Changes in behavior as side effects in methylphenidate treatment: review of the literature

Figures & data

Table 1 Overview of all 44 studies

Study	Treatment period	Follow-up	Patients completed (n)	Age (years)	Focus on side effects	Withdrawal (%)
Adler et al^Citation51	5 weeks + 6 months	None	218 (5 weeks), 170 (6 months)	18–60	Yes	19.7
Adler et al^Citation31	6–12 months	None	550	18–65	Yes	18.5
Bejerot et al^Citation52	2 years	None	133	31.1±10.9	No	17
Bron et al^Citation15	6 weeks	None	27	18–55	No	11.1
Buitelaar et al^Citation32	12 weeks	None	401, 370 (OL)	18–63	Yes	4.3, 5 (OL)
Buitelaar et al^Citation65	56 weeks	None	155 (OL), 45 (Wd)	18–65	Yes	10.4 (OL)
Casas et al^Citation33	14 weeks	1 week	279	18–65	No	16.9 (G1), 20.7 (G2), 1 (P)
Fredriksen et al^Citation53	12 months	None	250	18–60	No	12
Huss et al^Citation54,Citation55	66 weeks	None	725	18–60	Yes	11.3 (P1), 3.8 (P2), 5 (P3), 2.7 (ES)
Kooij et al^Citation45	7 weeks	None	45	20–56	No	0
Valdizán-Usón et al^Citation62	1 year	None	730	4–65	No	NK
Amiri et al^Citation23	6 weeks	None	60	6–15	No	0
Arabgol et al^Citation22	6 weeks	None	33	6.5–16	No	6.23
Barbaresi et al^Citation18	33.8 months	17.2 years	283	9.8 mean age	No	NK
Barkley et al^Citation46	30 days	None	83	5–13	Yes	3.6
Biederman et al^Citation21	19 weeks	None	161	6–14	No	4.35
Cherland and Fitzpatrick^Citation63	21 months	None	98	4–17	Yes	NK
Döpfner et al^Citation56	6–12 weeks	None	822	7–16	No	3.16
Efron et al^Citation47	4 weeks	None	125	104.8 months, mean age	Yes	3.2
Findling et al^Citation24	3 weeks	None	318	6–12	No	6.6
Garg et al^Citation57	8 weeks	None	69 (33 MPH)	6–14	Yes	18.18
Gau et al^Citation27	28 days	None	64	6–15	No	0
Ghuman et al^Citation16	24 months	None	27	3–5	No	6
Greenhill et al^Citation26	9 weeks	None	97	6–17	No	0
Haertling et al^Citation58	12 weeks	None	262	10.9±2.5	No	NK
Karabekiroglu et al^Citation59	15 days	None	90	5–16	Yes	8.9
Kemner et al^Citation28	21 days	None	1,323 (850 MPH)	6–12	No	4.8
Khajehpiri et al^Citation60	6 months	None	71	4–15	Yes	0
Kratochvil et al^Citation30	10 weeks	None	228 (44 MPH)	7–15 months, 7–9 weeks	No	11.4
Lee et al^Citation48	2 weeks	None	157	6–12	Yes	NK
Maayan et al^Citation17	4 weeks	None	11	4–5	No	27
MTA group^Citation34^–^Citation39	14 months	24 months, 6 and 8 years	579	7–9.9	No	<1
Newcorn et al^Citation25	12 weeks	6 weeks	516	6–16	No	5
PATS group^Citation40^–^Citation42	70 weeks	3, 4, and 6 years	165	3–5.5	Yes	11
Pelham et al^Citation49	3 weeks	None	70	6–12	No	0
Smith et al^Citation19	14 years	Longitudinal	131	1–17	No	NK
Ramtvedt et al^Citation64	6 weeks	None	34	11.3 mean age	Yes	2.94
Robb et al^Citation61	6–8 weeks	None	45	6–12	Yes	13.3
Silva et al^Citation14	2 weeks	None	54	6–12	No	1 (P)
Steele et al^Citation66	8 weeks	None	145	6–12	No	11.6
Stein et al^Citation50	4 weeks	None	47	5–16	Yes	NK
Swanson et al^Citation29	21 days	None	184	6–12	No	0
Wigal et al^Citation44	12 weeks	30 days	230	6–18	No	2
Zarinara et al^Citation43	6 weeks	None	38	6–13	No	5.3

Abbreviations: ES, extension study; G1, group 1; MPH, methylphenidate; NK, not known; SE, side effect; OL, open-label; P1, Phase I; P, placebo; Wd, withdrawal.

Table 2 Overview of behavioral changes observed in persons treated with methylphenidate

Study	Limit for symptoms (%)	Abnormal behavior	Accidental injury	Agitation	Aggression	Anxiety	Depression	Depressed mood
Adler et al^Citation51	*1)	–	–	5%	–	12%	–	–
Adler et al^Citation31	10	–	–	–	–	13%	–	–
Bejerot et al^Citation52	–	–	–	–	–	–	–	–
Bron et al^Citation15	–	–	–	–	–	–	–	–
Buitelaar et al^Citation32	2	–	–	–	–	5%	–	4%
Buitelaar et al^Citation65	4–5 *2)	–	–	–	–	2%	–	5%
Casas et al^Citation33	5	–	–	8%	–	9%	–	6%
Fredriksen et al^Citation53	–	–	–	Yes	Yes	Yes	–	–
Huss et al^Citation54,Citation55	5	–	–	–	–	5%	–	–
Kooij et al^Citation45	–	–	–	–	–	–	–	–
Valdizán-Usón et al^Citation62	–	–	–	–	–	–	–	–
Amiri et al^Citation23	–	–	–	–	–	13%	–	–
Arabgol et al^Citation22	–	–	–	–	–	–	–	–
Barbaresi et al^Citation18	–	–	–	–	–	–	–	–
Barkley et al^Citation46	–	–	–	–	–	58%	–	–
Biederman et al^Citation21	–	–	–	–	–	Yes	–	–
Cherland and Fitzpatrick^Citation63	–	–	–	–	–	–	–	–
Döpfner et al^Citation56	–	–	–	–	3%	–	1%	1%
Efron et al^Citation47	–	–	–	–	–	61%	–	–
Findling et al^Citation24	3	3%	–	–	3%	–	–	–
Garg et al^Citation57	–	–	–	–	–	–	–	–
Gau et al^Citation27	–	–	–	–	–	31%	–	–
Ghuman et al^Citation16	–	–	–	11%	–	3%	–	–
Greenhill et al^Citation26	2	–	–	–	–	–	–	–
Haertling et al^Citation58	–	–	–	1%	1%	–	1%	–
Karabekiroglu et al^Citation59	–	–	–	–	–	–	–	–
Kemner et al^Citation28	1	1%	–	–	1%	–	–	–
Khajehpiri et al^Citation60	–	–	–	36%	–	–	–	–
Kratochvil et al^Citation30	5	5%	12%	–	–	–	5%	–
Lee et al^Citation48	–	–	–	–	–	38%	–	–
Maayan et al^Citation17	–	–	–	–	9%	–	–	–
MTA group^Citation34^–^Citation39	–	–	–	–	–	–	–	–
Newcorn et al^Citation25	5	–	–	–	–	–	–	–
PATS group^Citation40^–^Citation42	*3)	–	–	–	4%	3%	–	–
Pelham et al^Citation49	2	–	4%	–	–	–	–	–
Smith et al^Citation19	–	–	–	–	–	–	–	–
Ramtvedt et al^Citation64	–	–	–	–	–	30%	–	–
Robb et al^Citation61	5	–	–	–	6%	–	–	–
Silva et al^Citation14	–	–	–	–	–	–	–	–
Steele et al^Citation66	10	–	–	11%	–	–	–	–
Stein et al^Citation50	–	–	–	–	–	55%	–	–
Swanson et al^Citation29	2	–	–	–	–	–	–	–
Wigal et al^Citation44	5	–	–	–	–	–	–	–
Zarinara et al^Citation43	–	–	–	–	–	–	–	–
Total	–	1%–5%	4%–12%	1%–36%	1%–9%	2%–61%	1%–5%	1%–6%
Placebo in total	–	0%–4%	0%–3%	0%–1%	0%–5%	1%–58%	–	1%–5%
Adult	–	–	–	5%–8%	–	2%–13%	–	4%–6%
Placebo adult	–	–	–	1%	–	1%–7%	–	1%–5%
Child	–	1%–5%	4%–12%	1%–36%	1%–9%	3%–61%	1%–5%	1%
Placebo child	–	0%–4%	0%–3%	–	0%–5%	1%–58%	–	–

Study	Disinterested in others	Dizziness	Drowsiness	Emotional lability	Euphoria	Feeling jittery	Irritability	Mood alteration	Nail biting
Adler et al^Citation51	–	–	–	–	–	13%	8%	–	–
Adler et al^Citation31	–	–	–	–	–	–	10%	–	–
Bejerot et al^Citation52	–	17%	–	–	–	–	–	10%	–
Bron et al^Citation15	–	–	–	–	–	–	–	–	–
Buitelaar et al^Citation32	–	8%	–	–	–	–	5%	–	–
Buitelaar et al^Citation65	–	–	–	–	–	–	4%	–	–
Casas et al^Citation33	–	12%	–	–	–	–	5%	–	–
Fredriksen et al^Citation53	–	–	–	Yes	–	–	–	–	–
Huss et al^Citation54,Citation55	–	6%	–	–	–	–	6%	–	–
Kooij et al^Citation45	–	16%		–	–	–	15%	–	–
Valdizán-Usón et al^Citation62	–	–	–	–	–	–	–	–	–
Amiri et al^Citation23	–	–	–	–	–	–	20%	–	–
Arabgol et al^Citation22	–	–	0	–	–	–	6%	–	–
Barbaresi et al^Citation18	–	–	–	–	–	–	–	–	–
Barkley et al^Citation46	43%	10%	25%	–	43%	–	66%	–	29%
Biederman et al^Citation21	–	–	Yes	Yes	–	–	–	–	–
Cherland and	–	–	–	–	–	–	–	–	–
Fitzpatrick^Citation63
Döpfner et al^Citation56	–	–	–	–	–	–	–	–	–
Efron et al^Citation47	31%	12%	18%	–	28%	–	80%	–	45%
Findling et al^Citation24	–	–	–	3%	–	–	3%	–	–
Garg et al^Citation57	–	–	3%	–	–	–	6%	–	–
Gau et al^Citation27	40%	–	25%	–	28%	–	21%	–	25%
Ghuman et al^Citation16	–	–	18%	29%	–	–	29%	–	–
Greenhill et al^Citation26	–	–	–	3%	–	–	3%	–	–
Haertling et al^Citation58	–	1%	–	1%	–	–	–	1%	–
Karabekiroglu et al^Citation59	–	–	–	–	–	–	–	–	–
Kemner et al^Citation28	–	1%	–	1%	–	–	1%	1%	–
Khajehpiri et al^Citation60	–	–	–	–	–	–	57%	–	–
Kratochvil et al^Citation30	–	–	0	5%	–	–	–	–	–
Lee et al^Citation48	17%	6%	16%	–	25%	–	64%	–	30%
Maayan et al^Citation17	–	–	9%	18%	–	–	–	–	–
MTA group^Citation34^–^Citation39	–	–	–	–	–	–	–	–	–
Newcorn et al^Citation25	–	–	–	–	–	–	6%	–	–
PATS group^Citation40^–^Citation42	–	–	Yes	15%	–	–	8%	7%	–
Pelham et al^Citation49	–	3%	–	–	–	–	–	–	–
Smith et al^Citation19	–	–	–	–	–	–	–	–	–
Ramtvedt et al^Citation64	21%	18%	32%	–	18%	–	65%	–	–
Robb et al^Citation61	–	6%	–	26%	–	–	13%	–	–
Silva et al^Citation14	–	–	–	–	–	–	0	–	–
Steele et al^Citation66	–	–	–	13%	–	–	–	–	–
Stein et al^Citation50	34%	11%	28%	–	16%	–	71%	–	22%
Swanson et al^Citation29	–	–	–	–	–	–	1%	–	–
Wigal et al^Citation44	–	9%	–	–	–	–	–	–	–
Zarinara et al^Citation43	–	–	–	–	–	–	–	–	–
Total	17%–41%	1%–18%	0%–32%	1%–29%	16%–43%	13%	0%–80%	1%–10%	22%–45%
Placebo in total	17%–36%	0%–15%	8%–53%	0%–11%	25%–45%	2%	1%–80%	6%	15%–29%
Adult	–	6%–17%	0%–32%	–	–	13%	4%–15%	10%	–
Placebo, adult	–	2%–7%	8%–53%	–	–	2%	1%–23%	–	–
Child	17%–41%	1%–18%	0%–32%	1%–29%	16%–43%	–	0%–80%	1%–7%	22%–45%
Placebo, child	17%–36%	0%–15%	8%–53%	0%–11%	25%–45%	–	1%–80%	6%	15%–29%

Study	Nervousness	Nightmares	Prone to crying	Psychomotor hyperactivity	Restlessness	Sadness	Staring	Talks less	Tics
Adler et al^Citation51	–	–	–	5%	–	–	–	–	–
Adler et al^Citation31	–	–	–	–	–	–	–	–	–
Bejerot et al^Citation52	12%	–	–	–	–	–	–	–	1%
Bron et al^Citation15	23%	–	–	–	–	–	–	–	–
Buitelaar et al^Citation32	3%	–	–	–	5%	–	–	–	–
Buitelaar et al^Citation65	–	–	–	–	7%	–	–	–	–
Casas et al^Citation33	–	–	–	–	9%	–	–	–	–
Fredriksen et al^Citation53	–	–	–	–	–	–	–	–	Yes
Huss et al^Citation54,Citation55	–	–	–	–	4%	–	–	–	–
Kooij et al^Citation45	–	–	–	–	–	–	–	–	7%
Valdizán-Usón et al^Citation62	–	–	–	–	–	–	–	–	–
Amiri et al^Citation23	–	–	–	–	–	20%	–	–	–
Arabgol et al^Citation22	–	–	–	–	–	–	–	–	–
Barbaresi et al^Citation18	–	–	–	–	–	–	–	–	–
Barkley et al^Citation46	–	21%	59%	28%	–	48%	57%	42%	–
Biederman et al^Citation21	–	–	–	–	–	–	–	–	–
Cherland and	–	–	–	–	–	–	–	–	–
Fitzpatrick^Citation63
Döpfner et al^Citation56	–	–	–	–	–	17%	–	–	12%
Efron et al^Citation47	–	21%	71%	–	–	56%	62%	28%	28%
Findling et al^Citation24	–	–	–	–	–	–	–	–	0
Garg et al^Citation57	–	–	–	–	–	–	–	–	–
Gau et al^Citation27	–	25%	47%	–	–	–	31%	31%	18%
Ghuman et al^Citation16	–	–	29%	3%	–	–	–	–	–
Greenhill et al^Citation26	–	–	–	–	–	–	–	–	–
Haertling et al^Citation58	–	–	–	–	–	–	–	–	–
Karabekiroglu et al^Citation59	–	–	–	–	–	–	–	–	–
Kemner et al^Citation28	–	–	1%	–	–	–	–	–	–
Khajehpiri et al^Citation60	–	24%	–	–	–	–	–	–	35%
Kratochvil et al^Citation30	10%	–	–	–	–	–	–	–	–
Lee et al^Citation48	–	13%	49%	–	–	38%	35%	27%	17%
Maayan et al^Citation17	–	–	–	–	–	–	–	–	–
MTA group^Citation34^–^Citation39	–	–	–	–	–	–	–	–	–
Newcorn et al^Citation25	–	–	–	–	–	–	–	–	–
PATS group^Citation40^–^Citation42	–	–	–	–	–	–	–	–	–
Pelham et al^Citation49	–	–	–	5%	–	–	–	–	–
Smith et al^Citation19	–	–	–	–	–	–	–	–	–
Ramtvedt et al^Citation64	–	9%	65%	–	–	41%	21%	29%	15%
Robb et al^Citation61	–	–	–	–	–	–	–	–	–
Silva et al^Citation14	–	–	–	–	–	–	–	–	–
Steele et al^Citation66	–	13%	–	–	–	–	–	–	–
Stein et al^Citation50	–	17%	54%	–	–	47%	54%	32%	17%
Swanson et al^Citation29	–	–	–	–	–	–	–	–	–
Wigal et al^Citation44	–	–	–	–	–	–	–	–	–
Zarinara et al^Citation43	–	–	–	–	26%	–	–	–	–
Total	3%–23%	9%–25%	1%–71%	3%–28%	4%–26%	0%–56%	21%–62%	27%–42%	0%–35%
Placebo in total	1%	12%–20%	38%–49%	0%–7%	0%–4%	31%–50%	30%–68%	15%–38%	2%–30%
Adult	3%–23%	–	–	5%	4%–9%	–	–	–	1%
Placebo, adult	1%	–	–	7%	0%–4%	–	–	–	2%
Child	10%	9%–25%	1%–71%	3%–28%	26%	0%–47%	21%–62%	27%–42%	0%–35%
Placebo, child	–	12%–20%	38%–49%	–	–	31%–50%	30%–68%	15%–38%	4%–30%

Notes:

*1) “most frequently recorded”.

*2) 5 (recorded in open-label), 4 (recorded in withdrawal);

*3) 15 most frequently recorded adverse events.

Table 3 Studies that recorded and discussed changes in behavior

Study	Adler et al^Citation31	Cherland and Fitzpatrick^Citation63	Karabekiroglu et al^Citation59	PATS group^Citation40^–^Citation42	Ramtvedt et al^Citation64
Study design	Open-label	Retrospective	Open-label	Crossover, parallel	Crossover
Treatment period	6–12 months	21 months	15 days	70 weeks	6 weeks
Follow-up	No	No	No	Yes	No
Patients completed	550	98	90	165	34
Age, years	18–65	4–17	5–15	3.5–5	11.3
Placebo group	No	No	No	Yes	Yes
Methylphenidate-naïve	No	Not known	Yes	Yes	Yes
Limit for symptoms	10%	Not known	Not known	15 most frequent	Not known
Changes in behavior	1.8%	Single cases	No	Yes	Yes
Focus of study	Changes in behavior in relation to long-term safety of methylphenidate	Psychotic side effects of methylphenidate	Short-term side effects of methylphenidate	Safety and tolerability of methylphenidate	Use of methylphenidate in minimizing adverse events

Notes: For Adler et al, changes in behavior were mentioned in the article, but are not shown in the tables.³¹ For Cherland and Fitzpatrick, it was impossible to determine with certainty whether the behavioral changes observed were reversible.⁶³ The Karabekiroglu et al study was specifically designed to study short-term effects.⁵⁹ Subjects in the PATS group studies used methylphenidate off-label because of their age.^40–42 In Ramtvedt et al, methylphenidate treatment was limited to 2 weeks.⁶⁴

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