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Emtriva (Emtricitabine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Emtriva (Emtricitabine) 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 (19)
Death (2)

Reports by Reaction Type

Stillbirth (8)PRE-Eclampsia (8)Maternal Exposure During Pregnancy (5)Immune Reconstitution Syndrome (4)Renal Tubular Disorder (3)Condition Aggravated (3)Anaemia (2)Abdominal Pain (1)Agitation (1)Confusional State (1)Drug Interaction (1)Suicidal Ideation (1)

Possible Emtriva side effects in 44 year old female

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

Patient: 44 year old female

Reactions: Immune Reconstitution Syndrome

Adverse event resulted in: death

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

Efavirenz
    Indication: HIV Infection

Emtriva
    Indication: HIV Infection

Other drugs received by patient: Methylprednisolone; Prednisone TAB



Possible Emtriva side effects in 54 year old male

Reported by a physician from Japan on 2012-08-06

Patient: 54 year old male

Reactions: Immune Reconstitution Syndrome, Anaemia

Adverse event resulted in: hospitalization

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

Efavirenz
    Indication: HIV Infection

Viread
    Indication: HIV Infection



Possible Emtriva side effects in 37 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-10

Patient: 37 year old male

Reactions: Renal Failure Acute

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

Viread
    Indication: HIV Infection

Other drugs received by patient: Diflucan; Pantoprazole; Raltegravir; Ceftriaxon; Trimethoprim; Enoxaparin; Mirtazapine; Sulfamethoxazol; Folic Acid



Possible Emtriva side effects in 54 year old male

Reported by a physician from Japan on 2012-06-15

Patient: 54 year old male

Reactions: Immune Reconstitution Syndrome, Anaemia

Adverse event resulted in: hospitalization

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

Emtriva
    Indication: HIV Infection

Efavirenz
    Indication: HIV Infection



Possible Emtriva side effects in 25 year old female

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

Patient: 25 year old female

Reactions: Stillbirth, Maternal Exposure During Pregnancy, PRE-Eclampsia

Drug(s) suspected as cause:
Truvada
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Emtriva
    Dosage: 200mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Norvir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Combivir
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-05
    End date: 2011-07-05

Reyataz
    Dosage: 400mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05



Possible Emtriva side effects in 25 year old female

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

Patient: 25 year old female

Reactions: Stillbirth, PRE-Eclampsia

Drug(s) suspected as cause:
Combivir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05

Reyataz
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Norvir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05

Truvada
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Emtriva
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05



Possible Emtriva side effects in 25 year old female

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

Patient: 25 year old female

Reactions: Stillbirth, PRE-Eclampsia

Drug(s) suspected as cause:
Truvada
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Norvir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Combivir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05

Emtriva
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05

Reyataz
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05



Possible Emtriva side effects in 25 year old female

Reported by a physician from United States on 2012-02-09

Patient: 25 year old female

Reactions: Stillbirth, Maternal Exposure During Pregnancy, PRE-Eclampsia

Drug(s) suspected as cause:
Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05

Emtriva
    Dosage: 200mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Norvir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Truvada
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Combivir
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-05
    End date: 2011-07-05

Reyataz
    Dosage: 400mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05



Possible Emtriva side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-08

Patient: 25 year old female

Reactions: Stillbirth, Maternal Exposure During Pregnancy, PRE-Eclampsia

Drug(s) suspected as cause:
Combivir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05

Reyataz
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Truvada
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05

Emtriva
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Norvir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05



Possible Emtriva side effects in 25 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-07

Patient: 25 year old female

Reactions: Stillbirth, Maternal Exposure During Pregnancy, PRE-Eclampsia

Drug(s) suspected as cause:
Emtriva
    Dosage: 200mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Truvada
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Norvir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05

Combivir
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-05
    End date: 2011-07-05

Reyataz
    Dosage: 400mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05



Possible Emtriva side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-06

Patient: female

Reactions: Maternal Exposure During Pregnancy, Stillbirth, PRE-Eclampsia

Drug(s) suspected as cause:
Emtriva
    Dosage: 200mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Combivir
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-05
    End date: 2011-07-05

Truvada
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Reyataz
    Dosage: 400mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Norvir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05



Possible Emtriva side effects in 51 year old male

Reported by a consumer/non-health professional from France on 2012-02-01

Patient: 51 year old male

Reactions: Renal Tubular Disorder, Condition Aggravated

Drug(s) suspected as cause:
Emtriva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-03-26

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-03-26
    End date: 2011-05-03

Viread
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-03-26

Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-21
    End date: 2011-05-03

Other drugs received by patient: Zoledronoc Acid; Crestor



Possible Emtriva side effects in male

Reported by a physician from France on 2012-02-01

Patient: male

Reactions: Hypophosphataemia, Renal Tubular Disorder, Condition Aggravated, Hypercalcaemia

Drug(s) suspected as cause:
Reyataz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-21
    End date: 2011-05-03

Emtriva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-07-06

Viread
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-07-06

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-21
    End date: 2011-05-03

Other drugs received by patient: Raltegravir; Crestor; Alcasta



Possible Emtriva side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-31

Patient: female

Reactions: Stillbirth, PRE-Eclampsia

Drug(s) suspected as cause:
Emtriva
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Truvada
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Norvir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Reyataz
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-05

Combivir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-09
    End date: 2011-07-05



Possible Emtriva side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-27

Patient: male

Reactions: Renal Tubular Disorder, Condition Aggravated

Drug(s) suspected as cause:
Viread
    Dosage: 0.5 df, unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-03-26

Reyataz
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2009-12-21
    End date: 2011-05-03

Norvir
    Dosage: 1 df, unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-03-26
    End date: 2011-05-03

Emtriva
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-03-26

Reyataz
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-12-21
    End date: 2011-05-03

Other drugs received by patient: Crestor; Zoledronoc Acid



Possible Emtriva side effects in male

Reported by a physician from Japan on 2011-11-28

Patient: male

Reactions: Immune Reconstitution Syndrome, Hepatitis B

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Viread
    Administration route: Oral
    Indication: HIV Antibody Positive
    Start date: 2009-10-01

Emtriva
    Administration route: Oral
    Indication: HIV Antibody Positive
    Start date: 2009-10-01

Norvir
    Administration route: Oral
    Indication: HIV Antibody Positive
    Start date: 2009-10-01

Prezista
    Administration route: Oral
    Indication: HIV Antibody Positive
    Start date: 2009-10-01



Possible Emtriva side effects in male

Reported by a consumer/non-health professional from France on 2011-11-09

Patient: male

Reactions: Abdominal Pain, Nausea, Diarrhoea, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Truvada
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-01-01
    End date: 2011-07-01

Emtriva
    Dosage: 200 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-07-01
    End date: 2011-09-01

Other drugs received by patient: Omacor / 06312301 /; Aspirin; Atenolol; Humalog; Flagyl; Kaletra; Rovamycine / 00074401 /; Crestor



Possible Emtriva side effects in

Reported by a physician from United Kingdom on 2011-10-26

Patient:

Reactions: Confusional State, Agitation, Malaise

Adverse event resulted in: death

Drug(s) suspected as cause:
Viread
    Indication: Asymptomatic HIV Infection

Efavirenz
    Administration route: Oral
    Indication: Asymptomatic HIV Infection
    Start date: 2011-08-03
    End date: 2011-08-13

Emtriva
    Indication: Asymptomatic HIV Infection

Other drugs received by patient: Nevirapine; Combivir



Possible Emtriva side effects in 44 year old male

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

Patient: 44 year old male

Reactions: Anxiety, Paranoia, Psychomotor Skills Impaired, Drug Interaction, Depression, Psychiatric Decompensation, Tearfulness, Suicidal Ideation

Adverse event resulted in: hospitalization

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

Tenofovir

Clonazepam

Risperidone

Bupropion Hydrochloride

Citalopram

Quetiapine Fumarate

Reyataz

Emtriva

Ritonavir

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