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Bivalirudin adverse events reported to FDA.

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Summary

FDA Adverse Reports: 7. View All

Bivalirudin FDA safety alerts: No

Reported deaths: 1

Reported hospitalizations: 3

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Often additional risks of using a medication, such as Bivalirudin, 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 Bivalirudin users, Learn more about unwanted side effects & find ways to reduce them. Browse Bivalirudin Adverse Reports reported to FDA and participate in Bivalirudin discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Bivalirudin. 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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Bivalirudin Adverse Effect Reports (FDA)

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6382014-8 | Femoral Bruit, Haematoma, Vascular Pseudoaneurysm
on Sep 14, 2009 Male patient from UNITED STATES , 82 years of age, weighting 145.5 lb, was treated with Bivalirudin (View Usage). Patient experienced the following unwanted or unexpected effects: femoral bruit, haematoma, vascular pseudoaneurysm. Bivalirudin dosage: 50 Mg, Bolus, Intravenous; 115 Mg, Intravenous. During the same period patient was treated with CLOPIDOGREL (4 Pre-procedure Capsules, Single, Oral) (View Clopidogrel Review and Clopidogrel Label ), ASPIRIN (325 Mg, Qd, Oral) (View Aspirin Review and Aspirin Label ), HEPARIN (850 Ut, Hr, Intravenous) (View Heparin Review and Heparin Label ). Patient was hospitalized.

5721518-5 | Cough, Hypotension, Hypoxia, Wheezing
Patient was taking Bivalirudin (View Usage). Patient had the following side effects: cough, hypotension, hypoxia, wheezing on Apr 28, 2008 from UNITED STATES Additional patient health information: Male patient , 88 years of age, . Bivalirudin dosage: . During the same period patient was treated with CONTRAST (View Contrast Review and Contrast Label ), MIDAZOLAM HCL (View Midazolam Hcl Review and Midazolam Hcl Label ). Patient was hospitalized.

5310291-0 | Bradycardia
Adverse event was reported on Apr 17, 2007 by a Male patient taking Bivalirudin (View Usage) (Dosage: Unk) was diagnosed with percutaneous coronary intervention and. Location: UNITED STATES , 75 years of age, weighting 191.8 lb, After Bivalirudin was administered, patient had the following side effects: bradycardia. During the same period patient was treated with PLAVIX (Four Capsules Prior To Pci And Four Capsules Post Pci) (View Plavix Review and Plavix Label ), FENTANYL (Unk) (View Fentanyl Review and Fentanyl Label ), MIDAZOLAM HCL (Unk) (View Midazolam Hcl Review and Midazolam Hcl Label ).

5206909-3 | Hypotension, Infusion Related Reaction, Loss Of Consciousness, Thrombosis
on Jan 05, 2007 Female patient from UNITED STATES , 70 years of age, weighting 141.5 lb, was treated with Bivalirudin (View Usage). Patient experienced the following unwanted or unexpected effects: hypotension, infusion related reaction, loss of consciousness, thrombosis. Bivalirudin dosage: 12.75mg Iv X 1; 29.75mg/hr. During the same period patient was treated with AMIODARONE HCL (View Amiodarone Hcl Review and Amiodarone Hcl Label ), ENALAPRIL MALEATE (View Enalapril Maleate Review and Enalapril Maleate Label ), HYDROMORPHONE HCL (View Hydromorphone Hcl Review and Hydromorphone Hcl Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ), ACETYLCYSTEINE (View Acetylcysteine Review and Acetylcysteine Label ).


4965801-X | Cardiac Arrest, Cardiac Failure, Coagulation Time Prolonged, Oxygen Saturation Decreased, Pulmonary Haemorrhage, Ventricular Fibrillation
on Apr 06, 2006 Female patient from UNITED STATES , 66 years of age, weighting 167.6 lb, was diagnosed with atrial thrombosis, deep vein thrombosis (What is deep vein thrombosis?), heparin-induced thrombocytopenia, pulmonary artery thrombosis, pulmonary embolism (What is pulmonary embolism?) and was treated with Bivalirudin (View Usage). Patient had the following side effects: cardiac arrest (What is cardiac arrest?), cardiac failure, coagulation time prolonged, oxygen saturation decreased, pulmonary haemorrhage, ventricular fibrillation. Bivalirudin dosage: See Image.

4867493-7 | Coronary Artery Thrombosis
Patient was taking Bivalirudin (View Usage). After Bivalirudin was administered, patient had the following side effects: coronary artery thrombosis on Dec 27, 2005 from UNITED STATES Additional patient health information: Male patient , 58 years of age, weighting 210.5 lb, was diagnosed with catheterisation cardiac and. Bivalirudin dosage: 71mg Bolus X1 Iv Bolus; 166mg/hr X30 Min Iv Drip.

4653245-X | Post Procedural Complication
Adverse event was reported on May 03, 2005 by a Female patient taking Bivalirudin (View Usage) (Dosage: Bolus-} 70 Mg Continuing 185 Mg/m2) was diagnosed with angioplasty (What is angioplasty?), chest pain (What is chest pain?) and. Location: , 85 years of age, Patient experienced the following unwanted or unexpected effects: post procedural complication. Patient was hospitalized.


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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 Bivalirudin 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 Bivalirudin quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Bivalirudin 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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During the same period patient was treated with IOHEXOL (View Iohexol Review and Iohexol Label ), BIVALIRUDIN (View Bivalirudin Review and Bivalirudin Label ).

During the same period patient was treated with IOHEXOL (View Iohexol Review and Iohexol Label ), BIVALIRUDIN (View Bivalirudin Review and Bivalirudin Label ).

Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction. Read more. Altace Side Effects During the same period patient ...

During the same period patient was treated with BIVALIRUDIN (BIVALIRUDIN) (7.9 Milligram(s) Daily Intravenous Injection Daily Dose: 7.9 Milligram(s), 11.9 Milligram(s ...

Report a Drug Side Effect. ... This anonymous Drug Side Effect Survey has 13 questions and takes less than 2 minutes to complete.

During the same period patient was treated with BIVALIRUDIN (I.v.) (View Bivalirudin Review and Bivalirudin Label ), MIDAZOLAM HYDROCHLORIDE (2 Mg, I.v.) (View Midazolam ...

During the same period patient was treated with IOHEXOL (View Iohexol Review and Iohexol Label ), BIVALIRUDIN (View Bivalirudin Review and Bivalirudin Label ).

During the same period patient was treated with HYDROCORTISONE (View Hydrocortisone Review and Hydrocortisone Label ), BIVALIRUDIN (View Bivalirudin Review and Bivalirudin ...

Efficacy Study of Combined Prasugrel and Bivalirudin Versus Clopidogrel and Heparin in Myocardial Infarction. Read more. Altace Side Effects During the same period patient ...

During the same period patient was treated with BIVALIRUDIN. Patient was hospitalized. Plavix Side Effects Report: 4576567-X,Chest Pain, Gastrointestinal Haemorrhage on ...

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Bivalirudin Reactions
Bradycardia
Cardiac ArrestWhat is Cardiac arrest?
Cardiac Failure
Coagulation Time Prolonged
Coronary Artery Thrombosis
Cough
Femoral Bruit
Haematoma
Hypotension
Hypoxia
Infusion Related Reaction
Loss Of Consciousness
Oxygen Saturation Decreased
Post Procedural Complication
Pulmonary Haemorrhage
Thrombosis
Vascular Pseudoaneurysm
Ventricular Fibrillation
Wheezing
Bivalirudin 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 Bivalirudin 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!