This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rhophylac (RHO D Immune Globulin) 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 (23)
Reports by Reaction Type
Maternal Exposure During Pregnancy (7),
Drug Ineffective (5),
Malaise (5),
Foetal-Maternal Haemorrhage (3),
Body Temperature Increased (3),
Pyrexia (3),
Feeling Cold (3),
Rhesus Antibodies (3),
Abdominal Pain (2),
Somnolence (2),
Palpitations (2),
Lymphadenopathy (1)
Possible Rhophylac side effects in 20 year old female
Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-07-30
Patient: 20 year old female
Reactions: Malaise, Body Temperature Increased, Medication Error, Chills, Somnolence, Feeling Cold
Drug(s) suspected as cause:
Rhophylac
Other drugs received by patient: Acetaminophen; Chlorpheniramine Maleate; Hydrocortone; Mefenamic Acid
Possible Rhophylac side effects in 33 year old female
Reported by a individual with unspecified qualification from United States on 2012-07-23
Patient: 33 year old female
Reactions: Vomiting, Lymphadenopathy, Viral Infection, Diarrhoea, Wrong Drug Administered, Tonsillitis, Pyrexia
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-01
Patient: female
Reactions: Abdominal Pain, Regurgitation, Maternal Drugs Affecting Foetus, Anterior Displaced Anus, Abdominal Tenderness, Meconium Ileus, Abdominal Distension, Gastrointestinal Hypomotility, Breech Presentation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-01
Patient: female
Reactions: Foetal-Maternal Haemorrhage, Haemorrhage, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-30
Patient: female
Reactions: Foetal-Maternal Haemorrhage, Maternal Exposure During Pregnancy, Condition Aggravated
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in
Reported by a pharmacist from United States on 2012-05-10
Patient:
Reactions: Syringe Issue
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in female
Reported by a individual with unspecified qualification from Netherlands on 2012-05-04
Patient: female
Reactions: Hypersensitivity, Maternal Exposure During Pregnancy, Unresponsive To Stimuli, Pyrexia, Somnolence, Delirium
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in female
Reported by a physician from United States on 2012-03-21
Patient: female, weighing 86.2 kg (189.6 pounds)
Reactions: Drug Ineffective, Rhesus Antibodies
Drug(s) suspected as cause:
Rhophylac
Dosage: intravenous
Start date: 2008-10-06
End date: 2008-10-06
Rhophylac
Dosage: intravenous
Start date: 2008-12-16
End date: 2008-12-16
Possible Rhophylac side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-21
Patient: female, weighing 79.8 kg (175.6 pounds)
Reactions: Coombs Direct Test Positive, Drug Ineffective
Drug(s) suspected as cause:
Rhophylac
Dosage: daily dose quantity: 300, daily dose unit: ug intramuscular
Indication: Prophylaxis Against RH Isoimmunisation
Start date: 2008-06-30
End date: 2008-06-30
Rhophylac
Dosage: 300 ug, daily dose quantity: 300, daily dose unit: ug intramuscular
Indication: Prophylaxis Against RH Isoimmunisation
Start date: 2008-09-22
End date: 2008-09-22
Possible Rhophylac side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-21
Patient: female
Reactions: Drug Ineffective, Rhesus Antibodies Positive
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-21
Patient: female
Reactions: Drug Ineffective, Injection Site Pain
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-21
Patient: female, weighing 86.2 kg (189.6 pounds)
Reactions: Flushing, Swelling Face, Dysphonia, Oedema Peripheral, Rash, Swollen Tongue
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rhophylac
Other drugs received by patient: Diptheria / Tetox Vaccine (Diphtheria, Tetanus and Acellular Pertussis); Hydrocodone Bitartrate and Ibuprofen
Possible Rhophylac side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-21
Patient: female
Reactions: Drug Ineffective, Rhesus Antibodies
Drug(s) suspected as cause:
Rhophylac
Dosage: intravenous
Indication: Rhesus Incompatibility
Start date: 2009-08-08
Rhophylac
Dosage: intravenous
Indication: Rhesus Incompatibility
Rhophylac
Dosage: intravenous
Indication: Rhesus Incompatibility
Start date: 2009-05-29
Rhophylac
Dosage: intravenous
Indication: Rhesus Incompatibility
Other drugs received by patient: PRE-Natal Vitamins (Prenataal Vitamins)
Possible Rhophylac side effects in female
Reported by a physician from United States on 2012-03-21
Patient: female, weighing 68.5 kg (150.7 pounds)
Reactions: Rhesus Antibodies
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in 21 year old female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-14
Patient: 21 year old female
Reactions: Caesarean Section, Rhesus Incompatibility, Maternal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in 20 year old female
Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-03-08
Patient: 20 year old female
Reactions: Malaise, Body Temperature Increased, Feeling Cold
Drug(s) suspected as cause:
Rhophylac
Other drugs received by patient: Chlorpheniramine Maleate; Hydrocortone
Possible Rhophylac side effects in 20 year old female
Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-02-23
Patient: 20 year old female
Reactions: Malaise, Body Temperature Increased, Feeling Cold
Drug(s) suspected as cause:
Rhophylac
Other drugs received by patient: Hydrocortone; Chlorpheniramine Maleate
Possible Rhophylac side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-02-23
Patient: female
Reactions: Foetal-Maternal Haemorrhage, Maternal Exposure During Pregnancy, Foetal Death
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in female
Reported by a physician from United States on 2012-02-13
Patient: female, weighing 61.2 kg (134.7 pounds)
Reactions: Abdominal Pain, Chest Discomfort, Blood Pressure Systolic Increased, Blood Immunoglobulin A Decreased, Heart Rate Increased, Pyrexia, Respiratory Distress
Drug(s) suspected as cause:
Rhophylac
Dosage: (300 mcg vial intravenous (not otherwise specified)), (300 mcg vial intravenous (not otherwise spec
Indication: Rhesus Incompatibility
Start date: 2012-01-19
End date: 2012-01-20
Rhophylac
Dosage: (300 mcg vial intravenous (not otherwise specified)), (300 mcg vial intravenous (not otherwise spec
Indication: Rhesus Incompatibility
Start date: 2012-01-19
End date: 2012-01-20
Rhophylac
Dosage: (300 mcg vial intravenous (not otherwise specified)), (300 mcg vial intravenous (not otherwise spec
Indication: Rhesus Incompatibility
Start date: 2012-01-19
End date: 2012-01-20
Rhophylac
Dosage: (300 mcg vial intravenous (not otherwise specified)), (300 mcg vial intravenous (not otherwise spec
Indication: Rhesus Incompatibility
Start date: 2012-01-19
End date: 2012-01-20
Rhophylac
Dosage: (300 mcg vial intravenous (not otherwise specified)), (300 mcg vial intravenous (not otherwise spec
Indication: Rhesus Incompatibility
Start date: 2012-01-19
End date: 2012-01-20
Rhophylac
Dosage: (300 mcg vial intravenous (not otherwise specified)), (300 mcg vial intravenous (not otherwise spec
Indication: Rhesus Incompatibility
Start date: 2012-01-19
End date: 2012-01-20
Rhophylac
Dosage: (300 mcg vial intravenous (not otherwise specified)), (300 mcg vial intravenous (not otherwise spec
Indication: Rhesus Incompatibility
Start date: 2012-01-19
End date: 2012-01-20
Rhophylac
Dosage: (300 mcg vial intravenous (not otherwise specified)), (300 mcg vial intravenous (not otherwise spec
Indication: Rhesus Incompatibility
Start date: 2012-01-19
End date: 2012-01-20
Other drugs received by patient: Rhophylac; Rhophylac; Rhophylac
Possible Rhophylac side effects in 33 year old female
Reported by a individual with unspecified qualification from France on 2012-01-13
Patient: 33 year old female
Reactions: Malaise, Nausea, Palpitations, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Rhophylac
Dosage: 200 ug, 300 ug, intramuscular
Indication: Prophylaxis Against RH Isoimmunisation
Start date: 2011-05-25
Rhophylac
Dosage: 200 ug, 300 ug, intramuscular
Indication: Prophylaxis Against RH Isoimmunisation
Start date: 2011-10-03
Possible Rhophylac side effects in 32 year old
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-11
Patient: 32 year old
Reactions: Malaise, Palpitations, Tachycardia, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Rhophylac
Indication: Prophylaxis Against RH Isoimmunisation
Start date: 2011-05-01
Rhophylac
Indication: Prophylaxis Against RH Isoimmunisation
Start date: 2011-09-01
Possible Rhophylac side effects in 7 year old female
Reported by a physician from United States on 2011-11-30
Patient: 7 year old female, weighing 26.7 kg (58.7 pounds)
Reactions: Intravascular Haemolysis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rhophylac
Possible Rhophylac side effects in 30 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2011-10-04
Patient: 30 year old female
Reactions: Abnormal Behaviour
Drug(s) suspected as cause:
Rhophylac
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