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
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 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 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
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 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 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 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 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 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 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 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 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 female
Reported by a physician from France on 2012-08-17
Patient: female
Reactions: Foetal Exposure During Pregnancy, Congenital Central Nervous System Anomaly, Abortion Induced, Congenital Absence of Cranial Vault
Adverse event resulted in: death
Drug(s) suspected as cause:
Truvada
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Reyataz
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: Cytogenetic Abnormality, Brain Malformation, Spina Bifida, Abortion Induced, Vertical Talus
Adverse event resulted in: death
Drug(s) suspected as cause:
Isentress
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Combivir
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Possible Truvada side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: female, weighing 3.7 kg (8.1 pounds)
Reactions: Neurofibromatosis, Foetal Exposure During Pregnancy, Cafe AU Lait Spots
Drug(s) suspected as cause:
Truvada
Norvir
Indication: Maternal Exposure Timing Unspecified
Reyataz
Possible Truvada side effects in 36 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: 36 year old female
Reactions: Premature Rupture of Membranes
Drug(s) suspected as cause:
Kaletra
Dosage: 4 tab/caps daily (taking at conception)
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-01-15
Retrovir
Dosage: taking at conception
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-01-15
Retrovir
Dosage: not taking at conception
Start date: 2011-07-29
End date: 2011-07-29
Truvada
Dosage: 1 tab/caps daily (taking at conception)
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-01-15
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