Azelastine and Sedation aggravated - a phase IV clinical study of FDA data

Summary:

Sedation aggravated is reported as a side effect among people who take Azelastine (azelastine hydrochloride), especially for people who are female, 60+ old, have been taking the drug for 1 - 2 years also take Xyrem, and have Narcolepsy.

The phase IV clinical study analyzes which people have Sedation aggravated when taking Azelastine. It is created by eHealthMe based on reports of 17,147 people who have side effects when taking Azelastine from the FDA, and is updated regularly.

What is Azelastine?

Azelastine has active ingredients of azelastine hydrochloride. It is often used in allergies. eHealthMe is studying from 17,400 Azelastine users. Check the latest studies of Azelastine.

What is Sedation aggravated?

Sedation aggravated is found to be associated with 1,157 drugs and 495 conditions by eHealthMe. Check the latest studies of Sedation aggravated.



On Aug, 03, 2026

17,147 people reported to have side effects when taking Azelastine.
Among them, 22 people (0.13%) have Sedation aggravated.

Could Azelastine cause Sedation aggravated?

Among these 22 people:

How long have people been on Azelastine when they have Sedation aggravated? *

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

What is the gender of people who have Sedation aggravated when taking Azelastine? *

  • female: 95.24 %
  • male: 4.76 %

What is the age of people who have Sedation aggravated when taking Azelastine? *

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 7.14 %
  • 30-39: 0.0 %
  • 40-49: 14.29 %
  • 50-59: 21.43 %
  • 60+: 57.14 %

What are other drugs people take besides Azelastine? *

  1. Xyrem: 9 people, 40.91%
  2. Zyrtec: 7 people, 31.82%
  3. Seroquel: 5 people, 22.73%
  4. Singulair: 5 people, 22.73%
  5. Vitamin B12: 5 people, 22.73%
  6. Enbrel: 4 people, 18.18%
  7. Nucynta: 4 people, 18.18%
  8. Lubiprostone: 4 people, 18.18%
  9. Lidoderm: 4 people, 18.18%
  10. Keppra: 4 people, 18.18%

What are other side effects people have besides Sedation aggravated? *

  1. Fatigue (feeling of tiredness): 7 people, 31.82%
  2. Stress And Anxiety: 6 people, 27.27%
  3. Drowsiness: 5 people, 22.73%
  4. Weight Increased: 5 people, 22.73%
  5. The Flu (the flu is caused by an influenza virus): 4 people, 18.18%
  6. Dizziness: 4 people, 18.18%
  7. Drug Hypersensitivity: 4 people, 18.18%
  8. Ulcerative Colitis (inflammatory bowel disease (ibd). it causes swelling, ulcerations, and loss of function of the large intestine): 4 people, 18.18%
  9. Arrhythmias (irregular heartbeat): 4 people, 18.18%
  10. Therapeutic Response Unexpected: 3 people, 13.64%

What are the existing conditions these people have? *

  1. Drowsiness: 6 people, 27.27%
  2. Narcolepsy (brain's inability to regulate sleep-wake cycles normally): 6 people, 27.27%
  3. Cataplexy (loss of muscle tone accompanied by full conscious awareness): 5 people, 22.73%
  4. Sleep Apnea Syndrome: 4 people, 18.18%
  5. Fibromyalgia (a long-term condition which causes pain all over the body): 4 people, 18.18%
  6. Asthma: 3 people, 13.64%
  7. Hypersensitivity: 3 people, 13.64%
  8. Dermatitis Allergic (inflammation of the skin due allergic reaction): 2 people, 9.09%
  9. Ulcerative Colitis (inflammatory bowel disease (ibd). it causes swelling, ulcerations, and loss of function of the large intestine): 2 people, 9.09%
  10. Primary Immunodeficiency Syndrome: 2 people, 9.09%

* Approximation only. Some reports may have incomplete information.

Do you take Azelastine and have Sedation aggravated?

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Related studies:

Effectiveness of, long term effects of, and alternative drugs to Azelastine:

Sedation aggravated treatments and more:

How severe was Sedation aggravated and when was it recovered:

Expand to all the drugs that have ingredients of azelastine 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 Azelastine:

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 Sedation aggravated:

Browse all the conditions that are associated with Sedation aggravated:


How the study uses the data?

The study uses data from the FDA. It is based on azelastine hydrochloride (the active ingredients of Azelastine) and Azelastine (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.

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



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