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Index of reports
> Cases with Premature Baby (11)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ultiva (Remifentanil) where reactions include premature baby. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Ultiva side effects in male
Reported by a physician from Japan on 2012-08-08
Patient: male, weighing 2.5 kg (5.4 pounds)
Reactions: Blood Alkaline Phosphatase Increased, Transient Tachypnoea of THE Newborn, Vomiting, Premature Baby, Hyperreflexia, Drug Withdrawal Syndrome Neonatal, Irritability, Gamma-Glutamyltransferase Increased, Feeding Disorder, Analgesic Drug Level Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Phenobarbital TAB
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-27
End date: 2011-10-27
Phenobarbital TAB
Start date: 2011-10-27
End date: 2011-10-31
Fentanyl Citrate
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Morphine HCL Elixir
Indication: Foetal Exposure During Pregnancy
Ultiva
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Metoclopramide
Indication: Foetal Exposure During Pregnancy
Fentanyl-100
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
End date: 2011-10-27
Possible Ultiva side effects in male
Reported by a physician from Japan on 2012-07-30
Patient: male, weighing 2.5 kg (5.4 pounds)
Reactions: Blood Alkaline Phosphatase Increased, Vomiting, Transient Tachypnoea of THE Newborn, Premature Baby, Hyperreflexia, Drug Withdrawal Syndrome Neonatal, Irritability, Gamma-Glutamyltransferase Increased, Feeding Disorder, Analgesic Drug Level Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metoclopramide
Indication: Foetal Exposure During Pregnancy
Fentanyl Citrate
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Morphine Hydrochloride
Indication: Foetal Exposure During Pregnancy
Phenobarbital TAB
Start date: 2011-10-27
End date: 2011-10-31
Fentanyl-100
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
End date: 2011-10-27
Phenobarbital TAB
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-27
End date: 2011-10-27
Ultiva
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Possible Ultiva side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-23
Patient: female
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Heart Sounds Abnormal
Drug(s) suspected as cause:
Ultiva
Indication: Maternal Exposure During Pregnancy
Levothyroxine Sodium
Indication: Maternal Exposure During Pregnancy
Dopamine HCL
Indication: Maternal Exposure During Pregnancy
Isoflurane
Indication: Maternal Exposure During Pregnancy
Possible Ultiva side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-23
Patient: female
Reactions: Maternal Drugs Affecting Foetus, Caesarean Section, Premature Baby, Foetal Exposure During Pregnancy, Heart Sounds Abnormal
Drug(s) suspected as cause:
Isoflurane
Indication: Maternal Exposure During Pregnancy
Levothyroxine Sodium
Indication: Maternal Exposure During Pregnancy
Ultiva
Indication: Maternal Exposure During Pregnancy
Dopamine HCL
Indication: Maternal Exposure During Pregnancy
Possible Ultiva side effects in
Reported by a physician from Japan on 2012-07-06
Patient: , weighing 2.3 kg (5.1 pounds)
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Heart Sounds Abnormal
Drug(s) suspected as cause:
Isoflurane
Indication: Maternal Exposure Timing Unspecified
Ultiva
Indication: Maternal Exposure Timing Unspecified
Levothyroxine Sodium
Indication: Maternal Exposure Timing Unspecified
Dopamine HCL
Indication: Maternal Exposure Timing Unspecified
Possible Ultiva side effects in male
Reported by a physician from Japan on 2012-05-04
Patient: male, weighing 2.5 kg (5.4 pounds)
Reactions: Irritability, Vomiting, Transient Tachypnoea of THE Newborn, Premature Baby, Hyperreflexia, Feeding Disorder, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metoclopramide
Indication: Foetal Exposure During Pregnancy
Fentanyl Citrate
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Fentanyl-100
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
End date: 2011-10-27
Ultiva
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Morphine Hydrochloride
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
Possible Ultiva side effects in male
Reported by a physician from Japan on 2012-05-04
Patient: male, weighing 2.5 kg (5.4 pounds)
Reactions: Blood Alkaline Phosphatase Increased, Vomiting, Transient Tachypnoea of THE Newborn, Premature Baby, Hyperreflexia, Drug Withdrawal Syndrome Neonatal, Irritability, Gamma-Glutamyltransferase Increased, Feeding Disorder, Analgesic Drug Level Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentanyl-100
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
End date: 2011-10-27
Fentanyl Citrate
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Phenobarbital TAB
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-27
End date: 2011-10-27
Phenobarbital TAB
Start date: 2011-10-27
End date: 2011-10-31
Ultiva
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Metoclopramide
Indication: Foetal Exposure During Pregnancy
Morphine Hydrochloride
Indication: Foetal Exposure During Pregnancy
Possible Ultiva side effects in male
Reported by a physician from Japan on 2012-02-28
Patient: male, weighing 2.5 kg (5.4 pounds)
Reactions: Irritability, Vomiting, Transient Tachypnoea of THE Newborn, Premature Baby, Hyperreflexia, Feeding Disorder, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentanyl Citrate
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Ultiva
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Metoclopramide
Indication: Foetal Exposure During Pregnancy
Fentanyl-100
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
End date: 2011-10-27
Morphine Hydrochloride
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
Possible Ultiva side effects in male
Reported by a physician from Japan on 2012-01-24
Patient: male, weighing 2.5 kg (5.4 pounds)
Reactions: Irritability, Transient Tachypnoea of THE Newborn, Vomiting, Premature Baby, Hyperreflexia, Feeding Disorder, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Morphine HCL Elixir
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
Fentanyl Citrate
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Metoclopramide
Indication: Foetal Exposure During Pregnancy
Fentanyl-100
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
End date: 2011-10-27
Ultiva
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Possible Ultiva side effects in male
Reported by a physician from Japan on 2012-01-19
Patient: male, weighing 2.5 kg (5.4 pounds)
Reactions: Maternal Drugs Affecting Foetus, Drug Withdrawal Syndrome Neonatal, Muscle Tightness, Caesarean Section, Anticonvulsant Drug Level Increased, Mean Cell Haemoglobin Increased, Blood Sodium Increased, Vomiting, Transient Tachypnoea of THE Newborn, Premature Baby, Vomiting Neonatal, Hyperreflexia, Tremor Neonatal, Irritability, Feeding Disorder, Feeding Disorder Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentanyl-100
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
End date: 2011-10-27
Fentanyl Citrate
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Ultiva
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Metoclopramide
Indication: Foetal Exposure During Pregnancy
Morphine HCL Elixir
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
Possible Ultiva side effects in male
Reported by a physician from Japan on 2011-11-30
Patient: male, weighing 2.5 kg (5.4 pounds)
Reactions: Irritability, Caesarean Section, Transient Tachypnoea of THE Newborn, Vomiting, Premature Baby, Foetal Exposure During Pregnancy, Hyperreflexia, Feeding Disorder, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Metoclopramide
Indication: Foetal Exposure During Pregnancy
Fentanyl-100
Indication: Foetal Exposure During Pregnancy
Start date: 2005-01-01
End date: 2011-10-27
Fentanyl Citrate
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Ultiva
Indication: Foetal Exposure During Pregnancy
Start date: 2011-10-25
End date: 2011-10-25
Morphine Hydrochloride
Indication: Foetal Exposure During Pregnancy
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