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Refacto adverse events reported to FDA.

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Summary

FDA Adverse Reports: 290. View All

Refacto FDA safety alerts: No

Reported deaths: 9

Reported hospitalizations: 104

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Often additional risks of using a medication, such as Refacto, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Refacto users, Learn more about unwanted side effects & find ways to reduce them. Browse Refacto Adverse Reports reported to FDA and participate in Refacto discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Refacto. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Refacto Adverse Effect Reports (FDA)

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7010539-0 | Coagulation Factor Viii Level Decreased, Epistaxis, Factor Viii Inhibition, Haemarthrosis, Infection
on Sep 14, 2010 Male patient from GERMANY , weighting 154.3 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: coagulation factor viii level decreased, epistaxis, factor viii inhibition, haemarthrosis, infection (What is infection?). Refacto dosage: .

7010538-9 | Coagulation Factor Viii Level Decreased, Epistaxis, Factor Viii Inhibition, Haemarthrosis, Infection
Patient was taking Refacto (View Usage). Patient had the following side effects: coagulation factor viii level decreased, epistaxis, factor viii inhibition, haemarthrosis, infection (What is infection?) on Sep 14, 2010 from GERMANY Additional patient health information: Male patient , weighting 154.3 lb, was diagnosed with factor viii deficiency and. Refacto dosage: .

6973213-2 | Coagulation Factor Viii Level Decreased, Epistaxis, Factor Viii Inhibition, Infection
Adverse event was reported on Sep 02, 2010 by a Male patient taking Refacto (View Usage) (Dosage: ) was diagnosed with factor viii deficiency and. Location: GERMANY , weighting 154.3 lb, After Refacto was administered, patient had the following side effects: coagulation factor viii level decreased, epistaxis, factor viii inhibition, infection (What is infection?).

6940380-6 | Product Quality Issue
on Jul 27, 2010 Male patient from UNITED KINGDOM , weighting 216.1 lb, was diagnosed with prophylaxis and was treated with Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: product quality issue. Refacto dosage: . During the same period patient was treated with CODEINE PHOSPHATE/PARACETAMOL (1-2 Dose Forms As Required) (View Codeine Phosphate/paracetamol Review and Codeine Phosphate/paracetamol Label ).


6901099-0 | Product Quality Issue
on Jul 30, 2010 Male patient from UNITED KINGDOM , weighting 216.1 lb, was diagnosed with prophylaxis and was treated with Refacto (View Usage). Patient had the following side effects: product quality issue. Refacto dosage: . During the same period patient was treated with CODEINE PHOSPHATE/PARACETAMOL (1-2 Dose Forms As Required) (View Codeine Phosphate/paracetamol Review and Codeine Phosphate/paracetamol Label ).

6827119-X | Factor Viii Inhibition, Haematoma
Patient was taking Refacto (View Usage). After Refacto was administered, patient had the following side effects: factor viii inhibition, haematoma on Jul 05, 2010 from UNITED KINGDOM Additional patient health information: Male patient , weighting 119.0 lb, was diagnosed with factor viii deficiency and. Refacto dosage: . Patient was hospitalized.

6820537-5 | Factor Viii Inhibition, Haematoma
Adverse event was reported on Jul 05, 2010 by a Male patient taking Refacto (View Usage) (Dosage: ) was diagnosed with factor viii deficiency and. Location: UNITED KINGDOM , weighting 119.0 lb, Patient experienced the following unwanted or unexpected effects: factor viii inhibition, haematoma. Patient was hospitalized.

6819652-1 | Factor Viii Inhibition, Haemorrhage
on Jun 28, 2010 Male patient from BELGIUM , 32 years of age, weighting 172.0 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). Patient had the following side effects: factor viii inhibition, haemorrhage. Refacto dosage: 3 Times/week. Patient was hospitalized.

6819651-X | Factor Viii Inhibition, Haematoma, No Therapeutic Response
on Jul 01, 2010 Male patient from SPAIN , child 4 years of age, weighting 28.66 lb, was diagnosed with factor viii deficiency, prophylaxis and was treated with Refacto (View Usage). After Refacto was administered, patient had the following side effects: factor viii inhibition, haematoma, no therapeutic response. Refacto dosage: . Patient was hospitalized.

6817882-6 | Factor Viii Inhibition, Haemorrhage
Patient was taking Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: factor viii inhibition, haemorrhage on Jun 28, 2010 from BELGIUM Additional patient health information: Male patient , 32 years of age, weighting 172.0 lb, was diagnosed with factor viii deficiency and. Refacto dosage: 3 Times/week. Patient was hospitalized.

6810119-3 | False Positive Laboratory Result
Adverse event was reported on Jun 23, 2010 by a Male patient taking Refacto (View Usage) (Dosage: 2000iu On Demand (28iu/kg)) was diagnosed with factor viii deficiency and. Location: ITALY , weighting 158.7 lb, Patient had the following side effects: false positive laboratory result.

6809505-7 | Factor Viii Inhibition, Haemarthrosis
on Jun 18, 2010 Male patient from GERMANY , weighting 25.24 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). After Refacto was administered, patient had the following side effects: factor viii inhibition, haemarthrosis. Refacto dosage: . Patient was hospitalized.

6780147-5 | Factor Viii Inhibition, Haemarthrosis
on Jun 08, 2010 Male patient from GERMANY , weighting 22.05 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: factor viii inhibition, haemarthrosis. Refacto dosage: . Patient was hospitalized.

6771239-5 | Factor Viii Inhibition, Fall, Haemorrhage
Patient was taking Refacto (View Usage). Patient had the following side effects: factor viii inhibition, fall (What is fall?), haemorrhage on Jun 08, 2010 from UNITED KINGDOM Additional patient health information: Male patient , 51 years of age, was diagnosed with factor viii deficiency and. Refacto dosage: .

6767308-6 | Anti Factor Viii Antibody Test, Fall, Haemorrhage
Adverse event was reported on Jun 08, 2010 by a Male patient taking Refacto (View Usage) (Dosage: ) was diagnosed with factor viii deficiency and. Location: UNITED KINGDOM , 51 years of age, After Refacto was administered, patient had the following side effects: anti factor viii antibody test, fall (What is fall?), haemorrhage.

6756958-9 | Factor Viii Inhibition
on Jun 01, 2010 Male patient from FRANCE , weighting 165.3 lb, was diagnosed with factor viii deficiency, pain (What is pain?) and was treated with Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: factor viii inhibition. Refacto dosage: . During the same period patient was treated with ACETAMINOPHEN AND CODEINE PHOSPHATE (View Acetaminophen And Codeine Phosphate Review and Acetaminophen And Codeine Phosphate Label ).

6754543-6 | Factor Viii Inhibition
on Jun 01, 2010 Male patient from FRANCE , weighting 165.3 lb, was diagnosed with factor viii deficiency, pain (What is pain?) and was treated with Refacto (View Usage). Patient had the following side effects: factor viii inhibition. Refacto dosage: 2500 To 3000 Iu Per Injection, On Demand. During the same period patient was treated with ACETAMINOPHEN AND CODEINE PHOSPHATE (View Acetaminophen And Codeine Phosphate Review and Acetaminophen And Codeine Phosphate Label ).

6754542-4 | Factor Viii Inhibition
Patient was taking Refacto (View Usage). After Refacto was administered, patient had the following side effects: factor viii inhibition on Feb 17, 2010 from BELGIUM Additional patient health information: Male patient , 45 years of age, was diagnosed with knee arthroplasty and. Refacto dosage: 500 Iu. Patient was hospitalized.

6742461-9 | Factor Viii Inhibition
Adverse event was reported on May 17, 2010 by a Male patient taking Refacto (View Usage) (Dosage: 2000iu On Demand (28iu/kg)) was diagnosed with factor viii deficiency and. Location: ITALY , weighting 158.7 lb, Patient experienced the following unwanted or unexpected effects: factor viii inhibition.

6742174-3 | Intestinal Infarction, Salmonellosis, Small Intestinal Haemorrhage
on May 21, 2010 Male patient from GERMANY , weighting 158.7 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). Patient had the following side effects: intestinal infarction, salmonellosis, small intestinal haemorrhage. Refacto dosage: . Patient was hospitalized.

6734289-0 | Factor Viii Inhibition
on May 13, 2010 Male patient from UNITED KINGDOM , weighting 26.46 lb, was diagnosed with factor viii deficiency, mucosal haemorrhage and was treated with Refacto (View Usage). After Refacto was administered, patient had the following side effects: factor viii inhibition. Refacto dosage: . During the same period patient was treated with TRANEXAMIC ACID (View Tranexamic Acid Review and Tranexamic Acid Label ).

6734286-5 | Factor Viii Inhibition
Patient was taking Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: factor viii inhibition on May 13, 2010 from UNITED KINGDOM Additional patient health information: Male patient , weighting 26.46 lb, was diagnosed with factor viii deficiency, mucosal haemorrhage and. Refacto dosage: . During the same period patient was treated with TRANEXAMIC ACID (View Tranexamic Acid Review and Tranexamic Acid Label ).

6729761-3 | Anti Factor Viii Antibody Test, Haemorrhage
Adverse event was reported on May 12, 2010 by a Male patient taking Refacto (View Usage) (Dosage: Prophylactic, On Demand: 30 Iu/kg) was diagnosed with factor viii inhibition and. Location: BELGIUM , 32 years of age, weighting 172.0 lb, Patient had the following side effects: anti factor viii antibody test, haemorrhage. Patient was hospitalized.

6726247-7 | Factor Viii Inhibition, Haematoma, No Therapeutic Response
on May 04, 2010 Male patient from SPAIN , child 4 years of age, weighting 28.66 lb, was diagnosed with factor viii deficiency, prophylaxis and was treated with Refacto (View Usage). After Refacto was administered, patient had the following side effects: factor viii inhibition, haematoma, no therapeutic response. Refacto dosage: . Patient was hospitalized.

6718429-5 | Factor Viii Inhibition, Haematoma, No Therapeutic Response
on May 04, 2010 Male patient from SPAIN , child 4 years of age, weighting 28.66 lb, was diagnosed with factor viii deficiency, prophylaxis and was treated with Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: factor viii inhibition, haematoma, no therapeutic response. Refacto dosage: . Patient was hospitalized.

6692858-0 | Factor Viii Inhibition, Haematoma, No Therapeutic Response
Patient was taking Refacto (View Usage). Patient had the following side effects: factor viii inhibition, haematoma, no therapeutic response on Apr 13, 2010 from SPAIN Additional patient health information: Male patient , child 4 years of age, weighting 28.66 lb, was diagnosed with factor viii deficiency, prophylaxis and. Refacto dosage: . Patient was hospitalized.

6688952-0 | Factor Viii Inhibition, Haematoma, No Therapeutic Response
Adverse event was reported on Apr 13, 2010 by a Male patient taking Refacto (View Usage) (Dosage: ) was diagnosed with factor viii deficiency, prophylaxis and. Location: SPAIN , child 4 years of age, weighting 28.66 lb, After Refacto was administered, patient had the following side effects: factor viii inhibition, haematoma, no therapeutic response. Patient was hospitalized.

6682332-X | Factor Viii Inhibition
on Apr 07, 2010 Male patient from SPAIN , child 4 years of age, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: factor viii inhibition. Refacto dosage: . Patient was hospitalized.

6679971-9 | Incorrect Product Storage
on Mar 30, 2010 Male patient from AUSTRALIA , weighting 132.3 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). Patient had the following side effects: incorrect product storage. Refacto dosage: 3000iu, Started 2-3 Years Ago, Suspect Batch In Dec-2009 To Jan-2010 For 2-3 Wks, Then New Batch.

6615869-X | Factor Viii Inhibition, Haemarthrosis
Patient was taking Refacto (View Usage). After Refacto was administered, patient had the following side effects: factor viii inhibition, haemarthrosis on Feb 26, 2010 from FRANCE Additional patient health information: Male patient , weighting 165.3 lb, was diagnosed with factor viii deficiency and. Refacto dosage: 3 500 Iu Per Injection, On Demand.

6615868-8 | Incorrect Product Storage
Adverse event was reported on Mar 01, 2010 by a Male patient taking Refacto (View Usage) (Dosage: 3000iu, Started 2-3 Years Ago, Suspect Batch In Dec-2009 To Jan-2010 For 2-3 Wks, Then New Batch) was diagnosed with factor viii deficiency and. Location: AUSTRALIA , weighting 132.3 lb, Patient experienced the following unwanted or unexpected effects: incorrect product storage.

6605188-X | Incorrect Product Storage
on Feb 24, 2010 Male patient from AUSTRALIA , weighting 132.3 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). Patient had the following side effects: incorrect product storage. Refacto dosage: 3000iu, Started 2-3 Years Ago, Suspect Batch In Dec-2009 To Jan-2010 For 2-3 Wks, Then New Batch.

6594733-9 | Factor Viii Inhibition, Post Procedural Haemorrhage
on Feb 17, 2010 Male patient from BELGIUM , 45 years of age, was diagnosed with knee arthroplasty and was treated with Refacto (View Usage). After Refacto was administered, patient had the following side effects: factor viii inhibition, post procedural haemorrhage. Refacto dosage: 500 Iu. Patient was hospitalized.

6567782-4 | Arthralgia, Factor Viii Inhibition, Haemorrhage, Muscle Haemorrhage, Pain In Extremity
Patient was taking Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: arthralgia, factor viii inhibition, haemorrhage, muscle haemorrhage, pain in extremity on Jan 27, 2010 from FINLAND Additional patient health information: Male patient , weighting 134.5 lb, was diagnosed with factor viii deficiency and. Refacto dosage: . Patient was hospitalized.

6566251-5 | False Positive Laboratory Result
Adverse event was reported on Jan 22, 2010 by a Male patient taking Refacto (View Usage) (Dosage: ) was diagnosed with factor viii deficiency, viral infection (What is viral infection?) and. Location: SPAIN , weighting 185.2 lb, Patient had the following side effects: false positive laboratory result. During the same period patient was treated with TENOFOVIR DISOPROXIL FUMARATE (Not Provided) (View Tenofovir Disoproxil Fumarate Review and Tenofovir Disoproxil Fumarate Label ), LOPINAVIR/RITONAVIR (Not Provided) (View Lopinavir/ritonavir Review and Lopinavir/ritonavir Label ), PANTOPRAZOLE (Not Provided) (View Pantoprazole Review and Pantoprazole Label ), ABACAVIR (Not Provided) (View Abacavir Review and Abacavir Label ).

6565528-7 | Factor Viii Inhibition
on Jan 29, 2010 Male patient from FINLAND , weighting 24.25 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). After Refacto was administered, patient had the following side effects: factor viii inhibition. Refacto dosage: .

6565527-5 | Haemarthrosis, Haematospermia
on Jan 29, 2010 Male patient from GERMANY , weighting 224.9 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: haemarthrosis, haematospermia. Refacto dosage: 2000 Iu 1 Time Per 3 Days. Patient was hospitalized.

6557862-1 | Factor Viii Inhibition
Patient was taking Refacto (View Usage). Patient had the following side effects: factor viii inhibition on Jan 26, 2010 from SPAIN Additional patient health information: Male patient , 24 years of age, weighting 198.4 lb, was diagnosed with haemophilia and. Refacto dosage: 3000 Ui On Demand.

6557338-1 | Haemarthrosis, Haematospermia
Adverse event was reported on Jan 20, 2010 by a Male patient taking Refacto (View Usage) (Dosage: 2000 Iu 1 Time Per 3 Days) was diagnosed with factor viii deficiency and. Location: GERMANY , weighting 224.9 lb, After Refacto was administered, patient had the following side effects: haemarthrosis, haematospermia. Patient was hospitalized.

6551436-4 | Free Haemoglobin Present
on Jan 19, 2010 Male patient from GERMANY , weighting 24.25 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: free haemoglobin present. Refacto dosage: .

6550423-X | Free Haemoglobin Present
on Jan 19, 2010 Male patient from GERMANY , weighting 24.25 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). Patient had the following side effects: free haemoglobin present. Refacto dosage: .

6550420-4 | Fall, Subdural Haematoma
Patient was taking Refacto (View Usage). After Refacto was administered, patient had the following side effects: fall (What is fall?), subdural haematoma on Jan 19, 2010 from GERMANY Additional patient health information: Male patient , weighting 31.97 lb, was diagnosed with factor viii deficiency and. Refacto dosage: Regular Dosage 3x 250 Iu/week. Patient was hospitalized.

6543226-3 | Device Related Infection, Enteritis, Factor Viii Inhibition, Foot Fracture, Haemarthrosis, Haematoma, Traumatic Brain Injury
Adverse event was reported on Jan 15, 2010 by a Male patient taking Refacto (View Usage) (Dosage: ) was diagnosed with factor viii deficiency and. Location: GERMANY , weighting 22.05 lb, Patient experienced the following unwanted or unexpected effects: device related infection, enteritis, factor viii inhibition, foot fracture, haemarthrosis, haematoma, traumatic brain injury (What is traumatic brain injury?). Patient was hospitalized.

6538821-1 | Factor Viii Inhibition
on Jan 11, 2010 Male patient from DENMARK , weighting 172.0 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). Patient had the following side effects: factor viii inhibition. Refacto dosage: 1000 Iu; Cumulative Dose 16000 Iu. Patient was hospitalized.

6531092-1 | Coagulation Factor Viii Level Decreased, Epistaxis, Factor Viii Inhibition, Infection
on Dec 30, 2009 Male patient from GERMANY , weighting 154.3 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). After Refacto was administered, patient had the following side effects: coagulation factor viii level decreased, epistaxis, factor viii inhibition, infection (What is infection?). Refacto dosage: .

6530283-3 | Blood Lactate Dehydrogenase Increased, Free Haemoglobin Present
Patient was taking Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: blood lactate dehydrogenase increased, free haemoglobin present on Dec 29, 2009 from GERMANY Additional patient health information: Male patient , weighting 18.74 lb, was diagnosed with factor viii deficiency and. Refacto dosage: .

6528793-8 | Fall, Subdural Haematoma
Adverse event was reported on Dec 28, 2009 by a Male patient taking Refacto (View Usage) (Dosage: Regular Dosage 3x 250 Iu/week) was diagnosed with factor viii deficiency and. Location: GERMANY , weighting 31.97 lb, Patient had the following side effects: fall (What is fall?), subdural haematoma. Patient was hospitalized.

6528587-3 | Blood Lactate Dehydrogenase Increased, Free Haemoglobin Present
on Dec 29, 2009 Male patient from GERMANY , weighting 18.74 lb, was diagnosed with factor viii deficiency and was treated with Refacto (View Usage). After Refacto was administered, patient had the following side effects: blood lactate dehydrogenase increased, free haemoglobin present. Refacto dosage: .

6525979-3 | Factor Viii Inhibition
on Dec 23, 2009 Male patient from SPAIN , weighting 185.2 lb, was diagnosed with factor viii deficiency, viral infection (What is viral infection?) and was treated with Refacto (View Usage). Patient experienced the following unwanted or unexpected effects: factor viii inhibition. Refacto dosage: . During the same period patient was treated with TENOFOVIR DISOPROXIL FUMARATE (Not Provided) (View Tenofovir Disoproxil Fumarate Review and Tenofovir Disoproxil Fumarate Label ), LOPINAVIR AND RITONAVIR (Not Provided) (View Lopinavir And Ritonavir Review and Lopinavir And Ritonavir Label ), PANTOPRAZOLE (Not Provided) (View Pantoprazole Review and Pantoprazole Label ), ABACAVIR (Not Provided) (View Abacavir Review and Abacavir Label ).

6521365-0 | Joint Arthroplasty
Patient was taking Refacto (View Usage). Patient had the following side effects: joint arthroplasty on Dec 21, 2009 from GERMANY Additional patient health information: Female patient , weighting 183.0 lb, was diagnosed with factor viii deficiency and. Refacto dosage: . Patient was hospitalized.

Showing 1-50 of 290  Next Page  >


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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Refacto risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Refacto quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Refacto use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Refacto Reactions
Abdominal Pain Lower
Activated Partial Thromboplastin Time Prolonged
Anti Factor Viii Antibody Positive
Arthralgia
Atelectasis
Catheter Related Complication
Cerebral Haemorrhage
Coagulation Factor Viii Level Decreased
Contusion
Epistaxis
Factor Viii Inhibition
FallWhat is Fall?
Free Haemoglobin Present
Haemarthrosis
Haematoma
Haemorrhage
InfectionWhat is Infection?
Inflammation
Infusion Site Haematoma
Mouth Haemorrhage
Muscle Haemorrhage
Muscle Strain
No Therapeutic Response
Pain In Extremity
Pleurisy
Retroperitoneal Haematoma
Soft Tissue Haemorrhage
Spontaneous Haematoma
Varicella
Weight Increased
Refacto Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Refacto adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!