DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Atripla (Efavirenz / Emtricitabine / Tenofovir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Atripla 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 (209)
Death (11)
Life Threatening Events (8)
Disability (8)

Reports by Reaction Type

Dyspnoea (25)Anaemia (25)Chest Pain (21)Aplasia Pure RED Cell (21)Lethargy (20)Cardiac Failure (20)Megakaryocytes Increased (19)Histiocytosis Haematophagic (19)RED Blood Cell Abnormality (18)Bone Marrow Disorder (18)White Blood Cell Disorder (18)Congenital Teratoma (14)

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

Possible Atripla side effects in 44 year old male

Reported by a physician from Germany on 2012-08-23

Patient: 44 year old male

Reactions: Road Traffic Accident, Transient Psychosis, Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in 49 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-22

Patient: 49 year old male

Reactions: Drug Eruption, Pigmentation Disorder

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

Sulfamethoxazole Trimethoprim
    Indication: Product Used FOR Unknown Indication



Possible Atripla side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient: male

Reactions: Glomerular Filtration Rate Decreased, Osteoporosis

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in 49 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 49 year old male

Reactions: Photosensitivity Reaction, Hyperkeratosis, Pruritus, Lymphadenopathy, Skin Exfoliation, Skin Burning Sensation, Herpes Simplex, Skin Lesion, Rash Papular, Pseudomonas Infection, Ear Infection, Skin Oedema, Rash, Skin Plaque, Lichen Planus, Bacteraemia, Staphylococcal Infection, Skin Depigmentation, Dermatitis Exfoliative

Adverse event resulted in: hospitalization

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

Sulfamethoxazole and Trimethoprim



Possible Atripla side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: male

Reactions: Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Atripla
    Indication: Maternal Exposure Timing Unspecified

Combivir
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Atripla side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 66 year old male

Reactions: Sialoadenitis, Salivary Gland Calculus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-05-01

Pravastatin
    Administration route: Oral

Sustiva
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01

Truvada
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01



Possible Atripla side effects in 66 year old male

Reported by a consumer/non-health professional from France on 2012-08-13

Patient: 66 year old male

Reactions: Sialoadenitis, Salivary Gland Calculus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla
    Administration route: Oral
    Start date: 2010-05-01

Pravastatin
    Administration route: Oral

Sustiva
    Administration route: Oral
    Start date: 2008-07-01
    End date: 2010-05-01

Truvada
    Administration route: Oral
    Start date: 2008-07-01
    End date: 2010-05-01



Possible Atripla side effects in 29 year old male

Reported by a physician from Spain on 2012-08-10

Patient: 29 year old male

Reactions: Rash, Transaminases Increased, Liver Disorder

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in male

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

Patient: male

Reactions: Salivary Gland Calculus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-05-01

Pravastatin Sodium
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sustiva
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01

Truvada
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01



Possible Atripla side effects in female

Reported by a physician from France on 2012-08-07

Patient: female

Reactions: Muscle Disorder, Muscle Rupture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla

Other drugs received by patient: Vitamin D



Possible Atripla side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male

Reactions: Palpitations, Insomnia, Motor Dysfunction, Disorientation, Hypoaesthesia, Heart Rate Irregular, Paraesthesia

Drug(s) suspected as cause:
Atripla
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2012-03-19

Atripla
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    End date: 2012-03-16

Atripla
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2012-03-17
    End date: 2012-03-18



Possible Atripla side effects in male

Reported by a physician from United States on 2012-08-02

Patient: male

Reactions: Weight Increased, Rhabdomyolysis

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in male

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

Patient: male

Reactions: Salivary Gland Calculus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-05-01

Pravastatin Sodium
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sustiva
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01

Truvada
    Dosage: unk
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-01
    End date: 2010-05-01



Possible Atripla side effects in 40 year old male

Reported by a pharmacist from Belgium on 2012-08-02

Patient: 40 year old male

Reactions: Rhabdomyolysis, Renal Impairment, Sepsis

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in 30 year old female

Reported by a physician from United States on 2012-08-01

Patient: 30 year old female

Reactions: Platelet Count Decreased

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: male

Reactions: Adverse Event

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Atripla

Sustiva



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

Complera
    Administration route: Oral

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



Possible Atripla side effects in 42 year old female

Reported by a physician from Switzerland on 2012-07-25

Patient: 42 year old female

Reactions: Muscular Weakness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Atripla

Other drugs received by patient: Efavirenz; Truvada



Possible Atripla side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-24

Patient: female

Reactions: Renal Tubular Disorder, Anaemia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in 21 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient: 21 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Atripla
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    End date: 2012-02-20

Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-02-20

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-02-20



Possible Atripla side effects in male

Reported by a physician from United States on 2012-07-19

Patient: male

Reactions: Incorrect Product Storage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in 65 year old male

Reported by a physician from Greece on 2012-07-19

Patient: 65 year old male

Reactions: Viral Load Increased, CD4 Lymphocytes Decreased, Drug Ineffective

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in male

Reported by a physician from United States on 2012-07-18

Patient: male

Reactions: Rhabdomyolysis

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in 21 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-18

Patient: 21 year old female

Reactions: Abortion Spontaneous

Drug(s) suspected as cause:
Atripla
    Administration route: Oral
    Indication: Antiretroviral Therapy
    End date: 2012-02-20

Combivir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-02-20

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-02-20



Possible Atripla side effects in

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient:

Reactions: Abnormal Dreams, Shigella Infection, Sexual Dysfunction, Depression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in 21 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-18

Patient: 21 year old female

Reactions: Abortion Spontaneous

Drug(s) suspected as cause:
Atripla
    Administration route: Oral
    Indication: Antiretroviral Therapy
    End date: 2012-02-20

Combivir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-02-20

Kaletra
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-02-20



Possible Atripla side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-18

Patient: male

Reactions: Confusional State, Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17

Patient: 60 year old female

Reactions: Renal Tubular Disorder, Tubulointerstitial Nephritis, Pain, Renal Tubular Necrosis, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actonel
    Dosage: 30 mg once weekly, oral
    Administration route: Oral
    End date: 2012-02-20

Atripla
    Dosage: 1 df daily, oral
    Administration route: Oral
    Indication: HIV Infection
    End date: 2012-02-20

Indapamide
    Dosage: 2.5 mg daily, oral
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-02-18

Mediatensyl
    Dosage: 30 mg, bid
    Indication: Hypertension
    End date: 2012-02-20

Plavix
    Dosage: 75 mg, qd, oral
    Administration route: Oral
    End date: 2012-02-20

Tarka
    Dosage: unk, oral
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-02-18

Other drugs received by patient: Ezetimibe / Simvastatin; Imovane (Zopiclone)



Possible Atripla side effects in 42 year old female

Reported by a physician from Switzerland on 2012-07-17

Patient: 42 year old female

Reactions: Muscular Weakness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Atripla



Possible Atripla side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-16

Patient: 60 year old female

Reactions: Renal Tubular Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Actonel
    Administration route: Oral
    End date: 2012-02-20

Atripla
    Administration route: Oral
    Indication: HIV Infection
    End date: 2012-02-20

Indapamide
    Administration route: Oral
    End date: 2012-02-18

Mediatensyl
    Administration route: Oral
    End date: 2012-02-20

Plavix
    Administration route: Oral
    End date: 2012-02-20

Trandolapril
    Administration route: Oral
    End date: 2012-02-18

Other drugs received by patient: Imovane; Ezetimibe

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017