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Rhophylac (RHO D Immune Globulin) - Side Effect Reports to FDA

 
 



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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