Drug
Buprenorphine Hydrochloride And Naloxone 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 | Drug Withdrawal Syndrome Neonatal | 82 | 51.1 | 53.0 | signal |
| 2 | Dental Caries | 57 | 48.1 | 49.3 | signal |
| 3 | Withdrawal Syndrome | 113 | 24.9 | 26.2 | signal |
| 4 | Drug Withdrawal Syndrome | 202 | 21.2 | 23.2 | signal |
| 5 | Tooth Loss | 34 | 15.1 | 15.3 | signal |
| 6 | Euphoric Mood | 16 | 14.4 | 14.5 | signal |
| 7 | Product Substitution Issue | 84 | 13.6 | 14.0 | signal |
| 8 | Tooth Fracture | 16 | 13.5 | 13.6 | signal |
| 9 | Oral Discomfort | 20 | 13.4 | 13.5 | signal |
| 10 | Drug Dependence | 230 | 13.1 | 14.5 | signal |
| 11 | Injection Site Reaction | 91 | 12.3 | 12.8 | signal |
| 12 | Restless Legs Syndrome | 22 | 11.2 | 11.3 | signal |
| 13 | Foetal Exposure During Pregnancy | 86 | 9.8 | 10.2 | signal |
| 14 | Product Taste Abnormal | 14 | 9.7 | 9.7 | signal |
| 15 | Drug Abuse | 81 | 9.0 | 9.3 | signal |
| 16 | Cold Sweat | 17 | 8.9 | 9.0 | signal |
| 17 | Toothache | 16 | 8.2 | 8.3 | signal |
| 18 | Therapy Change | 8 | 7.7 | 7.7 | signal |
| 19 | Insurance Issue | 12 | 7.5 | 7.5 | signal |
| 20 | Renal Pain | 8 | 7.0 | 7.1 | signal |
| 21 | Product Packaging Issue | 7 | 7.0 | 7.0 | signal |
| 22 | Hyperhidrosis | 96 | 6.9 | 7.2 | signal |
| 23 | Serotonin Syndrome | 14 | 6.8 | 6.8 | signal |
| 24 | Bipolar Disorder | 8 | 6.8 | 6.8 | signal |
| 25 | Incorrect Route Of Product Administration | 12 | 6.6 | 6.7 | signal |
| 26 | Wrong Technique In Product Usage Process | 142 | 6.5 | 6.9 | signal |
| 27 | Drug Level Decreased | 7 | 6.4 | 6.4 | signal |
| 28 | Restlessness | 25 | 6.3 | 6.4 | signal |
| 29 | Cardio-respiratory Arrest | 28 | 6.2 | 6.2 | signal |
| 30 | Product Dispensing Error | 14 | 6.0 | 6.0 | signal |
| 31 | Product Packaging Quantity Issue | 7 | 6.0 | 6.0 | signal |
| 32 | Impaired Quality Of Life | 9 | 5.8 | 5.8 | signal |
| 33 | Drug Effect Incomplete | 22 | 5.5 | 5.6 | signal |
| 34 | Thinking Abnormal | 11 | 5.5 | 5.5 | signal |
| 35 | Respiratory Depression | 7 | 5.3 | 5.3 | signal |
| 36 | Mouth Ulceration | 12 | 5.3 | 5.3 | signal |
| 37 | Drug Effect Less Than Expected | 8 | 5.3 | 5.3 | signal |
| 38 | Product Physical Issue | 11 | 5.1 | 5.1 | signal |
| 39 | Apathy | 8 | 5.1 | 5.1 | signal |
| 40 | Product Prescribing Error | 13 | 5.1 | 5.1 | signal |
| 41 | Tooth Infection | 7 | 4.9 | 4.9 | signal |
| 42 | Impaired Driving Ability | 6 | 4.9 | 4.9 | signal |
| 43 | Product Use Complaint | 8 | 4.8 | 4.8 | signal |
| 44 | Sexual Dysfunction | 6 | 4.8 | 4.8 | signal |
| 45 | Swollen Tongue | 16 | 4.8 | 4.8 | signal |
| 46 | Oral Pain | 11 | 4.5 | 4.6 | signal |
| 47 | Libido Decreased | 6 | 4.5 | 4.5 | signal |
| 48 | Product Preparation Error | 10 | 4.5 | 4.5 | signal |
| 49 | Mydriasis | 6 | 4.3 | 4.4 | signal |
| 50 | Intentional Product Use Issue | 40 | 4.2 | 4.3 | signal |
| 51 | Exposure During Pregnancy | 28 | 4.2 | 4.2 | signal |
| 52 | Drug Ineffective For Unapproved Indication | 25 | 4.2 | 4.2 | signal |
| 53 | Premature Delivery | 7 | 4.1 | 4.1 | signal |
| 54 | Mental Disorder | 19 | 4.0 | 4.1 | signal |
| 55 | Salivary Hypersecretion | 4 | 3.7 | 3.7 | signal |
| 56 | Pharyngeal Oedema | 6 | 3.6 | 3.6 | signal |
| 57 | Hallucination, Visual | 8 | 3.5 | 3.5 | signal |
| 58 | Feeling Jittery | 7 | 3.4 | 3.4 | signal |
| 59 | Feeling Abnormal | 87 | 3.4 | 3.5 | signal |
| 60 | Tooth Disorder | 8 | 3.3 | 3.3 | signal |
| 61 | Product Availability Issue | 8 | 3.3 | 3.3 | signal |
| 62 | Inappropriate Schedule Of Product Administration | 62 | 3.3 | 3.3 | signal |
| 63 | Therapeutic Response Decreased | 21 | 3.2 | 3.3 | signal |
| 64 | Suicidal Ideation | 31 | 3.1 | 3.2 | signal |
| 65 | Hepatitis C | 4 | 3.0 | 3.0 | no signal |
| 66 | Impaired Work Ability | 7 | 3.0 | 3.0 | signal |
| 67 | Toxicity To Various Agents | 54 | 3.0 | 3.0 | signal |
| 68 | Emotional Distress | 39 | 3.0 | 3.0 | signal |
| 69 | Irritability | 19 | 2.9 | 2.9 | signal |
| 70 | Glossodynia | 7 | 2.9 | 2.9 | signal |
| 71 | Injection Site Induration | 4 | 2.9 | 2.9 | no signal |
| 72 | Maternal Exposure During Pregnancy | 27 | 2.8 | 2.9 | signal |
| 73 | Completed Suicide | 25 | 2.8 | 2.8 | signal |
| 74 | Product Quality Issue | 40 | 2.8 | 2.8 | signal |
| 75 | Overdose | 63 | 2.7 | 2.7 | signal |
| 76 | Drug Effective For Unapproved Indication | 8 | 2.5 | 2.5 | signal |
| 77 | Dependence | 15 | 2.5 | 2.5 | signal |
| 78 | Hallucination, Auditory | 4 | 2.3 | 2.3 | no signal |
| 79 | Mania | 4 | 2.3 | 2.3 | no signal |
| 80 | Injection Site Extravasation | 3 | 2.2 | 2.2 | no signal |
| 81 | Drug Effect Decreased | 13 | 2.2 | 2.2 | signal |
| 82 | Device Occlusion | 3 | 2.0 | 2.0 | no signal |
| 83 | Drug Prescribing Error | 4 | 1.9 | 1.9 | no signal |
| 84 | Drug Dispensing Error | 3 | 1.8 | 1.8 | no signal |
| 85 | Drug Administration Error | 6 | 1.8 | 1.8 | no signal |
| 86 | Extra Dose Administered | 7 | 1.6 | 1.6 | no signal |
| 87 | Dystonia | 3 | 1.4 | 1.4 | no signal |
| 88 | Incorrect Route Of Drug Administration | 4 | 1.0 | 1.0 | no signal |