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Synagis Side Effects Report #5677544-8
Physician from NETHERLANDS reported SYNAGIS problem on Feb 28, 2008. Male patient, weighting 6.61 lb, was diagnosed with antiviral prophylaxis and was treated with SYNAGIS. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, brain oedema, cerebral haemorrhage, cerebral ischaemia, convulsion, granulocytopenia, haemoglobin decreased, infantile apnoeic attack, malaise, . SYNAGIS dosage: unknown. Patient was hospitalized. Patient recovered.

Inomax Side Effects Report #5623987-8
INOMAX problem was reported by a Health Professional from UNITED STATES on Feb 11, 2008. Female patient, weighting 7.94 lb, was diagnosed with pulmonary hypertension and was treated with INOMAX. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, cardio-respiratory arrest, hypotonia neonatal, medical device complication, oxygen saturation decreased, . INOMAX dosage: unknown. Patient died on 12/21/2007.

Diclofenac Side Effects Report #5645553-0
Health Professional from ITALY reported DICLOFENAC problem on July 06, 2007. Female patient was treated with DICLOFENAC. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, cyanosis neonatal, ductus arteriosus stenosis foetal, neonatal disorder, neonatal respiratory acidosis, neonatal respiratory distress syndrome, oligohydramnios, polyuria, . DICLOFENAC dosage: 75 MG, QD. During the same period patient was treated with ACETAMINOPHEN, NIMESULIDE. Patient recovered.

Zoloft Side Effects Report #5600702-5
ZOLOFT problem was reported by a Health Professional from FRANCE on Jan 11, 2008. Female patient, weighting 6.79 lb, was treated with ZOLOFT. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, . ZOLOFT dosage: unknown. During the same period patient was treated with RISPERDAL, TERCIAN, SULPIRIDE. Patient was hospitalized. Patient recovered.


Inomax Side Effects Report #5614443-1
Health Professional from UNITED KINGDOM reported INOMAX problem on Jan 21, 2008. Female patient was treated with INOMAX. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, device failure, . INOMAX dosage: unknown. Patient died on 12/29/2007.

Risperdal Side Effects Report #5546716-5
RISPERDAL problem was reported by a Health Professional from FRANCE on Dec 06, 2007. Female patient, weighting 6.79 lb, was treated with RISPERDAL. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, . RISPERDAL dosage: unknown. During the same period patient was treated with TERCIAN, ZOLOFT, DOGMATIL. Patient was hospitalized. Patient recovered.

Venlafaxine Side Effects Report #5499558-3
Physician from GERMANY reported VENLAFAXINE problem on Oct 16, 2007. Female patient was diagnosed with depression and was treated with VENLAFAXINE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, cyanosis neonatal, foetal macrosomia, premature baby, screaming, tremor neonatal, . VENLAFAXINE dosage: 225 MG DAILY. During the same period patient was treated with ZOLPIDEM TARTRATE. Patient was hospitalized. Patient recovered.

Haldol Side Effects Report #5452828-7
HALDOL problem was reported by a Health Professional from FRANCE on Sept 05, 2007. Female patient, weighting 20.94 lb, was treated with HALDOL. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, caesarean section, colonic stenosis, foetal distress syndrome, foetal heart rate deceleration, hypoglycaemia neonatal, hypotonia neonatal, hypoventilation neonatal, . HALDOL dosage: unknown. During the same period patient was treated with SERESTA, PARKINANE LP, IMOVANE, MEPRONIZINE. Patient was hospitalized. Patient recovered.

Nitric Side Effects Report #5416513-X
Health Professional from SPAIN reported NITRIC OXIDE problem on Aug 08, 2007. Male patient, weighting 1.48 lb, was diagnosed with lung disorder, prophylaxis and was treated with NITRIC OXIDE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, cardiac arrest neonatal, cerebral haemorrhage, haemorrhage neonatal, metabolic acidosis, neonatal disorder, pulmonary haemorrhage, . NITRIC OXIDE dosage: unknown. During the same period patient was treated with NITRIC OXIDE, IMIPENEM, GENTAMICIN, FUROSEMIDE, FENTANYL, DOPAMINE, MIDAZOLAM, RED BLOOD. Patient died on 12/17/2005.


Sertraline Side Effects Report #5339441-7
SERTRALINE problem was reported by a Health Professional from UNITED KINGDOM on May 14, 2007. Male patient, weighting 9.48 lb, was diagnosed with prophylaxis and was treated with SERTRALINE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, caesarean section, convulsion, convulsion neonatal, dyskinesia neonatal, grunting, hypervigilance, neonatal disorder, . SERTRALINE dosage: unknown. During the same period patient was treated with BENZYLPENICILLIN, GENTAMICIN. Patient was hospitalized. Patient recovered.

Methadone Side Effects Report #5392931-3
Physician from UNITED KINGDOM reported METHADONE problem on July 03, 2007. Female patient, weighting 6.30 lb, was treated with METHADONE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, electrocardiogram qt prolonged, . METHADONE dosage: unknown. Patient was hospitalized. Patient recovered.

Methadone Side Effects Report #5393004-6
METHADONE problem was reported by a Physician from UNITED KINGDOM on July 03, 2007. Female patient, weighting 6.17 lb, was treated with METHADONE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, electrocardiogram qt prolonged, neonatal disorder, . METHADONE dosage: unknown. Patient was hospitalized. Patient recovered.

Sertraline Side Effects Report #5339441-7
Health Professional from UNITED KINGDOM reported SERTRALINE problem on May 14, 2007. Male patient, weighting 9.48 lb, was diagnosed with prophylaxis and was treated with SERTRALINE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, caesarean section, convulsion, convulsion neonatal, dyskinesia neonatal, grunting, hypervigilance, neonatal disorder, . SERTRALINE dosage: unknown. During the same period patient was treated with BENZYLPENICILLIN, GENTAMICIN. Patient was hospitalized. Patient recovered.

Methadone Side Effects Report #5392931-3
METHADONE problem was reported by a Physician from UNITED KINGDOM on July 03, 2007. Female patient, weighting 6.30 lb, was treated with METHADONE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, electrocardiogram qt prolonged, . METHADONE dosage: unknown. Patient was hospitalized. Patient recovered.


Methadone Side Effects Report #5393004-6
Physician from UNITED KINGDOM reported METHADONE problem on July 03, 2007. Female patient, weighting 6.17 lb, was treated with METHADONE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, electrocardiogram qt prolonged, neonatal disorder, . METHADONE dosage: unknown. Patient was hospitalized. Patient recovered.

Subutex Side Effects Report #5755503-4
SUBUTEX problem was reported by a Health Professional from FRANCE on May 30, 2008. Female patient, weighting 7540 lb, was treated with SUBUTEX. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, . SUBUTEX dosage: unknown. During the same period patient was treated with ZOLOFT. Patient was hospitalized. Patient recovered.

Acyclovir Side Effects Report #5335469-1
Consumer or non-health professional from UNITED STATES reported ACYCLOVIR problem on May 02, 2007. Male patient was diagnosed with herpes simplex and was treated with ACYCLOVIR. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, csf culture positive, neonatal disorder, neonatal pneumonia, neonatal respiratory distress syndrome, pneumothorax, virus culture positive, . ACYCLOVIR dosage: 30MG/KG PER DAY. Patient died.

Sertraline Side Effects Report #5339441-7
SERTRALINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on May 14, 2007. Male patient, weighting 9.48 lb, was diagnosed with prophylaxis and was treated with SERTRALINE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, caesarean section, convulsion, convulsion neonatal, dyskinesia neonatal, grunting, hypervigilance, neonatal disorder, . SERTRALINE dosage: unknown. During the same period patient was treated with BENZYLPENICILLIN, GENTAMICIN. Patient was hospitalized. Patient recovered.

Sertraline Side Effects Report #5341715-0
Physician from UNITED KINGDOM reported SERTRALINE problem on May 15, 2007. Male patient, weighting 9.48 lb, was diagnosed with depression and was treated with SERTRALINE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, caesarean section, convulsion neonatal, dyskinesia neonatal, grunting, hypervigilance, neonatal disorder, neonatal tachypnoea, . SERTRALINE dosage: 50 MG, QD, TRANSPLACENTAL. During the same period patient was treated with PENICILLIN G, GENTAMICIN. Patient was hospitalized. Patient recovered.


Curosurf Side Effects Report #5301574-9
CUROSURF problem was reported by a Physician from ITALY on Mar 27, 2007. Male patient was diagnosed with respiratory distress and was treated with CUROSURF. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, cardio-respiratory arrest neonatal, . CUROSURF dosage: unknown. During the same period patient was treated with PENICILLIN G, MORPHINE. Patient was hospitalized. Patient recovered.

Curosurf Side Effects Report #5302035-3
Physician from ITALY reported CUROSURF problem on Mar 27, 2007. Male patient was diagnosed with respiratory distress and was treated with CUROSURF. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, cardio-respiratory arrest neonatal, . CUROSURF dosage: unknown. During the same period patient was treated with PENICILLIN G, MORPHINE. Patient was hospitalized. Patient recovered.

Selozok Side Effects Report #5312696-0
SELOZOK problem was reported by a Consumer or non-health professional from BRAZIL on Apr 24, 2007. Female patient, weighting 4.63 lb, was treated with SELOZOK. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, cardiac murmur, dyspnoea, neonatal disorder, premature baby, . SELOZOK dosage: unknown. Patient was hospitalized. Patient recovered.

Prozac Side Effects Report #5273377-5
Physician from FRANCE reported PROZAC problem on Mar 12, 2007. Female patient was treated with PROZAC. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, hypotonia neonatal, neonatal respiratory distress syndrome, . PROZAC dosage: 20 MG, DAILY (1/D). During the same period patient was treated with LARGACTIL, ATARAX, LOXEN, TRANDATE. Patient recovered.

Nitric Side Effects Report #5281089-7
NITRIC OXIDE problem was reported by a Physician from SPAIN on Mar 16, 2007. Male patient was diagnosed with lung disorder, prophylaxis and was treated with NITRIC OXIDE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, cardiac arrest neonatal, cerebral haemorrhage neonatal, metabolic acidosis, neonatal hypotension, pulmonary haemorrhage, respiratory tract haemorrhage neonatal, . NITRIC OXIDE dosage: unknown. During the same period patient was treated with NITRIC OXIDE, IMIPENEM, GENTAMICIN, FUROSEMIDE, FENTANYL, DOPAMINE, MIDAZOLAM, RED BLOOD. Patient died.

Thorazine Side Effects Report #5282604-X
Consumer or non-health professional from UNITED STATES reported THORAZINE problem on Mar 13, 2007. Female patient was treated with THORAZINE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, cerebral haemorrhage neonatal, convulsion neonatal, dysphagia, foetal distress syndrome, neonatal disorder, . THORAZINE dosage: unknown. During the same period patient was treated with RISPERIDONE, PROMETHAZINE, PHENOBARBITAL, CARBAMAZEPINE. Patient recovered.

Nitric Side Effects Report #5283002-5
NITRIC OXIDE problem was reported by a Health Professional from GERMANY on Mar 21, 2007. Female patient was diagnosed with lung disorder, prophylaxis and was treated with NITRIC OXIDE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, emphysema, intraventricular haemorrhage neonatal, lung hyperinflation, neonatal respiratory acidosis, neonatal respiratory failure, oxygen saturation decreased, . NITRIC OXIDE dosage: unknown. During the same period patient was treated with NITRIC OXIDE, CEFOTAXIME, AMPICILLIN, GENTAMICIN, AMPHOTERICIN B, BICARBONATE IN PLASTIC CONTAINER, SUPRARENIN, DEXAMETHASONE. Patient died.

Nitric Side Effects Report #5286734-8
Physician from SPAIN reported NITRIC OXIDE problem on Mar 26, 2007. Male patient was diagnosed with lung disorder, prophylaxis and was treated with NITRIC OXIDE. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, cerebral haemorrhage neonatal, neonatal hypotension, . NITRIC OXIDE dosage: unknown. During the same period patient was treated with NITRIC OXIDE, AMPICILLIN, GENTAMICIN, FENTANYL, MIDAZOLAM, DOPAMINE, DOBUTAMINE, INSULIN. Patient died.

Nitric Side Effects Report #5656263-8
NITRIC OXIDE problem was reported by a Physician from SPAIN on Feb 27, 2008. Male patient, weighting 1.94 lb, was diagnosed with lung disorder, prophylaxis and was treated with NITRIC OXIDE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, bradycardia neonatal, cerebral haemorrhage, . NITRIC OXIDE dosage: unknown. During the same period patient was treated with NITRIC OXIDE, NITRIC OXIDE, HYDROCORTISONE, NORADRENALINE, FENTANYL CITRATE, SEROALBUMIN, BLOOD TRANSFUSION, CEFOTAXIME. Patient died on 02/19/2008.

Lovenox Side Effects Report #5600282-4
Consumer or non-health professional from reported LOVENOX problem on Jan 14, 2008. Female patient, weighting 2.49 lb, was treated with LOVENOX. After drug was administered, patient experienced the following problems/side effects: atrial septal defect, bradycardia neonatal, congenital great vessel anomaly, foetal growth retardation, neonatal respiratory arrest, . LOVENOX dosage: unknown. During the same period patient was treated with TENORMIN, CIPRALAN, PREVISCAN. Patient was hospitalized. Patient recovered.

Amoxicillin Side Effects Report #5556286-3
AMOXICILLIN TRIHYDRATE problem was reported by a Consumer or non-health professional from CANADA on Nov 20, 2007. Female patient was diagnosed with pneumonia and was treated with AMOXICILLIN TRIHYDRATE. After drug was administered, patient experienced the following problems/side effects: anaemia neonatal, bradycardia neonatal, caesarean section, hydrocele, neonatal respiratory acidosis, neonatal respiratory distress syndrome, premature baby, retinopathy of prematurity, . AMOXICILLIN TRIHYDRATE dosage: unknown. During the same period patient was treated with CEFTRIAXONE, AZITHROMYCIN, HEPARIN, LEVOFLOXACIN, VANCOMYCIN. Patient was hospitalized. Patient recovered.

Yasmin Side Effects Report #5523858-1
Consumer or non-health professional from SWITZERLAND reported YASMIN problem on Nov 15, 2007. Female patient, weighting 2.40 lb, was treated with YASMIN. After drug was administered, patient experienced the following problems/side effects: amniotic cavity infection, bradycardia neonatal, hyperbilirubinaemia neonatal, hypertension neonatal, neonatal respiratory distress syndrome, patent ductus arteriosus, premature baby, sleep apnoea syndrome, . YASMIN dosage: unknown. Patient was hospitalized. Patient recovered.

Lexapro Side Effects Report #5525313-1
LEXAPRO problem was reported by a Physician from UNITED STATES on Nov 06, 2007. Female patient, weighting 6.56 lb, was treated with LEXAPRO. After drug was administered, patient experienced the following problems/side effects: body temperature fluctuation, bradycardia neonatal, convulsion neonatal, coordination abnormal, cyanosis neonatal, dehydration, dysphagia, . LEXAPRO dosage: 20 MG QD TRANSPLACENTAL. During the same period patient was treated with CYMBALTA, ZOLOFT. Patient was hospitalized. Patient recovered.

Cymbalta Side Effects Report #5447834-2
Consumer or non-health professional from UNITED STATES reported CYMBALTA problem on Aug 30, 2007. Female patient, weighting 4.56 lb, was treated with CYMBALTA. After drug was administered, patient experienced the following problems/side effects: apnoea, bradycardia neonatal, premature baby, small for dates baby, . CYMBALTA dosage: unknown. During the same period patient was treated with ZANTAC, PRENATAL VITAMINS, ZYRTEC, FOLIC ACID. Patient recovered.

Cymbalta Side Effects Report #5447839-1
CYMBALTA problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 30, 2007. Female patient, weighting 4.56 lb, was treated with CYMBALTA. After drug was administered, patient experienced the following problems/side effects: apnoea, bradycardia neonatal, patent ductus arteriosus, premature baby, pulmonary valve stenosis, small for dates baby, . CYMBALTA dosage: unknown. During the same period patient was treated with ZANTAC, PRENATAL VITAMINS, ZYRTEC, FOLIC ACID. Patient recovered.

Cymbalta Side Effects Report #5412812-6
Consumer or non-health professional from UNITED STATES reported CYMBALTA problem on July 31, 2007. Female patient, weighting 4.56 lb, was treated with CYMBALTA. After drug was administered, patient experienced the following problems/side effects: apnoea, bradycardia neonatal, premature baby, pulmonary valve stenosis, small for dates baby, . CYMBALTA dosage: unknown. During the same period patient was treated with ZANTAC, PRENATAL VITAMINS, ZYRTEC, FOLIC ACID. Patient recovered.

Cymbalta Side Effects Report #5412815-1
CYMBALTA problem was reported by a Consumer or non-health professional from UNITED STATES on July 31, 2007. Female patient, weighting 4.56 lb, was treated with CYMBALTA. After drug was administered, patient experienced the following problems/side effects: apnoea, bradycardia neonatal, premature baby, small for dates baby, . CYMBALTA dosage: unknown. During the same period patient was treated with ZANTAC, PRENATAL VITAMINS, ZYRTEC, FOLIC ACID. Patient recovered.

Cymbalta Side Effects Report #5743095-5
Physician from UNITED STATES reported CYMBALTA problem on May 07, 2008. Female patient, weighting 4.56 lb, was treated with CYMBALTA. After drug was administered, patient experienced the following problems/side effects: apnoea, bradycardia neonatal, bronchiolitis, choking, decreased appetite, diarrhoea, ear infection, patent ductus arteriosus, . CYMBALTA dosage: unknown. During the same period patient was treated with ZANTAC, VITAMIN, ZYRTEC, FOLIC ACID. Patient was hospitalized. Patient recovered.

Amevive Side Effects Report #5353238-3
AMEVIVE problem was reported by a Physician from UNITED STATES on May 30, 2007. Male patient was treated with AMEVIVE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, bradycardia neonatal, caesarean section, cardiac murmur, grunting, hypoglycaemia neonatal, infantile apnoeic attack, nasal flaring, . AMEVIVE dosage: unknown. During the same period patient was treated with VASOTEC, NORVASC, HYDROCHLOROTHIAZIDE, BETAMETHASONE. Patient was hospitalized. Patient recovered.

Humira Side Effects Report #5317257-5
Consumer or non-health professional from UNITED STATES reported HUMIRA problem on Apr 26, 2007. Female patient, weighting 8.26 lb, was treated with HUMIRA. After drug was administered, patient experienced the following problems/side effects: bradycardia neonatal, gastrooesophageal reflux disease, infantile apnoeic attack, . HUMIRA dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.

Indomethacin Side Effects Report #5304434-2
INDOMETHACIN problem was reported by a Health Professional from JAPAN on Apr 04, 2007. Male patient was diagnosed with patent ductus arteriosus and was treated with INDOMETHACIN. After drug was administered, patient experienced the following problems/side effects: anaemia neonatal, bradycardia neonatal, haemorrhage intracranial, haemorrhagic diathesis, hepatic haemorrhage, intraventricular haemorrhage, neonatal disorder, platelet count decreased, skin discolouration, . INDOMETHACIN dosage: 0.1 MG;QD;IV. Patient died on 06/09/2006.

Cozaar Side Effects Report #5589852-X
Health Professional from CANADA reported COZAAR problem on Feb 23, 2001. Female patient, weighting 6.61 lb, was diagnosed with hypertension, anaesthesia, nasopharyngitis and was treated with COZAAR. After drug was administered, patient experienced the following problems/side effects: adrenal disorder, apgar score low, bradycardia neonatal, brain oedema, caesarean section, cerebral calcification, cerebral haemorrhage neonatal, congenital anomaly, congenital pulmonary hypertension, . COZAAR dosage: unknown. During the same period patient was treated with METHYLDOPA, CLONIDINE HYDROCHLORIDE, PROPOFOL, ISOFLURANE, CEFATRIZINE, ALPHA AMYLASE, ACETAMINOPHEN, HELICIDINE. Patient was hospitalized. Patient died.

Trileptal Side Effects Report #5598187-0
TRILEPTAL problem was reported by a Consumer or non-health professional from FRANCE on Jan 11, 2008. Male patient, weighting 4.89 lb, was treated with TRILEPTAL. After drug was administered, patient experienced the following problems/side effects: base excess decreased, blood ph decreased, bradycardia neonatal, continuous positive airway pressure, electroencephalogram abnormal, hypercapnia, hypotonia neonatal, infantile apnoeic attack, . TRILEPTAL dosage: unknown. During the same period patient was treated with URBANYL, EPITOMAX, VALIUM, RIVOTRIL. Patient was hospitalized. Patient recovered.

Yasmin Side Effects Report #5523859-3
Consumer or non-health professional from SWITZERLAND reported YASMIN problem on Nov 15, 2007. Female patient, weighting 2.14 lb, was treated with YASMIN. After drug was administered, patient experienced the following problems/side effects: amniotic cavity infection, anaemia, bradycardia neonatal, haemangioma, hyperbilirubinaemia neonatal, hypertension neonatal, neonatal respiratory distress syndrome, premature baby, sleep apnoea syndrome, . YASMIN dosage: unknown. Patient was hospitalized. Patient recovered.

Indocin Side Effects Report #5318484-3
INDOCIN problem was reported by a Health Professional from JAPAN on Apr 17, 2007. Male patient was diagnosed with patent ductus arteriosus, shock and was treated with INDOCIN. After drug was administered, patient experienced the following problems/side effects: arrhythmia neonatal, blood pressure decreased, bradycardia neonatal, cerebral haemorrhage neonatal, disseminated intravascular coagulation, electrocardiogram qrs complex prolonged, hyperkalaemia, necrotising fasciitis, neonatal cardiac failure, . INDOCIN dosage: 0.06 MG; TID; IV. During the same period patient was treated with PITRESSIN, AMPICLOX. Patient died on 06/15/2006.