Respiratory depression and drugs of ingredients of phenytoin sodium - a phase IV clinical study of FDA data


Respiratory depression is found among people who take drugs with ingredients of phenytoin sodium, especially for people who are female, 60+ old , have been taking the drugs for < 1 month. This phase IV clinical study is created by eHealthMe based on reports of 35,831 people who have side effects when taking drugs with ingredients of phenytoin sodium from the FDA, and is updated regularly.

Drug(s) considered in the study (i.e. both brand name and generic drugs): Dilantin, Diphenylan sodium, Extended phenytoin sodium, Phenytek, Phenytex, Phenytoin sodium, Prompt phenytoin sodium.

Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. Our original studies have been referenced on 600+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.

On Feb, 07, 2023

35,831 people reported to have side effects when taking drugs with ingredients of phenytoin sodium.
Among them, 62 people (0.17%) have Respiratory depression

What is Respiratory depression?

Respiratory depression (respiration has a rate below 12 breaths) is found to be associated with 1,401 drugs and 818 conditions by eHealthMe.

Number of reports submitted per year:

Could drugs with ingredients of phenytoin sodium cause Respiratory depression?

Time on drugs with ingredients of phenytoin sodium when people have Respiratory depression *:

  • < 1 month: 100 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 0.0 %
  • 1 - 2 years: 0.0 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

Gender of people who have Respiratory depression when taking drugs with ingredients of phenytoin sodium *:

  • female: 59.57 %
  • male: 40.43 %

Age of people who have Respiratory depression when taking drugs with ingredients of phenytoin sodium *:

  • 0-1: 13.89 %
  • 2-9: 5.5600000000000005 %
  • 10-19: 5.5600000000000005 %
  • 20-29: 2.7800000000000002 %
  • 30-39: 13.89 %
  • 40-49: 16.67 %
  • 50-59: 2.7800000000000002 %
  • 60+: 38.89 %

Conditions people have *:

  1. Status Epilepticus (a life-threatening condition in which the brain is in a state of persistent seizure): 7 people, 11.29%
  2. Sedation: 3 people, 4.84%
  3. Pulmonary Hypertension (increase in blood pressure in the lung artery): 3 people, 4.84%
  4. Pain: 3 people, 4.84%
  5. Fever: 2 people, 3.23%
  6. Neuroleptic Malignant Syndrome (a life-threatening neurological disorder most often caused by an adverse reaction to neuroleptic or antipsychotic agents): 2 people, 3.23%
  7. Encephalitis (inflammation of the brain): 2 people, 3.23%
  8. Tremor (trembling or shaking movements in one or more parts of your body): 1 person, 1.61%
  9. Drug Dependence: 1 person, 1.61%
  10. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 1 person, 1.61%

Other drugs people take *:

  1. Clobazam: 10 people, 16.13%
  2. Xanax: 8 people, 12.90%
  3. Oxycontin: 7 people, 11.29%
  4. Primaxin: 5 people, 8.06%
  5. Aciphex: 5 people, 8.06%
  6. Lasix: 4 people, 6.45%
  7. Lanoxin: 4 people, 6.45%
  8. Aldactone: 4 people, 6.45%
  9. Symmetrel: 4 people, 6.45%
  10. Keppra: 4 people, 6.45%

Other side effects people have besides Respiratory depression *:

  1. Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body): 11 people, 17.74%
  2. Drug Withdrawal Syndrome (interfere with normal social, occupational, or other functioning. are not due to another medical condition, drug use, or discontinuation): 11 people, 17.74%
  3. Weakness: 11 people, 17.74%
  4. Depressed Level Of Consciousness: 10 people, 16.13%
  5. Fainting (loss of consciousness and postural tone): 9 people, 14.52%
  6. Drug Ineffective: 9 people, 14.52%
  7. Fall: 8 people, 12.90%
  8. Sedation: 7 people, 11.29%
  9. Overdose: 7 people, 11.29%
  10. Constipation: 7 people, 11.29%

* Approximation only. Some reports may have incomplete information.

How to use the study?

You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood.

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How the study uses the data?

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

Who is eHealthMe?

With medical big data and proven AI 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 600+ 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: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on 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.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.

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