Lansoprazole

Applies to lansoprazole: oral capsule delayed release, oral powder for suspension, oral tablet disintegrating delayed release

Along with its needed effects, lansoprazole 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 lansoprazole:

More common

• Diarrhea
• itching, skin rash

Less common

• Increased or decreased appetite
• joint pain
• nausea
• stomach pain
• vomiting

Rare

• Anxiety
• colds
• constipation
• increased cough
• mental depression
• muscle pain
• rectal bleeding
• unusual bleeding or bruising

Incidence not known

• Back or leg pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• bloody, black, or tarry stools
• change in mental status
• chest pain
• chills
• clay colored stools
• cough
• dark or bloody urine
• difficulty with swallowing
• drowsiness
• fast heartbeat
• fever
• general body swelling
• high fever
• hives
• hoarseness
• indigestion
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle spasms (tetany) or twitching seizures
• nosebleeds
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach tenderness
• swelling of the feet or lower legs
• swollen or painful glands
• tightness in the chest
• trembling
• unusual tiredness or weakness
• yellow eyes or skin

Some side effects of lansoprazole 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

• Dizziness
• headache

Less common

• Bleeding, blistering, burning, coldness, or discoloration of the skin
• mild nausea

Rare

• Bad, unusual, or unpleasant (after) taste
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• feeling of heat or warmth
• flushing or redness of the skin, especially on the face and neck
• mild diarrhea
• mild headache
• mild vomiting
• stomach discomfort or upset
• sweating

Incidence not known

• Decrease in passing urine (dribbling)
• decrease in the frequency of urination
• decrease in urine volume
• difficulty with speaking

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

The most commonly reported side effects include headache, dizziness, fatigue, and malaise.

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.

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

Skin rashes, urticaria, and pruritus generally resolved upon discontinuation of therapy.

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

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

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

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

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

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

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

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

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

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

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

A definitive relationship between use of this drug and hyponatremia has not been established.

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

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

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

Some cases of interstitial nephritis resulted in renal failure.

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

Rare (0.01% to 0.1%): Gynecomastia

Frequency not reported: Goiter, hypothyroidism, increased gastrin levels, increased glucocorticoids

Frequency not reported: Carcinoma, laryngeal neoplasia, metaplasia, skin carcinoma

Frequency not reported: Candidiasis, flu syndrome, infection NOS