Esomeprazole Side Effects
Some side effects of esomeprazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to esomeprazole: oral capsule delayed release, oral packet
Other dosage forms:
Along with its needed effects, esomeprazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking esomeprazole:Incidence not known
- Blistering, peeling, or loosening of the skin
- darkened urine
- difficulty with swallowing
- fast heartbeat
- joint or muscle pain
- loss of appetite
- mood or mental changes
- muscle spasms (tetany) or twitching
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- red skin lesions, often with a purple center
- shortness of breath
- skin rash
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- tightness in the chest
- unusual tiredness or weakness
- yellow eyes or skin
Some side effects of esomeprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Bad, unusual, or unpleasant (after) taste
- change in taste
- Sleepiness or unusual drowsiness
- back pain
- dry mouth
- excess air or gas in the stomach or intestines
- full feeling
- hair loss or thinning of the hair
- muscular weakness
- passing gas
- seeing, hearing, or feeling things that are not there
- swelling of the breasts or breast soreness in both females and males
- swelling or inflammation of the mouth
- swollen joints
For Healthcare Professionals
Applies to esomeprazole: intravenous powder for injection, oral delayed release capsule, oral powder for reconstitution delayed release
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 side effects have included confusion, dizziness, hypoesthesia, insomnia, migraine aggravation, paresthesia, sleep disorder, somnolence, tremor, vertigo, and seizures.
Cardiovascular side effects have included hypertension, angioedema, tachycardia, chest pain, irregular heartbeat, and substernal chest pain.
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 side effects have included anemia, hypochromic anemia, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, and thrombocytopenia. Agranulocytosis and pancytopenia have also been reported.
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 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 side effects have included abnormal urine, albuminuria, cystitis, dysuria, hematuria, micturition frequency, moniliasis, genital moniliasis, impotence, dysmenorrhea, menstrual disorder, vaginitis, and polyuria.
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.
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.
Respiratory side effects have included aggravated asthma, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, and sinusitis. Postmarketing side effects of bronchospasm have been reported.
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 side effects have included abnormal vision, conjunctivitis, and visual field defect. Blurred vision has also been reported.
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 side effects have included goiter.
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 side effects have included anaphylactic reaction or shock.
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.
Renal side effects including at least two cases of interstitial nephritis have been reported.
More about esomeprazole
- Esomeprazole delayed-release capsules
- Esomeprazole suspension
- Esomeprazole (Advanced Reading)
- Esomeprazole Oral, Intravenous (Advanced Reading)
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