Note: This document contains side effect information about lansoprazole. Some dosage forms listed on this page may not apply to the brand name Prevacid.

Applies to lansoprazole: oral capsules and orally disintegrating tablets, oral capsules for self-medication, oral prevpac kit.

Side effects include:

In children 1–11 years of age, constipation and headache. In children 12–17 years of age, headache, abdominal pain, nausea, dizziness. Pediatric adverse effect profile similar to that in adults.

In adults receiving oral lansoprazole (the active ingredient contained in Prevacid) diarrhea, abdominal pain, nausea, constipation.

For Healthcare Professionals

Applies to lansoprazole: compounding powder, intravenous powder for injection, oral delayed release capsule, oral granule for reconstitution, oral suspension, oral tablet disintegrating.

General

The most commonly reported side effects include headache, dizziness, fatigue, and malaise.^[Ref]

Gastrointestinal

Pseudomembranous colitis may occur with triple therapy for the eradication of H. pylori.

The majority of patients with severe/protracted cases of diarrhea who discontinued treatment had symptom resolution.^[Ref]

Common (1% to 10%): Abdominal pain, benign fundic gland polyps, constipation, diarrhea, dry mouth, flatulence, nausea, stomachache, vomiting

Rare (0.01% to 0.1%): Candidiasis of the esophagus, glossitis, macroscopic/microscopic colitis, pancreatitis

Very rare (less than 0.01%): Colitis, stomatitis

Frequency not reported: Abdomen enlarged, abnormal stools, bezoar, cardiospasm, collagenous colitis, duodenitis, dyspepsia, dysphagia, enteritis, epigastric discomfort, eructation, esophageal disorder, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly/disorder/hemorrhage, gastrointestinal moniliasis, gum hemorrhage, halitosis, hematemesis, hiatal hernia, impaired gastric emptying, increased salivation, melena, mouth ulceration, positive fecal occult blood, protracted diarrhea, pseudomembranous colitis/Clostridium difficile-associated diarrhea, rectal disorder, rectal hemorrhage, sore mouth, tenesmus, tongue disorder, ulcerative colitis, ulcerative stomatitis^[Ref]

Dermatologic

Skin rashes, urticaria, and pruritus generally resolved upon discontinuation of therapy.^[Ref]

Common (1% to 10%): Itching, pruritus, rash, urticaria

Rare (0.01% to 0.1%): Bullous rashes, cutaneous lupus erythematosus, erythema multiforme, erythematous rashes, hair loss, hair thinning, hyperhidrosis, petechia, photosensitivity, purpura, serious dermatological reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis

Frequency not reported: Acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, subacute cutaneous lupus erythematosus, skin disorder, sweating

Postmarketing reports: Fatal toxic epidermal necrolysis^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, taste perversion

Rare (0.01% to 0.1%): Paresthesia, somnolence, taste disturbance, tremor, vertigo

Frequency not reported: Amnesia, cerebrovascular accident/cerebral infarction, convulsion, dementia, hemiplegia, hyperkinesia, hypertonia, hypesthesia, migraine, parosmia, syncope, taste loss

Postmarketing reports: Speech disorder^[Ref]

Hepatic

Common (1% to 10%): Increased liver enzyme levels (alkaline phosphatase, ALT, AST, GGT)

Rare (0.01% to 0.1%): Hepatitis, jaundice

Frequency not reported: Bilirubinemia, cholelithiasis, increased alkaline phosphatase, increased ALT, increased AST, increased GGT

Postmarketing reports: Hepatotoxicity^[Ref]

Other

Common (1% to 10%): Fatigue

Rare (0.01% to 0.1%): Fever

Frequency not reported: Additional isolated laboratory abnormalities, asthenia, chills, deafness, ear disorder, malaise, otitis media, pain, tinnitus^[Ref]

Respiratory

Common (1% to 10%): Dry throat

Frequency not reported: Asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, hoarseness, interstitial pneumonia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, rhinitis, sinusitis, sore throat, stridor, upper respiratory tract infection, upper respiratory tract inflammation, wheezing^[Ref]

A definitive relationship between use of this drug and interstitial pneumonia has not been established.^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Arthralgia, fracture of the hip/wrist/spine, myalgia

Frequency not reported: Arthritis, back pain, bone disorder, bone fracture, joint disorder, leg cramps, myasthenia, musculoskeletal pain, neck pain, neck rigidity, synovitis, systemic lupus erythematosus

Postmarketing reports: Myositis^[Ref]

Hematologic

Uncommon (0.1% to 1%): Eosinophilia, leukopenia, thrombocytopenia

Rare (0.01% to 0.1%): Agranulocytosis, anemia, hematological effects, neutropenia, pancytopenia

Frequency not reported: Abnormal albumin globulin (AG) ratio, abnormal platelets, abnormal RBC, abnormal WBC, bruising, contusion, decreased platelets, decreased WBC, hemoglobin decreased, hemolysis, increased globulins, increased platelets, increased WBC, lymphadenopathy

Postmarketing reports: Aplastic anemia, hemolytic anemia, thrombotic thrombocytopenic purpura^[Ref]

Psychiatric

Rare (0.01% to 0.1%): Confusion, hallucination, insomnia, restlessness

Frequency not reported: Abnormal dreams, abnormal thinking, agitation, anxiety, apathy, depersonalization, emotional lability, hostility aggravated, libido increased/decreased, nervousness, neurosis, sleep disorder, visual hallucinations^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Edema

Frequency not reported: Angina, arrhythmia, bradycardia, chest pain (not otherwise specified [NOS]), hypertension, hypotension, myocardial infarction, palpitations, peripheral edema, shock/circulatory failure, tachycardia, vasodilation^[Ref]

Metabolic

Rare (0.01% to 0.1%): Anorexia, hypomagnesemia

Very rare (less than 0.01%): Hyponatremia, increased cholesterol/triglyceride levels

Frequency not reported: Avitaminosis, blood potassium increased, cyanocobalamin (vitamin B12) deficiency), decreased cholesterol, dehydration, diabetes mellitus, gout, hunger, hyperglycemia, hyperlipemia, hypoglycemia, increased appetite, increased lactate dehydrogenase (LDH), increased/decreased electrolytes, thirst, weight gain/loss^[Ref]

A definitive relationship between use of this drug and hyponatremia has not been established.^[Ref]

Genitourinary

Rare (0.01% to 0.1%): Erectile dysfunction, impotence

Frequency not reported: Abnormal menses, albuminuria, breast enlargement, breast pain, breast tenderness, crystal urine present, dysmenorrhea, dysuria, hematuria, leukorrhea, menorrhagia, menstrual disorder, pelvic pain, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urination impaired, vaginitis^[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Angioedema

Very rare (less than 0.01%): Anaphylactic reaction, anaphylactic shock

Frequency not reported: Allergic reaction

Postmarketing reports: Anaphylactoid reactions^[Ref]

Ocular

Rare (0.01% to 0.1%): Visual disturbances

Frequency not reported: Abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, diplopia, dry eyes, eye disorder, eye pain, glaucoma, photophobia, ptosis, retinal degeneration/disorder, visual field defect^[Ref]

Renal

Rare (0.01% to 0.1%): Interstitial nephritis

Frequency not reported: Acute interstitial nephritis, blood urea increased, kidney calculus, kidney pain, glycosuria, increased creatinine, renal dysfunction, renal failure^[Ref]

Some cases of interstitial nephritis resulted in renal failure.^[Ref]

Endocrine

Rare (0.01% to 0.1%): Gynecomastia

Frequency not reported: Goiter, hypothyroidism, increased gastrin levels, increased glucocorticoids^[Ref]

Oncologic

Frequency not reported: Carcinoma, laryngeal neoplasia, metaplasia, skin carcinoma^[Ref]

Immunologic

Frequency not reported: Candidiasis, flu syndrome, infection NOS^[Ref]