Drug

Safinamide Mesylate

65 flagged reaction(s) · 1,691 total co-reports · max PRR 60.1

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	Dyskinesia	153	60.1	67.8	signal
2	Muscle Rigidity	34	45.2	46.4	signal
3	Hypokinesia	38	41.6	42.8	signal
4	Delusion	34	34.9	35.8	signal
5	Hallucination	155	32.9	37.1	signal
6	Hallucination, Visual	38	28.8	29.6	signal
7	Device Occlusion	23	26.3	26.7	signal
8	Dystonia	30	24.5	25.0	signal
9	Anosmia	19	20.8	21.1	signal
10	Motor Dysfunction	12	18.8	19.0	signal
11	Therapeutic Response Shortened	34	17.0	17.4	signal
12	Infusion Site Pain	13	16.2	16.3	signal
13	Embedded Device	10	16.1	16.2	signal
14	Dementia	24	13.7	13.9	signal
15	Joint Dislocation	9	13.6	13.7	signal
16	Psychotic Disorder	25	13.4	13.7	signal
17	Sputum Discoloured	8	13.4	13.5	signal
18	Device Dislocation	36	13.2	13.5	signal
19	Dry Throat	8	12.5	12.6	signal
20	Mobility Decreased	56	12.4	12.9	signal
21	Gait Inability	24	11.5	11.7	signal
22	Head Injury	21	10.6	10.7	signal
23	Dysarthria	25	10.5	10.7	signal
24	Device Issue	56	10.2	10.6	signal
25	Personality Change	6	10.2	10.2	signal
26	Speech Disorder	33	10.0	10.2	signal
27	Unresponsive To Stimuli	16	9.9	10.0	signal
28	Cognitive Disorder	28	9.6	9.7	signal
29	Salivary Hypersecretion	6	9.5	9.6	signal
30	Disorientation	23	9.2	9.3	signal
31	Device Use Issue	10	9.2	9.2	signal
32	Tremor	87	8.3	8.8	signal
33	Dizziness Postural	5	8.3	8.3	signal
34	Restlessness	19	8.2	8.3	signal
35	Gait Disturbance	99	8.2	8.8	signal
36	Unintentional Medical Device Removal	6	8.1	8.2	signal
37	Mental Disorder	22	8.0	8.1	signal
38	Fall	166	7.9	8.9	signal
39	Aggression	25	7.9	8.0	signal
40	Apathy	7	7.6	7.7	signal
41	Hip Fracture	15	7.4	7.5	signal
42	Balance Disorder	40	7.3	7.5	signal
43	Incorrect Dose Administered By Device	11	6.9	6.9	signal
44	Epilepsy	13	6.8	6.8	signal
45	Drug Effect Less Than Expected	6	6.8	6.8	signal
46	Serotonin Syndrome	8	6.6	6.7	signal
47	Hypothermia	4	6.3	6.3	signal
48	Depressed Mood	20	6.0	6.1	signal
49	Middle Insomnia	7	6.0	6.0	signal
50	Sopor	5	5.9	6.0	signal
51	Fracture	7	5.9	5.9	signal
52	Mania	6	5.8	5.8	signal
53	Unevaluable Event	25	5.2	5.3	signal
54	Wrong Technique In Device Usage Process	15	5.2	5.3	signal
55	Tendon Rupture	4	5.1	5.1	signal
56	Parkinsonism	3	4.9	4.9	signal
57	Prostatic Specific Antigen Increased	4	4.6	4.6	signal
58	Device Difficult To Use	18	4.3	4.4	signal
59	Device Delivery System Issue	7	4.2	4.3	signal
60	Product Adhesion Issue	8	3.6	3.6	signal
61	Extrapyramidal Disorder	5	3.2	3.2	signal
62	Device Breakage	6	2.4	2.4	no signal
63	Device Leakage	5	1.9	1.9	no signal
64	Device Use Error	3	1.4	1.4	no signal
65	Drug Dose Omission By Device	3	0.6	0.6	no signal