Focalin xr and Drowsiness - a phase IV clinical study of FDA data

Summary:

Drowsiness is reported as a side effect among people who take Focalin xr (dexmethylphenidate hydrochloride), especially for people who are male, 10-19 old, have been taking the drug for < 1 month also take Adderall, and have Stress and anxiety.

The phase IV clinical study analyzes which people have Drowsiness when taking Focalin xr. It is created by eHealthMe based on reports of 1,589 people who have side effects when taking Focalin xr from the FDA, and is updated regularly.

What is Focalin xr?

Focalin xr has active ingredients of dexmethylphenidate hydrochloride. It is often used in attention deficit hyperactivity disorder. eHealthMe is studying from 2,159 Focalin xr users. Check the latest studies of Focalin xr.

What is Drowsiness?

Drowsiness is found to be associated with 2,863 drugs and 4,801 conditions by eHealthMe. Check the latest studies of Drowsiness.

eHealthMe: drug outcomes in the real world

eHealthMe runs one of the largest post-marketing drug safety studies in the world. We study millions of patients and 5,000 more each day. Our data-driven phase IV clinical trials have been referenced on 800+ peer-reviewed medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Tools to study our phase IV findings are available to the public, anonymous and free >>>.



On Jul, 27, 2026

1,589 people reported to have side effects when taking Focalin xr.
Among them, 32 people (2.01%) have Drowsiness.

Could Focalin xr cause Drowsiness?

Among these 32 people:

How long have people been on Focalin xr when they have Drowsiness? *

  • < 1 month: 50.0 %
  • 1 - 6 months: 33.33 %
  • 6 - 12 months: 16.67 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

What is the gender of people who have Drowsiness when taking Focalin xr? *

  • female: 36 %
  • male: 64 %

What is the age of people who have Drowsiness when taking Focalin xr? *

  • 0-1: 0.0 %
  • 2-9: 26.67 %
  • 10-19: 33.33 %
  • 20-29: 20.0 %
  • 30-39: 0.0 %
  • 40-49: 13.33 %
  • 50-59: 0.0 %
  • 60+: 6.67 %

What are other drugs people take besides Focalin xr? *

  1. Adderall: 6 people, 18.75%
  2. Xyrem: 4 people, 12.50%
  3. Depakote: 4 people, 12.50%
  4. Epidiolex: 3 people, 9.38%
  5. Geodon: 3 people, 9.38%
  6. Melatonin: 3 people, 9.38%
  7. Strattera: 3 people, 9.38%
  8. Prilosec: 2 people, 6.25%
  9. Paxil: 2 people, 6.25%
  10. Zoloft: 2 people, 6.25%

What are other side effects people have besides Drowsiness? *

  1. Fatigue (feeling of tiredness): 8 people, 25.00%
  2. Stress And Anxiety: 8 people, 25.00%
  3. Drug Ineffective: 5 people, 15.62%
  4. Depression: 5 people, 15.62%
  5. Feeling Abnormal: 4 people, 12.50%
  6. Irritability: 4 people, 12.50%
  7. Aggression: 4 people, 12.50%
  8. Confusional State: 4 people, 12.50%
  9. Headache (pain in head): 3 people, 9.38%
  10. Nausea (feeling of having an urge to vomit): 3 people, 9.38%

What are the existing conditions these people have? *

  1. Stress And Anxiety: 5 people, 15.62%
  2. Gilles De La Tourette Syndrome (a condition that causes people to make repeated, quick movements or sounds that they cannot control): 3 people, 9.38%
  3. Tic (a sudden, repetitive, nonrhythmic motor movement or vocalization involving discrete muscle groups): 2 people, 6.25%
  4. Lennox-Gastaut Syndrome (epilepsy characterized by frequent seizures and different seizure types): 2 people, 6.25%
  5. Cataplexy (loss of muscle tone accompanied by full conscious awareness): 2 people, 6.25%
  6. Bipolar Disorder (mood disorder): 2 people, 6.25%
  7. Urinary Incontinence (inability to control the flow of urine and involuntary urination): 1 person, 3.12%
  8. Sleep Disorder: 1 person, 3.12%
  9. Seizures (abnormal excessive or synchronous neuronal activity in the brain): 1 person, 3.12%
  10. Papilloma Viral Infection: 1 person, 3.12%

* Approximation only. Some reports may have incomplete information.

Do you take Focalin xr and have Drowsiness?

- Check whether Drowsiness is associated with a drug or a condition
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Related studies:

Effectiveness of, long term effects of, and alternative drugs to Focalin xr:

Drowsiness treatments and more:

How severe was Drowsiness and when was it recovered:

Expand to all the drugs that have ingredients of dexmethylphenidate hydrochloride:

Sub-studies by gender and age:

Female: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Male: 0-1 2-9 10-19 20-29 30-39 40-49 50-59 60+

Browse all side effects of Focalin xr:

a b c d e f g h i j k l m n o p q r s t u v w x y z

Browse all the drugs that are associated with Drowsiness:

Browse all the conditions that are associated with Drowsiness:


How the study uses the data?

The study uses data from the FDA. It is based on dexmethylphenidate hydrochloride (the active ingredients of Focalin xr) and Focalin xr (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

How to use the study?

DO NOT STOP MEDICATIONS without first consulting your doctor. If there are any serious or long term adverse effects discovered in the study, discuss the study with your doctor to ensure that proper medication management will be in place if applicable.

Who is eHealthMe?

With medical big data and proven AI/ML algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 800+ peer-reviewed medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API).

WARNING, DISCLAIMER, USE FOR PUBLICATION

WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on eHealthMe.com is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only. Our phase IV clinical studies alone cannot establish cause-effect relationship. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

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