DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Truvada (Emtricitabine / 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 Truvada 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 (889)
Death (104)
Life Threatening Events (61)
Disability (22)

Reports by Reaction Type

Foetal Exposure During Pregnancy (139)Maternal Exposure During Pregnancy (70)Abortion Spontaneous (63)Renal Failure Acute (47)Abortion Induced (33)Pyrexia (28)Anaemia (28)Stillbirth (26)Patent Ductus Arteriosus (24)Premature Baby (23)Diarrhoea (23)Pregnancy (22)

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

Possible Truvada side effects in female

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

Patient: female

Reactions: Immune Reconstitution Syndrome, Condition Aggravated, Progressive Multifocal Leukoencephalopathy

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-01-13
    End date: 2012-08-02

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-01-13
    End date: 2012-08-02

Intelence
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-01-13
    End date: 2012-08-02

Interleukins
    Indication: Progressive Multifocal Leukoencephalopathy
    Start date: 2012-06-21
    End date: 2012-07-05

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-01-13
    End date: 2012-08-02



Possible Truvada side effects in 31 year old female

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

Patient: 31 year old female

Reactions: Abortion Spontaneous

Drug(s) suspected as cause:
Norvir
    Dosage: 100 mg/day taken at conception
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-08-17

Truvada
    Dosage: 1 tab/caps daily taken at conception
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-08-17

Reyataz
    Dosage: 300 mg/day taken at conception
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2010-08-17



Possible Truvada side effects in

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

Patient:

Reactions: Foetal Chromosome Abnormality, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Vertical Talus

Drug(s) suspected as cause:
Truvada
    Dosage: 1 df, unk
    Start date: 2011-07-13
    End date: 2011-10-27

Reyataz
    Dosage: 300 mg, qd
    Start date: 2011-07-13
    End date: 2011-10-27

Combivir
    Dosage: 2 df, unk
    Start date: 2011-11-21

Norvir
    Dosage: 100 mg, qd
    Start date: 2011-07-13
    End date: 2011-10-27

Isentress
    Dosage: 800 mg, qd
    Start date: 2011-11-21



Possible Truvada side effects in

Reported by a consumer/non-health professional from United Kingdom on 2012-08-26

Patient:

Reactions: Congenital Anomaly

Drug(s) suspected as cause:
Truvada
    Start date: 2011-01-01

Efavirenz
    Start date: 2011-01-01



Possible Truvada side effects in 27 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-26

Patient: 27 year old female

Reactions: Abortion Induced, Pregnancy

Drug(s) suspected as cause:
Efavirenz
    Start date: 2011-01-01

Truvada
    Start date: 2011-01-01



Possible Truvada side effects in male

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

Patient: male

Reactions: Renal Failure, Coma, Convulsion

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Rifabutin
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Prazepam
    Dosage: 1 unit
    Administration route: Oral
    Start date: 2012-07-10

Olanzapine
    Dosage: 1 unit
    Administration route: Oral
    Start date: 2012-01-01

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Leucovorin Calcium
    Administration route: Oral
    Start date: 2012-07-10

Acetaminophen
    Indication: Pain
    Start date: 2012-07-11

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-01

Acupan
    Indication: Pain
    Start date: 2012-07-16
    End date: 2012-07-27

Potassium Chloride
    Administration route: Oral
    Start date: 2012-07-10

Clarithromycin
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Amikacin
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-11

Cernevit-12
    Indication: Vitamin Supplementation
    Start date: 2012-07-10
    End date: 2012-08-02

Perikabiven
    Indication: Parenteral Nutrition
    Start date: 2012-07-10

Isentress
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-01

Bactrim
    Administration route: Oral
    Indication: Atypical Mycobacterium Pericarditis
    Start date: 2012-07-13

Myambutol
    Dosage: 2 units
    Administration route: Oral
    Start date: 2012-07-11



Possible Truvada side effects in male

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

Patient: male

Reactions: Congenital Bladder Anomaly, Urethral Valves, Congenital Hydronephrosis, Foetal Exposure During Pregnancy, Bladder Obstruction, Congenital Renal Disorder

Drug(s) suspected as cause:
Lisinopril
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified

Atorvastatin
    Indication: Maternal Exposure Timing Unspecified

Norvir
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Truvada side effects in 35 year old male

Reported by a physician from Japan on 2012-08-24

Patient: 35 year old male

Reactions: Renal Impairment, Cytomegalovirus Chorioretinitis, Hypoaesthesia, Mycobacterium Avium Complex Infection, Hyperuricaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Valganciclovir
    Administration route: Oral
    Indication: Cytomegalovirus Chorioretinitis
    Start date: 2010-05-19
    End date: 2010-06-30

Valganciclovir
    Administration route: Oral
    Start date: 2010-07-01
    End date: 2011-01-20

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2011-03-31

Mycobutin
    Administration route: Oral
    Indication: Mycobacterium Avium Complex Infection
    Start date: 2009-11-20
    End date: 2009-12-11

Epzicom
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-11
    End date: 2010-09-20

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-03
    End date: 2011-03-31

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-22
    End date: 2009-12-02

Valganciclovir
    Administration route: Oral
    Indication: Cytomegalovirus Infection
    Start date: 2010-01-06
    End date: 2010-06-30

Valganciclovir
    Administration route: Oral
    Indication: Mycobacterium Avium Complex Infection
    Start date: 2010-02-16
    End date: 2010-03-24

Other drugs received by patient: Isentress; Pentamidine Isethionate; Intelence; Semen Coicis; Clindamycin Phosphate; Chlorhexidine Gluconate



Possible Truvada side effects in male

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

Patient: male

Reactions: Cleft LIP and Palate, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Kaletra
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Truvada side effects in

Reported by a physician from Japan on 2012-08-24

Patient:

Reactions: Sepsis, Renal Tubular Necrosis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Isentress
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-10-20
    End date: 2010-10-27

Truvada
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-10-20
    End date: 2010-10-27

Isentress
    Dosage: 800 mg, qd
    Administration route: Oral
    Start date: 2010-11-10



Possible Truvada side effects in 26 year old female

Reported by a physician from United States on 2012-08-23

Patient: 26 year old female

Reactions: Prenatal Screening Test Abnormal, Maternal Exposure During Pregnancy, Abortion Induced

Drug(s) suspected as cause:
Truvada
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27

Reyataz
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27

Norvir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27

Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-11-21

Raltegravir
    Dosage: 800mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-11-21



Possible Truvada side effects in

Reported by a physician from United States on 2012-08-23

Patient: , weighing 1.9 kg (4.2 pounds)

Reactions: Foetal Exposure During Pregnancy, Congenital Foot Malformation

Drug(s) suspected as cause:
Norvir
    Dosage: 100mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27

Truvada
    Dosage: 1tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27

Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-11-21

Raltegravir
    Dosage: 800mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2011-11-21

Reyataz
    Dosage: 300mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27



Possible Truvada side effects in

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

Patient:

Reactions: Mass, Acute Respiratory Distress Syndrome, Glomerulonephropathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ribavirin
    Dosage: 800 mg, qd
    Indication: Hepatitis C
    Start date: 2011-11-15

Boceprevir
    Dosage: 2400 mg, qd
    Indication: Hepatitis C
    Start date: 2011-12-13
    End date: 2012-07-28

Peginterferon Alfa-2B
    Dosage: 80 microgram, qw
    Indication: Hepatitis C
    Start date: 2011-11-15
    End date: 2012-07-28

Acetaminophen
    Dosage: 1000 mg, qd
    Indication: Influenza Like Illness
    Start date: 2011-11-15

Truvada
    Dosage: 1 df, qod
    Indication: HIV Infection
    Start date: 2007-01-23

Other drugs received by patient: Reyataz; Crestor; Levocarnil; Neorecormon; Sertraline Hydrochloride; Tamsulosin Hydrochloride; Plavix; Norvir; Crestor; Dexeryl Tablets



Possible Truvada side effects in

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

Patient:

Reactions: Mass, Sepsis, Glomerulonephropathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 1000 mg, qd
    Indication: Influenza Like Illness
    Start date: 2011-11-15

Boceprevir
    Dosage: 2400 mg, qd
    Indication: Hepatitis C
    Start date: 2011-12-13

Ribavirin
    Dosage: 800 mg, qd
    Indication: Hepatitis C
    Start date: 2011-11-15

Peginterferon Alfa-2B
    Dosage: 80 microgram, qw
    Indication: Hepatitis C
    Start date: 2011-11-15

Truvada
    Dosage: 1 df, qod
    Indication: HIV Infection
    Start date: 2007-01-23

Other drugs received by patient: Norvir; Sertraline Hydrochloride; Plavix; Tamsulosin Hydrochloride; Crestor; Levocarnil; Crestor; Neorecormon; Dexeryl Tablets; Reyataz



Possible Truvada side effects in 57 year old male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 57 year old male

Reactions: Renal Disorder, Gastrointestinal Disorder, Viral Mutation Identified

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

Truvada
    Indication: HIV Infection



Possible Truvada side effects in

Reported by a physician from Japan on 2012-08-22

Patient:

Reactions: Diabetes Mellitus, Hypertriglyceridaemia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Epivir
    Dosage: 150 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-09-16
    End date: 2006-02-28

Isentress
    Dosage: 800 mg divided dose frequency u
    Administration route: Oral
    Start date: 2008-08-05

Epivir
    Dosage: 150 mg, bid
    Administration route: Oral
    Start date: 2008-12-16

Intelence
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-02-11

Kaletra
    Dosage: 4 df
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2007-07-04
    End date: 2008-01-08

Zerit
    Dosage: 60 mg divided dose frequency u
    Administration route: Oral
    Start date: 2008-12-16
    End date: 2009-02-10

Truvada
    Dosage: 1 df, unk
    Administration route: Oral
    Start date: 2008-08-05
    End date: 2008-12-15

Zerit
    Dosage: 80 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-09-16
    End date: 2006-02-28

Prezista
    Dosage: 1200 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-01-09
    End date: 2008-05-01

Truvada
    Dosage: 1df
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2007-07-04
    End date: 2008-05-01

Other drugs received by patient: Rhythmy



Possible Truvada side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: female

Reactions: Atrial Septal Defect, Cardiac Murmur, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Pyelocaliectasis

Drug(s) suspected as cause:
Kaletra
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Truvada side effects in male

Reported by a health professional (non-physician/pharmacist) from Portugal on 2012-08-21

Patient: male

Reactions: Pneumonia, Foetal Exposure During Pregnancy, Respiratory Distress

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Truvada
    Indication: Maternal Exposure Timing Unspecified

Norvir
    Indication: Maternal Exposure Timing Unspecified

Prezista
    Indication: Maternal Exposure Timing Unspecified

Isentress
    Indication: Maternal Exposure Timing Unspecified



Possible Truvada side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: female

Reactions: Amniotic Fluid Volume Decreased, Abortion Spontaneous

Drug(s) suspected as cause:
Norvir
    Dosage: taken at conception
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-01-24

Truvada
    Dosage: taken at conception
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-01-24

Reyataz
    Dosage: taken at conception
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-01-24



Possible Truvada side effects in 37 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 37 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Liver Disorder

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Efavirenz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-08
    End date: 2012-07-27

Truvada
    Dosage: caps,1df=300/200 mg,qd.
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-08



Possible Truvada side effects in male

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

Patient: male

Reactions: Dysmorphism, Foetal Exposure During Pregnancy, Renal Dysplasia, Intestinal Malrotation, Persistent Cloaca, Trisomy 21, Bladder Dilatation, Cleft Palate, Protrusion Tongue, Renal Aplasia, LOW SET Ears, Abdominal Distension, Anal Atresia, Eagle Barrett Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Reyataz
    Indication: Maternal Exposure Timing Unspecified

Norvir
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified



Possible Truvada side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-21

Patient: 49 year old female

Reactions: Dehydration, Orthostatic Hypotension, Oedema, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Truvada
    Dosage: 1 df, qd
    Indication: HIV Infection
    Start date: 2012-07-17
    End date: 2012-07-23

Sustiva
    Dosage: 1 df, qd
    Indication: HIV Infection
    Start date: 2012-07-17
    End date: 2012-07-23



Possible Truvada side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: HIP Arthroplasty

Drug(s) suspected as cause:
Truvada

Other drugs received by patient: Kaletra; Isentress



Possible Truvada side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: male

Reactions: Bladder Dilatation, Eagle Barrett Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Norvir
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified



Possible Truvada side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: male

Reactions: Rash Pruritic

Drug(s) suspected as cause:
Prezista
    Dosage: ii qd, po
    Administration route: Oral

Multivitamin
    Dosage: i qd, po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-06-01

Norvir

Truvada



Possible Truvada side effects in male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-20

Patient: male

Reactions: Pruritus, Rash

Drug(s) suspected as cause:
Escitalopram
    Dosage: 1 df
    Administration route: Oral
    Indication: Depression
    Start date: 2012-04-01

Prezista
    Dosage: 300 mg
    Administration route: Oral
    Indication: HIV Infection CDC Category A1
    Start date: 2012-04-12
    End date: 2012-04-23

Truvada
    Dosage: 200 mg/245 mg
    Administration route: Oral
    Indication: HIV Infection CDC Category A1
    Start date: 2012-04-12
    End date: 2012-05-09

Other drugs received by patient: Norvir



Possible Truvada side effects in male

Reported by a physician from Japan on 2012-08-17

Patient: male

Reactions: Rhabdomyolysis, Dyspnoea, Hepatic Failure, Lactic Acidosis, Acidosis, Fall, Haematemesis, Haematochezia, Multi-Organ Failure, Spinal Compression Fracture, Fractured Ischium, Melaena, Renal Failure Acute, Hepatic Cirrhosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Sulfamethoxazole and Trimethoprim
    Indication: Prophylaxis

Sulfamethoxazole and Trimethoprim
    Administration route: Oral
    Indication: Pneumocystis Jiroveci Pneumonia
    End date: 2011-01-14

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-04-27
    End date: 2011-01-14

Kaletra
    Dosage: 4 dosage forms daily
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2007-09-12
    End date: 2011-01-14

Other drugs received by patient: Zerit; Lamivudine



Possible Truvada side effects in

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

Patient:

Reactions: Cystic Lymphangioma, Maternal Exposure During Pregnancy, Abortion Spontaneous

Adverse event resulted in: death

Drug(s) suspected as cause:
Truvada
    Indication: Maternal Exposure Timing Unspecified

Prezista
    Indication: Maternal Exposure Timing Unspecified

Edurant
    Indication: Maternal Exposure Timing Unspecified

Norvir
    Indication: Maternal Exposure Timing Unspecified



Possible Truvada side effects in male

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

Patient: male, weighing 3.7 kg (8.2 pounds)

Reactions: Hydronephrosis, Foetal Exposure During Pregnancy, Congenital Megaureter, Pyelocaliectasis

Drug(s) suspected as cause:
Norvir
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified

Combivir
    Indication: Maternal Exposure Timing Unspecified



Possible Truvada side effects in

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

Patient:

Reactions: Foetal Exposure During Pregnancy, Ultrasound Antenatal Screen Abnormal

Drug(s) suspected as cause:
Kaletra
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014