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Retrovir (Zidovudine) - Side Effect Reports to FDA

 
 



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 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 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

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 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 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 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 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 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 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 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 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 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

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 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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