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Drug

Naltrexone Hydrochloride

79 flagged reaction(s) · 1,434 total co-reports · max PRR 62.8
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 Hyperlipidaemia 53 62.8 65.0 signal
2 Impaired Quality Of Life 62 61.1 63.8 signal
3 Poor Quality Sleep 71 47.0 49.3 signal
4 Impaired Work Ability 60 39.6 41.3 signal
5 Oral Herpes 53 38.6 40.0 signal
6 Skin Disorder 55 23.4 24.3 signal
7 Bone Density Decreased 50 22.3 23.1 signal
8 Serotonin Syndrome 26 19.2 19.6 signal
9 Insurance Issue 17 16.2 16.4 signal
10 Cellulitis 57 16.0 16.6 signal
11 Herpes Zoster 60 14.7 15.3 signal
12 Infusion Site Pain 13 14.4 14.5 signal
13 Cataract 58 13.8 14.4 signal
14 Blood Triglycerides Increased 16 12.8 12.9 signal
15 Joint Range Of Motion Decreased 12 12.7 12.8 signal
16 Dermatitis Contact 10 12.5 12.5 signal
17 Thinking Abnormal 16 12.1 12.2 signal
18 Musculoskeletal Chest Pain 13 11.9 12.0 signal
19 Inflammatory Bowel Disease 8 11.5 11.6 signal
20 Viral Infection 26 11.1 11.2 signal
21 Blood Glucose Abnormal 13 9.9 10.0 signal
22 Scratch 7 9.6 9.6 signal
23 Head Injury 21 9.4 9.5 signal
24 Contusion 62 9.1 9.5 signal
25 Seasonal Allergy 9 9.0 9.1 signal
26 Skin Infection 7 8.9 8.9 signal
27 Gastroenteritis Viral 11 8.6 8.6 signal
28 Initial Insomnia 6 8.3 8.3 signal
29 Bursitis 7 8.2 8.2 signal
30 Panic Attack 21 8.1 8.2 signal
31 Rhabdomyolysis 23 7.8 7.9 signal
32 Blood Pressure Systolic Increased 10 7.2 7.3 signal
33 Drug Effect Less Than Expected 7 7.0 7.0 signal
34 Pancreatitis Acute 11 7.0 7.0 signal
35 Middle Insomnia 9 6.8 6.9 signal
36 Illness 47 6.6 6.8 signal
37 Pharyngitis Streptococcal 5 6.5 6.5 signal
38 Injection Site Mass 17 6.5 6.6 signal
39 Frequent Bowel Movements 12 6.3 6.3 signal
40 Pallor 12 6.2 6.3 signal
41 Hallucination, Auditory 7 6.2 6.2 signal
42 Contraindicated Product Administered 13 6.1 6.1 signal
43 Withdrawal Syndrome 18 6.0 6.1 signal
44 Hepatic Cytolysis 5 5.8 5.8 signal
45 Drug Reaction With Eosinophilia And Systemic Symptoms 10 5.5 5.6 signal
46 Hereditary Angioedema 4 5.4 5.4 signal
47 Product Prescribing Error 9 5.4 5.4 signal
48 Coma 18 5.3 5.4 signal
49 Eye Pruritus 12 5.1 5.2 signal
50 Intentional Self-injury 7 4.9 4.9 signal
51 Pregnancy 7 4.9 4.9 signal
52 Suicidal Ideation 31 4.8 4.9 signal
53 Colitis Ulcerative 15 4.8 4.8 signal
54 Abnormal Behaviour 13 4.6 4.6 signal
55 Psychotic Disorder 9 4.3 4.3 signal
56 Complication Associated With Device 4 4.3 4.3 signal
57 Ovarian Cyst 3 4.2 4.2 signal
58 Euphoric Mood 3 4.1 4.1 signal
59 Hepatocellular Injury 4 4.0 4.0 signal
60 Completed Suicide 23 3.9 3.9 signal
61 Injection Site Nodule 3 3.9 3.9 no signal
62 Sedation 7 3.8 3.8 signal
63 Product Preparation Error 5 3.4 3.4 signal
64 Abasia 6 3.4 3.4 signal
65 Suicide Attempt 14 3.3 3.3 signal
66 Drug Toxicity 3 3.1 3.1 no signal
67 Dermatitis Atopic 10 2.8 2.8 signal
68 Multiple Sclerosis Relapse 13 2.7 2.7 signal
69 Drug Abuse 14 2.4 2.4 signal
70 Therapeutic Response Shortened 5 2.2 2.2 no signal
71 Drug Withdrawal Syndrome 13 2.1 2.1 signal
72 Injection Site Warmth 3 2.1 2.1 no signal
73 Multiple Sclerosis 7 2.1 2.1 no signal
74 Tardive Dyskinesia 4 2.0 2.0 no signal
75 Intentional Overdose 8 1.8 1.8 no signal
76 Injection Site Pain 35 1.6 1.6 no signal
77 Breast Cancer Female 3 1.6 1.6 no signal
78 Wrong Technique In Device Usage Process 4 1.2 1.2 no signal
79 Drug Dependence 9 0.8 0.8 no signal