FDA Adverse Events Reports (FAERS) Summary for VEMLIDY

These tables and charts are based on 2,714 total reports for VEMLIDY (TENOFOVIR ALAFENAMIDE FUMARATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 2,209 pharmaceutical company-submitted and non-U.S. FAERS reports and 505 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 505 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch VEMLIDY summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	PRODUCT DOSE OMISSION ISSUE	128
2	DEATH	126
3	OFF LABEL USE	104
4	FATIGUE	96
5	HEADACHE	79
6	DRUG INEFFECTIVE	70
7	PRODUCT DOSE OMISSION	70
8	INTENTIONAL DOSE OMISSION	65
9	DIARRHEA	63
10	PRODUCT USE ISSUE	63
11	NAUSEA	60
12	RASH	57
13	PAIN	56
14	ITCHING	52
15	DIZZINESS	49
16	JOINT PAIN	46
17	KIDNEY IMPAIRMENT	46
18	HEPATITIS B	44
19	DIFFICULTY SWALLOWING	43
20	COVID-19	42
21	PRODUCT STORAGE ERROR	42
22	BACK PAIN	41
23	HOSPITALIZATION	39
24	PNEUMONIA	39
25	LACK OF STRENGTH AND ENERGY (ASTHENIA)	38
26	MATERNAL EXPOSURE DURING PREGNANCY	37
27	CHRONIC KIDNEY DISEASE	36
28	HEPATITIS B DNA INCREASED	32
29	HEPATOCELLULAR CARCINOMA	32
30	ALT LIVER ENZYME INCREASED	31
31	SHORTNESS OF BREATH	31
32	VOMITING	30
33	DECREASED APPETITE	29
34	PLATELET COUNT DECREASED	29
35	FEVER	29
36	ABDOMINAL PAIN UPPER	28
37	KIDNEY FAILURE	28
38	INTENTIONAL PRODUCT USE ISSUE	26
39	VIRAL LOAD INCREASED	26
40	ANXIETY	25
41	HEPATIC CANCER	25
42	ABDOMINAL PAIN	24
43	ACUTE KIDNEY INJURY	24
44	COUGH	24
45	PRODUCT DISPENSING ERROR	24
46	THERAPY CESSATION	24
47	WEIGHT DECREASED	24
48	HAIR LOSS	23
49	HIGH BLOOD PRESSURE	23
50	EMOTIONAL DISTRESS	22
51	INSOMNIA	22
52	MALAISE	22
53	LIVER FUNCTION ABNORMAL	21
54	KIDNEY DISORDER	21
55	ABDOMINAL DISTENSION	20
56	LOSS OF ALL PLEASURE	20
57	FALL	20
58	THERAPY INTERRUPTED	20
59	TREATMENT NONCOMPLIANCE	20
60	INDIGESTION	19
61	LIVER DISORDER	19
62	OSTEOPOROSIS	19
63	PRODUCT USE IN UNAPPROVED INDICATION	19
64	ANEMIA	18
65	DRUG INTERACTION	18
66	LIVER CIRRHOSIS	18
67	HEPATITIS B REACTIVATION	18
68	MUSCLE PAIN	18
69	ELEVATED LIVER ENZYMES	18
70	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	18
71	BONE PAIN	17
72	NUMBNESS	17
73	ELEVATED LIVER ENZYMES	17
74	CANCER MALIGNANT	17
75	PAIN IN EXTREMITY	17
76	PRODUCT DOSE OMISSION IN ERROR	17
77	ABDOMINAL DISCOMFORT	16
78	STROKE	16
79	CONSTIPATION	16
80	FANCONI SYNDROME ACQUIRED	16
81	ELEVATED LIVER ENZYMES	16
82	WEIGHT INCREASED	16
83	BLOOD CREATININE INCREASED	15
84	DEPRESSION	15
85	LIVER FAILURE	15
86	JAUNDICE	15
87	NO ADVERSE EVENT	15
88	PALPITATIONS	15
89	SEPSIS	15
90	URINARY TRACT INFECTION	15
91	WHITE BLOOD CELL COUNT DECREASED	15
92	CHEST DISCOMFORT	14
93	FOETAL EXPOSURE DURING PREGNANCY	14
94	HEPATITIS B DNA ASSAY POSITIVE	14
95	LIVER TRANSPLANT	14
96	MUSCULAR WEAKNESS	14
97	DROWSINESS	14
98	SURGERY	14
99	UNEVALUABLE EVENT	14
100	SWOLLEN ABDOMEN	13

Latest Known Outcomes for Reactions Reported for VEMLIDY

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1360
2	Patient has not recovered/symtoms have not resolved	617
3	Patient recovered	487
4	Patient is recovering/symptoms resolving	227
5	Patient died	158
6	Patient has recovered but has consequent health issues	10

Search all MedWatch and FAERS by keyword:

VEMLIDY Total Reports

Male	Female	Unknown	Total
1533	1026	155	2,714

Top Countries Reporting

	Country	Number of Reports
1	United States	1680
2	Japan	647
3	China	100
4	Switzerland	44
5	South Korea	43
6	Turkey	36
7	Taiwan	32
8	Italy	23
9	EU	16
10	Canada	9

Outcomes for Reports

Serious: 1584
Not Serious: 1128
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

Hepatitis B
Hepatitis B reactivation
Product used for unknown indication
Chronic hepatitis B
LIVER CIRRHOSIS

Top Companies Reporting

GILEAD

Safety-Related FDA Updates

VEMLIDY (TENOFOVIR ALAFENAMIDE FUMARATE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with VEMLIDY? Rate VEMLIDY 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 VEMLIDY 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.