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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