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Viread (Tenofovir Disoproxil) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Viread (Tenofovir Disoproxil) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (287)
Death (48)
Life Threatening Events (31)
Disability (7)

Reports by Reaction Type

Renal Failure Acute (19)Viral Load Increased (16)Renal Failure (15)Lactic Acidosis (14)Fanconi Syndrome (13)Maternal Exposure During Pregnancy (13)Renal Impairment (12)Drug Ineffective (10)Abortion Spontaneous (9)Death (9)Multi-Organ Failure (9)Pregnancy (9)

Below are a few examples of reports where side effects / adverse reactions may be related to Viread (Tenofovir Disoproxil). For a complete list or a specific selection of reports, please use the links above.

Possible Viread side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 36 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Induced

Drug(s) suspected as cause:
Epivir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiviral Treatment

Norvir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy

Reyataz
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy

Viread
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy



Possible Viread side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: 36 year old female

Reactions: Abortion Induced

Drug(s) suspected as cause:
Epivir
    Administration route: Oral
    Indication: Antiretroviral Therapy

Norvir
    Dosage: daily
    Administration route: Oral
    Indication: Antiretroviral Therapy

Reyataz
    Administration route: Oral
    Indication: Antiretroviral Therapy

Viread
    Administration route: Oral
    Indication: Antiretroviral Therapy



Possible Viread side effects in male

Reported by a physician from Australia on 2012-08-23

Patient: male

Reactions: Arrhythmia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Viread



Possible Viread side effects in 42 year old male

Reported by a individual with unspecified qualification from Netherlands on 2012-08-23

Patient: 42 year old male

Reactions: Femur Fracture, Osteonecrosis, Osteosclerosis, Pain in Extremity, Fanconi Syndrome Acquired, Osteomalacia

Drug(s) suspected as cause:
Viread

Other drugs received by patient: Ritonavir; Fosamprenavir Calcium; Delavirdine; Didanosine; Zalcitabine; Zidovudine; Stavudine; Epivir



Possible Viread side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient:

Reactions: Fanconi Syndrome, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Intelence
    Dosage: 200 mg, bid
    Administration route: Oral

Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Norvir
    Dosage: unk
    Administration route: Oral
    End date: 2011-06-01

Prezista
    Dosage: 400 mg, bid
    Administration route: Oral
    End date: 2011-06-01

Videx
    Dosage: unk
    Administration route: Oral
    End date: 2011-05-27

Viread
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: [composition Unspecified]; Aspirin; Crestor; Clomipramine Hydrochloride; Omeprazole



Possible Viread side effects in male

Reported by a physician from Germany on 2012-08-23

Patient: male

Reactions: Squamous Cell Carcinoma

Drug(s) suspected as cause:
Viread



Possible Viread side effects in

Reported by a physician from Poland on 2012-08-23

Patient:

Reactions: Lymphadenopathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Boceprevir
    Dosage: 800 mg, tid
    Administration route: Oral
    Start date: 2010-07-29

Boceprevir
    Dosage: 800 mg, tid
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2010-07-29

Boceprevir
    Dosage: 800 mg, tid
    Administration route: Oral
    Start date: 2010-07-29

Boceprevir
    Dosage: 800 mg, tid
    Administration route: Oral
    Start date: 2010-07-29

Epivir
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-05-18

Lopinavir and Ritonavir
    Dosage: 2 df, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-05-18

Peginterferon Alfa-2B
    Dosage: 80 microgram, qw
    Indication: Hepatitis C
    Start date: 2010-07-01

Ribavirin
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2010-07-01

Viread
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-05-18

Other drugs received by patient: Bebetina; Bebetina; Bebetina; Bebetina



Possible Viread side effects in 53 year old male

Reported by a individual with unspecified qualification from Netherlands on 2012-08-23

Patient: 53 year old male

Reactions: CD4 Lymphocytes Decreased, Fanconi Syndrome Acquired, Osteomalacia

Drug(s) suspected as cause:
Viread
    Dosage: unk
    Start date: 2005-07-05

Viread
    Dosage: unk, qd
    Start date: 2008-09-23
    End date: 2008-10-14

Viread
    Dosage: unk
    Indication: HIV Infection
    Start date: 2003-11-17

Viread
    Dosage: 300 mg, qd
    Start date: 2003-09-01

Viread
    Dosage: 300 mg, qod
    Start date: 2008-01-01
    End date: 2008-01-01

Viread
    Dosage: unk
    Start date: 2007-05-24

Other drugs received by patient: Didanosine; Didanosine; AZT; Lopinavir / Ritonavir; Didanosine; Raltegravir; Didanosine; Lopinavir / Ritonavir; Lopinavir / Ritonavir; Didanosine; Lopinavir / Ritonavir; Didanosine; Lopinavir / Ritonavir



Possible Viread side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient: male

Reactions: Multi-Organ Failure, Fanconi Syndrome, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Intelence
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Norvir
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Prezista
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-06-01

Videx
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Viread
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: Omeprazole; Clomipramine HCL; Crestor; Aspirin; Unknown Medication



Possible Viread side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient:

Reactions: Multi-Organ Failure, Metabolic Acidosis, Fanconi Syndrome, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Intelence
    Dosage: 200 mg, bid
    Administration route: Oral

Isentress
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Norvir
    Dosage: unk
    Administration route: Oral
    End date: 2011-06-01

Prezista
    Dosage: 400 mg, bid
    Administration route: Oral
    End date: 2011-06-01

Videx
    Dosage: unk
    Administration route: Oral
    End date: 2011-05-27

Viread
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: Crestor; Omeprazole; [composition Unspecified]; Aspirin; Clomipramine Hydrochloride



Possible Viread side effects in female

Reported by a physician from France on 2012-08-21

Patient: female

Reactions: Drug Ineffective, Clostridium Difficile Colitis, Neurocryptococcosis, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Ambisome
    Dosage: unk
    Indication: Neurocryptococcosis
    Start date: 2012-01-01

Prograf
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant

Viread
    Dosage: 1 df, uid/qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2011-12-12

Other drugs received by patient: Duragesic-100; Neurontin; Atorvastatin; Prednisone TAB; Baraclude; Cellcept; Morphine Sulfate; Flucytosine; Lasix



Possible Viread side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-17

Patient: male

Reactions: Renal Failure Acute

Drug(s) suspected as cause:
Viread

Other drugs received by patient: Pantoprazole; Mirtazapine; Raltegravir; Armodafinil; Enoxaparin; Emtriva; Trimethoprim; Folic Acid; Ceftriaxon; Sulfamethoxazol; Doxycycline HCL



Possible Viread side effects in 60 year old male

Reported by a physician from Korea, Republic of on 2012-08-16

Patient: 60 year old male

Reactions: Therapeutic Response Decreased, Eyelid Oedema, Fatigue, Blood Creatine Phosphokinase Increased, Asthenia, Blood Creatinine Increased

Drug(s) suspected as cause:
Entecavir
    Dosage: 1 mg, unk
    Indication: Hepatitis B
    Start date: 2010-08-20
    End date: 2012-05-21

Hepsera
    Dosage: 10 mg, unk
    Indication: Hepatitis B
    Start date: 2010-08-20
    End date: 2012-05-21

Sebivo
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2012-05-21

Viread
    Dosage: 300 mg, qod
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2012-06-18

Viread
    Dosage: 300 mg, qd
    Administration route: Oral
    Start date: 2012-05-21
    End date: 2012-06-17



Possible Viread side effects in female

Reported by a physician from Japan on 2012-08-15

Patient: female

Reactions: Renal Impairment, Diarrhoea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-01-06
    End date: 2011-05-30

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-01-06
    End date: 2011-05-30

Viread
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-01-06
    End date: 2011-05-30

Other drugs received by patient: Epivir; Epivir; Epzicom; Candesartan Cilexetil; Zyrtec; Isentress



Possible Viread side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13

Patient: male

Reactions: Fanconi Syndrome Acquired, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Intelence
    Dosage: 400 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Isentress
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Norvir
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-06-01

Prezista
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-06-01

Videx
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Viread
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: Aspirin; Clomipramine HCL; Crestor; Mopral / 00661201 /; Suprane



Possible Viread side effects in male

Reported by a physician from Australia on 2012-08-13

Patient: male

Reactions: Circulatory Collapse, Arrhythmia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Viread



Possible Viread side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Combivir
    Dosage: 2 df, unk
    Administration route: Oral
    Start date: 2012-05-28

Isentress
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2012-03-28
    End date: 2012-05-23

Kaletra
    Dosage: 4 df, unk
    Administration route: Oral
    Start date: 2012-05-28

Viread
    Dosage: 300 mg, qd
    Administration route: Oral
    Start date: 2012-03-28
    End date: 2012-05-23



Possible Viread side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Circumstance or Information Capable of Leading To Medication Error

Drug(s) suspected as cause:
Norvir
    Indication: Product Used FOR Unknown Indication

Viread
    Indication: Product Used FOR Unknown Indication



Possible Viread side effects in male

Reported by a physician from France on 2012-08-10

Patient: male

Reactions: Weight Decreased, Confusional State, Hyperlactacidaemia, Hypothermia, Fanconi Syndrome, Tachycardia, Hypotension, Hepatic Failure, General Physical Health Deterioration, Dyspraxia, Livedo Reticularis, Pallor, Multi-Organ Failure, Hallucination, Visual, Tachypnoea, Cardiac Arrest, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Intelence
    Dosage: form strength: 100mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Norvir
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-06-01

Prezista
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-06-01

Videx
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Viread
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: Aspirin; Crestor; Clomipramine HCL; Omeprazole; Drug NOS



Possible Viread side effects in male

Reported by a physician from France on 2012-08-10

Patient: male

Reactions: Weight Decreased, Confusional State, Hyperlactacidaemia, Hypothermia, Fanconi Syndrome, Hypotension, Tachycardia, General Physical Health Deterioration, Hepatic Failure, Livedo Reticularis, Pallor, Incoherent, Multi-Organ Failure, Hallucination, Visual, Tachypnoea, Cardiac Arrest, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Intelence
    Dosage: form strength: 100mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Norvir
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-06-01

Prezista
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-06-01

Videx
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Viread
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: Crestor; Omeprazole; Aspirin; Drug NOS; Clomipramine HCL



Possible Viread side effects in

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient:

Reactions: Circumstance or Information Capable of Leading To Medication Error

Drug(s) suspected as cause:
Norvir
    Indication: Product Used FOR Unknown Indication

Viread
    Indication: Product Used FOR Unknown Indication



Possible Viread side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-09

Patient: male

Reactions: Multi-Organ Failure, Fanconi Syndrome, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Intelence
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-05-27
    End date: 2011-06-01

Norvir
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-06-01

Prezista
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-06-01

Videx
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Viread
    Administration route: Oral
    Indication: HIV Infection
    End date: 2011-05-27

Other drugs received by patient: Crestor; Clomipramine HCL; Omeprazole; Unknown Medication; Aspirin



Possible Viread side effects in female

Reported by a physician from France on 2012-08-09

Patient: female

Reactions: Drug Ineffective, Clostridium Difficile Colitis, Neurocryptococcosis, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Ambisome
    Indication: Neurocryptococcosis

Prograf
    Dosage: unk
    Administration route: Oral
    Indication: Renal Transplant

Viread
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Hepatitis B
    Start date: 2011-12-12

Other drugs received by patient: Baraclude; Cellcept / 01275104 /; Duragesic-100; Morphine Sulfate; Neurontin; Prednisone TAB; Atorvastatin; Lasix



Possible Viread side effects in male

Reported by a physician from Australia on 2012-08-09

Patient: male

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Viread



Possible Viread side effects in 54 year old male

Reported by a physician from Japan on 2012-08-08

Patient: 54 year old male

Reactions: Gamma-Glutamyltransferase Increased, Depression

Drug(s) suspected as cause:
Efavirenz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-04-01
    End date: 2012-02-02

Epivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-04-01
    End date: 2012-02-02

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-03

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-03

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-03

Viread
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-04-01
    End date: 2012-02-02



Possible Viread side effects in 69 year old female

Reported by a consumer/non-health professional from Japan on 2012-08-08

Patient: 69 year old female

Reactions: Renal Impairment, Diarrhoea, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epivir
    Dosage: tabs. 14dec04 to 30dec04:150mgx2
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-01-06
    End date: 2011-05-30

Norvir
    Dosage: caps. 06jan05-26ap2011,27apr11 to 30may11
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-01-06
    End date: 2011-05-30

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-01-06
    End date: 2011-05-30

Viread
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-01-06
    End date: 2011-05-30

Other drugs received by patient: Zyrtec; Candesartan Cilexetil



Possible Viread side effects in 37 year old female

Reported by a health professional (non-physician/pharmacist) from Argentina on 2012-08-08

Patient: 37 year old female

Reactions: Endometrial Disorder, Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Epivir
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-09-21

Kaletra
    Dosage: 4tab unknown
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-09-21

Viread
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-09-21



Possible Viread side effects in 44 year old female

Reported by a individual with unspecified qualification from Spain on 2012-08-08

Patient: 44 year old female

Reactions: Immune Reconstitution Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Efavirenz
    Indication: HIV Infection

Emtriva
    Indication: HIV Infection

Viread
    Indication: HIV Infection

Other drugs received by patient: Methylprednisolone; Prednisone TAB



Possible Viread side effects in 35 year old female

Reported by a physician from Mexico on 2012-08-06

Patient: 35 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-05-28

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-05-28

Raltegravir
    Dosage: 400mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-28
    End date: 2012-05-23

Viread
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-28
    End date: 2012-05-23



Possible Viread side effects in 54 year old male

Reported by a physician from Japan on 2012-08-06

Patient: 54 year old male

Reactions: Immune Reconstitution Syndrome, Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Efavirenz
    Indication: HIV Infection

Emtriva
    Indication: HIV Infection

Viread
    Indication: HIV Infection

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