FDA Adverse Events Reports (FAERS) Summary for COMBIVIR

These tables and charts are based on 6,702 total reports for COMBIVIR (LAMIVUDINE\ZIDOVUDINE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 6,670 pharmaceutical company-submitted and non-U.S. FAERS reports and 32 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 32 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch COMBIVIR summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with COMBIVIR (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG EXPOSURE DURING PREGNANCY	1129
2	PAIN	596
3	EMOTIONAL DISTRESS	554
4	ANXIETY	553
5	FOETAL EXPOSURE DURING PREGNANCY	551
6	LOSS OF ALL PLEASURE	502
7	ANEMIA	426
8	MISCARRIAGE	383
9	PREMATURE BABY	321
10	CHRONIC KIDNEY DISEASE	316
11	FEVER	265
12	OSTEOPOROSIS	260
13	DEPRESSION	258
14	FATIGUE	257
15	MATERNAL EXPOSURE DURING PREGNANCY	255
16	KIDNEY FAILURE	249
17	NAUSEA	248
18	STILLBIRTH	248
19	DIARRHEA	225
20	VOMITING	222
21	LACK OF STRENGTH AND ENERGY (ASTHENIA)	190
22	BONE DENSITY DECREASED	189
23	ECONOMIC PROBLEM	187
24	PREGNANCY	184
25	OSTEOPENIA	177
26	ABORTION INDUCED	173
27	EXPOSURE DURING PREGNANCY	159
28	CAESAREAN SECTION	158
29	HEADACHE	153
30	KIDNEY IMPAIRMENT	152
31	SHORTNESS OF BREATH	145
32	RASH	139
33	LOW WHITE BLOOD CELL COUNTS	137
34	GAIT DISTURBANCE	134
35	ACUTE KIDNEY INJURY	131
36	ALT LIVER ENZYME INCREASED	131
37	BLOOD CREATININE INCREASED	124
38	JOINT PAIN	121
39	DIZZINESS	118
40	ABDOMINAL PAIN	110
41	WEIGHT DECREASED	109
42	ASPARTATE AMINOTRANSFERASE INCREASED	108
43	DRUG INTERACTION	104
44	HEPATITIS	102
45	HAEMOGLOBIN DECREASED	98
46	INSOMNIA	98
47	BONE DEMINERALISATION	96
48	DEATH	94
49	LIVE BIRTH	94
50	KIDNEY FAILURE	93
51	LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES	93
52	MALAISE	93
53	PANCYTOPENIA	92
54	HIGH BLOOD PRESSURE	91
55	PNEUMONIA	91
56	BACK PAIN	90
57	PAIN IN EXTREMITY	86
58	DRUG INEFFECTIVE	85
59	ABDOMINAL DISTENSION	82
60	ITCHING	82
61	COUGH	81
62	MATERNAL DRUGS AFFECTING FOETUS	81
63	OSTEONECROSIS	81
64	THROMBOCYTOPENIA	79
65	JAUNDICE	78
66	PREMATURE LABOUR	76
67	SEPSIS	73
68	MULTIPLE FRACTURES	72
69	BLOOD BILIRUBIN INCREASED	71
70	LIPODYSTROPHY ACQUIRED	71
71	TRISOMY 21	70
72	BLOOD CREATINE PHOSPHOKINASE INCREASED	69
73	POLYDACTYLY	69
74	INTRA-UTERINE DEATH	68
75	CARDIAC MURMUR	67
76	GENERAL PHYSICAL HEALTH DETERIORATION	64
77	PRE-ECLAMPSIA	64
78	KIDNEY STONES	63
79	PREMATURE RUPTURE OF MEMBRANES	61
80	VENTRICULAR SEPTAL DEFECT	61
81	LIVER DAMAGE	60
82	NORMAL NEWBORN	60
83	MOBILITY DECREASED	59
84	MUSCLE PAIN	59
85	SWELLING OF LIMBS	59
86	ATRIAL SEPTAL DEFECT	58
87	CONGENITAL ANOMALY	58
88	QUALITY OF LIFE DECREASED	58
89	DIFFICULTY IN STANDING	57
90	ELEVATED LIVER ENZYMES	57
91	HYPERTRIGLYCERIDAEMIA	56
92	NEUROPATHY PERIPHERAL	56
93	BLOOD LACTIC ACID INCREASED	55
94	CONGENITAL CENTRAL NERVOUS SYSTEM ANOMALY	55
95	TOOTH LOSS	55
96	ANAEMIA MACROCYTIC	54
97	HEART ATTACK (MYOCARDIAL INFARCTION)	54
98	PREMATURE DELIVERY	54
99	CONFUSIONAL STATE	53
100	DANDY-WALKER SYNDROME	53

Latest Known Outcomes for Reactions Reported for COMBIVIR

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1921
2	Patient has not recovered/symtoms have not resolved	877
3	Patient recovered	874
4	Patient died	156
5	Patient is recovering/symptoms resolving	151
6	Patient has recovered but has consequent health issues	30

Search all MedWatch and FAERS by keyword:

COMBIVIR Total Reports

Male	Female	Unknown	Total
2974	3094	634	6,702

Top Countries Reporting

	Country	Number of Reports
1	United States	1256
2	France	298
3	United Kingdom	144
4	Russia	120
5	Germany	95
6	Japan	66
7	Brazil	54
8	Romania	50
9	Portugal	46
10	Canada	37

Outcomes for Reports

Serious: 6089
Not Serious: 613
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 1997-09-26

COMBIVIR (LAMIVUDINE; ZIDOVUDINE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with COMBIVIR? Rate COMBIVIR at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for COMBIVIR reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.