Drug
Naltrexone Hydrochloride
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 |