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Review Rhogam Safety Reports submitted to FDA

Total Rhogam reports: 9.
Rhogam FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Rhogam Side Effects: chlamydial infection, hepatitis c virus, metal poisoning, headache, feeling hot, fatigue, dyspnoea, chest discomfort, body temperature increased, back pain, abdominal pain upper.
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Rhogam Side Effects Report #5649904-2
Physician from UNITED STATES reported RHOGAM problem on Feb 13, 2008. Female patient was diagnosed with pregnancy and was treated with RHOGAM. After drug was administered, patient experienced the following problems/side effects: dermatosis, injection site erythema, injection site swelling, refusal of treatment by patient, telangiectasia. RHOGAM dosage: unknown. Patient recovered.

Rhogam Side Effects Report #5490515-X
RHOGAM problem was reported by a Pharmacist from UNITED STATES on Oct 18, 2007. Male patient, weighting 59.97 lb, was diagnosed with idiopathic thrombocytopenic purpura and was treated with RHOGAM. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, choking, cold sweat, cough, dyspnoea, pallor, retching. RHOGAM dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.

Rhogam Side Effects Report #5404922-4
Health Professional from UNITED STATES reported RHOGAM problem on Aug 01, 2007. Female patient, 56 years of age, was diagnosed with blood incompatibility haemolytic anaemia of newborn, prophylaxis and was treated with RHOGAM. After drug was administered, patient experienced the following problems/side effects: metal poisoning. RHOGAM dosage: unknown. Patient recovered.

Rhogam Side Effects Report #5449826-6
RHOGAM problem was reported by a Physician from UNITED STATES on Aug 17, 2007. Female patient was diagnosed with pregnancy and was treated with RHOGAM. After drug was administered, patient experienced the following problems/side effects: hepatitis c virus. RHOGAM dosage: unknown. Patient recovered.

Rhogam Side Effects Report #5398886-X
Consumer or non-health professional from UNITED STATES reported RHOGAM problem on July 25, 2007. Female patient, 26 years of age, weighting 290.0 lb, was diagnosed with prophylaxis against rh isoimmunisation and was treated with RHOGAM. After drug was administered, patient experienced the following problems/side effects: abdominal pain, abdominal pain upper, back pain, body temperature increased, chest discomfort, dyspnoea, fatigue, feeling hot, headache. RHOGAM dosage: unknown. Patient recovered.

Rhogam Side Effects Report #5398886-X
RHOGAM problem was reported by a Consumer or non-health professional from UNITED STATES on July 25, 2007. Female patient, 26 years of age, weighting 290.0 lb, was diagnosed with prophylaxis against rh isoimmunisation and was treated with RHOGAM. After drug was administered, patient experienced the following problems/side effects: abdominal pain, abdominal pain upper, back pain, body temperature increased, chest discomfort, dyspnoea, fatigue, feeling hot, headache. RHOGAM dosage: unknown. Patient recovered.

Rhogam Side Effects Report #5782852-6
Consumer or non-health professional from UNITED STATES reported RHOGAM problem on June 19, 2008. Female patient, 40 years of age, weighting 160.0 lb, was diagnosed with pregnancy, rhesus antibodies negative and was treated with RHOGAM. After drug was administered, patient experienced the following problems/side effects: dizziness, dyspnoea, dysstasia, feeling abnormal, gait disturbance, hypotension, movement disorder, presyncope, sensation of heaviness. RHOGAM dosage: unknown. Patient recovered.

Rhogam Side Effects Report #5802481-5
RHOGAM problem was reported by a Health Professional from UNITED STATES on June 16, 2008. Female patient, 31 years of age, was diagnosed with uterine dilation and curettage and was treated with RHOGAM. After drug was administered, patient experienced the following problems/side effects: guillain-barre syndrome, muscular weakness. RHOGAM dosage: unknown. Patient was hospitalized. Patient recovered.

Rhogam Side Effects Report #5341319-X
Consumer or non-health professional from UNITED STATES reported RHOGAM problem on May 08, 2007. Female patient was diagnosed with pregnancy and was treated with RHOGAM. After drug was administered, patient experienced the following problems/side effects: pyrexia. RHOGAM dosage: unknown. Patient was hospitalized. Patient recovered.


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dermatosis, injection site erythema, injection site swelling, refusal of treatment by patient, telangiectasia, , was diagnosed with pregnancy and was diagnosed with idiopathic thrombocytopenic purpura and was diagnosed with blood incompatibility haemolytic anaemia of newborn, prophylaxis and