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Dexmethylphenidate Side Effects

The most commonly reported side effects of dexmethylphenidate include anxiety, nausea, and headache, based on 4,601 FDA adverse event reports from 2004 to 2025. 13.9% of reports found the drug to be ineffective.

Dexmethylphenidate side effects

Percentages show how often each reaction appears relative to total reports for dexmethylphenidate.

1
Drug Ineffective13.9%638
2
Anxiety3.9%180
3
Nausea3.7%172
4
Headache3.7%170
5
Fatigue3.7%169
6
Off Label Use3.3%152
7
Insomnia3.0%140
8
Abnormal Behaviour3.0%137
9
Decreased Appetite2.8%131
10
Feeling Abnormal2.7%125
11
Depression2.7%125
12
Disturbance In Attention2.7%124
13
Irritability2.5%117
14
Aggression2.4%111
15
Vomiting2.3%107

These are voluntary reports and do not establish that dexmethylphenidate caused these reactions.

Report severity

38.0%Serious1,750 reports
11.1%Hospitalizations510 reports
2.6%Fatal120 reports

Seriousness is determined by the reporter, not by OpenClaim.

Dexmethylphenidate drug interactions

Other drugs that appear in adverse event reports alongside dexmethylphenidate. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Serdexmethylphenidate-chloride12.1%556
2
Methylphenidate11.1%512
3
Sodium-oxybate6.3%291
4
Dextroamphetamine3.0%139
5
Amphetamine3.0%136
6
Somatropin2.7%123
7
Lisdexamfetamine-dimesylate2.5%113
8
Atomoxetine-hydrochloride2.3%105
9
Dupilumab2.2%101
10
Aripiprazole2.0%91
11
Risperidone1.9%86
12
Guanfacine-hydrochloride1.3%62
13
Quetiapine-fumarate1.2%57
14
Diazepam1.0%48
15
Ivacaftor1.0%46

Taken alongside

1
Ergocalciferol7.0%320
2
Methylphenidate6.8%313
3
Albuterol5.5%254
4
Acetaminophen4.9%226
5
Sertraline-hydrochloride4.6%211
6
Levothyroxine-sodium4.3%200
7
Fluoxetine-hydrochloride4.3%198
8
Guanfacine-hydrochloride4.1%187
9
Gabapentin4.1%187
10
Fluticasone4.0%184
11
Cetirizine-hydrochloride3.9%181
12
Bupropion3.6%167
13
Dextroamphetamine3.6%164
14
Omeprazole3.5%161
15
Amphetamine3.5%160

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports dexmethylphenidate side effects

35.6% of dexmethylphenidate adverse event reports involve female patients and 47.0% involve male patients. The largest age group is adult at 39%. These figures reflect who reports side effects, not underlying risk.

Sex

Female35.6%
Male47.0%
Unknown17.4%

Age group

< 20.3%
2–1133.3%
12–1723.9%
18–6439.2%
65+3.3%

What is dexmethylphenidate used for

Conditions and purposes for which patients were taking dexmethylphenidate when the adverse event was reported.

Abnormal BehaviourAccidental Exposure To Product By ChildAcneAdhdAdjuvant TherapyAdverse Drug ReactionAffective DisorderAggressionAngerAnxietyAsperger's DisorderAstheniaAttention Deficit DisorderAttention Deficit Hyperactivity DisorderAttention Deficit-hyperactivity Disorder

Showing 15 of 103 indications

Dexmethylphenidate brand names and reporting trend

Dexmethylphenidate is sold under the brand name Focalin.

Brand names

Focalin426

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking dexmethylphenidate with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.