Drug

Dolutegravir Sodium And Lamivudine

79 flagged reaction(s) · 3,597 total co-reports · max PRR 50.0

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Product Dose Omission In Error	224	50.0	53.3	signal
2	Intentional Dose Omission	109	23.8	24.5	signal
3	Product Dose Omission Issue	1,093	22.9	32.7	signal
4	Anhedonia	92	20.7	21.2	signal
5	Osteopenia	38	14.8	15.0	signal
6	Inability To Afford Medication	17	10.3	10.3	signal
7	Treatment Noncompliance	89	9.7	10.0	signal
8	Neurotoxicity	26	8.9	9.0	signal
9	Inappropriate Schedule Of Product Administration	256	8.6	9.2	signal
10	Osteoporosis	58	8.4	8.5	signal
11	Bone Density Decreased	41	7.7	7.8	signal
12	Helicobacter Infection	12	7.0	7.0	signal
13	Extra Dose Administered	46	6.9	6.9	signal
14	Product Use Issue	195	6.2	6.5	signal
15	Vitamin D Deficiency	10	6.1	6.1	signal
16	Adverse Drug Reaction	89	5.9	6.0	signal
17	Glomerular Filtration Rate Decreased	12	5.9	5.9	signal
18	Hepatitis C	11	5.4	5.4	signal
19	Nephropathy	8	5.1	5.1	signal
20	Economic Problem	13	5.0	5.0	signal
21	Emotional Distress	102	5.0	5.1	signal
22	Chronic Kidney Disease	61	4.7	4.8	signal
23	Foot Fracture	15	4.7	4.7	signal
24	Depressed Mood	41	4.6	4.7	signal
25	Renal Impairment	60	4.3	4.3	signal
26	Dysstasia	20	4.1	4.1	signal
27	Exposure During Pregnancy	41	3.9	4.0	signal
28	Secretion Discharge	8	3.8	3.9	signal
29	Illness	64	3.8	3.8	signal
30	Abortion Induced	6	3.8	3.8	signal
31	Brain Fog	9	3.7	3.7	signal
32	Splenomegaly	7	3.6	3.6	signal
33	Wrist Fracture	7	3.5	3.5	signal
34	Proteinuria	11	3.5	3.5	signal
35	Erectile Dysfunction	15	3.5	3.5	signal
36	Peripheral Coldness	8	3.5	3.5	signal
37	Nightmare	20	3.4	3.4	signal
38	Gastritis	15	3.4	3.4	signal
39	Renal Pain	6	3.4	3.4	signal
40	Blood Triglycerides Increased	10	3.4	3.4	signal
41	Decreased Activity	6	3.3	3.3	signal
42	Tooth Fracture	6	3.2	3.2	signal
43	Anxiety	155	3.2	3.3	signal
44	Multiple Fractures	9	3.2	3.2	signal
45	Transaminases Increased	12	3.2	3.2	signal
46	Injection Site Induration	7	3.2	3.2	signal
47	Quality Of Life Decreased	7	3.1	3.1	signal
48	Product Administration Error	10	3.0	3.0	signal
49	Tuberculosis	6	2.8	2.8	signal
50	Bipolar Disorder	5	2.7	2.7	no signal
51	Osteonecrosis	15	2.7	2.7	signal
52	Incorrect Dose Administered	98	2.6	2.6	signal
53	Renal Injury	13	2.6	2.6	signal
54	Drug Resistance	11	2.5	2.6	signal
55	Lower Limb Fracture	8	2.5	2.5	signal
56	Therapy Change	4	2.5	2.5	no signal
57	Face Oedema	7	2.5	2.5	signal
58	Bone Loss	6	2.3	2.4	no signal
59	Foetal Exposure During Pregnancy	32	2.3	2.4	signal
60	Skeletal Injury	4	2.3	2.3	no signal
61	Therapeutic Response Unexpected	17	2.2	2.3	signal
62	Musculoskeletal Disorder	7	2.2	2.2	no signal
63	Cytomegalovirus Infection	6	2.1	2.1	no signal
64	Abnormal Dreams	10	2.1	2.1	signal
65	Hospitalisation	54	2.1	2.1	signal
66	Suicidal Ideation	32	2.1	2.1	signal
67	Premature Baby	10	2.0	2.0	no signal
68	Sars-cov-2 Test Positive	4	1.8	1.8	no signal
69	Abortion Spontaneous	12	1.8	1.8	no signal
70	Toxic Skin Eruption	3	1.8	1.8	no signal
71	Circumstance Or Information Capable Of Leading To Medication Error	9	1.6	1.6	no signal
72	Neoplasm Malignant	17	1.5	1.5	no signal
73	Injection Site Discolouration	3	1.4	1.4	no signal
74	Product Complaint	6	1.4	1.4	no signal
75	Injection Site Mass	5	0.8	0.8	no signal
76	Renal Cancer	5	0.6	0.6	no signal
77	Gynaecomastia	3	0.6	0.6	no signal
78	Myelosuppression	3	0.5	0.5	no signal
79	Prostate Cancer	5	0.4	0.4	no signal