Drug

Stiripentol

59 flagged reaction(s) · 3,136 total co-reports · max PRR 73.4

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	Seizure	854	73.4	121.5	signal
2	Status Epilepticus	78	68.0	70.5	signal
3	Generalised Tonic-clonic Seizure	76	45.7	47.3	signal
4	Epilepsy	81	26.1	27.0	signal
5	Prescribed Underdose	50	24.6	25.2	signal
6	Hypotonia	24	23.5	23.7	signal
7	Myoclonus	23	18.9	19.1	signal
8	Product Use In Unapproved Indication	350	14.1	16.6	signal
9	Ataxia	17	14.0	14.1	signal
10	Psychomotor Hyperactivity	22	12.9	13.1	signal
11	Aggression	66	12.9	13.3	signal
12	Mitral Valve Incompetence	14	12.1	12.2	signal
13	Eating Disorder	26	11.9	12.1	signal
14	Somnolence	230	11.2	12.4	signal
15	Decreased Appetite	254	10.8	12.1	signal
16	Drug Level Increased	18	10.7	10.7	signal
17	Sedation	24	9.0	9.1	signal
18	Pneumonia Aspiration	22	8.7	8.7	signal
19	Erythema Multiforme	8	8.4	8.4	signal
20	Abnormal Behaviour	34	8.4	8.5	signal
21	Hypersomnia	22	7.5	7.6	signal
22	Product Use Complaint	11	7.0	7.0	signal
23	Prescribed Overdose	13	6.6	6.6	signal
24	Sleep Disorder	46	6.4	6.6	signal
25	Encephalopathy	16	6.4	6.4	signal
26	Irritability	39	6.3	6.4	signal
27	Anger	21	6.1	6.1	signal
28	Hospitalisation	94	6.0	6.3	signal
29	Product Dose Omission Issue	172	5.9	6.3	signal
30	Hepatitis	15	5.7	5.8	signal
31	Lethargy	33	5.6	5.7	signal
32	Altered State Of Consciousness	12	5.5	5.5	signal
33	Pharyngitis Streptococcal	6	5.4	5.4	signal
34	Feeding Disorder	11	5.4	5.4	signal
35	Agitation	38	5.1	5.1	signal
36	Drug Ineffective For Unapproved Indication	28	4.9	5.0	signal
37	Salivary Hypersecretion	5	4.9	4.9	signal
38	Liver Injury	12	4.9	4.9	signal
39	Respiratory Depression	6	4.8	4.8	signal
40	Toxic Epidermal Necrolysis	7	4.5	4.6	signal
41	Head Injury	14	4.3	4.4	signal
42	Personality Change	4	4.2	4.2	signal
43	Affect Lability	4	4.1	4.1	signal
44	Illness	39	3.8	3.9	signal
45	Acute Hepatic Failure	5	3.6	3.6	signal
46	Dystonia	7	3.5	3.5	signal
47	Drug Resistance	9	3.4	3.4	signal
48	Surgery	20	3.4	3.4	signal
49	Eosinophilia	6	3.4	3.4	signal
50	Mood Altered	9	3.2	3.3	signal
51	Crying	12	3.2	3.2	signal
52	Hepatic Cytolysis	4	3.2	3.2	signal
53	No Adverse Event	45	2.5	2.5	signal
54	Intentional Self-injury	5	2.4	2.4	no signal
55	Wrong Technique In Product Usage Process	49	2.4	2.4	signal
56	Product Dose Omission	16	2.4	2.4	signal
57	Product Preparation Error	3	1.4	1.4	no signal
58	Gynaecomastia	4	1.3	1.3	no signal
59	Menstruation Irregular	3	1.1	1.1	no signal