Drug

Dolutegravir Sodium And Rilpivirine Hydrochloride

64 flagged reaction(s) · 3,165 total co-reports · max PRR 115.2

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	Anhedonia	251	115.2	134.4	signal
2	Economic Problem	84	66.0	69.3	signal
3	Osteopenia	69	54.7	56.9	signal
4	End Stage Renal Disease	83	54.5	57.2	signal
5	Decreased Activity	32	36.1	36.7	signal
6	Quality Of Life Decreased	40	35.9	36.8	signal
7	Chronic Kidney Disease	203	32.0	36.0	signal
8	Bone Density Decreased	83	31.6	33.2	signal
9	Emotional Distress	278	27.6	32.7	signal
10	Osteoporosis	92	26.9	28.4	signal
11	Nephropathy	17	21.8	22.0	signal
12	Multiple Fractures	29	21.1	21.4	signal
13	Vitamin D Deficiency	15	18.5	18.7	signal
14	Proteinuria	29	18.5	18.8	signal
15	Glomerular Filtration Rate Decreased	17	16.9	17.1	signal
16	Tooth Loss	26	15.0	15.2	signal
17	Loss Of Personal Independence In Daily Activities	55	13.9	14.4	signal
18	Foot Fracture	20	12.7	12.8	signal
19	Product Dose Omission Issue	295	12.5	14.8	signal
20	Renal Tubular Necrosis	10	12.3	12.3	signal
21	Anxiety	285	12.0	14.2	signal
22	Renal Failure	132	11.9	12.8	signal
23	Blood Creatinine Increased	64	11.8	12.2	signal
24	Bone Loss	14	11.1	11.2	signal
25	Renal Impairment	77	11.1	11.6	signal
26	Dialysis	12	10.2	10.2	signal
27	Ankle Fracture	13	10.1	10.2	signal
28	Skeletal Injury	8	9.2	9.2	signal
29	Rib Fracture	15	8.8	8.9	signal
30	Renal Pain	7	8.0	8.0	signal
31	Renal Disorder	29	7.5	7.6	signal
32	Inability To Afford Medication	6	7.3	7.4	signal
33	Renal Injury	18	7.2	7.3	signal
34	Polyneuropathy	7	7.1	7.1	signal
35	Peripheral Coldness	8	7.0	7.0	signal
36	Hepatitis C	7	6.9	6.9	signal
37	Acute Kidney Injury	87	6.9	7.2	signal
38	Drug Resistance	14	6.6	6.6	signal
39	Arteriosclerosis	5	6.4	6.4	signal
40	Depression	120	6.3	6.7	signal
41	Therapy Change	5	6.2	6.3	signal
42	Impaired Work Ability	11	6.2	6.2	signal
43	Dysstasia	15	6.2	6.2	signal
44	Decreased Immune Responsiveness	5	6.2	6.2	signal
45	Coeliac Disease	5	6.1	6.1	signal
46	Product Dispensing Error	11	6.1	6.1	signal
47	Pain	311	6.1	7.2	signal
48	Bursitis	6	6.0	6.0	signal
49	Osteonecrosis	16	5.8	5.9	signal
50	Infusion Site Pain	6	5.7	5.7	signal
51	Poisoning Deliberate	4	5.2	5.2	signal
52	Folliculitis	4	4.7	4.7	signal
53	Fracture	7	4.5	4.5	signal
54	Upper Limb Fracture	7	4.2	4.2	signal
55	Exposure During Pregnancy	21	4.1	4.1	signal
56	Hepatic Cytolysis	4	3.9	3.9	signal
57	Product Storage Error	25	3.5	3.5	signal
58	Nephropathy Toxic	3	3.2	3.2	no signal
59	Product Dose Omission In Error	7	3.1	3.1	signal
60	Product Dose Omission	17	3.1	3.1	signal
61	Extra Dose Administered	7	2.1	2.1	no signal
62	Circumstance Or Information Capable Of Leading To Medication Error	5	1.8	1.8	no signal
63	Oesophageal Carcinoma	4	1.6	1.6	no signal
64	Gynaecomastia	3	1.2	1.2	no signal