Drug

Baclofen Injection

68 flagged reaction(s) · 4,167 total co-reports · max PRR 446.2

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	Muscle Spasticity	764	446.2	592.6	signal
2	Device Failure	154	69.7	73.3	signal
3	Withdrawal Syndrome	410	66.6	76.7	signal
4	Hypotonia	79	53.9	55.3	signal
5	Muscle Tightness	81	34.2	35.1	signal
6	Device Occlusion	65	31.9	32.6	signal
7	Device Issue	376	29.4	33.3	signal
8	Drug Withdrawal Syndrome	272	20.9	22.8	signal
9	Device Malfunction	151	15.3	16.0	signal
10	Muscle Rigidity	25	14.2	14.3	signal
11	Mental Status Changes	51	12.5	12.7	signal
12	Device Dislocation	77	12.1	12.4	signal
13	Device Breakage	63	10.9	11.1	signal
14	Unresponsive To Stimuli	32	8.5	8.5	signal
15	Complication Associated With Device	16	8.2	8.3	signal
16	Infection	163	7.7	8.1	signal
17	Underdose	79	7.4	7.5	signal
18	Staphylococcal Infection	34	7.0	7.0	signal
19	Drug Effect Decreased	51	6.3	6.4	signal
20	Aspiration	10	6.3	6.3	signal
21	Agitation	67	6.2	6.3	signal
22	Device Leakage	38	6.1	6.2	signal
23	Therapy Non-responder	40	6.1	6.2	signal
24	No Therapeutic Response	11	6.0	6.1	signal
25	Hypothermia	9	6.0	6.0	signal
26	Irritability	52	5.9	6.0	signal
27	Musculoskeletal Stiffness	73	5.7	5.8	signal
28	Dystonia	16	5.6	5.6	signal
29	Muscle Spasms	146	5.4	5.6	signal
30	Overdose	170	5.3	5.6	signal
31	Muscle Twitching	17	5.0	5.0	signal
32	Respiratory Depression	9	5.0	5.0	signal
33	Device Related Infection	11	4.8	4.9	signal
34	Salivary Hypersecretion	7	4.8	4.8	signal
35	Sedation	17	4.4	4.5	signal
36	Depressed Level Of Consciousness	25	4.3	4.3	signal
37	Lethargy	36	4.3	4.3	signal
38	Osteomyelitis	10	3.8	3.8	signal
39	Wound Infection	6	3.8	3.8	signal
40	Hypokinesia	8	3.7	3.7	signal
41	Discomfort	33	3.7	3.7	signal
42	Dyskinesia	22	3.7	3.7	signal
43	Urinary Retention	18	3.7	3.7	signal
44	Therapy Change	5	3.5	3.5	signal
45	Seizure	53	3.1	3.2	signal
46	Therapeutic Response Decreased	26	2.9	2.9	signal
47	Hyperhidrosis	54	2.8	2.9	signal
48	Drug Administration Error	13	2.8	2.8	signal
49	Scar	7	2.8	2.8	signal
50	Bladder Disorder	4	2.7	2.7	no signal
51	Limb Discomfort	12	2.6	2.6	signal
52	Respiratory Arrest	10	2.4	2.4	signal
53	Incorrect Dose Administered By Device	9	2.4	2.4	signal
54	Unevaluable Event	26	2.3	2.3	signal
55	No Adverse Event	58	2.2	2.2	signal
56	Product Dispensing Error	7	2.2	2.2	no signal
57	Personality Change	3	2.2	2.2	no signal
58	Abasia	8	2.2	2.2	no signal
59	Musculoskeletal Disorder	6	2.1	2.1	no signal
60	Activities Of Daily Living Impaired	6	2.0	2.0	no signal
61	Device Deployment Issue	3	1.7	1.7	no signal
62	Product Dose Omission	14	1.4	1.4	no signal
63	Drug Dispensing Error	3	1.3	1.3	no signal
64	Incorrect Route Of Drug Administration	7	1.3	1.3	no signal
65	Drug Dose Omission	28	1.1	1.1	no signal
66	Device Delivery System Issue	4	1.0	1.0	no signal
67	Drug Dose Omission By Device	4	0.4	0.4	no signal
68	Device Difficult To Use	3	0.3	0.3	no signal