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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