Drug

Fluvoxamine Maleate

142 flagged reaction(s) · 2,842 total co-reports · max PRR 37.3

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	Serotonin Syndrome	81	37.3	38.6	signal
2	Neuroleptic Malignant Syndrome	33	24.4	24.7	signal
3	Drug Toxicity	30	19.1	19.3	signal
4	Blood Lactate Dehydrogenase Increased	30	16.5	16.7	signal
5	Blood Creatine Phosphokinase Increased	55	16.5	16.9	signal
6	Muscle Rigidity	21	15.4	15.6	signal
7	Akathisia	23	14.8	14.9	signal
8	Inappropriate Antidiuretic Hormone Secretion	17	14.7	14.8	signal
9	Drug Level Increased	26	13.8	13.9	signal
10	Bipolar Disorder	17	13.6	13.7	signal
11	Myoclonus	18	13.3	13.4	signal
12	Sopor	20	13.2	13.3	signal
13	Intentional Self-injury	29	12.6	12.8	signal
14	Drug Interaction	220	12.2	13.3	signal
15	Mydriasis	17	11.7	11.7	signal
16	Suicide Attempt	80	11.6	11.9	signal
17	Schizophrenia	16	11.6	11.6	signal
18	Salivary Hypersecretion	13	11.4	11.5	signal
19	Grand Mal Convulsion	11	10.3	10.4	signal
20	Electrocardiogram Qt Prolonged	42	10.3	10.4	signal
21	Altered State Of Consciousness	25	10.2	10.3	signal
22	Body Temperature Decreased	11	9.7	9.8	signal
23	Suicidal Ideation	100	9.6	10.0	signal
24	Blood Potassium Increased	17	9.2	9.3	signal
25	Blood Thyroid Stimulating Hormone Increased	9	8.6	8.6	signal
26	Restlessness	35	8.4	8.5	signal
27	Paranoia	16	8.1	8.2	signal
28	Parkinsonism	9	8.1	8.1	signal
29	Completed Suicide	69	7.2	7.4	signal
30	Status Epilepticus	9	7.0	7.0	signal
31	Mania	13	6.9	7.0	signal
32	Anorexia	10	6.7	6.7	signal
33	Apathy	11	6.6	6.7	signal
34	Pulmonary Congestion	10	6.6	6.7	signal
35	Intentional Overdose	48	6.6	6.7	signal
36	Alanine Aminotransferase Increased	46	6.6	6.7	signal
37	Orthostatic Hypotension	13	6.5	6.6	signal
38	Respiratory Depression	9	6.4	6.5	signal
39	Delirium	25	6.3	6.4	signal
40	Rhabdomyolysis	30	6.3	6.4	signal
41	Aggression	36	6.3	6.4	signal
42	Agitation	52	6.2	6.3	signal
43	Sinus Tachycardia	10	6.2	6.2	signal
44	Blood Sodium Decreased	13	6.1	6.1	signal
45	Hallucination, Auditory	11	6.1	6.1	signal
46	Initial Insomnia	7	6.0	6.0	signal
47	Extrapyramidal Disorder	17	6.0	6.0	signal
48	Psychotic Disorder	20	5.9	6.0	signal
49	Cardio-respiratory Arrest	28	5.8	5.9	signal
50	Depressed Level Of Consciousness	26	5.8	5.8	signal
51	Sedation	17	5.7	5.8	signal
52	Delusion	10	5.7	5.7	signal
53	Libido Decreased	8	5.7	5.7	signal
54	Brain Oedema	8	5.6	5.6	signal
55	Sleep Apnoea Syndrome	12	5.5	5.5	signal
56	Diplopia	16	5.4	5.4	signal
57	Convulsion	35	5.3	5.4	signal
58	Subarachnoid Haemorrhage	6	5.2	5.2	signal
59	Gamma-glutamyltransferase Increased	13	5.1	5.2	signal
60	Petechiae	6	5.1	5.1	signal
61	Somnolence	115	5.0	5.2	signal
62	Obesity	9	5.0	5.0	signal
63	Disorientation	22	4.9	4.9	signal
64	Abnormal Behaviour	22	4.8	4.9	signal
65	Mental Disorder	24	4.8	4.9	signal
66	Irritability	33	4.8	4.9	signal
67	Metabolic Acidosis	17	4.7	4.7	signal
68	Mental Impairment	13	4.7	4.7	signal
69	Renal Failure Acute	23	4.7	4.7	signal
70	Shock	12	4.6	4.6	signal
71	Hypersomnia	15	4.6	4.6	signal
72	Myocardial Ischaemia	6	4.6	4.6	signal
73	Sinus Bradycardia	5	4.5	4.5	signal
74	Treatment Noncompliance	28	4.5	4.6	signal
75	Drug Eruption	9	4.5	4.5	signal
76	Disturbance In Attention	27	4.4	4.4	signal
77	Tremor	82	4.3	4.4	signal
78	Dyskinesia	20	4.3	4.4	signal
79	Sluggishness	5	4.3	4.3	signal
80	Hepatic Cytolysis	6	4.3	4.3	signal
81	Drug Reaction With Eosinophilia And Systemic Symptoms	12	4.1	4.1	signal
82	Circulatory Collapse	8	4.1	4.1	signal
83	Panic Attack	17	4.1	4.1	signal
84	Pharyngitis Streptococcal	5	4.1	4.1	signal
85	Coma	22	4.1	4.1	signal
86	Epilepsy	14	4.0	4.0	signal
87	Hepatic Function Abnormal	17	4.0	4.0	signal
88	Head Discomfort	8	4.0	4.0	signal
89	Product Substitution Issue	26	4.0	4.0	signal
90	Blood Triglycerides Increased	8	4.0	4.0	signal
91	Hyperhidrosis	57	3.9	4.0	signal
92	Middle Insomnia	8	3.8	3.8	signal
93	Hallucination, Visual	9	3.8	3.8	signal
94	Toxicity To Various Agents	71	3.7	3.8	signal
95	Ataxia	5	3.7	3.7	signal
96	Feeling Jittery	8	3.7	3.7	signal
97	Hepatitis C	5	3.6	3.6	signal
98	No Therapeutic Response	5	3.5	3.6	signal
99	Hypotonia	4	3.5	3.5	signal
100	Respiratory Arrest	11	3.5	3.5	signal
101	Diabetes Mellitus Inadequate Control	7	3.5	3.5	signal
102	Thirst	7	3.4	3.5	signal
103	Anger	13	3.4	3.4	signal
104	Drug Abuse	32	3.4	3.4	signal
105	Sudden Death	4	3.3	3.3	signal
106	Thinking Abnormal	7	3.3	3.3	signal
107	Fear	10	3.2	3.2	signal
108	Psychomotor Hyperactivity	6	3.2	3.2	signal
109	Dystonia	7	3.2	3.2	signal
110	Stevens-johnson Syndrome	8	3.2	3.2	signal
111	Crying	13	3.1	3.1	signal
112	Activities Of Daily Living Impaired	7	3.1	3.1	signal
113	Nightmare	12	3.0	3.0	signal
114	Sexual Dysfunction	4	3.0	3.0	no signal
115	Accident	4	2.9	3.0	no signal
116	Withdrawal Syndrome	14	2.9	2.9	signal
117	Muscle Spasticity	4	2.8	2.8	no signal
118	Poisoning Deliberate	3	2.8	2.8	no signal
119	Emotional Disorder	10	2.8	2.8	signal
120	Increased Appetite	6	2.8	2.8	signal
121	Affect Lability	3	2.7	2.7	no signal
122	Product Taste Abnormal	4	2.6	2.6	no signal
123	Toxic Skin Eruption	3	2.6	2.6	no signal
124	Mood Altered	8	2.6	2.6	signal
125	Drug Level Decreased	3	2.6	2.6	no signal
126	Drug Exposure During Pregnancy	10	2.5	2.6	signal
127	Drug Withdrawal Syndrome	25	2.5	2.5	signal
128	Tardive Dyskinesia	8	2.5	2.5	signal
129	Overdose	59	2.4	2.4	signal
130	Drug Withdrawal Syndrome Neonatal	4	2.3	2.3	no signal
131	Diabetic Ketoacidosis	6	2.2	2.2	no signal
132	Poisoning	3	2.1	2.1	no signal
133	Abortion Spontaneous	8	1.7	1.7	no signal
134	Pregnancy	4	1.7	1.7	no signal
135	Multiple Fractures	3	1.6	1.6	no signal
136	Complication Of Device Removal	3	1.6	1.6	no signal
137	Gynaecomastia	5	1.4	1.4	no signal
138	Drug Prescribing Error	3	1.4	1.4	no signal
139	Wrong Technique In Drug Usage Process	5	1.2	1.2	no signal
140	Product Complaint	3	1.1	1.1	no signal
141	Device Breakage	4	0.9	0.9	no signal
142	Drug Dependence	12	0.6	0.6	no signal