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Fuzeon (Enfuvirtide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fuzeon (Enfuvirtide) 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 (30)
Death (4)

Reports by Reaction Type

Premature Rupture of Membranes (5)Neutropenia (5)Pancytopenia (4)Leukopenia (4)Plagiocephaly (3)Premature Baby (3)Expired Drug Administered (2)Disorientation (2)Maternal Exposure During Pregnancy (2)Skin Disorder (2)Acute Stress Disorder (2)Irritability (2)

Possible Fuzeon side effects in male

Reported by a pharmacist from United States on 2012-06-27

Patient: male

Reactions: Hodgkin's Disease

Drug(s) suspected as cause:
Fuzeon



Possible Fuzeon side effects in 25 year old female

Reported by a pharmacist from France on 2012-06-26

Patient: 25 year old female

Reactions: Accidental Exposure

Drug(s) suspected as cause:
Fuzeon



Possible Fuzeon side effects in 35 year old male

Reported by a physician from Russian Federation on 2012-06-13

Patient: 35 year old male

Reactions: Irritability, Arthralgia, Disorientation

Drug(s) suspected as cause:
Fuzeon
    Indication: HIV Infection
    Start date: 2012-05-24

Panangin
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Dexamethasone; Isoniazid; Meropenem; Vitamin B6; Avelox; Rifabutin; Epivir; Dexamethasone; Capreomycin; Kaletra; Pyrazinamide



Possible Fuzeon side effects in 35 year old male

Reported by a physician from Russian Federation on 2012-06-05

Patient: 35 year old male

Reactions: Irritability, Disorientation

Drug(s) suspected as cause:
Fuzeon

Other drugs received by patient: Epivir



Possible Fuzeon side effects in 46 year old male

Reported by a individual with unspecified qualification from Brazil on 2012-05-08

Patient: 46 year old male

Reactions: Dependence, Abnormal Behaviour

Drug(s) suspected as cause:
Fuzeon

Other drugs received by patient: Lamivudine; Ritonavir; Darunavir Hydrate; Raltegravir; Abacavir



Possible Fuzeon side effects in 46 year old male

Reported by a physician from Brazil on 2012-05-08

Patient: 46 year old male

Reactions: Dependence

Drug(s) suspected as cause:
Fuzeon
    Indication: HIV Infection

Fuzeon
    Indication: Hepatitis C

Other drugs received by patient: Tenofovir; Tenofovir; Ritonavir; Lamivudine; Darunavir Hydrate; Raltegravir; Lamivudine; Ritonavir; Darunavir Hydrate; Raltegravir



Possible Fuzeon side effects in 39 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-04

Patient: 39 year old female

Reactions: Plagiocephaly, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Combivir
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Retrovir
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Fuzeon
    Indication: Product Used FOR Unknown Indication

Isentress
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Fuzeon side effects in 39 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-05-04

Patient: 39 year old female

Reactions: Premature Rupture of Membranes, Premature Baby

Drug(s) suspected as cause:
Combivir
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Fuzeon
    Indication: Product Used FOR Unknown Indication

Isentress
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Retrovir
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Fuzeon side effects in male

Reported by a physician from Germany on 2012-05-02

Patient: male

Reactions: Skin Fibrosis, Injection Site Nodule

Drug(s) suspected as cause:
Fuzeon

Other drugs received by patient: Lantus; Viread; Metformin HCL; Norvir; Retrovir; Glimepirida; Epivir; Prezista; Isentress



Possible Fuzeon side effects in 25 year old female

Reported by a pharmacist from France on 2012-04-19

Patient: 25 year old female

Reactions: Wrong Technique in Drug Usage Process, Injury Associated With Device, Accidental Exposure

Drug(s) suspected as cause:
Fuzeon



Possible Fuzeon side effects in male

Reported by a physician from France on 2012-03-29

Patient: male

Reactions: Pancytopenia, Neutropenia, Leukopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Azithromycin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Bactrim
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-15

Intelence
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10

Rifabutin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Fuzeon
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10

Valganciclovir
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-15

Isentress
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10

Ethambutol Hydrochloride
    Indication: Product Used FOR Unknown Indication

Epivir
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10

Retrovir
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10
    End date: 2012-02-14

Other drugs received by patient: Ritonavir; Medrol; Darunavir Hydrate; Truvada; Megestrol Acetate



Possible Fuzeon side effects in 39 year old female

Reported by a physician from Australia on 2012-03-28

Patient: 39 year old female

Reactions: Premature Rupture of Membranes, Premature Baby, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Isentress
    Administration route: Oral
    Indication: Antiviral Treatment

Fuzeon
    Administration route: Oral
    Indication: Antiviral Treatment

Lamivudine + Zidovudine
    Administration route: Oral
    Indication: Antiviral Treatment

Zidovudine
    Administration route: Oral
    Indication: Antiviral Treatment



Possible Fuzeon side effects in 39 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-03-27

Patient: 39 year old female

Reactions: Premature Rupture of Membranes, Premature Baby, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Lamivudine + Zidovudine
    Administration route: Oral
    Indication: Antiviral Treatment

Fuzeon
    Administration route: Oral
    Indication: Antiviral Treatment

Zidovudine
    Administration route: Oral
    Indication: Antiviral Treatment

Isentress
    Administration route: Oral
    Indication: Antiviral Treatment



Possible Fuzeon side effects in male

Reported by a physician from United States on 2012-03-26

Patient: male, weighing 93.9 kg (206.6 pounds)

Reactions: Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Tmc125
    Administration route: Oral

Tmc125
    Dosage: temporarily stopped
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-12-14
    End date: 2007-08-30

Fuzeon
    Indication: HIV Infection
    Start date: 2006-12-14

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-12-14

Other drugs received by patient: Monopril; Mepron; Lyrica; Hivid; Oxandrolone; Prezista; Lomotil; Zovirax; Multiple Vitamins; Diflucan; Cialis; Lovaza; Hydrocortisone; Androgel; Vitamin B Complex CAP



Possible Fuzeon side effects in 42 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-26

Patient: 42 year old male

Reactions: Pancytopenia, Neutropenia, Leukopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Isentress
    Dosage: 400 mg, 2x/day
    Administration route: Oral
    Start date: 2012-02-10

Fuzeon
    Dosage: unk
    Start date: 2012-02-10

Valganciclovir
    Dosage: 500 mg every 3 days
    End date: 2012-02-15

Rifabutin
    Dosage: 150 mg/day
    Administration route: Oral

Bactrim
    Dosage: 1 ampule, 1x/day
    End date: 2012-02-15

Etravirine
    Dosage: unk
    Administration route: Oral
    Start date: 2012-02-10

Ethambutol Hydrochloride
    Dosage: 1200 mg, unk

Azithromycin Dihydrate
    Dosage: 500 mg, 1x/day
    Administration route: Oral

Epivir
    Dosage: 15 ml, 2x/day
    Administration route: Oral
    Start date: 2012-02-10

Retrovir
    Dosage: 300 mg, 2x/day
    Start date: 2012-02-10
    End date: 2012-02-14

Other drugs received by patient: Medrol



Possible Fuzeon side effects in male

Reported by a physician from France on 2012-03-26

Patient: male

Reactions: Pancytopenia, Neutropenia, Leukopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Epivir
    Dosage: 15ml twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-10

Ethambutol Hydrochloride
    Indication: Product Used FOR Unknown Indication

Isentress
    Dosage: 400mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-10

Bactrim
    Dosage: 1amp per day
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-15

Fuzeon
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10

Intelence
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-02-10

Azithromycin
    Dosage: 500mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Retrovir
    Dosage: 300mg twice per day
    Indication: HIV Infection
    Start date: 2012-02-10
    End date: 2012-02-14

Valganciclovir HCL
    Dosage: 500mg every 3 days
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-15

Rifabutin
    Dosage: 150mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Truvada; Megestrol Acetate; Darunavir Hydrate; Ritonavir; Medrol



Possible Fuzeon side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-22

Patient:

Reactions: Plagiocephaly

Drug(s) suspected as cause:
Zidovudine
    Indication: Foetal Exposure During Pregnancy

Isentress
    Indication: Foetal Exposure During Pregnancy

Fuzeon
    Indication: Foetal Exposure During Pregnancy

Lopinavir / Ritonavir
    Indication: Foetal Exposure During Pregnancy

Lamivudine + Zidovudine
    Indication: Foetal Exposure During Pregnancy



Possible Fuzeon side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-03-22

Patient: 39 year old female

Reactions: Premature Rupture of Membranes, Acute Stress Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fuzeon
    Administration route: Oral
    Indication: Antiretroviral Therapy

Lopinavir / Ritonavir
    Administration route: Oral
    Indication: Antiretroviral Therapy

Zidovudine
    Administration route: Oral
    Indication: Antiretroviral Therapy

Isentress
    Administration route: Oral
    Indication: Antiretroviral Therapy

Lamivudine + Zidovudine
    Administration route: Oral
    Indication: Antiretroviral Therapy



Possible Fuzeon side effects in male

Reported by a physician from France on 2012-03-21

Patient: male

Reactions: Surgical Failure, Neutropenia, Polyneuropathy, Arterial Stenosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sustiva
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-11-23

Emtricitabine and Tenofovir Disoproxil Fumarate
    Dosage: 1 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-11-23
    End date: 2007-03-06

Fuzeon
    Dosage: 90 mg, bid
    Indication: HIV Infection
    Start date: 2006-11-23
    End date: 2007-03-06

Bactrim
    Dosage: unk unk, qd
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2006-11-03
    End date: 2007-05-11

Other drugs received by patient: Aspirin



Possible Fuzeon side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-20

Patient: male

Reactions: Pancytopenia, Neutropenia, Leukopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Azithromycin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Bactrim
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-15

Valganciclovir
    Indication: Product Used FOR Unknown Indication
    End date: 2012-02-15

Rifabutin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Isentress
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10

Ethambutol Hydrochloride
    Indication: Product Used FOR Unknown Indication

Fuzeon
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10

Intelence
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10

Retrovir
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10
    End date: 2012-02-14

Epivir
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-10

Other drugs received by patient: Medrol



Possible Fuzeon side effects in 54 year old male

Reported by a consumer/non-health professional from Canada on 2012-02-22

Patient: 54 year old male

Reactions: Diplopia, Dysphagia, Mitochondrial Toxicity, Progressive External Ophthalmoplegia, Eyelid Ptosis, Lipodystrophy Acquired, Blood Lactic Acid Increased

Drug(s) suspected as cause:
Videx

Zidovudine

Viramune

Viramune

Lamivudine

Saquinavir

Reyataz

Crixivan
    Administration route: Oral

Fuzeon

Lamivudine

Ritonavir

Kaletra

Lamivudine

Viramune

Reyataz

Ziagen

Videx

Viread

Zerit

Videx



Possible Fuzeon side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-15

Patient:

Reactions: Plagiocephaly

Drug(s) suspected as cause:
Isentress
    Indication: Foetal Exposure During Pregnancy

Fuzeon
    Indication: Foetal Exposure During Pregnancy

Lopinavir / Ritonavir
    Indication: Foetal Exposure During Pregnancy

Zidovudine
    Indication: Foetal Exposure During Pregnancy

Lamivudine + Zidovudine
    Indication: Foetal Exposure During Pregnancy



Possible Fuzeon side effects in 39 year old female

Reported by a consumer/non-health professional from United States on 2012-02-15

Patient: 39 year old female

Reactions: Premature Rupture of Membranes, Acute Stress Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lamivudine + Zidovudine
    Administration route: Oral
    Indication: Antiretroviral Therapy

Isentress
    Administration route: Oral
    Indication: Antiretroviral Therapy

Zidovudine
    Administration route: Oral
    Indication: Antiretroviral Therapy

Fuzeon
    Administration route: Oral
    Indication: Antiretroviral Therapy

Lopinavir / Ritonavir
    Administration route: Oral
    Indication: Antiretroviral Therapy



Possible Fuzeon side effects in 52 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-01-17

Patient: 52 year old male

Reactions: Ecchymosis, Underdose, Accidental Overdose

Drug(s) suspected as cause:
Isentress
    Administration route: Oral

Fuzeon

Prezista
    Administration route: Oral

Isentress

Ziagen

Prezista
    Administration route: Oral

Ritonavir

Other drugs received by patient: Imodium; Aspirin; Bactrim



Possible Fuzeon side effects in male

Reported by a physician from Germany on 2012-01-13

Patient: male

Reactions: Skin Disorder

Drug(s) suspected as cause:
Fuzeon



Possible Fuzeon side effects in 50 year old male

Reported by a pharmacist from United States on 2011-11-11

Patient: 50 year old male

Reactions: Expired Drug Administered

Drug(s) suspected as cause:
Fuzeon



Possible Fuzeon side effects in 50 year old male

Reported by a pharmacist from United States on 2011-11-03

Patient: 50 year old male

Reactions: Expired Drug Administered, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fuzeon



Possible Fuzeon side effects in

Reported by a individual with unspecified qualification from United States on 2011-11-01

Patient:

Reactions: Malabsorption, Skin Disorder

Drug(s) suspected as cause:
Fuzeon



Possible Fuzeon side effects in 63 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2011-10-27

Patient: 63 year old male

Reactions: Renal Impairment, Hepatic Function Abnormal, Rash Maculo-Papular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prezista
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-07

Norvir
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-07

Bactrim DS
    Administration route: Oral
    Indication: Pneumocystis Jiroveci Pneumonia
    Start date: 2011-08-30
    End date: 2011-09-07

Truvada
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-07

Fuzeon
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-05

Other drugs received by patient: Pantoprazole Sodium; Fungizone; Acetaminophen; Polyethylene Glycol; Sodium Alginate; Castor OIL; Pantoprazole; Atorvastatin Calcium; Motilium



Possible Fuzeon side effects in 56 year old male

Reported by a health professional (non-physician/pharmacist) from Canada on 2011-10-24

Patient: 56 year old male

Reactions: Neuropathy Peripheral, Diarrhoea, Prostate Cancer, Injection Site Reaction, Depression

Drug(s) suspected as cause:
Isentress
    Administration route: Oral

Fuzeon

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