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

General

The most frequently occurring adverse reactions were headache and diarrhea.
The most frequently reported adverse reactions for patients who received triple therapy for 10 days were diarrhea, taste perversion, and abdominal pain.[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, headache, abdominal pain, nausea, vomiting, regurgitation
Uncommon (0.1% to 1%): Abdomen enlargement, bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting
Frequency not reported: Duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett's esophagus, and mucosal discoloration
Postmarketing reports: Pancreatitis; stomatitis; microscopic colitis, GI candidiasis, Clostridium difficile associated diarrhea[Ref]

Hepatic

Common (1% to 10%): Increased liver enzymes
Uncommon (0.1% to 1%): Bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased
Postmarketing reports: Hepatic failure, hepatitis with or without jaundice[Ref]

Respiratory

Common (1% to 10%): Tachypnea (in pediatrics)
Uncommon (0.1% to 1%): Asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis, chest pain, substernal chest pain
Postmarketing reports: Bronchospasm[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Flushing, hypertension, tachycardia
Frequency not reported: Irregular heartbeat[Ref]

Dermatologic

Uncommon (0.1% to 1%): Acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria
Postmarketing reports: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)[Ref]

Endocrine

Uncommon (0.1% to 1%): Goiter[Ref]

Genitourinary

Uncommon (0.1% to 1%): Abnormal urine, albuminuria, dysuria, hematuria, micturition frequency, polyuria, impotence, vaginitis, cystitis, fungal infection, moniliasis, genital moniliasis, dysmenorrhea, menstrual disorder
Postmarketing reports: Gynecomastia[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia
Postmarketing reports: Agranulocytosis, pancytopenia[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction
Postmarketing reports: Anaphylactic reaction/shock[Ref]

Metabolic

Uncommon (0.1% to 1%): Glycosuria, hyperuricemia, hyponatremia, increased alkaline
phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease, appetite increased, anorexia
Postmarketing reports: Hypomagnesemia, with or without hypocalcemia and/or hypokalemia[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatic, back pain, fracture of the hip, wrist or spine
Postmarketing reports: Muscular weakness, myalgia, bone fracture[Ref]

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.[Ref]

Nervous system

Uncommon (0.1% to 1%):Dizziness, hypertonia, nervousness, hypoesthesia, migraine, migraine aggravated, paresthesia, somnolence, tremor, visual field defect, parosmia, taste loss, taste perversion
Postmarketing reports: Hepatic encephalopathy, taste disturbance[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis, abnormal vision
Postmarketing reports: Blurred vision[Ref]

Other

Uncommon (0.1% to 1%): Earache, tinnitus, facial edema, peripheral edema, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors, fatigue, asthenia, vertigo, otitis media[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression aggravated, apathy, confusion, insomnia, sleep disorder
Postmarketing reports: Aggression, agitation, depression, hallucination[Ref]

Renal

Very rare (less than 0.01%): Interstitial nephritis concomitantly with renal failure
Postmarketing reports: Interstitial nephritis[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Esomeprazole Strontium (esomeprazole)." Amneal Pharmaceuticals, Glasgow, KY.

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Nexium (esomeprazole)" Astra-Zeneca Pharmaceuticals, Wilmington, DE.

5. "Product Information. NexIUM I.V. (esomeprazole)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

6. Mennecier D, Ceppa F, Gidenne S, Vergeau B "Hyponatremia with consciousness disturbance associated with esomeprazole." Ann Pharmacother 39 (2005): 774-5

7. Yang YX, Lewis JD, Epstein S, Metz DC "Long-term proton pump inhibitor therapy and risk of hip fracture." JAMA 296 (2006): 2947-53

8. Rosenshein B, Flockhart DA, Ho H "Induction of Testosterone Metabolism by Esomeprazole in a CYP2C19*2 Heterozygote." Am J Med Sci 327 (2004): 289-293

9. Geevasinga N, Kairaitis L, Rangan GK, Coleman PL "Acute interstitial nephritis secondary to esomeprazole." Med J Aust 182 (2005): 235-6

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