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Complera (Emtricitabine / Rilpivirine / Tenofovir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Complera 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 (31)
Death (6)
Life Threatening Events (4)
Disability (1)

Reports by Reaction Type

Fatigue (5)Virologic Failure (5)Death (4)Rash (4)Night Sweats (3)Weight Decreased (3)Pruritus (3)Polyuria (3)Hepatitis (3)Myalgia (3)Vomiting (3)Urinary Tract Infection (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Complera. For a complete list or a specific selection of reports, please use the links above.

Possible Complera side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male, weighing 78.5 kg (172.6 pounds)

Reactions: Fatigue

Drug(s) suspected as cause:
Complera



Possible Complera side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: male

Reactions: Rhabdomyolysis

Drug(s) suspected as cause:
Complera



Possible Complera side effects in 26 year old female

Reported by a pharmacist from United States on 2012-08-23

Patient: 26 year old female, weighing 68.0 kg (149.7 pounds)

Reactions: Adrenal Insufficiency, Lactic Acidosis

Drug(s) suspected as cause:
Complera

Other drugs received by patient: Insulin Insulatard NPH Nordisk; Tramadol HCL; Vitamin D; Ibuprofen; Diphenhydramine Hydrochloride; Hydroxyzine; Lorazepam; Morphine; Insulin Lispro; Prednisone



Possible Complera side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient: male

Reactions: Rhabdomyolysis

Drug(s) suspected as cause:
Complera



Possible Complera side effects in male

Reported by a pharmacist from United States on 2012-07-26

Patient: male

Reactions: Product Label ON Wrong Product

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

Atripla
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection

Other drugs received by patient: Hydrochlorothiazide; Cyanocobalamin; Evaluprot (Illegible); Hydrocodone Bitartrate and Acetaminophen; Bupropion HCL; Lyrica; Folic Acid



Possible Complera side effects in 33 year old female

Reported by a pharmacist from United States on 2012-07-06

Patient: 33 year old female, weighing 52.2 kg (114.8 pounds)

Reactions: Malaise, Fatigue, Oedema Peripheral

Drug(s) suspected as cause:
Complera
    Dosage: 1 tablet daily by mouth/oral
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-14
    End date: 2012-05-21

Atripla



Possible Complera side effects in 47 year old male

Reported by a consumer/non-health professional from United States on 2012-06-27

Patient: 47 year old male, weighing 68.9 kg (151.7 pounds)

Reactions: Hydronephrosis, Renal Impairment, Drug Administration Error, Constipation, Treatment Noncompliance

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Complera
    Indication: HIV Infection
    Start date: 2011-10-01
    End date: 2012-03-28

Complera
    Indication: HIV Infection
    Start date: 2011-04-28
    End date: 2011-10-01

Other drugs received by patient: Vitamin B6; Isoniazid



Possible Complera side effects in

Reported by a physician from United States on 2012-06-07

Patient:

Reactions: Nervous System Disorder, Rash

Drug(s) suspected as cause:
Complera

Sustiva



Possible Complera side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-05

Patient: female

Reactions: Virologic Failure, Unevaluable Event

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

Complera
    Indication: HIV Infection



Possible Complera side effects in 27 year old female

Reported by a physician from United States on 2012-05-18

Patient: 27 year old female

Reactions: Diffuse Large B-Cell Lymphoma

Drug(s) suspected as cause:
Complera



Possible Complera side effects in female

Reported by a physician from United States on 2012-04-24

Patient: female

Reactions: Virologic Failure, Medication Error

Drug(s) suspected as cause:
Complera
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-28

Multi-Vitamins
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Kaletra; Combivir



Possible Complera side effects in male

Reported by a pharmacist from United States on 2012-04-13

Patient: male, weighing 72.6 kg (159.7 pounds)

Reactions: Abasia, Myelitis Transverse

Drug(s) suspected as cause:
Complera

Other drugs received by patient: Complera



Possible Complera side effects in male

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

Patient: male

Reactions: Virologic Failure, Viral Mutation Identified

Drug(s) suspected as cause:
Complera

Other drugs received by patient: Valtrex; INH; Vitamin B6; Nicotine; Bactrim DS



Possible Complera side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-09

Patient: male

Reactions: Abnormal Dreams, Nightmare, Suicide Attempt, Unevaluable Event, Depression

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Complera

Other drugs received by patient: Prozac



Possible Complera side effects in female

Reported by a physician from United States on 2012-04-09

Patient: female

Reactions: Virologic Failure, Medication Error

Drug(s) suspected as cause:
Multi-Vitamins
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Complera
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-29

Other drugs received by patient: Combivir; Kaletra



Possible Complera side effects in female

Reported by a physician from United States on 2012-03-28

Patient: female

Reactions: Proteinuria, Nephrotic Syndrome

Drug(s) suspected as cause:
Complera

Other drugs received by patient: Vitamin D; Furosemide



Possible Complera side effects in male

Reported by a physician from United States on 2012-03-23

Patient: male

Reactions: Pruritus, Acute Hepatic Failure, Rash, Hepatitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Complera

Other drugs received by patient: Carvedilol; Simvastatin



Possible Complera side effects in 38 year old male

Reported by a physician from United States on 2012-03-21

Patient: 38 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Complera



Possible Complera side effects in male

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

Patient: male

Reactions: Virologic Failure, Viral Mutation Identified

Drug(s) suspected as cause:
Complera

Other drugs received by patient: Nicotine; Vitamin B6; INH; Bactrim DS; Valtrex



Possible Complera side effects in 27 year old female

Reported by a physician from United States on 2012-03-20

Patient: 27 year old female

Reactions: Diffuse Large B-Cell Lymphoma

Drug(s) suspected as cause:
Complera



Possible Complera side effects in 28 year old female

Reported by a consumer/non-health professional from United States on 2012-03-16

Patient: 28 year old female

Reactions: Pathogen Resistance

Drug(s) suspected as cause:
Complera



Possible Complera side effects in male

Reported by a physician from United States on 2012-03-12

Patient: male

Reactions: Pruritus, Acute Hepatic Failure, Rash, Hepatitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Complera

Other drugs received by patient: Simvastatin; Carvedilol



Possible Complera side effects in 38 year old male

Reported by a physician from United States on 2012-03-06

Patient: 38 year old male

Reactions: Night Sweats, Weight Decreased, Jaundice, Pneumonia Primary Atypical, Vomiting, Immune Reconstitution Syndrome, Hypersensitivity, Urinary Tract Infection, Polyuria, Myalgia, Fatigue, Platelet Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: unk
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2011-10-10
    End date: 2011-12-19

Complera
    Dosage: 1 df, qd
    Indication: HIV Infection
    Start date: 2011-09-08
    End date: 2011-12-31



Possible Complera side effects in female

Reported by a physician from United States on 2012-03-05

Patient: female

Reactions: Proteinuria, Nephrotic Syndrome

Drug(s) suspected as cause:
Complera

Other drugs received by patient: Vitamin D; Furosemide



Possible Complera side effects in male

Reported by a physician from United States on 2012-03-05

Patient: male

Reactions: Pruritus, Acute Hepatic Failure, Rash, Hepatitis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Complera

Other drugs received by patient: Simvastatin; Carvedilol



Possible Complera side effects in 38 year old male

Reported by a physician from United States on 2012-02-03

Patient: 38 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Complera



Possible Complera side effects in male

Reported by a physician from United States on 2012-01-25

Patient: male

Reactions: Renal Disorder

Drug(s) suspected as cause:
Complera



Possible Complera side effects in 38 year old male

Reported by a pharmacist from United States on 2012-01-13

Patient: 38 year old male

Reactions: Weight Decreased, Night Sweats, Jaundice, Immune Reconstitution Syndrome, Hypersensitivity, Vomiting, Pneumonia Primary Atypical, Urinary Tract Infection, Polyuria, Myalgia, Death, Fatigue, Platelet Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: unk
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2011-10-10
    End date: 2011-12-19

Complera
    Dosage: 1 df, qd
    Indication: HIV Infection
    Start date: 2011-09-08
    End date: 2011-12-31



Possible Complera side effects in 38 year old male

Reported by a physician from United States on 2012-01-12

Patient: 38 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Complera



Possible Complera side effects in 38 year old male

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

Patient: 38 year old male, weighing 108.0 kg (237.5 pounds)

Reactions: Dialysis, Sepsis, Supraventricular Tachycardia, Cardiac Failure Congestive

Adverse event resulted in: death

Drug(s) suspected as cause:
Complera

Other drugs received by patient: Bactrim DS

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