This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Retrovir (Zidovudine) 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 (151)
Death (9)
Life Threatening Events (11)
Disability (2)
Reports by Reaction Type
Foetal Exposure During Pregnancy (76),
Premature Baby (23),
Anaemia (23),
Maternal Exposure During Pregnancy (19),
Patent Ductus Arteriosus (11),
Foetal Growth Restriction (10),
Leukopenia (10),
Congenital Cytomegalovirus Infection (9),
Regurgitation (8),
Tricuspid Valve Incompetence (8),
Nausea (8),
Premature Rupture of Membranes (7)
Below are a few examples of reports where side effects / adverse reactions may be related to Retrovir (Zidovudine). For a complete list or a specific selection of reports, please use the links above.
Possible Retrovir 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:
Atorvastatin
Indication: Maternal Exposure Timing Unspecified
Lisinopril
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir 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
Retrovir
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir 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
Possible Retrovir 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:
Combivir
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17
Patient: male, weighing 2.0 kg (4.4 pounds)
Reactions: Trisomy 21, Premature Baby, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Limb Malformation, Acoustic Stimulation Tests Abnormal
Drug(s) suspected as cause:
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-15
Epivir
Dosage: 300mgd per day
Indication: Antiretroviral Therapy
End date: 2011-07-15
Retrovir
Dosage: 2mgkh per day
Indication: Antiretroviral Therapy
Start date: 2011-10-07
End date: 2011-10-07
Viramune
Dosage: 400mgd per day
Indication: Antiretroviral Therapy
Zerit
Dosage: 40mgd per day
Indication: Antiretroviral Therapy
End date: 2011-07-15
Possible Retrovir side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15
Patient:
Reactions: Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Combivir
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in male
Reported by a physician from United States on 2012-08-15
Patient: male, weighing 1.2 kg (2.6 pounds)
Reactions: Cardiac Murmur, Premature Baby, Intraventricular Haemorrhage Neonatal, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Retrovir
Dosage: 2mgkh per day
Indication: Antiretroviral Therapy
Start date: 2011-07-09
End date: 2011-07-09
Retrovir
Dosage: 1mgkh per day
Start date: 2011-07-09
End date: 2011-07-09
Trizivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-05-16
Possible Retrovir side effects in male
Reported by a physician from France on 2012-08-15
Patient: male
Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Dysphonia, Oral Candidiasis, Foetal Heart Rate Disorder, Oesophageal Atresia, Venous Thrombosis Limb, Cough, Oxygen Saturation Decreased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Epzicom
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: male
Reactions: Urethral Valves, Congenital Bladder Anomaly, Congenital Hydronephrosis, Foetal Exposure During Pregnancy, Bladder Obstruction, Congenital Renal Disorder
Drug(s) suspected as cause:
Norvir
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in 34 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 34 year old female
Reactions: Oligohydramnios, Vulvovaginal Mycotic Infection, Vulvovaginitis Trichomonal
Drug(s) suspected as cause:
Combivir
Dosage: 2 tablets daily
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-11-10
End date: 2012-06-07
Norvir
Dosage: 100 mg daily
Administration route: Oral
Indication: Antiretroviral Therapy
Retrovir
Indication: Antiretroviral Therapy
Start date: 2012-05-25
End date: 2012-05-25
Retrovir
Start date: 2012-05-25
End date: 2012-05-25
Reyataz
Dosage: 300 mg daily
Administration route: Oral
Indication: Antiretroviral Therapy
Truvada
Administration route: Oral
Indication: Antiretroviral Therapy
End date: 2011-11-10
Other drugs received by patient: Terazol 7; Metronidazole; Fluconazole; Tricholoroacetric Acid
Possible Retrovir side effects in male
Reported by a physician from United States on 2012-08-09
Patient: male, weighing 2.1 kg (4.6 pounds)
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Rash, Congenital Cytomegalovirus Infection, Foetal Growth Restriction, Microcephaly, Laboratory Test Abnormal, Hepatomegaly, Hypervitaminosis
Drug(s) suspected as cause:
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-14
Kaletra
Dosage: 4tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-14
End date: 2011-12-05
Retrovir
Indication: Antiretroviral Therapy
Start date: 2011-12-05
End date: 2011-12-05
Possible Retrovir side effects in 9 year old female
Reported by a consumer/non-health professional from Ireland on 2012-08-08
Patient: 9 year old female
Reactions: Regurgitation, Aphagia, Malaise, Nausea, Insomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epivir
Indication: Product Used FOR Unknown Indication
Kaletra
Indication: Product Used FOR Unknown Indication
Maxolon
Indication: Product Used FOR Unknown Indication
Motilium
Indication: Product Used FOR Unknown Indication
Retrovir
Indication: Product Used FOR Unknown Indication
Possible Retrovir side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08
Patient: female
Reactions: Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-08-08
Patient: 40 year old female
Reactions: Premature Rupture of Membranes, Premature Baby, Maternal Exposure During Pregnancy, PRE-Eclampsia
Drug(s) suspected as cause:
Epivir
Dosage: 600mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-03-22
Intelence
Dosage: 400mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-04-19
End date: 2011-06-14
Kaletra
Dosage: 4tab per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-06-16
Norvir
Dosage: 100mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-04-04
End date: 2011-04-18
Retrovir
Dosage: 800mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-06-16
Reyataz
Dosage: 800mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-04-19
End date: 2011-06-16
Reyataz
Dosage: 300mgd per day
Administration route: Oral
Start date: 2011-04-04
End date: 2011-04-18
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06
Patient: male
Reactions: Urethral Valves, Congenital Bladder Anomaly, Congenital Hydronephrosis, Foetal Exposure During Pregnancy, Bladder Obstruction, Congenital Renal Disorder
Drug(s) suspected as cause:
Norvir
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in 35 year old male
Reported by a individual with unspecified qualification from Brazil on 2012-08-03
Patient: 35 year old male
Reactions: Agitation, Confusional State, Immune Reconstitution Syndrome, Psychomotor Hyperactivity, Hyperreflexia, Aggression, Irritability, Dysarthria, Syncope, Brain Oedema, Paracoccidioides Infection, Coordination Abnormal, Phonophobia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Efavirenz
Lamivudine
Indication: Product Used FOR Unknown Indication
Retrovir
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Itraconazole; Amphotericin B
Possible Retrovir side effects in female
Reported by a physician from France on 2012-08-03
Patient: female
Reactions: Anaemia, Pyrexia, Aplasia Pure RED Cell, Conjunctival Pallor
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bactrim
Dosage: 5ml per day
Administration route: Oral
Indication: Prophylaxis
End date: 2012-05-24
Depakene
Dosage: 100mg per day
Administration route: Oral
Indication: Encephalopathy
End date: 2012-05-27
Retrovir
Dosage: 15ml twice per day
Administration route: Oral
Indication: HIV Infection
End date: 2012-05-24
Other drugs received by patient: Viramune; Epivir; Ursolvan
Possible Retrovir side effects in male
Reported by a physician from France on 2012-08-02
Patient: male, weighing 4.7 kg (10.3 pounds)
Reactions: Hypothermia, Foetal Exposure During Pregnancy, Anaemia, Tachycardia, Lactic Acidosis, Foetal Distress Syndrome, Apparent Death, Electroencephalogram Abnormal, Renal Failure, Rash Erythematous, Thrombocytopenia, Leukopenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
Indication: Prophylaxis
Start date: 2011-01-01
End date: 2012-06-26
Kaletra
Indication: Prophylaxis
Start date: 2011-01-01
End date: 2012-06-26
Retrovir
Start date: 2012-06-26
End date: 2012-06-29
Retrovir
Indication: Prophylaxis
Start date: 2012-06-26
End date: 2012-06-26
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02
Patient: male, weighing 3.7 kg (8.2 pounds)
Reactions: Hydronephrosis, Foetal Exposure During Pregnancy, Congenital Megaureter, Pyelocaliectasis
Drug(s) suspected as cause:
Combivir
Indication: Maternal Exposure Timing Unspecified
Norvir
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02
Patient: male
Reactions: Cleft LIP and Palate, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in male
Reported by a physician from United States on 2012-07-30
Patient: male, weighing 2.0 kg (4.4 pounds)
Reactions: Trisomy 21, Premature Baby, Foetal Exposure During Pregnancy, Limb Malformation
Drug(s) suspected as cause:
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-15
Epivir
Dosage: 300mgd per day
Indication: Antiretroviral Therapy
End date: 2011-07-15
Retrovir
Dosage: 2mgkh per day
Indication: Antiretroviral Therapy
Start date: 2011-10-07
End date: 2011-10-07
Viramune
Dosage: 400mgd per day
Indication: Antiretroviral Therapy
Zerit
Dosage: 40mgd per day
Indication: Antiretroviral Therapy
End date: 2011-07-15
Possible Retrovir side effects in 9 year old female
Reported by a consumer/non-health professional from Ireland on 2012-07-27
Patient: 9 year old female
Reactions: Poor Quality Sleep, Malaise, Nausea, Hypophagia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
ALL Other Therapeutic Products
Dosage: twice a day
Indication: Product Used FOR Unknown Indication
Epivir
Dosage: twice a day
Indication: Product Used FOR Unknown Indication
Kaletra
Dosage: twice a day
Indication: Product Used FOR Unknown Indication
Maxolon
Dosage: twice a day
Indication: Product Used FOR Unknown Indication
Retrovir
Dosage: twice a day
Indication: Product Used FOR Unknown Indication
Possible Retrovir side effects in male
Reported by a physician from France on 2012-07-27
Patient: male
Reactions: Foetal Exposure During Pregnancy, Anaemia, Lactic Acidosis, Ill-Defined Disorder, Hepatic Enzyme Increased, Apparent Death, Foetal Distress Syndrome, Renal Failure, C-Reactive Protein Increased, Thrombocytopenia, Leukopenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Prophylaxis Against HIV Infection
Start date: 2012-06-26
End date: 2012-06-26
Retrovir
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27
Patient: female
Reactions: Congenital Anomaly
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in 9 year old female
Reported by a consumer/non-health professional from Ireland on 2012-07-27
Patient: 9 year old female
Reactions: Aphagia, Regurgitation, Malaise, Nausea, Insomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epivir
Indication: Product Used FOR Unknown Indication
Kaletra
Indication: Product Used FOR Unknown Indication
Maxolon
Indication: Product Used FOR Unknown Indication
Motilium
Indication: Product Used FOR Unknown Indication
Retrovir
Indication: Product Used FOR Unknown Indication
Possible Retrovir side effects in
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient:
Reactions: LOW Birth Weight Baby, Foetal Growth Restriction, Small FOR Dates Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Epzicom
Dosage: 1 df, qd
Start date: 2011-11-15
End date: 2012-05-16
Intelence
Dosage: 400 mg, qd
Start date: 2011-11-15
End date: 2012-05-16
Isentress
Dosage: 800 mg, qd
Indication: HIV Infection
Start date: 2011-11-15
End date: 2012-05-16
Norvir
Dosage: 200 mg, qd
Start date: 2011-11-15
End date: 2012-05-16
Prezista
Dosage: 1200 mg, qd
Start date: 2011-11-15
End date: 2012-05-16
Retrovir
Dosage: 2000 mg, qd
Start date: 2011-11-15
End date: 2012-05-16
Possible Retrovir side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26
Patient: female
Reactions: Dysphagia, Respiratory Disorder, Foetal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Kaletra
Dosage: 4tab per day
Indication: HIV Infection
Start date: 2009-08-01
Lamivudine + Zidovudine
Dosage: 2tab per day
Indication: HIV Infection
Start date: 2009-08-01
Retrovir
Indication: Antiviral Prophylaxis
Start date: 2010-04-02
End date: 2010-04-02
Possible Retrovir side effects in 37 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26
Patient: 37 year old female
Reactions: Maternal Exposure During Pregnancy, Adverse Event, Hypertension, Premature Delivery
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Retrovir
Dosage: 480mgd per day
Indication: Antiretroviral Therapy
Start date: 2010-06-13
End date: 2010-06-13
Trizivir
Dosage: 2tab per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2010-03-04
Possible Retrovir side effects in 50 year old male
Reported by a physician from Japan on 2012-07-26
Patient: 50 year old male, weighing 52.0 kg (114.4 pounds)
Reactions: Tubulointerstitial Nephritis, Hallucination
Drug(s) suspected as cause:
Atazanavir
Dosage: 300mg per day
Administration route: Oral
Start date: 2010-08-01
Atazanavir
Administration route: Oral
Indication: HIV Infection
Start date: 2005-07-01
End date: 2010-08-01
Efavirenz
Administration route: Oral
Indication: HIV Infection
Start date: 2005-05-01
End date: 2005-07-01
Epivir
Administration route: Oral
Indication: HIV Infection
Start date: 2005-05-01
End date: 2010-08-01
Epivir
Dosage: 150mg per day
Administration route: Oral
Start date: 2010-08-01
Retrovir
Administration route: Oral
Indication: HIV Infection
Start date: 2005-05-01
End date: 2005-07-01
Ritonavir
Administration route: Oral
Indication: HIV Infection
Start date: 2005-07-01
End date: 2010-08-01
Ritonavir
Dosage: 100mg per day
Administration route: Oral
Start date: 2010-08-01
Tenofovir Disoproxil Fumarate
Administration route: Oral
Indication: HIV Infection
Start date: 2005-07-01
End date: 2008-11-01
Ziagen
Dosage: 600mg per day
Administration route: Oral
Start date: 2010-08-01
Ziagen
Administration route: Oral
Indication: HIV Infection
Start date: 2008-11-01
End date: 2010-08-01
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-25
Patient: male
Reactions: Urethral Valves, Congenital Bladder Anomaly, Congenital Hydronephrosis, Foetal Exposure During Pregnancy, Bladder Obstruction, Congenital Renal Disorder
Drug(s) suspected as cause:
Norvir
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
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