Drug

Buprenorphine And Naloxone

49 flagged reaction(s) · 1,059 total co-reports · max PRR 56.6

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	Dental Caries	36	56.6	58.3	signal
2	Withdrawal Syndrome	76	31.2	33.2	signal
3	Tooth Fracture	15	23.6	23.9	signal
4	Product Substitution Issue	78	23.5	25.0	signal
5	Injection Site Reaction	91	23.0	24.8	signal
6	Tooth Loss	25	20.7	21.2	signal
7	Product Packaging Quantity Issue	12	19.0	19.2	signal
8	Cardio-respiratory Arrest	42	17.3	17.9	signal
9	Drug Abuse	71	14.7	15.5	signal
10	Drug Withdrawal Syndrome	73	14.2	15.1	signal
11	Drug Withdrawal Syndrome Neonatal	12	13.9	14.0	signal
12	Bipolar Disorder	8	12.6	12.7	signal
13	Serotonin Syndrome	13	11.8	11.9	signal
14	Restless Legs Syndrome	12	11.4	11.5	signal
15	Respiratory Depression	8	11.3	11.4	signal
16	Respiratory Arrest	18	11.2	11.4	signal
17	Oral Discomfort	9	11.2	11.3	signal
18	Therapy Change	6	10.8	10.8	signal
19	Incorrect Route Of Product Administration	10	10.3	10.4	signal
20	Euphoric Mood	6	10.1	10.1	signal
21	Renal Pain	6	9.8	9.9	signal
22	Poisoning	7	9.6	9.7	signal
23	Insurance Issue	8	9.3	9.4	signal
24	Product Taste Abnormal	7	9.0	9.1	signal
25	Product Dispensing Error	11	8.8	8.8	signal
26	Restlessness	18	8.5	8.6	signal
27	Tooth Extraction	6	8.3	8.4	signal
28	Product Physical Issue	9	7.8	7.9	signal
29	Product Prescribing Issue	9	7.7	7.7	signal
30	Toothache	8	7.7	7.7	signal
31	Premature Delivery	7	7.6	7.6	signal
32	Hyperhidrosis	55	7.4	7.7	signal
33	Libido Decreased	5	7.0	7.0	signal
34	Tooth Disorder	9	7.0	7.0	signal
35	Toxicity To Various Agents	67	6.9	7.3	signal
36	Cold Sweat	7	6.9	6.9	signal
37	Product Use Complaint	6	6.7	6.7	signal
38	Completed Suicide	31	6.4	6.5	signal
39	Apathy	5	6.0	6.0	signal
40	Mydriasis	4	5.4	5.4	signal
41	Poor Quality Product Administered	3	5.1	5.1	signal
42	Exposure During Pregnancy	16	4.5	4.5	signal
43	Drug Dependence	40	4.3	4.4	signal
44	Wrong Technique In Product Usage Process	41	3.5	3.6	signal
45	Product Quality Issue	27	3.5	3.5	signal
46	Foetal Exposure During Pregnancy	16	3.4	3.4	signal
47	Dystonia	3	2.7	2.7	no signal
48	Intentional Drug Misuse	3	2.4	2.5	no signal
49	Dependence	4	1.2	1.2	no signal