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Telbivudine adverse events reported to FDA.

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Summary

FDA Adverse Reports: 25. View All

Telbivudine FDA safety alerts: No

Reported deaths: 1

Reported hospitalizations: 10

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

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7018383-5 | Abdominal Distension, Abdominal Pain, Abdominal Pain Upper, Abdominal Tenderness, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Amylase Increased, Blood Creatine Phosphokinase Increased
on Sep 17, 2010 Male patient from CHINA , 29 years of age, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Telbivudine (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal distension, abdominal pain (What is abdominal pain?), abdominal pain upper, abdominal tenderness, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood amylase increased, blood creatine phosphokinase increased. Telbivudine dosage: 600 Mg, Qd. During the same period patient was treated with INTERFERON ALFA 2B (3,000,000 Iu) (View Interferon Alfa-2b Review and Interferon Alfa-2b Label ), SODIUM BICARBONATE (5%) (View Sodium Bicarbonate Review and Sodium Bicarbonate Label ), ANTIBIOTICS (View Antibiotics Review and Antibiotics Label ). Patient was hospitalized.

7016361-3 | Asthenia, Base Excess Increased, Blood Bicarbonate Decreased, Blood Creatine Phosphokinase Increased, Blood Creatine Phosphokinase Mb Increased, Blood Creatinine Abnormal, Blood Lactate Dehydrogenase Increased, Blood Ph Decreased, Blood Pressure Decreased
Patient was taking Telbivudine (View Usage). Patient had the following side effects: asthenia, base excess increased, blood bicarbonate decreased, blood creatine phosphokinase increased, blood creatine phosphokinase mb increased, blood creatinine abnormal, blood lactate dehydrogenase increased, blood ph decreased, blood pressure decreased on Sep 13, 2010 from CHINA Additional patient health information: Male patient , 26 years of age, was diagnosed with hepatitis b (What is hepatitis b?) and. Telbivudine dosage: 0.65 Mg, Daily. Patient was hospitalized.

6993611-0 | Acute Hepatic Failure, Ammonia Increased, Coagulopathy, Encephalopathy, Haematemesis, International Normalised Ratio Increased, Prothrombin Time Prolonged, Thrombocytopenia
Adverse event was reported on Sep 14, 2010 by a Male patient taking Telbivudine (View Usage) (Dosage: ) was diagnosed with hepatitis b (What is hepatitis b?) and. Location: UNITED STATES , 42 years of age, After Telbivudine was administered, patient had the following side effects: acute hepatic failure, ammonia increased, coagulopathy, encephalopathy, haematemesis, international normalised ratio increased, prothrombin time prolonged, thrombocytopenia. During the same period patient was treated with RITONAVIR (View Ritonavir Review and Ritonavir Label ), ATAZANAVIR (View Atazanavir Review and Atazanavir Label ), LAMIVUDINE (View Lamivudine Review and Lamivudine Label ), ABACAVIR (View Abacavir Review and Abacavir Label ), FOSAMPRENAVIR (View Fosamprenavir Review and Fosamprenavir Label ), EMTRICITABINE (View Emtricitabine Review and Emtricitabine Label ), TENOFOVIR (View Tenofovir Review and Tenofovir Label ), ADEFOVIR DIPIVOXIL KIT (View Adefovir Dipivoxil Kit Review and Adefovir Dipivoxil Kit Label ).

6941353-X | Abdominal Distension, Abdominal Pain, Abdominal Pain Upper, Abdominal Tenderness, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Amylase Increased, Blood Creatine Phosphokinase Increased
on Aug 09, 2010 Male patient from CHINA , 29 years of age, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Telbivudine (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal distension, abdominal pain (What is abdominal pain?), abdominal pain upper, abdominal tenderness, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood amylase increased, blood creatine phosphokinase increased. Telbivudine dosage: 600 Mg, Qd. During the same period patient was treated with INTERFERON ALFA 2B (3,000,000 Iu) (View Interferon Alfa-2b Review and Interferon Alfa-2b Label ), SODIUM BICARBONATE (5%) (View Sodium Bicarbonate Review and Sodium Bicarbonate Label ), ANTIBIOTICS (View Antibiotics Review and Antibiotics Label ). Patient was hospitalized.


6172392-7 | Pathogen Resistance, Viral Mutation Identified
on Apr 20, 2009 Male patient from CHINA , 20 years of age, was treated with Telbivudine (View Usage). Patient had the following side effects: pathogen resistance, viral mutation identified. Telbivudine dosage: 600 Mg/day. During the same period patient was treated with LAMIVUDINE (100 Mg/day) (View Lamivudine Review and Lamivudine Label ), ADEFOVIR DIPIVOXIL KIT (10 Mg/day) (View Adefovir Dipivoxil Kit Review and Adefovir Dipivoxil Kit Label ).

6154776-6 | Meconium In Amniotic Fluid
Patient was taking Telbivudine (View Usage). After Telbivudine was administered, patient had the following side effects: meconium in amniotic fluid on Apr 01, 2009 from CHINA Additional patient health information: Female patient , 30 years of age, was diagnosed with hepatitis b (What is hepatitis b?) and. Telbivudine dosage: 600 Mg, Qd.

6076682-8 | Activities Of Daily Living Impaired, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Bilirubin Increased, Chromaturia, Neuropathy Peripheral, Pain In Extremity
Adverse event was reported on Feb 04, 2009 by a Male patient taking Telbivudine (View Usage) (Dosage: 600 Mg Qd) was diagnosed with hepatitis b (What is hepatitis b?) and. Location: CHINA , 35 years of age, Patient experienced the following unwanted or unexpected effects: activities of daily living impaired, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, chromaturia, neuropathy peripheral, pain in extremity. During the same period patient was treated with PEGINTRON ^ESSEX CHEMIE^ (50 Ug, Qw) (View Pegintron ^essex Chemie^ Review and Pegintron ^essex Chemie^ Label ).

5958516-2 | Meconium In Amniotic Fluid
on Nov 11, 2008 Female patient from CHINA , 30 years of age, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Telbivudine (View Usage). Patient had the following side effects: meconium in amniotic fluid. Telbivudine dosage: 600 Mg, Qd.

5815993-5 | Arrhythmia, Blood Creatine Phosphokinase Increased, Hypoaesthesia, Muscular Weakness, Myalgia, Neuralgia
on Jul 09, 2008 Male patient from CHINA , 35 years of age, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Telbivudine (View Usage). After Telbivudine was administered, patient had the following side effects: arrhythmia (What is arrhythmia?), blood creatine phosphokinase increased, hypoaesthesia, muscular weakness, myalgia, neuralgia. Telbivudine dosage: 600 Mg, Qd. During the same period patient was treated with ADEFOVIR DIPIVOXIL KIT (View Adefovir Dipivoxil Kit Review and Adefovir Dipivoxil Kit Label ).

5815990-X | Asthenia, Blood Creatine Phosphokinase Increased, Hypoaesthesia, Myalgia, Neuralgia
Patient was taking Telbivudine (View Usage). Patient experienced the following unwanted or unexpected effects: asthenia, blood creatine phosphokinase increased, hypoaesthesia, myalgia, neuralgia on Jul 09, 2008 from CHINA Additional patient health information: Male patient , 25 years of age, . Telbivudine dosage: 600 Mg, Qd. During the same period patient was treated with INTERFERON (View Interferon Review and Interferon Label ).

5815978-9 | Arrhythmia, Blood Creatine Phosphokinase Increased, Hypoaesthesia, Muscular Weakness, Myalgia, Neuralgia
Adverse event was reported on Jul 09, 2008 by a Male patient taking Telbivudine (View Usage) (Dosage: 600 Mg, Qd) was diagnosed with hepatitis b (What is hepatitis b?) and. Location: CHINA , 30 years of age, Patient had the following side effects: arrhythmia (What is arrhythmia?), blood creatine phosphokinase increased, hypoaesthesia, muscular weakness, myalgia, neuralgia. During the same period patient was treated with INTERFERON (View Interferon Review and Interferon Label ).

5815964-9 | Arrhythmia, Blood Creatine Phosphokinase Increased, Hypoaesthesia, Muscular Weakness, Myalgia, Neuralgia
on Jul 09, 2008 Male patient from CHINA , 37 years of age, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Telbivudine (View Usage). After Telbivudine was administered, patient had the following side effects: arrhythmia (What is arrhythmia?), blood creatine phosphokinase increased, hypoaesthesia, muscular weakness, myalgia, neuralgia. Telbivudine dosage: 600 Mg, Qd. During the same period patient was treated with INTERFERON (View Interferon Review and Interferon Label ).

5815961-3 | Arrhythmia, Blood Creatine Phosphokinase Increased, Hypersplenism, Hypoaesthesia, Muscular Weakness, Musculoskeletal Pain, Myalgia, Myopathy, Neuralgia
on Jul 09, 2008 Male patient from CHINA , 45 years of age, was diagnosed with hepatitis b (What is hepatitis b?), hepatic cirrhosis and was treated with Telbivudine (View Usage). Patient experienced the following unwanted or unexpected effects: arrhythmia (What is arrhythmia?), blood creatine phosphokinase increased, hypersplenism, hypoaesthesia, muscular weakness, musculoskeletal pain, myalgia, myopathy, neuralgia. Telbivudine dosage: 600 Mg, Bid.

5662457-8 | Abdominal Pain, Asthenia, Dehydration, Nausea
Patient was taking Telbivudine (View Usage). Patient had the following side effects: abdominal pain (What is abdominal pain?), asthenia, dehydration, nausea (What is nausea?) on Mar 03, 2008 from CANADA Additional patient health information: Female patient , 63 years of age, weighting 108.5 lb, was diagnosed with hepatitis b (What is hepatitis b?) and. Telbivudine dosage: 600 Mg,. Patient was hospitalized.

5646624-5 | Demyelinating Polyneuropathy, Hypoaesthesia, Limb Discomfort, Muscle Atrophy, Muscular Weakness, Musculoskeletal Pain, Myalgia, Myopathy, Polymyositis
Adverse event was reported on Feb 20, 2008 by a Male patient taking Telbivudine (View Usage) (Dosage: 600 Mg,) was diagnosed with hepatitis b (What is hepatitis b?) and. Location: TAIWAN, PROVINCE OF CHINA , 56 years of age, After Telbivudine was administered, patient had the following side effects: demyelinating polyneuropathy, hypoaesthesia, limb discomfort, muscle atrophy, muscular weakness, musculoskeletal pain, myalgia, myopathy, polymyositis. Patient was hospitalized.

5595888-5 | Clumsiness, Pain, Paraesthesia, Peripheral Sensory Neuropathy
on Jan 10, 2008 Male patient from NEW ZEALAND , 32 years of age, weighting 132.3 lb, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Telbivudine (View Usage). Patient experienced the following unwanted or unexpected effects: clumsiness, pain (What is pain?), paraesthesia, peripheral sensory neuropathy. Telbivudine dosage: 600 Mg,. During the same period patient was treated with PEGASYS (180 Ug,) (View Pegasys Review and Pegasys Label ).

5577654-X | Blood Creatine Phosphokinase Increased, Mitochondrial Myopathy, Muscle Necrosis, Myalgia
on Dec 21, 2007 Male patient from FRANCE , 32 years of age, weighting 180.8 lb, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Telbivudine (View Usage). Patient had the following side effects: blood creatine phosphokinase increased, mitochondrial myopathy, muscle necrosis, myalgia. Telbivudine dosage: 600 Mg,. During the same period patient was treated with PEGASYS (180 Ug,) (View Pegasys Review and Pegasys Label ).

5577653-8 | Blood Creatine Phosphokinase Increased, Myalgia, Myositis, Neuropathy Peripheral, Paraesthesia
Patient was taking Telbivudine (View Usage). After Telbivudine was administered, patient had the following side effects: blood creatine phosphokinase increased, myalgia, myositis (What is myositis?), neuropathy peripheral, paraesthesia on Dec 21, 2007 from ARGENTINA Additional patient health information: Male patient , 47 years of age, weighting 208.3 lb, was diagnosed with hepatitis b (What is hepatitis b?) and. Telbivudine dosage: 600 Mg, Qd. During the same period patient was treated with PEGASYS (180 Ug, Qw) (View Pegasys Review and Pegasys Label ).

5572790-6 | Hypoaesthesia, Peripheral Sensory Neuropathy
Adverse event was reported on Dec 14, 2007 by a Male patient taking Telbivudine (View Usage) (Dosage: 600 Mg,) was diagnosed with hepatitis b (What is hepatitis b?) and. Location: SINGAPORE , 45 years of age, weighting 144.4 lb, Patient experienced the following unwanted or unexpected effects: hypoaesthesia, peripheral sensory neuropathy. During the same period patient was treated with COMPARATOR PEGASYS (180 Ug,) (View Comparator Pegasys Review and Comparator Pegasys Label ).

5524841-2 | Dysaesthesia, Paraesthesia
on Nov 14, 2007 Female patient from ISRAEL , 23 years of age, weighting 89.51 lb, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Telbivudine (View Usage). Patient had the following side effects: dysaesthesia, paraesthesia. Telbivudine dosage: 600 Mg,.

5476602-0 | Pain In Extremity, Peripheral Sensory Neuropathy
on Sep 25, 2007 Female patient from , 24 years of age, weighting 121.7 lb, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Telbivudine (View Usage). After Telbivudine was administered, patient had the following side effects: pain in extremity, peripheral sensory neuropathy. Telbivudine dosage: 600 Mg, Unk. During the same period patient was treated with COMPARATOR PEGASYS (180 Mg, Unk) (View Comparator Pegasys Review and Comparator Pegasys Label ).

5476601-9 | Thyroid Neoplasm, Thyroid Nodule Removal
Patient was taking Telbivudine (View Usage). Patient experienced the following unwanted or unexpected effects: thyroid neoplasm, thyroid nodule removal on Sep 25, 2007 from CAYMAN ISLANDS Additional patient health information: Male patient , 52 years of age, was diagnosed with hepatitis b (What is hepatitis b?) and. Telbivudine dosage: 600 Mg, Unk. Patient was hospitalized.

5475379-2 | Thyroid Neoplasm, Thyroid Nodule Removal
Adverse event was reported on Sep 25, 2007 by a Male patient taking Telbivudine (View Usage) (Dosage: 600 Mg, Unk) was diagnosed with hepatitis b (What is hepatitis b?) and. Location: CAYMAN ISLANDS , 52 years of age, Patient had the following side effects: thyroid neoplasm, thyroid nodule removal. Patient was hospitalized.

5441358-4 | Asthenia, Blood Creatine Phosphokinase Increased, Muscle Atrophy, Weight Decreased
on Aug 23, 2007 Male patient from CAYMAN ISLANDS , 46 years of age, weighting 119.0 lb, was diagnosed with hepatitis b (What is hepatitis b?), hypertension and was treated with Telbivudine (View Usage). After Telbivudine was administered, patient had the following side effects: asthenia, blood creatine phosphokinase increased, muscle atrophy, weight decreased. Telbivudine dosage: 600 Mg,. During the same period patient was treated with METOPROLOL SUCCINATE (View Metoprolol Succinate Review and Metoprolol Succinate Label ).

5397457-9 | Myopathy
on Jul 19, 2007 Male patient from CAYMAN ISLANDS , 54 years of age, was diagnosed with hepatitis b (What is hepatitis b?) and was treated with Telbivudine (View Usage). Patient experienced the following unwanted or unexpected effects: myopathy. Telbivudine dosage: 600 Mg, Unk.


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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 Telbivudine 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 Telbivudine quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Telbivudine 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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Telbivudine Reactions
Abdominal Distension
Abdominal PainWhat is Abdominal pain?
Abdominal Pain Upper
Abdominal Tenderness
Activities Of Daily Living Impaired
Acute Hepatic Failure
Alanine Aminotransferase Increased
Ammonia Increased
ArrhythmiaWhat is Arrhythmia?
Aspartate Aminotransferase Increased
Asthenia
Base Excess Increased
Blood Alkaline Phosphatase Increased
Blood Amylase Increased
Blood Bicarbonate Decreased
Blood Creatine Phosphokinase Increased
Hypoaesthesia
Meconium In Amniotic Fluid
Muscle Atrophy
Muscular Weakness
Musculoskeletal Pain
Myalgia
Myopathy
Neuralgia
Neuropathy Peripheral
Pain In Extremity
Paraesthesia
Peripheral Sensory Neuropathy
Thyroid Neoplasm
Thyroid Nodule Removal
Telbivudine 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 Telbivudine 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!