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Efferalgan Safety Reports submitted to FDA

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Total Efferalgan reports: 8.
Efferalgan FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 8.
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FDA Reported Efferalgan Side Effects: asthenia, dyspnoea, dizziness, cardiomyopathy, aspartate aminotransferase increased, abdominal pain, alanine aminotransferase, hypertension, cardiogenic shock, atrial fibrillation, alanine aminotransferase increased.
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Efferalgan Side Effects Report #5040746-8
Physician from FRANCE reported EFFERALGAN problem on June 08, 2006. Male patient, 21 years of age, weighting 92.59 lb, was diagnosed with headache, blood iron increased and was treated with EFFERALGAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, alanine aminotransferase, aspartate aminotransferase increased, asthenia, cardiomyopathy, dizziness, dyspnoea, face oedema, haemoglobin decreased. EFFERALGAN dosage: unknown. Patient was hospitalized. Patient recovered.

Efferalgan Side Effects Report #5043616-4
EFFERALGAN problem was reported by a Physician from FRANCE on Apr 25, 2006. Female patient, 65 years of age, was diagnosed with hypothyroidism, gastritis, hypertension and was treated with EFFERALGAN. After drug was administered, patient experienced the following problems/side effects: anaemia, asthenia, bone marrow myelogram abnormal, myeloid leukaemia, thrombocytopenia. EFFERALGAN dosage: unknown. During the same period patient was treated with LEVOTHYROX, OGAST, COTAREG. Patient was hospitalized. Patient recovered.

Efferalgan Side Effects Report #5058440-6
Physician from FRANCE reported EFFERALGAN problem on June 08, 2006. Male patient, 21 years of age, weighting 92.59 lb, was diagnosed with headache, blood iron increased and was treated with EFFERALGAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, alanine aminotransferase, alanine aminotransferase increased, aspartate aminotransferase increased, asthenia, cardiomyopathy, dizziness, dyspnoea, face oedema. EFFERALGAN dosage: unknown. Patient was hospitalized. Patient recovered.

Efferalgan Side Effects Report #5145963-4
EFFERALGAN problem was reported by a Physician from FRANCE on June 08, 2006. Male patient, 21 years of age, weighting 92.59 lb, was diagnosed with headache, blood iron increased and was treated with EFFERALGAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, alanine aminotransferase, aspartate aminotransferase increased, asthenia, atrial fibrillation, cardiogenic shock, cardiomyopathy, dizziness, dyspnoea. EFFERALGAN dosage: unknown. During the same period patient was treated with EXJADE. Patient was hospitalized. Patient recovered.

Efferalgan Side Effects Report #5157076-6
Physician from FRANCE reported EFFERALGAN problem on June 08, 2006. Male patient, 21 years of age, weighting 92.59 lb, was diagnosed with headache, blood iron increased and was treated with EFFERALGAN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, alanine aminotransferase, aspartate aminotransferase increased, asthenia, atrial fibrillation, cardiac failure, cardiogenic shock, cardiomyopathy, dizziness. EFFERALGAN dosage: unknown. During the same period patient was treated with EXJADE. Patient was hospitalized. Patient died on 11/19/2006.

Efferalgan Side Effects Report #5166649-6
EFFERALGAN problem was reported by a Physician from FRANCE on Aug 02, 2006. Male patient, 30 years of age, was diagnosed with pseudomonas infection, chest pain and was treated with EFFERALGAN. After drug was administered, patient experienced the following problems/side effects: dyspnoea, fatigue, increased bronchial secretion, inflammation, pseudomonas infection, pyrexia, staphylococcal infection. EFFERALGAN dosage: unknown. During the same period patient was treated with DAFALGAN, COLCHICINE, MYOLASTAN. Patient was hospitalized. Patient recovered.

Efferalgan Side Effects Report #5389221-1
Physician from ITALY reported EFFERALGAN problem on July 16, 2007. Female patient, 71 years of age, was diagnosed with back pain and was treated with EFFERALGAN. After drug was administered, patient experienced the following problems/side effects: hypertension. EFFERALGAN dosage: unknown. During the same period patient was treated with COUMADIN, AULIN, VOLTAREN, MUSCORIL. Patient was hospitalized. Patient recovered.

Efferalgan Side Effects Report #5392513-3
EFFERALGAN problem was reported by a Physician from ITALY on July 20, 2007. Female patient, 71 years of age, was diagnosed with back pain and was treated with EFFERALGAN. After drug was administered, patient experienced the following problems/side effects: hypertension. EFFERALGAN dosage: unknown. During the same period patient was treated with AULIN, VOLTAREN, MUSCORIL, COUMADIN. Patient was hospitalized. Patient recovered.


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abdominal pain, alanine aminotransferase, aspartate aminotransferase increased, asthenia, cardiomyopathy, dizziness, dyspnoea, face oedema, haemoglobin decreased, was diagnosed with headache, blood iron increased and was diagnosed with hypothyroidism, gastritis, hypertension and