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Fraxodi Side Effects

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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.

Fraxodi Side Effects Reported to FDA



Fraxodi Side Effect Report#7712656-6
Lung Disorder
This is a report of a female patient (weight: NA) from France, suffering from the following health 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): Lung Disorder 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.
Fraxodi Side Effect Report#7369669-6
Weight Decreased, Blood Creatinine Increased
This report suggests a potential Fraxodi Weight Decreased 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. After starting Fraxodi the patient began experiencing various side effects, including: Weight Decreased, Blood Creatinine IncreasedAdditional 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.
Fraxodi Side Effect Report#7366925-2
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 using Fraxodi, the patient experienced the following unwanted symptoms/side effects: AngioedemaAlthough 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.
Fraxodi Side Effect Report#7227070-X
Sepsis
This Sepsis side effect was reported by a consumer or non-health professional from Germany. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fraxodi (drug dosage: NA), which was initiated on
Apr 26, 2010. Concurrently used drugs:
  • Cap Vorinostat (300 Mg/daily Po)
  • Novalgin
.After starting to take Fraxodi the consumer reported adverse symptoms, such as: SepsisThese side effects may potentially be related to Fraxodi. The patient was hospitalized.
Fraxodi Side Effect Report#5161747-5
Blood Alkaline Phosphatase Increased, Cholestasis, Mixed Hepatocellular-cholestatic Injury, Transaminases Increased
This is a report of a 56-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: deep vein thrombosis, who was treated with Fraxodi (dosage: .7ml Per Day, start time:
Sep 12, 2006), combined with:
  • 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)
and developed a serious reaction and side effect(s): Blood Alkaline Phosphatase Increased, Cholestasis, Mixed Hepatocellular-cholestatic Injury, Transaminases Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fraxodi treatment in male patients, resulting in Blood Alkaline Phosphatase Increased side effect. The patient was hospitalized.
Fraxodi Side Effect Report#5045205-4
Anaemia, Cervix Disorder, Deep Vein Thrombosis, Heparin-induced Thrombocytopenia, Hyponatraemia, Melaena, Pulmonary Embolism, Renal Infarct, Urine Output Decreased
This report suggests a potential Fraxodi Anaemia side effect(s) that can have serious consequences. A 84-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: atrial fibrillation,thrombosis prophylaxis and used Fraxodi (dosage: .6ml Per Day) starting
Mar 14, 2006. After starting Fraxodi the patient began experiencing various side effects, including: Anaemia, Cervix Disorder, Deep Vein Thrombosis, Heparin-induced Thrombocytopenia, Hyponatraemia, Melaena, Pulmonary Embolism, Renal Infarct, Urine Output DecreasedAdditional drugs used concurrently:
  • 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. Although Fraxodi demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaemia, may still occur.
Fraxodi Side Effect Report#4966022-7
Anaemia, Cervix Disorder, Deep Vein Thrombosis, Heparin-induced Thrombocytopenia, Hyponatraemia, Melaena, Pulmonary Embolism, Renal Infarct, Urine Output Decreased
This Anaemia problem was reported by a physician from France. A 84-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 14, 2006 this consumer started treatment with Fraxodi (dosage: .6ml Per Day). The following drugs were being taken at the same time:
  • 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
When using Fraxodi, the patient experienced the following unwanted symptoms/side effects: Anaemia, Cervix Disorder, Deep Vein Thrombosis, Heparin-induced Thrombocytopenia, Hyponatraemia, Melaena, Pulmonary Embolism, Renal Infarct, Urine Output DecreasedThe 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 Anaemia, may become evident only after a product is in use by the general population.
Fraxodi Side Effect Report#4958248-3
Anaemia, Cervix Disorder, Deep Vein Thrombosis, Heparin-induced Thrombocytopenia, Hyponatraemia, Melaena, Pulmonary Embolism, Renal Infarct, Urine Output Decreased
This Anaemia side effect was reported by a physician from France. A 84-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fraxodi (drug dosage: .6ml Per Day), which was initiated on
Mar 14, 2006. Concurrently used drugs:
  • 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
.After starting to take Fraxodi the consumer reported adverse symptoms, such as: Anaemia, Cervix Disorder, Deep Vein Thrombosis, Heparin-induced Thrombocytopenia, Hyponatraemia, Melaena, Pulmonary Embolism, Renal Infarct, Urine Output DecreasedThese side effects may potentially be related to Fraxodi. The patient was hospitalized.


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.


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.

    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.

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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