OpenClaim

Methylphenidate Side Effects

The most commonly reported side effects of methylphenidate include off label use, no adverse event, and product quality issue, based on 77,041 FDA adverse event reports from 2004 to 2025. 9.7% of reports found the drug to be ineffective.

Methylphenidate side effects

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

1
Drug Ineffective9.7%7,481
2
Off Label Use9.0%6,945
3
No Adverse Event7.3%5,626
4
Product Quality Issue4.6%3,512
5
Fatigue3.9%2,989
6
Headache3.7%2,846
7
Anxiety3.6%2,768
8
Nausea3.5%2,729
9
Product Quality Issue2.9%2,252
10
Insomnia2.7%2,051
11
Depression2.7%2,051
12
Disturbance In Attention2.7%2,043
13
Product Substitution Issue2.4%1,857
14
Drug Dose Omission2.4%1,855
15
Decreased Appetite2.4%1,816

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

Report severity

50.5%Serious38,903 reports
16.5%Hospitalizations12,686 reports
3.7%Fatal2,827 reports

Seriousness is determined by the reporter, not by OpenClaim.

Methylphenidate drug interactions

Other drugs that appear in adverse event reports alongside methylphenidate. 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
Sodium-oxybate12.4%9,545
2
Risperidone1.8%1,418
3
Aripiprazole1.8%1,364
4
Atomoxetine-hydrochloride1.7%1,329
5
Quetiapine-fumarate1.6%1,201
6
Amphetamine1.5%1,178
7
Dextroamphetamine1.4%1,111
8
Lisdexamfetamine-dimesylate1.4%1,059
9
Bupropion1.2%889
10
Sertraline-hydrochloride1.1%878
11
Fluoxetine-hydrochloride0.9%702
12
Pregabalin0.9%685
13
Dalfampridine0.9%661
14
Duloxetine-hydrochloride0.8%648
15
Clonazepam0.8%635

Taken alongside

1
Acetaminophen7.5%5,802
2
Ergocalciferol7.4%5,692
3
Albuterol5.5%4,218
4
Levothyroxine-sodium5.2%3,990
5
Gabapentin5.2%3,988
6
Omeprazole4.8%3,681
7
Bupropion4.6%3,534
8
Fluticasone4.5%3,442
9
Ibuprofen4.2%3,259
10
Fluoxetine-hydrochloride3.7%2,846
11
Sertraline-hydrochloride3.7%2,812
12
Aspirin3.6%2,810
13
Clonazepam3.6%2,786
14
Modafinil3.6%2,761
15
Dextroamphetamine3.6%2,747

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 methylphenidate side effects

40.7% of methylphenidate adverse event reports involve female patients and 44.2% involve male patients. The largest age group is adult at 50%. These figures reflect who reports side effects, not underlying risk.

Sex

Female40.7%
Male44.2%
Unknown15.1%

Age group

< 20.5%
2–1125.8%
12–1717.0%
18–6450.1%
65+6.6%

What is methylphenidate used for

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

AbasiaAbnormal BehaviourAbnormal Loss Of WeightAbuliaAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By ChildAcquired Epileptic AphasiaAdcy5-related DyskinesiaAddAddison^s DiseaseAdhdAdjustment DisorderAdjustment Disorder With Depressed MoodAdjuvant Therapy

Showing 15 of 707 indications

Methylphenidate brand names and reporting trend

Methylphenidate is sold under brand names including Methylphenidate, Metadate Er.

Brand names

Methylphenidate30,486
Metadate Er1

Quarterly reports (20042025)

20052010201520202025

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

Taking methylphenidate with another medication?

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