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Review Ferrlecit Safety Reports submitted to FDA

Total Ferrlecit reports: 16.
Ferrlecit FDA safety alerts: No.
   Reported hospitalizations: 5.
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FDA Reported Ferrlecit Side Effects: hypotension, dyspnoea, nausea, anaphylactic reaction, dizziness, vomiting, infusion related reaction, back pain, hyperhidrosis, paraesthesia, pain in extremity.
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Ferrlecit Side Effects Report #5585146-7
Pharmacist from UNITED STATES reported FERRLECIT problem on Jan 04, 2008. Female patient, 71 years of age, was diagnosed with iron deficiency and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. FERRLECIT dosage: unknown. During the same period patient was treated with LOPRESSOR, CYMBALTA, SEROQUEL, LEVAQUIN, COUMADIN, LIDODERM, ASPIRIN, ISOSORBIDE DINITRATE. Patient was hospitalized. Patient recovered.

Ferrlecit Side Effects Report #5586867-2
FERRLECIT problem was reported by a Health Professional from UNITED STATES on Jan 08, 2008. Female patient, 42 years of age, weighting 110.0 lb, was diagnosed with iron deficiency, menorrhagia and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: chest discomfort, rash, urticaria. FERRLECIT dosage: 250 MG. Patient recovered.

Ferrlecit Side Effects Report #5614720-4
Pharmacist from CANADA reported FERRLECIT problem on Jan 24, 2008. Female patient, 80 years of age, was diagnosed with anaemia of chronic disease, iron deficiency anaemia, renal disorder and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: convulsion, faecal incontinence, hypotension, loss of consciousness, malaise, muscle twitching. FERRLECIT dosage: 250 MG IN 250ML NS, SINGLE, INTRAVENOUS. Patient recovered.

Ferrlecit Side Effects Report #5614863-5
FERRLECIT problem was reported by a Physician from GERMANY on Jan 28, 2008. Female patient, 44 years of age, was diagnosed with iron deficiency, bronchitis and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: hepatotoxicity, liver injury. FERRLECIT dosage: unknown. During the same period patient was treated with CLARITHROMYCIN. Patient recovered.

Ferrlecit Side Effects Report #5542572-X
Pharmacist from UNITED STATES reported FERRLECIT problem on Dec 05, 2007. Female patient, 41 years of age, was diagnosed with iron deficiency anaemia and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, back pain, chest discomfort, nausea, oedema peripheral, pruritus. FERRLECIT dosage: 250MG ONCE IV DRIP. Patient was hospitalized. Patient recovered.

Ferrlecit Side Effects Report #5513919-5
FERRLECIT problem was reported by a Pharmacist from UNITED STATES on Nov 09, 2007. Female patient, 76 years of age, weighting 135.0 lb, was diagnosed with anaemia and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, bradycardia, cold sweat, faecal incontinence, hyperhidrosis, hypotension, infusion related reaction, pallor, unresponsive to stimuli. FERRLECIT dosage: 250MG FIRST DOSE IV DRIP. Patient was hospitalized. Patient recovered.

Ferrlecit Side Effects Report #5534244-2
Health Professional from ITALY reported FERRLECIT problem on Nov 21, 2007. Female patient, 41 years of age, was diagnosed with iron deficiency anaemia and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: bone pain, hyperventilation, loss of consciousness, vomiting. FERRLECIT dosage: 125 MG, ONCE A MONTH, INTRAVENOUS. Patient recovered.

Ferrlecit Side Effects Report #5455183-1
FERRLECIT problem was reported by a Health Professional from ITALY on Aug 30, 2007. Male patient was diagnosed with iron deficiency and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: bradycardia, crying, flatulence. FERRLECIT dosage: 40 MG, SINGLE , INTRAVENOUS. Patient recovered.

Ferrlecit Side Effects Report #5465453-9
Consumer or non-health professional from UNITED STATES reported FERRLECIT problem on Sept 13, 2007. Female patient, 36 years of age, was diagnosed with iron deficiency anaemia and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, coordination abnormal, fatigue, headache, memory impairment, speech disorder. FERRLECIT dosage: 250 MG/100ML NS OVER 2 HRS, INTRAVENOUS. Patient recovered.

Ferrlecit Side Effects Report #5412225-7
FERRLECIT problem was reported by a Health Professional from UNITED STATES on Aug 03, 2007. Female patient, 36 years of age, was diagnosed with gastric bypass, iron deficiency anaemia and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, anxiety, arthralgia, asthenia, dysphonia, fatigue, myalgia. FERRLECIT dosage: 125 MG, 1/WEEK OVER 20 MIN. X2, INTRAVENOUS. Patient recovered.

Ferrlecit Side Effects Report #5381690-6
Health Professional from UNITED STATES reported FERRLECIT problem on July 05, 2007. Female patient, 39 years of age, was diagnosed with iron deficiency anaemia and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: back pain, chest discomfort, infusion related reaction, no therapeutic response, respiratory distress. FERRLECIT dosage: 125 MG TIMES ONE IV. Patient recovered.

Ferrlecit Side Effects Report #5397807-3
FERRLECIT problem was reported by a Pharmacist from UNITED STATES on July 23, 2007. Female patient, 46 years of age, was diagnosed with iron deficiency anaemia and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. FERRLECIT dosage: 250 MG ONCE IV. During the same period patient was treated with ALBUTEROL, ADVAIR DISKUS, FERROUS SULPHATE, LOTREL. Patient recovered.

Ferrlecit Side Effects Report #5403776-X
Health Professional from UNITED STATES reported FERRLECIT problem on July 31, 2007. Female patient, 62 years of age, was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: asthenia, blood pressure decreased, burning sensation, cold sweat, loss of consciousness, nausea, shock. FERRLECIT dosage: 250MG X1 IV X 1 DOSE. Patient was hospitalized. Patient recovered.

Ferrlecit Side Effects Report #5381690-6
FERRLECIT problem was reported by a Health Professional from UNITED STATES on July 05, 2007. Female patient, 39 years of age, was diagnosed with iron deficiency anaemia and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: back pain, chest discomfort, infusion related reaction, no therapeutic response, respiratory distress. FERRLECIT dosage: 125 MG TIMES ONE IV. Patient recovered.

Ferrlecit Side Effects Report #5397807-3
Pharmacist from UNITED STATES reported FERRLECIT problem on July 23, 2007. Female patient, 46 years of age, was diagnosed with iron deficiency anaemia and was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction. FERRLECIT dosage: 250 MG ONCE IV. During the same period patient was treated with ALBUTEROL, ADVAIR DISKUS, FERROUS SULPHATE, LOTREL. Patient recovered.

Ferrlecit Side Effects Report #5403776-X
FERRLECIT problem was reported by a Health Professional from UNITED STATES on July 31, 2007. Female patient, 62 years of age, was treated with FERRLECIT. After drug was administered, patient experienced the following problems/side effects: asthenia, blood pressure decreased, burning sensation, cold sweat, loss of consciousness, nausea, shock. FERRLECIT dosage: 250MG X1 IV X 1 DOSE. Patient was hospitalized. Patient recovered.


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anaphylactic reaction, chest discomfort, rash, urticaria, convulsion, faecal incontinence, hypotension, loss of consciousness, malaise, muscle twitching, , was diagnosed with iron deficiency and was diagnosed with iron deficiency, menorrhagia and was diagnosed with anaemia of chronic disease, iron deficiency anaemia, renal disorder and