DEXMETHYLPHENIDATE HYDROCHLORIDE

N/A

Manufactured by Novartis Pharmaceuticals Corporation

7,728 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXMETHYLPHENIDATE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. The most commonly reported adverse reactions for DEXMETHYLPHENIDATE HYDROCHLORIDE include DRUG INEFFECTIVE, NAUSEA, ANXIETY, HEADACHE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXMETHYLPHENIDATE HYDROCHLORIDE.

Top Adverse Reactions

DRUG INEFFECTIVE740 reports
NAUSEA196 reports
ANXIETY189 reports
HEADACHE183 reports
FATIGUE169 reports
ABNORMAL BEHAVIOUR166 reports
FEELING ABNORMAL162 reports
DISTURBANCE IN ATTENTION155 reports
DECREASED APPETITE152 reports
OFF LABEL USE148 reports
AGGRESSION141 reports
INSOMNIA139 reports
DEPRESSION135 reports
VOMITING134 reports
DIZZINESS125 reports
SOMNOLENCE115 reports
IRRITABILITY114 reports
PRODUCT QUALITY ISSUE102 reports
PRODUCT SUBSTITUTION ISSUE102 reports
SUICIDAL IDEATION102 reports
WEIGHT INCREASED101 reports
MALAISE100 reports
ANGER96 reports
PRODUCT DOSE OMISSION ISSUE94 reports
DYSPNOEA92 reports
WEIGHT DECREASED92 reports
PAIN88 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS84 reports
CONDITION AGGRAVATED82 reports
ABDOMINAL PAIN UPPER77 reports
RASH77 reports
CRYING70 reports
AGITATION68 reports
NO ADVERSE EVENT68 reports
TREATMENT FAILURE68 reports
CHEST PAIN67 reports
PALPITATIONS66 reports
ASTHENIA65 reports
MOOD SWINGS65 reports
COUGH64 reports
HYPERHIDROSIS64 reports
PYREXIA62 reports
PSYCHOMOTOR HYPERACTIVITY61 reports
EMOTIONAL DISORDER60 reports
TREMOR59 reports
BLOOD PRESSURE INCREASED58 reports
TIC58 reports
HEART RATE INCREASED57 reports
HALLUCINATION56 reports
CONFUSIONAL STATE55 reports
ABDOMINAL DISCOMFORT53 reports
DIARRHOEA53 reports
GYNAECOMASTIA53 reports
LOSS OF CONSCIOUSNESS52 reports
HYPERTENSION51 reports
HYPERSENSITIVITY50 reports
PRURITUS49 reports
ATTENTION DEFICIT/HYPERACTIVITY DISORDER48 reports
ILLNESS48 reports
VISION BLURRED48 reports
DEPRESSED MOOD47 reports
FALL47 reports
MEMORY IMPAIRMENT47 reports
PARANOIA47 reports
WITHDRAWAL SYNDROME47 reports
CONVULSION46 reports
NASOPHARYNGITIS46 reports
PARAESTHESIA46 reports
MUSCLE SPASMS45 reports
PRODUCT USE IN UNAPPROVED INDICATION45 reports
ARTHRALGIA42 reports
EMOTIONAL DISTRESS42 reports
HYPOAESTHESIA42 reports
DRUG DOSE OMISSION41 reports
INCORRECT DOSE ADMINISTERED41 reports
PRODUCT USE ISSUE41 reports
ERYTHEMA40 reports
SEIZURE40 reports
ADVERSE DRUG REACTION39 reports
PRODUCT PHYSICAL ISSUE39 reports
TACHYCARDIA39 reports
URTICARIA39 reports
WRONG TECHNIQUE IN DRUG USAGE PROCESS39 reports
CONSTIPATION38 reports
DYSPHAGIA38 reports
LETHARGY37 reports
UNEVALUABLE EVENT37 reports
INTENTIONAL PRODUCT MISUSE36 reports
MIGRAINE36 reports
MUSCULAR WEAKNESS36 reports
SINUSITIS36 reports
DRUG EFFECT DECREASED35 reports
DRY MOUTH34 reports
INJECTION SITE PAIN34 reports
MOOD ALTERED34 reports
PRODUCT AVAILABILITY ISSUE34 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION33 reports
ABDOMINAL DISTENSION32 reports
PNEUMONIA32 reports
BACK PAIN31 reports

Report Outcomes

Out of 4,080 classified reports for DEXMETHYLPHENIDATE HYDROCHLORIDE:

Serious 37.6%Non-Serious 62.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male2,060 (56.3%)
Female1,472 (40.3%)
Unknown124 (3.4%)

Reports by Age

Age 10146 reports
Age 9124 reports
Age 8109 reports
Age 1398 reports
Age 1297 reports
Age 1190 reports
Age 1490 reports
Age 685 reports
Age 784 reports
Age 1567 reports
Age 1664 reports
Age 1747 reports
Age 539 reports
Age 1932 reports
Age 4930 reports
Age 1828 reports
Age 2025 reports
Age 2122 reports
Age 2421 reports
Age 4221 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with DEXMETHYLPHENIDATE HYDROCHLORIDE?

This profile reflects 7,728 FDA FAERS reports that mention DEXMETHYLPHENIDATE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DEXMETHYLPHENIDATE HYDROCHLORIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, NAUSEA, ANXIETY, HEADACHE, FATIGUE, ABNORMAL BEHAVIOUR. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DEXMETHYLPHENIDATE HYDROCHLORIDE?

Labeling and FAERS entries often list Novartis Pharmaceuticals Corporation in connection with DEXMETHYLPHENIDATE HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.