Urine Output Decreased
A 84-year-old female patient from FRANCE (weight: NA) experienced symptoms, such as: atrial fibrillation,thrombosis prophylaxis and was treated with Fraxodi(dosage: .6ml Per Day). The treatment was initiated on Mar 14, 2006. After that a consumer reported the following side effect(s):
  • Anaemia
  • Cervix Disorder
  • Deep Vein Thrombosis
  • Heparin-induced Thrombocytopenia
  • Hyponatraemia
  • Melaena
  • Pulmonary Embolism
  • Renal Infarct
  • Urine Output Decreased
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Fraxodi efficacy:
  • Arixtra (2.5mg Per Day)
  • Lovenox (40mg Per Day)
  • Digoxin (1unit Per Day)
  • Manidipine (1tab At Night)
  • Cokenzen (1tab In The Morning)
  • Celebrex
  • Omeprazole
  • Lamaline
The patient was hospitalized.

Anaemia, Cervix Disorder, Deep Vein Thrombosis, Heparin-induced Thrombocytopenia, Hyponatraemia, Melaena, Pulmonary Embolism, Renal Infarct, Urine Output Decreased
In this report, Fraxodi was administered for the following condition: NA.A 84-year-old female consumer from FRANCE (weight: NA) started Fraxodi treatment (dosage: .6ml Per Day) on Mar 14, 2006.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Anaemia
  • Cervix Disorder
  • Deep Vein Thrombosis
  • Heparin-induced Thrombocytopenia
  • Hyponatraemia
  • Melaena
  • Pulmonary Embolism
  • Renal Infarct
  • Urine Output Decreased
A possible interaction with other drugs could have contributed to this reaction:
  • Arixtra (2.5mg Per Day)
  • Lovenox (40mg Per Day)
  • Digoxin (1unit Per Day)
  • Manidipine (1tab At Night)
  • Cokenzen (1tab In The Morning)
  • Celebrex
  • Omeprazole
  • Lamaline
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 Fraxodi treatment could be related to the listed above side effect(s).

Anaemia, Cervix Disorder, Deep Vein Thrombosis, Heparin-induced Thrombocytopenia, Hyponatraemia, Melaena, Pulmonary Embolism, Renal Infarct, Urine Output Decreased
This is a report of the following Fraxodi side effect(s):
  • Anaemia
  • Cervix Disorder
  • Deep Vein Thrombosis
  • Heparin-induced Thrombocytopenia
  • Hyponatraemia
  • Melaena
  • Pulmonary Embolism
  • Renal Infarct
  • Urine Output Decreased
A 84-year-old female patient from FRANCE (weight: NA) presented with the following condition: NA and received a treatment with Fraxodi (dosage: .6ml Per Day) starting: Mar 14, 2006.The following concurrently used drugs could have generated interactions:
  • Arixtra (2.5mg Per Day)
  • Sectral (200mg Twice Per Day)
  • Digoxin (1unit Per Day)
  • Manidipine (1tab At Night)
  • Cokenzen (1tab In The Morning)
  • Celebrex
  • Omeprazole
  • Lamaline
The patient was hospitalized.This report suggests that a Fraxodi treatment could be associated with the listed above side effect(s).



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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    Fraxodi Safety Alerts, Active Ingredients, Usage Information

    More About Fraxodi

    Side Effects reported to FDA: 8

    Fraxodi safety alerts: No

    Reported hospitalizations: 7

    Latest Fraxodi clinical trials