Cymbalta and Aphthous stomatitis - a phase IV clinical study of FDA data


We study 141,667 people who have side effects when taking Cymbalta. Aphthous stomatitis is found, especially among people who are female, 60+ old, have been taking the drug for < 1 month, also take Ambien and have Osteoporosis.

The phase IV clinical study analyzes which people take Cymbalta and have Aphthous stomatitis. It is created by eHealthMe based on reports from the FDA, and is updated regularly. You may use the study as a second opinion to make health care decisions.

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 700+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.

On Oct, 04, 2023

141,667 people reported to have side effects when taking Cymbalta.
Among them, 81 people (0.06%) have Aphthous stomatitis.

What is Cymbalta?

Cymbalta has active ingredients of duloxetine hydrochloride. It is used in depression. Currently, eHealthMe is studying from 151,241 Cymbalta users.

What is Aphthous stomatitis?

Aphthous stomatitis (mouth ulcer) is found to be associated with 1,159 drugs and 768 conditions by eHealthMe. Currently, we are studying 3,782 people who have Aphthous stomatitis.

Number of Cymbalta and Aphthous stomatitis reports submitted per year:

Could Cymbalta cause Aphthous stomatitis?

Time on Cymbalta when people have Aphthous stomatitis *:

  • < 1 month: 71.43 %
  • 1 - 6 months: 0.0 %
  • 6 - 12 months: 14.29 %
  • 1 - 2 years: 14.29 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

Gender of people who have Aphthous stomatitis when taking Cymbalta *:

  • female: 88.75 %
  • male: 11.25 %

Age of people who have Aphthous stomatitis when taking Cymbalta *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 2.74 %
  • 30-39: 2.74 %
  • 40-49: 10.96 %
  • 50-59: 34.25 %
  • 60+: 49.32 %

Common drugs people take besides Cymbalta *:

  1. Ambien: 26 people, 32.10%
  2. Nexium: 18 people, 22.22%
  3. Nystatin: 18 people, 22.22%
  4. Celebrex: 17 people, 20.99%
  5. Lorazepam: 16 people, 19.75%
  6. Lexapro: 16 people, 19.75%
  7. Cephalexin: 16 people, 19.75%
  8. Effexor: 15 people, 18.52%
  9. Zometa: 15 people, 18.52%
  10. Levoxyl: 14 people, 17.28%

Common side effects people have besides Aphthous stomatitis *:

  1. Fatigue (feeling of tiredness): 30 people, 37.04%
  2. Back Pain: 25 people, 30.86%
  3. Diarrhea: 24 people, 29.63%
  4. Aseptic Necrosis (the death of bone tissue due to a lack of blood supply): 24 people, 29.63%
  5. Pain: 23 people, 28.40%
  6. Osteomyelitis (infection of bone): 19 people, 23.46%
  7. Joint Pain: 19 people, 23.46%
  8. Oral Pain: 18 people, 22.22%
  9. Breathing Difficulty: 17 people, 20.99%
  10. Dizziness: 16 people, 19.75%

Common conditions people have *:

  1. Osteoporosis (bones weak and more likely to break): 15 people, 18.52%
  2. Pain: 11 people, 13.58%
  3. High Blood Pressure: 11 people, 13.58%
  4. Gastroesophageal Reflux Disease (a condition in which stomach contents leak backward from the stomach into the oesophagus): 11 people, 13.58%
  5. High Blood Cholesterol: 9 people, 11.11%
  6. Affective Disorder (mental disorder): 9 people, 11.11%
  7. Sleep Disorder: 9 people, 11.11%
  8. Genital Herpes (herpes infection of genital): 9 people, 11.11%
  9. Hyperchlorhydria (gastric acid levels are higher in stomach): 8 people, 9.88%
  10. Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body): 8 people, 9.88%

* Approximation only. Some reports may have incomplete information.

Do you take Cymbalta and have Aphthous stomatitis?

Check whether Aphthous stomatitis is associated with a drug or a condition

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.

Related studies

Cymbalta side effects by duration, gender and age:

Aphthous stomatitis treatments and more:

Common drugs associated with Aphthous stomatitis:

All the drugs that are associated with Aphthous stomatitis:

Common conditions associated with Aphthous stomatitis:

All the conditions that are associated with Aphthous stomatitis:

How the study uses the data?

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

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 700+ 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.

Recent studies on eHealthMe: