Sertraline and Lip injury - a phase IV clinical study of FDA data


We study 136,783 people who have side effects when taking Sertraline. Lip injury is found, especially among people who are female, 60+ old, also take Levothyroxine sodium and have Osteopenia.

The phase IV clinical study analyzes which people take Sertraline and have Lip injury. 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 Sep, 26, 2023

136,783 people reported to have side effects when taking Sertraline.
Among them, 18 people (0.01%) have Lip injury.

What is Sertraline?

Sertraline has active ingredients of sertraline hydrochloride. It is used in depression. Currently, eHealthMe is studying from 143,350 Sertraline users.

What is Lip injury?

Lip injury is found to be associated with 509 drugs and 301 conditions by eHealthMe. Currently, we are studying 1,369 people who have Lip injury.

Number of Sertraline and Lip injury reports submitted per year:

Could Sertraline cause Lip injury?

Gender of people who have Lip injury when taking Sertraline *:

  • female: 76.47 %
  • male: 23.53 %

Age of people who have Lip injury when taking Sertraline *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 0.0 %
  • 20-29: 7.69 %
  • 30-39: 0.0 %
  • 40-49: 0.0 %
  • 50-59: 0.0 %
  • 60+: 92.31 %

Common drugs people take besides Sertraline *:

  1. Levothyroxine Sodium: 6 people, 33.33%
  2. Synthroid: 5 people, 27.78%
  3. Bupropion Hydrochloride: 5 people, 27.78%
  4. Colace: 5 people, 27.78%
  5. Enoxaparin Sodium: 5 people, 27.78%
  6. Estrace: 5 people, 27.78%
  7. Fosamax: 5 people, 27.78%
  8. Pantoprazole: 5 people, 27.78%
  9. Prilosec: 5 people, 27.78%
  10. Zolpidem Tartrate: 4 people, 22.22%

Common side effects people have besides Lip injury *:

  1. Fall: 14 people, 77.78%
  2. Pain In Extremity: 9 people, 50.00%
  3. Back Pain: 8 people, 44.44%
  4. Fatigue (feeling of tiredness): 8 people, 44.44%
  5. Exostosis (formation of new bone on the surface of a bone): 8 people, 44.44%
  6. Muscle Spasms (muscle contraction): 7 people, 38.89%
  7. Musculoskeletal Discomfort (discomfort in the body's muscles, joints, tendons, ligaments and nerves): 7 people, 38.89%
  8. Head Injury: 7 people, 38.89%
  9. Foot Fracture: 7 people, 38.89%
  10. Headache (pain in head): 7 people, 38.89%

Common conditions people have *:

  1. Osteoporosis Post-Menopausal (weak bone with possibility to break after stopped menstrual cycles): 5 people, 27.78%
  2. Osteopenia (a condition where bone mineral density is lower than normal): 5 people, 27.78%
  3. Muscle Spasms (muscle contraction): 3 people, 16.67%
  4. Multiple Sclerosis (a nervous system disease that affects your brain and spinal cord. it damages the myelin sheath): 3 people, 16.67%
  5. Intervertebral Disc Displacement: 3 people, 16.67%
  6. Restless Leg Syndrome (a powerful urge to move your legs): 2 people, 11.11%
  7. Parkinson's Disease: 2 people, 11.11%
  8. Breast Cancer Metastatic: 2 people, 11.11%
  9. Gait Disturbance: 2 people, 11.11%
  10. Hypersensitivity: 2 people, 11.11%

* Approximation only. Some reports may have incomplete information.

Do you take Sertraline and have Lip injury?

Check whether Lip injury 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 publications that referenced our studies

Related studies

Sertraline side effects by duration, gender and age:

Lip injury treatments and more:

All the drugs that are associated with Lip injury:

Common conditions associated with Lip injury:

All the conditions that are associated with Lip injury:

How the study uses the data?

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

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