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Combivir (Lamivudine / Zidovudine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Combivir (Lamivudine / Zidovudine) 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 (461)
Death (49)
Life Threatening Events (20)
Disability (5)

Reports by Reaction Type

Foetal Exposure During Pregnancy (173)Maternal Exposure During Pregnancy (105)Premature Baby (68)Abortion Spontaneous (65)Stillbirth (33)Anaemia (28)Atrial Septal Defect (25)Foetal Growth Restriction (24)Talipes (23)Single Umbilical Artery (18)Heart Disease Congenital (18)Hydronephrosis (17)

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

Possible Combivir side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Ultrasound Scan Abnormal, Foetal Exposure During Pregnancy, Abortion Induced, Talipes, Meningomyelocele

Adverse event resulted in: death

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in male

Reported by a physician from France on 2012-08-27

Patient: male

Reactions: Eyelid Oedema, Lymphadenopathy, Skin Exfoliation, Conjunctivitis, Tachycardia, Scab, Pyrexia, Cheilitis, Penile Ulceration, Face Oedema, Scrotal Oedema, Optic Disc Haemorrhage, Myocarditis, Stevens-Johnson Syndrome, Dysphagia, N-Terminal Prohormone Brain Natriuretic Peptide Increased, Troponin Increased, LIP Haemorrhage, Drug Rash With Eosinophilia and Systemic Symptoms, Anal Erosion, Mucosal Erosion, Cardiac Failure, Cytomegalovirus Chorioretinitis, Epidermal Necrosis, Electrocardiogram Abnormal, Oedema Genital, Rash Maculo-Papular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sulfadiazine
    Dosage: 6g per day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09

Prezista
    Dosage: 400mg twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Dosage: 100mg per day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Combivir
    Dosage: 1tab twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Bactrim
    Dosage: 1unit per day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Norvir
    Dosage: 100mg per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Other drugs received by patient: Malocide; Folinate



Possible Combivir side effects in male

Reported by a physician from France on 2012-08-27

Patient: male

Reactions: Myalgia, Burning Sensation, Amyotrophy, Decreased Appetite

Drug(s) suspected as cause:
Combivir
    Dosage: 1unit twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-10-17
    End date: 2012-06-03

Kaletra
    Dosage: 2tab twice per day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-10-17
    End date: 2012-06-15



Possible Combivir side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient:

Reactions: Foetal Chromosome Abnormality, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Vertical Talus

Drug(s) suspected as cause:
Truvada
    Dosage: 1 df, unk
    Start date: 2011-07-13
    End date: 2011-10-27

Reyataz
    Dosage: 300 mg, qd
    Start date: 2011-07-13
    End date: 2011-10-27

Combivir
    Dosage: 2 df, unk
    Start date: 2011-11-21

Norvir
    Dosage: 100 mg, qd
    Start date: 2011-07-13
    End date: 2011-10-27

Isentress
    Dosage: 800 mg, qd
    Start date: 2011-11-21



Possible Combivir side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: male

Reactions: Haemoglobin Decreased, Drug Rash With Eosinophilia and Systemic Symptoms, Blood Sodium Decreased, Myocarditis, Blood Creatinine Increased, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prezista
    Dosage: 2 tablets at 400 mg a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Bactrim
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Fluconazole
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Combivir
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09

Norvir
    Dosage: 2 tablets a day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04



Possible Combivir side effects in male

Reported by a physician from France on 2012-08-24

Patient: male

Reactions: Dysphagia, Cytomegalovirus Chorioretinitis, Drug Hypersensitivity, Conjunctivitis, Drug Rash With Eosinophilia and Systemic Symptoms, Myocarditis, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Administration route: Oral
    Indication: Pneumocystis Jiroveci Pneumonia
    Start date: 2012-06-12
    End date: 2012-07-05

Sulfadiazine
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09

Bactrim
    Indication: Prophylaxis

Combivir
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Prezista
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30



Possible Combivir side effects in female

Reported by a physician from France on 2012-08-24

Patient: female

Reactions: Cholestasis of Pregnancy, Maternal Exposure During Pregnancy, Adverse Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kaletra
    Dosage: 2tab twice per day
    Administration route: Oral
    Indication: Antiviral Prophylaxis
    Start date: 2012-03-19
    End date: 2012-05-24

Abacavir Sulfate / Lamivudine
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiviral Prophylaxis
    Start date: 2012-03-05
    End date: 2012-03-19

Combivir
    Dosage: 1tab twice per day
    Administration route: Oral
    Indication: Antiviral Prophylaxis
    Start date: 2012-03-19
    End date: 2012-05-24



Possible Combivir side effects in male

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

Patient: male

Reactions: Foetal Exposure During Pregnancy, Congenital Anomaly

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

Combivir
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in 58 year old male

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

Patient: 58 year old male

Reactions: Tachycardia, Transferrin Decreased, Cerebral Toxoplasmosis, Transferrin Saturation Decreased, Eye Haemorrhage, Gamma-Glutamyltransferase Increased, Blood Sodium Decreased, Myocarditis, Electrocardiogram Repolarisation Abnormality, Stevens-Johnson Syndrome, Blood Iron Decreased, Blood Lactate Dehydrogenase Increased, Renal Cyst, Drug Rash With Eosinophilia and Systemic Symptoms, Nephrotic Syndrome, Renal Failure, Cytomegalovirus Chorioretinitis, Electrocardiogram ST Segment Elevation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bactrim
    Dosage: 1 tablet, 1x/day
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2012-06-12
    End date: 2012-07-05

Norvir
    Dosage: 100 mg, 1x/day (1 df)
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Sulfadiazine
    Dosage: 6 g, 1x/day
    Administration route: Oral
    Indication: Cerebral Toxoplasmosis
    Start date: 2012-06-18
    End date: 2012-07-09

Combivir
    Dosage: 1 df, 2x/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Fluconazole
    Dosage: 100 mg, 1x/day
    Administration route: Oral
    Indication: Oesophageal Candidiasis
    Start date: 2012-06-08
    End date: 2012-06-30

Prezista
    Dosage: 400 mg, 1x/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-06-27
    End date: 2012-07-04

Other drugs received by patient: Malocide; Malocide; Calcium Folinate; Malocide



Possible Combivir side effects in 26 year old female

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

Patient: 26 year old female

Reactions: Prenatal Screening Test Abnormal, Maternal Exposure During Pregnancy, Abortion Induced

Drug(s) suspected as cause:
Truvada
    Dosage: 1tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27

Reyataz
    Dosage: 300mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27

Norvir
    Dosage: 100mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27

Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-11-21

Raltegravir
    Dosage: 800mgd per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-11-21



Possible Combivir side effects in

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

Patient: , weighing 1.9 kg (4.2 pounds)

Reactions: Foetal Exposure During Pregnancy, Congenital Foot Malformation

Drug(s) suspected as cause:
Norvir
    Dosage: 100mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27

Truvada
    Dosage: 1tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27

Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-11-21

Raltegravir
    Dosage: 800mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2011-11-21

Reyataz
    Dosage: 300mgd per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-13
    End date: 2011-10-27



Possible Combivir side effects in male

Reported by a physician from France on 2012-08-22

Patient: male

Reactions: Myalgia, Burning Sensation, Amyotrophy, Decreased Appetite

Drug(s) suspected as cause:
Combivir
    Dosage: dosage form: 150/300 mg, 2 in 1 day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-10-17
    End date: 2012-06-03

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-10-17
    End date: 2012-06-15



Possible Combivir side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient:

Reactions: Atrial Septal Defect, Jaundice, Cardiac Murmur, Dysmorphism, Premature Baby, Foetal Exposure During Pregnancy, Anaemia, Ascites, Hydrops Foetalis, Talipes

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 46 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Renal Colic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Combivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-10-19

Combivir
    Dosage: 1 df=150/300mg,last dose:04oct2010
    Administration route: Oral
    Start date: 2009-10-19

Atazanavir
    Dosage: last dose:04oct2010
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-02-18

Other drugs received by patient: Ketoprofen; Metoclopramide; Morphine; Diazepam; Ketoprofen; Orphenadrine Citrate; Scopolamine; Diazepam; Phenergan; Ketoprofen; Scopolamine; Dipirone; Orphenadrine Citrate; Caffeine + Dipyrone; Hyoscine HBR HYT; Ramipril; Metoclopramide; Hyoscine HBR HYT; Dipirone; Morphine; Phenergan; Codeine Phosphate and Acetaminophen; Caffeine + Dipyrone; Codeine Phosphate and Acetaminophen; Ciprofloxacin



Possible Combivir side effects in

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient:

Reactions: Foetal Exposure During Pregnancy, Plagiocephaly

Drug(s) suspected as cause:
Isentress

Combivir



Possible Combivir side effects in male

Reported by a consumer/non-health professional from Russian Federation on 2012-08-20

Patient: male

Reactions: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Pain

Drug(s) suspected as cause:
Efavirenz
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-07-01

Combivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-07-01



Possible Combivir side effects in female

Reported by a pharmacist from France on 2012-08-20

Patient: female

Reactions: Cholestasis of Pregnancy, Gestational Diabetes, Adverse Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-19
    End date: 2012-05-24

Combivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-19
    End date: 2012-05-24

Other drugs received by patient: Isentress; Truvada



Possible Combivir side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient:

Reactions: Ultrasound Scan Abnormal, Foetal Exposure During Pregnancy, Abortion Induced, Talipes, Meningomyelocele

Adverse event resulted in: death

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

Combivir
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male, weighing 2.9 kg (6.4 pounds)

Reactions: Prenatal Screening Test Abnormal, Drug Screen Positive, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-10

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-05-10

Other drugs received by patient: Cocaine; Tetrahydrocannabinol



Possible Combivir side effects in male

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

Patient: male, weighing 2.0 kg (4.4 pounds)

Reactions: Trisomy 21, Premature Baby, Patent Ductus Arteriosus, Foetal Exposure During Pregnancy, Limb Malformation, Acoustic Stimulation Tests Abnormal

Drug(s) suspected as cause:
Viramune
    Dosage: 400mgd per day
    Indication: Antiretroviral Therapy

Retrovir
    Dosage: 2mgkh per day
    Indication: Antiretroviral Therapy
    Start date: 2011-10-07
    End date: 2011-10-07

Zerit
    Dosage: 40mgd per day
    Indication: Antiretroviral Therapy
    End date: 2011-07-15

Epivir
    Dosage: 300mgd per day
    Indication: Antiretroviral Therapy
    End date: 2011-07-15

Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-07-15



Possible Combivir side effects in

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

Patient:

Reactions: Cytogenetic Abnormality, Brain Malformation, Spina Bifida, Abortion Induced, Vertical Talus

Adverse event resulted in: death

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

Norvir
    Indication: Maternal Exposure Timing Unspecified

Combivir
    Indication: Maternal Exposure Timing Unspecified

Truvada
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male, weighing 3.7 kg (8.1 pounds)

Reactions: Hydronephrosis, Foetal Exposure During Pregnancy, Congenital Megaureter, Pyelocaliectasis

Drug(s) suspected as cause:
Truvada
    Dosage: 1tab per day
    Indication: Antiretroviral Therapy
    End date: 2011-11-10

Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-11-10
    End date: 2012-06-07

Norvir
    Dosage: 100mgd per day
    Indication: Antiretroviral Therapy

Reyataz
    Dosage: 300mgd per day
    Indication: Antiretroviral Therapy

Other drugs received by patient: Retrovir; Fluconazole; Terazol Cream; Retrovir; Unspecified Medication



Possible Combivir side effects in male

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

Patient: male, weighing 3.7 kg (8.2 pounds)

Reactions: Hydronephrosis, Foetal Exposure During Pregnancy, Congenital Megaureter, Pyelocaliectasis

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

Truvada
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified

Combivir
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir 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:
Kaletra
    Indication: Maternal Exposure Timing Unspecified

Atripla
    Indication: Maternal Exposure Timing Unspecified

Combivir
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-16

Patient: 32 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: Abortion Missed, Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Efavirenz
    Dosage: 600 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-05-29

Septra
    Dosage: 480 mg, qd
    Administration route: Oral
    Indication: Antifungal Prophylaxis
    Start date: 2003-04-29
    End date: 2009-08-04

Acyclovir
    Dosage: 800 mg
    Administration route: Oral
    Indication: Antiviral Prophylaxis
    Start date: 2003-04-29

Combivir
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2003-05-29



Possible Combivir side effects in

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

Patient:

Reactions: Premature Baby, Foetal Exposure During Pregnancy

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Combivir side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Foetal Exposure During Pregnancy, Foetal Death, Nervous System Disorder, Heart Disease Congenital, Single Umbilical Artery

Adverse event resulted in: death

Drug(s) suspected as cause:
Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy

Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy



Possible Combivir side effects in male

Reported by a physician from Japan on 2012-08-15

Patient: male

Reactions: Renal Function Test Abnormal, Hyperkalaemia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Combivir
    Administration route: Oral
    Start date: 2012-01-16

Combivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-04-01
    End date: 2011-12-22

Reyataz
    Dosage: 300-400 mg/day
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-04-01
    End date: 2011-12-22

Norvir
    Start date: 2011-12-24

Reyataz
    Dosage: 300-400 mg/day
    Administration route: Oral
    Start date: 2011-12-24

Norvir
    Indication: HIV Infection
    Start date: 2005-10-06
    End date: 2011-12-22

Other drugs received by patient: Allopurinol



Possible Combivir side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Foetal Exposure During Pregnancy, Nervous System Disorder, Foetal Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Kaletra
    Dosage: 4tab per day
    Indication: Antiretroviral Therapy

Combivir
    Dosage: 2tab per day
    Indication: Antiretroviral Therapy



Possible Combivir side effects in

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

Patient:

Reactions: Congenital Aortic Stenosis, Dandy-Walker Syndrome, Premature Baby, Foetal Exposure During Pregnancy, Congenital Pulmonary Artery Anomaly, Sepsis, Foetal Heart Rate Abnormal, Heart Disease Congenital, Talipes

Adverse event resulted in: death

Drug(s) suspected as cause:
Kaletra
    Dosage: 4tab per day
    Indication: HIV Infection
    Start date: 2010-08-30

Combivir
    Dosage: 2tab per day
    Indication: HIV Infection
    Start date: 2010-08-30

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