Esomeprazole Side Effects

Not all side effects for esomeprazole may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to esomeprazole: oral capsule delayed release

In addition to its needed effects, some unwanted effects may be caused by esomeprazole. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking esomeprazole:

Rare
  • Bloody, black, or tarry stools
  • chest pain or chest tightness
  • cough
  • difficulty swallowing
  • dizziness
  • excess air or gas in the stomach
  • fast heartbeat
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • pain or discomfort in the chest, upper stomach, or throat
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash, hives, or itching
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • chills
  • dark-colored urine
  • diarrhea
  • drowsiness
  • headache
  • high fever
  • joint or muscle pain
  • light-colored stools
  • loss of appetite
  • mood or mental changes
  • muscle spasms (tetany) or twitching
  • nausea or vomiting
  • seizures
  • sore throat
  • trembling
  • unexplained bleeding or bruising
  • watery and severe diarrhea, which may also be bloody
  • yellow eyes or skin

Some of the side effects that can occur with esomeprazole may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Difficulty having a bowel movement (stool)
  • dry mouth
  • passing gas
Rare
  • Back pain
  • change in taste
  • changes in vision
  • continuing ringing or buzzing or other unexplained noise in the ears
  • fast, pounding, or irregular heartbeat or pulse
  • hearing loss
  • hiccup
  • slow heartbeat
Incidence not known
  • Hair loss or thinning of the hair
  • swelling of the breasts or breast soreness in both females and males

For Healthcare Professionals

Applies to esomeprazole: intravenous powder for injection, oral delayed release capsule, oral powder for reconstitution delayed release

Gastrointestinal

Gastrointestinal (GI) side effects have included bowel irregularity, aggravated constipation, dyspepsia, dysphagia, dysplasia, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, rectal disorder, increased appetite, anorexia, ulcerative stomatitis, and vomiting. Pancreatitis has also been reported. Postmarketing reports of microscopic colitis, GI candidiasis, and clostridium difficile associated diarrhea have been received.

Nervous system

Nervous system side effects have included confusion, dizziness, hypoesthesia, insomnia, migraine aggravation, paresthesia, sleep disorder, somnolence, tremor, vertigo, and seizures.

Cardiovascular

Cardiovascular side effects have included hypertension, angioedema, tachycardia, chest pain, irregular heartbeat, and substernal chest pain.

Musculoskeletal

Musculoskeletal side effects have included muscle spasm (tetany), arthralgia, aggravation of arthritis, arthropathy, cramps, fibromyalgia syndrome, hernia, hypertonia, polymyalgia rheumatica, and back pain. Muscle weakness, myalgia and bone fracture have also been reported postmarketing.

An increased risk of hip fracture has been reported in a cohort study. The risk was significantly increased among patients prescribed long-term high PPIs.

Hematologic

Hematologic side effects have included anemia, hypochromic anemia, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, and thrombocytopenia. Agranulocytosis and pancytopenia have also been reported.

Hepatic

Hepatic side effects have included bilirubinemia, abnormal hepatic function, and increase in SGOT and SGPT. Hepatic failure, hepatic encephalopathy and hepatitis, with or without jaundice, have also been reported postmarketing.

Metabolic

Metabolic side effects have included glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, excessive thirst, vitamin B12 deficiency, and weight increase/decrease. FDA warns that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year).

FDA warns that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Patients who develop hypomagnesemia may experience seizures, dizziness, abnormal or fast heart beat, or skipped heartbeat, jitteriness, jerking movements or tremors, muscle weakness, spasms of the hands and feet, cramps or muscle aches, and spasm of the voice box.

Genitourinary

Genitourinary side effects have included abnormal urine, albuminuria, cystitis, dysuria, hematuria, micturition frequency, moniliasis, genital moniliasis, impotence, dysmenorrhea, menstrual disorder, vaginitis, and polyuria.

Psychiatric

Psychiatric side effects have included apathy, confusion, aggravated depression, and nervousness. At least one case of loss of libido has been reported. Postmarketing side effects of aggression, agitation and hallucinations have been reported.

A 42-year-old female with previously normal sexual function experienced loss of libido during esomeprazole therapy. She had been prescribed 40 mg esomeprazole twice daily for one month for symptoms of acid reflux disease. Over a 10 week period, she experienced a decline in sexual function until she could no longer respond sexually. After discontinuation of esomeprazole, her symptoms improved but did not return to what she considered normal.

Respiratory

Respiratory side effects have included aggravated asthma, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, and sinusitis. Postmarketing side effects of bronchospasm have been reported.

General

General side effects including hot flushes, fatigue, fever, flu-like disorder, leg edema, malaise, pain, earache, tinnitus, otitis, parosmia, taste loss, taste perversion, and enlarged abdomen have been reported.

Ocular

Ocular side effects have included abnormal vision, conjunctivitis, and visual field defect. Blurred vision has also been reported.

Dermatologic

Dermatologic side effects have included acne, dermatitis, pruritus, erythematous rash, maculopapular rash, skin inflammation, and increased sweating. Alopecia and erythema multiforme have also been reported. Duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett's esophagus, and mucosal discoloration have also been reported. Postmarketing side effects of gynecomastia, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome and toxic epidermal necrolysis (some fatal) have been reported.

Endocrine

Endocrine side effects have included goiter.

Hypersensitivity

Hypersensitivity side effects have rarely included allergic reactions (less than 1%). Toxic epidermal necrolysis (some cases fatal) and Stevens-Johnson syndrome have also been reported.

Immunologic

Immunologic side effects have included anaphylactic reaction or shock.

Renal

Renal side effects including at least two cases of interstitial nephritis have been reported.

A 63-year-old female with dyspepsia experienced acute interstitial nephritis coincident with esomeprazole therapy. She presented to the hospital with a 1-month history of nausea and intermittent vomiting. Three weeks before presentation, she was empirically prescribed esomeprazole for the treatment of dyspepsia. A week before presentation, she stopped taking this drug, as she suspected it was exacerbating the malaise, nauseas, and vomiting. On day 4 of admission, a renal biopsy showed acute interstitial nephritis. Prednisolone therapy was continued for 4 weeks. Supportive dialysis was needed for 4 days, by which time renal function had improved. However, at follow-up 8 months later, serum creatinine levels remained abnormal.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web4)