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Ferrlecit (Sodium Ferric Gluconate) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ferrlecit (Sodium Ferric Gluconate) 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 (10)
Death (2)
Life Threatening Events (1)
Disability (1)

Reports by Reaction Type

Abdominal Pain (2)Circulatory Collapse (2)Back Pain (2)Dyspnoea (2)Nausea (2)Toxicity To Various Agents (2)Application Site Swelling (1)Tachycardia (1)Headache (1)Oropharyngeal Pain (1)Death (1)Cyanosis (1)

Possible Ferrlecit side effects in 79 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-16

Patient: 79 year old male, weighing 91.0 kg (200.2 pounds)

Reactions: Anxiety, Blood Pressure Increased, Cerebral Infarction, Tachycardia, Circulatory Collapse, Coma, Headache, Altered State of Consciousness, Muscle Spasms

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Ferrlecit

Other drugs received by patient: Vitamin B-12; Acetylsalicylic Acid SRT; Metoprolol Tartrate and Hydrochlorothiazide; Folic Acid; Insulin Human; Pantoprazole; Carbamazepine; Antihypertensives; Levofloxacin; Ezetimibe; Metoprolol Tartrate and Hydrochlorothiazide; Metformin HCL; RED Blood Cells, Concentrated



Possible Ferrlecit side effects in 34 year old female

Reported by a pharmacist from United States on 2012-04-12

Patient: 34 year old female, weighing 606.9 kg (1335.2 pounds)

Reactions: Abdominal Pain, Back Pain, Dyspnoea, Hypersensitivity, Nausea, Urticaria, Oropharyngeal Pain, Joint Stiffness, Flushing, Malaise, Oedema Peripheral, Dizziness, Infusion Related Reaction

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Ferrlecit

Other drugs received by patient: Sertraline Hydrochloride; Alprazolam; Alprazolam



Possible Ferrlecit side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-11

Patient: female

Reactions: Vulval Disorder

Drug(s) suspected as cause:
Ferrlecit
    Indication: Foetal Exposure During Pregnancy
    Start date: 2011-01-28
    End date: 2011-08-28

Folic Acid
    Indication: Foetal Exposure During Pregnancy
    Start date: 2011-01-28
    End date: 2011-08-28

Norvir
    Indication: Foetal Exposure During Pregnancy
    End date: 2011-08-28

Prezista
    Indication: Foetal Exposure During Pregnancy
    Start date: 2011-03-22
    End date: 2011-08-28

Reyataz
    Indication: Foetal Exposure During Pregnancy
    End date: 2011-03-22

Truvada
    Indication: Foetal Exposure During Pregnancy
    Start date: 2011-03-22
    End date: 2011-08-28



Possible Ferrlecit side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-02

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Ferrlecit



Possible Ferrlecit side effects in 27 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-04-02

Patient: 27 year old female, weighing 45.0 kg (99.0 pounds)

Reactions: Circulatory Collapse, Blood Pressure Decreased

Drug(s) suspected as cause:
Ferrlecit



Possible Ferrlecit side effects in 59 year old female

Reported by a pharmacist from United States on 2012-02-22

Patient: 59 year old female

Reactions: Abdominal Pain, Back Pain, Dyspnoea, Nausea, Toxicity To Various Agents, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ferrlecit

Other drugs received by patient: Metoclopramide; Prevacid; Multi-Vitamins; Sandostatin LAR; Estradiol



Possible Ferrlecit side effects in

Reported by a physician from United States on 2012-02-21

Patient:

Reactions: Drug Intolerance

Drug(s) suspected as cause:
Ferrlecit



Possible Ferrlecit side effects in

Reported by a pharmacist from United States on 2011-12-29

Patient:

Reactions: Toxicity To Various Agents

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ferrlecit



Possible Ferrlecit side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-12-15

Patient: female

Reactions: LIP Swelling, Chest Discomfort, Cyanosis, Swollen Tongue, Loss of Consciousness

Drug(s) suspected as cause:
Cathflo Activase
    Indication: Device Occlusion
    Start date: 2010-12-11

Ferrlecit
    Dosage: 2mg/2ml
    Indication: Iron Deficiency
    Start date: 2010-12-11



Possible Ferrlecit side effects in 12 year old male

Reported by a pharmacist from Germany on 2011-10-26

Patient: 12 year old male

Reactions: Wrong Technique in Drug Usage Process, Application Site Swelling, Necrosis, Application Site Pain, Application Site Induration, Osteonecrosis, Application Site Warmth, Application Site Erythema, Application Site Nodule

Drug(s) suspected as cause:
Ferrlecit

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