. 2018 May 24;9:541. doi: 10.3389/fphar.2018.00541

Table 5.

Comparison of detected ADRs of methylphenidate with SPC and Vigibase.

	SOC	Frequency	Detected as a signal				Described in SPC	Reported in VigiBase
	PT		PRR	ROR	BCPNN	MGPS
	Psychiatric disorders	22
1	Aggression	3	x	x	x	x		x
2	Psychotic disorder	3	x	x	x	x		x
3	Anger	2	x	x	x	x		x
4	Anxiety	2				x	x
5	Abnormal behavior	1	x	x			x
6	Affective disorder	1	x	x			x
7	Delusion	1	x	x			x
8	Dependence	1				x	x
9	Depression	1				x	x
10	Euphoric mood	1					x
11	Negativism	1					x
12	Nervousness	1	x	x		x	x
13	Paranoia	1	x	x			x
14	Sleep disorder	1	x	x		x	x
15	Stress	1
16	Substance abuse	¹	x	x			x
	Nervous system disorders	17
17	Psychomotor hyperactivity	4	x	x	x	x	x	x
18	Headache	3	x	x		x	x
19	Convulsion	3	x	x		x	x
20	Insomnia	2				x	x
21	Tic	2	x	x	x	x	x	x
22	Dyslexia	1					x
23	Crying	1	x	x			x
24	Poor quality sleep	1	x	x			x
	Psychiatric disorders, nervous system disorders	2
25.	Disturbance in attention	2	x	x	x	x		x
	Investigations	8
26.	Weight decreased	3	x	x		x	x
27.	Amphetamines	2	x	x	x	x		x
28.	Heart sounds	1	x	x
29.	Neuropsychological test	1
30.	Weight	1
	General disorders and administration site conditions	7
31.	Fatigue	3				x
32.	Malaise	2
33.	Drug intolerance	1					x
34.	Rebound effect	¹	x	x			x
	Psychiatric disorders, general disorders and administration site conditions	1
35.	Irritability	¹	x	x		x	x
	Cardiac disorders	1
36.	Palpitations	¹	x	x		x	x
	Musculoskeletal and connective tissue disorders	1
37.	Muscle spasms	¹	x	x		x
	Metabolism and nutrition disorders	1
38.	Decreased appetite	¹	x	x			x
	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	1
39.	Neoplasm malignant	¹	x	x
	Total	⁶¹