OpenPV Signal Explorer
FAERS disproportionality dashboard
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Drug

Rilpivirine

147 flagged reaction(s) · 6,391 total co-reports · max PRR 43.2
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 Injection Site Nodule 157 43.2 44.2 signal
2 Product Complaint 177 21.3 21.8 signal
3 Injection Site Discomfort 68 19.8 19.9 signal
4 Drug Resistance 150 17.5 17.9 signal
5 Nodule 63 14.4 14.6 signal
6 Drug Level Decreased 41 12.0 12.1 signal
7 Injection Site Induration 42 9.7 9.7 signal
8 Product Administered At Inappropriate Site 58 9.5 9.6 signal
9 Exposure During Pregnancy 172 8.3 8.4 signal
10 Hepatitis C 32 7.8 7.9 signal
11 Product Dose Omission Issue 669 7.0 7.6 signal
12 Product Administration Error 46 6.9 6.9 signal
13 Wrong Technique In Device Usage Process 103 6.7 6.8 signal
14 Injection Site Pain 673 6.6 7.2 signal
15 Treatment Failure 172 6.3 6.4 signal
16 Injection Site Mass 77 6.2 6.3 signal
17 Product Storage Error 176 6.1 6.2 signal
18 Treatment Noncompliance 103 5.7 5.7 signal
19 Nephropathy Toxic 20 5.4 5.4 signal
20 Erectile Dysfunction 45 5.2 5.2 signal
21 Abscess 27 5.1 5.1 signal
22 Glomerular Filtration Rate Decreased 20 4.9 4.9 signal
23 Sciatica 26 4.9 4.9 signal
24 Tuberculosis 21 4.9 4.9 signal
25 Injection Site Warmth 31 4.5 4.5 signal
26 Incorrect Route Of Product Administration 24 4.3 4.3 signal
27 Abortion Spontaneous 54 4.0 4.0 signal
28 Product Dispensing Error 29 4.0 4.0 signal
29 Psychotic Disorder 38 3.8 3.9 signal
30 Injection Site Reaction 87 3.8 3.8 signal
31 Neurotoxicity 21 3.6 3.6 signal
32 Liver Function Test Increased 24 3.4 3.4 signal
33 Poor Quality Product Administered 11 3.2 3.2 signal
34 Gait Inability 35 3.2 3.2 signal
35 Weight Fluctuation 11 3.1 3.2 signal
36 Musculoskeletal Pain 55 3.1 3.1 signal
37 Inappropriate Schedule Of Product Administration 184 3.1 3.2 signal
38 Exposure Via Skin Contact 23 3.0 3.0 signal
39 Drug Interaction 155 2.9 3.0 signal
40 Injection Site Swelling 74 2.9 2.9 signal
41 Muscle Atrophy 12 2.8 2.8 signal
42 Presyncope 23 2.8 2.8 signal
43 Mass 13 2.8 2.8 signal
44 Eyelid Ptosis 9 2.6 2.6 signal
45 Injection Site Extravasation 11 2.6 2.6 signal
46 Product Preparation Error 18 2.6 2.6 signal
47 Eyelid Oedema 10 2.5 2.5 signal
48 Abortion Induced 8 2.5 2.5 signal
49 Feeling Hot 51 2.5 2.5 signal
50 Hepatitis 20 2.3 2.3 signal
51 Injection Site Haematoma 11 2.2 2.2 signal
52 Lactic Acidosis 24 2.2 2.2 signal
53 Therapy Change 7 2.2 2.2 no signal
54 Drug Level Increased 12 2.2 2.2 signal
55 Depressed Mood 38 2.2 2.2 signal
56 Hepatotoxicity 16 2.2 2.2 signal
57 Aggression 36 2.1 2.1 signal
58 Lymphoma 11 2.1 2.1 signal
59 Neoplasm 8 2.1 2.1 no signal
60 Circumstance Or Information Capable Of Leading To Medication Error 23 2.0 2.0 signal
61 Foetal Exposure During Pregnancy 54 2.0 2.0 no signal
62 Hepatic Cytolysis 8 2.0 2.0 no signal
63 Myalgia 107 1.9 1.9 no signal
64 Premature Baby 19 1.9 1.9 no signal
65 Pharyngeal Swelling 6 1.9 1.9 no signal
66 Mood Altered 17 1.9 1.9 no signal
67 Depression 142 1.9 1.9 no signal
68 Discomfort 36 1.8 1.8 no signal
69 Influenza Like Illness 49 1.8 1.8 no signal
70 Emphysema 6 1.8 1.8 no signal
71 Peripheral Coldness 8 1.7 1.7 no signal
72 Syncope 58 1.7 1.7 no signal
73 Oral Discomfort 8 1.7 1.7 no signal
74 Anaphylactic Reaction 31 1.7 1.7 no signal
75 Type 2 Diabetes Mellitus 18 1.6 1.6 no signal
76 Night Sweats 17 1.6 1.6 no signal
77 Economic Problem 8 1.5 1.5 no signal
78 Pain 319 1.5 1.6 no signal
79 Skin Lesion 14 1.5 1.5 no signal
80 Splenomegaly 6 1.5 1.5 no signal
81 Abnormal Dreams 14 1.5 1.5 no signal
82 Pneumocystis Jirovecii Pneumonia 5 1.5 1.5 no signal
83 Toxic Skin Eruption 5 1.5 1.5 no signal
84 Helicobacter Infection 5 1.5 1.5 no signal
85 Flushing 50 1.5 1.5 no signal
86 Paraesthesia Oral 7 1.5 1.5 no signal
87 Hyperbilirubinaemia 5 1.4 1.4 no signal
88 Mental Disorder 21 1.4 1.4 no signal
89 Electrocardiogram Qt Prolonged 17 1.4 1.4 no signal
90 Diabetes Mellitus 36 1.4 1.4 no signal
91 Sudden Death 5 1.4 1.4 no signal
92 Scar 8 1.4 1.4 no signal
93 Mobility Decreased 33 1.4 1.4 no signal
94 Ill-defined Disorder 28 1.4 1.4 no signal
95 Eye Disorder 15 1.4 1.4 no signal
96 Bipolar Disorder 5 1.4 1.4 no signal
97 Anhedonia 12 1.4 1.4 no signal
98 Rash Maculo-papular 10 1.3 1.3 no signal
99 Basal Cell Carcinoma 7 1.3 1.3 no signal
100 Incorrect Dose Administered 99 1.3 1.3 no signal
101 Product Use Issue 82 1.3 1.3 no signal
102 Premature Delivery 7 1.3 1.3 no signal
103 Injection Site Erythema 54 1.3 1.3 no signal
104 Sleep Disorder Due To A General Medical Condition 7 1.3 1.3 no signal
105 Nightmare 15 1.3 1.3 no signal
106 Underdose 31 1.3 1.3 no signal
107 Haematoma 11 1.3 1.3 no signal
108 Leukopenia 21 1.3 1.3 no signal
109 Polyneuropathy 5 1.3 1.3 no signal
110 Hyperhidrosis 54 1.2 1.2 no signal
111 Gynaecomastia 13 1.2 1.2 no signal
112 Inability To Afford Medication 4 1.2 1.2 no signal
113 Suicidal Ideation 37 1.2 1.2 no signal
114 Eosinophilia 7 1.2 1.2 no signal
115 Suicide Attempt 24 1.2 1.2 no signal
116 Incorrect Product Administration Duration 8 1.2 1.2 no signal
117 Lip Swelling 13 1.2 1.2 no signal
118 Product Use Complaint 6 1.2 1.2 no signal
119 Nervous System Disorder 12 1.1 1.1 no signal
120 Therapeutic Response Unexpected 17 1.1 1.1 no signal
121 Fistula 4 1.1 1.1 no signal
122 Injury Associated With Device 7 1.0 1.0 no signal
123 Wrong Technique In Product Usage Process 70 1.0 1.0 no signal
124 Injection Site Pruritus 23 1.0 1.0 no signal
125 Ocular Hyperaemia 16 1.0 1.0 no signal
126 Product Prescribing Error 8 1.0 1.0 no signal
127 Extra Dose Administered 13 1.0 1.0 no signal
128 Cardiovascular Disorder 8 0.9 0.9 no signal
129 Anaphylactic Shock 8 0.9 0.9 no signal
130 Mania 5 0.9 0.9 no signal
131 Oesophageal Carcinoma 9 0.9 0.9 no signal
132 Unintended Pregnancy 3 0.9 0.9 no signal
133 Hepatocellular Injury 4 0.8 0.8 no signal
134 Accidental Exposure To Product 27 0.8 0.8 no signal
135 Injection Site Discolouration 3 0.7 0.7 no signal
136 Injection Site Rash 7 0.7 0.7 no signal
137 Injection Site Haemorrhage 18 0.7 0.7 no signal
138 Product Taste Abnormal 3 0.7 0.7 no signal
139 Osteonecrosis 7 0.6 0.6 no signal
140 Extrapyramidal Disorder 5 0.6 0.6 no signal
141 Syringe Issue 3 0.5 0.5 no signal
142 Completed Suicide 13 0.5 0.5 no signal
143 Menstruation Irregular 4 0.4 0.4 no signal
144 Prostate Cancer 12 0.4 0.4 no signal
145 Incorrect Dose Administered By Device 3 0.4 0.4 no signal
146 Device Use Error 3 0.3 0.3 no signal
147 Device Difficult To Use 4 0.2 0.2 no signal