Index of reports
> Cases with Premature Baby (23)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Retrovir (Zidovudine) where reactions include premature baby. The selected reports were submitted to the FDA during the sample period of about a year.
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:
Viramune
Dosage: 400mgd per day
Indication: Antiretroviral Therapy
Retrovir
Dosage: 2mgkh per day
Indication: Antiretroviral Therapy
Start date: 2011-10-07
End date: 2011-10-07
Zerit
Dosage: 40mgd per day
Indication: Antiretroviral Therapy
End date: 2011-07-15
Epivir
Dosage: 300mgd per day
Indication: Antiretroviral Therapy
End date: 2011-07-15
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-15
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:
Trizivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-05-16
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
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 2012-08-09
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:
Kaletra
Dosage: 4tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-14
End date: 2011-12-05
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-14
Retrovir
Indication: Antiretroviral Therapy
Start date: 2011-12-05
End date: 2011-12-05
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:
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
Epivir
Dosage: 600mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-03-22
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
Intelence
Dosage: 400mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-04-19
End date: 2011-06-14
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 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:
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
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
Zerit
Dosage: 40mgd per day
Indication: Antiretroviral Therapy
End date: 2011-07-15
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: male, weighing 2.1 kg (4.6 pounds)
Reactions: Foetal Growth Restriction, Hepatomegaly, Microcephaly, Laboratory Test Abnormal, Premature Baby, Foetal Exposure During Pregnancy, Rash, Hypervitaminosis, Congenital Cytomegalovirus Infection
Drug(s) suspected as cause:
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-14
Retrovir
Indication: Antiretroviral Therapy
Start date: 2011-12-05
End date: 2011-12-05
Kaletra
Dosage: 4tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-14
Kaletra
Dosage: 6tab per day
Start date: 2011-09-22
End date: 2011-12-05
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17
Patient: male
Reactions: Full Blood Count Abnormal, Premature Baby, Foetal Exposure During Pregnancy, Rash, Congenital Cytomegalovirus Infection, Foetal Growth Restriction, Hepatomegaly, Microcephaly, Hypervitaminosis
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
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-11
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 39 year old female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-04
Patient: 39 year old female
Reactions: Premature Rupture of Membranes, Premature Baby
Drug(s) suspected as cause:
Combivir
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Fuzeon
Indication: Product Used FOR Unknown Indication
Isentress
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Retrovir
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-27
Patient: male
Reactions: Foetal Growth Restriction, Microcephaly, Hepatomegaly, Premature Baby, Full Blood Count Abnormal, Foetal Exposure During Pregnancy, Rash, Hypervitaminosis, Congenital Cytomegalovirus Infection
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Combivir
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 2012-04-25
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 health professional (non-physician/pharmacist) from United States on 2012-04-24
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:
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
Zerit
Dosage: 40mgd per day
Indication: Antiretroviral Therapy
End date: 2011-07-15
Viramune
Dosage: 400mgd per day
Indication: Antiretroviral Therapy
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-15
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-23
Patient: male
Reactions: Full Blood Count Abnormal, Premature Baby, Foetal Exposure During Pregnancy, Rash, Congenital Cytomegalovirus Infection, Vitamin D Increased, Foetal Growth Restriction, Hepatomegaly, Microcephaly
Drug(s) suspected as cause:
Kaletra
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Combivir
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-19
Patient: male, weighing 2.1 kg (4.6 pounds)
Reactions: Foetal Growth Restriction, Hepatomegaly, Laboratory Test Abnormal, Microcephaly, Premature Baby, Foetal Exposure During Pregnancy, Rash, Hypervitaminosis, Congenital Cytomegalovirus Infection
Drug(s) suspected as cause:
Kaletra
Dosage: 4tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-14
Combivir
Dosage: 2tab per day
Indication: Antiretroviral Therapy
Start date: 2011-07-14
Kaletra
Dosage: 6tab per day
Start date: 2011-09-22
End date: 2011-12-05
Retrovir
Indication: Antiretroviral Therapy
Start date: 2011-12-05
End date: 2011-12-05
Possible Retrovir side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-04-17
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
Reyataz
Dosage: 300mgd per day
Administration route: Oral
Start date: 2011-04-04
End date: 2011-04-18
Kaletra
Dosage: 4tab per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-06-16
Intelence
Dosage: 400mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-04-19
End date: 2011-06-14
Reyataz
Dosage: 800mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-04-19
End 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
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-12
Patient: male
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Congenital Cytomegalovirus Infection
Drug(s) suspected as cause:
Retrovir
Indication: Maternal Exposure Timing Unspecified
Combivir
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-23
Patient: male, weighing 2.1 kg (4.6 pounds)
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Congenital Cytomegalovirus Infection
Drug(s) suspected as cause:
Kaletra
Dosage: 6tab per day
Start date: 2011-09-22
End date: 2011-12-05
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
Retrovir
Indication: Antiretroviral Therapy
Start date: 2011-12-05
End date: 2011-12-05
Possible Retrovir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-23
Patient: male, weighing 2.1 kg (4.7 pounds)
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Congenital Cytomegalovirus Infection
Drug(s) suspected as cause:
Combivir
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Kaletra
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in 40 year old female
Reported by a physician from Thailand on 2012-03-12
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
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
Retrovir
Dosage: 800mgd 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
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
Possible Retrovir side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from Thailand on 2012-03-05
Patient: 40 year old female
Reactions: Premature Rupture of Membranes, Premature Baby, Maternal Exposure During Pregnancy, PRE-Eclampsia
Drug(s) suspected as cause:
Kaletra
Dosage: 1000mgd 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: 2011-03-22
Intelence
Dosage: 400mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-04-19
End date: 2011-06-14
Reyataz
Dosage: 800mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-03-22
End date: 2011-06-16
Epivir
Dosage: 600mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-03-22
Retrovir
Dosage: 800mgd per day
Administration route: Oral
Indication: Antiretroviral Therapy
Start date: 2011-06-16
Possible Retrovir side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-09
Patient: female
Reactions: Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Norvir
Indication: Maternal Exposure Timing Unspecified
Retrovir
Indication: Maternal Exposure Timing Unspecified
Truvada
Indication: Maternal Exposure Timing Unspecified
Reyataz
Indication: Maternal Exposure Timing Unspecified
Possible Retrovir side effects in
Reported by a physician from France on 2011-10-28
Patient:
Reactions: Maternal Drugs Affecting Foetus, Premature Baby, Speech Disorder Developmental, Anaemia, Maternal Exposure During Pregnancy, Foetal Distress Syndrome, Autism, Caesarean Section
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Epivir
Indication: Prophylaxis Against HIV Infection
Start date: 2004-02-22
End date: 2004-05-15
Retrovir
Start date: 2004-02-22
End date: 2004-05-15
Retrovir
Dosage: 1.96mg four times per day
Administration route: Oral
Indication: Prophylaxis Against HIV Infection
Start date: 2004-05-15
End date: 2004-06-15
Other drugs received by patient: Nelfinavir Mesylate
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