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Prevacid OTC Side Effects

Generic Name: lansoprazole

Note: This page contains side effects data for the generic drug lansoprazole. It is possible that some of the dosage forms included below may not apply to the brand name Prevacid OTC.

For the Consumer

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

As well as its needed effects, lansoprazole (the active ingredient contained in Prevacid OTC) may cause unwanted side effects that require medical attention.

Severity: Major

If any of the following side effects occur while taking lansoprazole, check with your doctor immediately:

More common:
  • Diarrhea
  • skin rash or itching
Less common:
  • Abdominal or stomach pain
  • increased or decreased appetite
  • joint pain
  • nausea
  • vomiting
Rare:
  • Anxiety
  • cold or flu-like symptoms
  • constipation
  • increased cough
  • mental depression
  • muscle pain
  • rectal bleeding
  • unusual bleeding or bruising
Incidence not known:
  • Abdominal or stomach tenderness
  • 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 or hoarseness
  • dark or bloody urine
  • difficulty with swallowing
  • drowsiness
  • fast heartbeat
  • fever
  • general body swelling
  • high fever
  • hives
  • 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, irritated eyes
  • red skin lesions, often with a purple center
  • seizures
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the feet or lower legs
  • swollen or painful glands
  • tightness in the chest
  • trembling
  • unusual tiredness or weakness
  • yellow eyes or skin

Severity: Minor

Some lansoprazole side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Dizziness
  • headache
Less common:
  • Bleeding, blistering, burning, coldness, or discoloration of the skin
  • mild nausea
Rare:
  • Acid or sour stomach
  • bad, unusual or unpleasant (after) taste
  • belching
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • feeling faint, dizzy, or lightheaded
  • 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

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%): Nausea, diarrhea, stomachache/abdominal pain, constipation, vomiting, dry/sore mouth/throat, flatulence
Rare (0.01% to 0.1%): Glossitis, candidiasis of the esophagus, taste disturbances, pancreatitis
Very rare (less than 0.01%): Macroscopic/microscopic colitis, stomatitis
Frequency not reported: Dyspepsia, pseudomembranous colitis, abdomen enlarged, halitosis, abnormal stools, bezoar, cardiospasm, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcers, esophagitis, fecal discoloration, gastric nodules, fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly/disorder/hemorrhage, gum hemorrhage, hematemesis, increased salivation, melena, mouth ulceration, gastrointestinal moniliasis, rectal disorder/hemorrhage, tongue disorder, ulcerative colitis/stomatitis, tenesmus, positive fecal occult blood
Postmarketing reports: Clostridium difficile associated diarrhea[Ref]

Dermatologic

Common (1% to 10%): Urticaria, pruritus/itching, rash
Rare (0.01% to 0.1%): Petechia, hair loss/thinning/alopecia, erythema multiforme, photosensitivity, hyperhidrosis/sweating
Very rare (less than 0.01%): Steven-Johnson syndrome, toxic epidermal necrolysis
Frequency not reported: Subacute cutaneous lupus erythematosus (erythematous/bullous rashes), acne, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, skin disorder[Ref]

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

Nervous system

Common (1% to 10%): Headache, dizziness
Rare (0.01% to 0.1%): Vertigo, paresthesia, taste disturbance/loss/perversion, somnolence, tremor
Frequency not reported: Cerebrovascular accident/cerebral infarction, migraine, amnesia, convulsion, dementia, hemiplegia, hyperkinesia, hypertonia, hypesthesia, parosmia
Postmarketing reports: Speech disorder[Ref]

Hepatic

Common (1% to 10%): Increased liver enzyme levels (ALT, AST, GGTP, alkaline phosphatase)
Rare (0.01% to 0.1%): Hepatitis, jaundice
Frequency not reported: Cholelithiasis, bilirubinemia
Postmarketing reports: Hepatotoxicity[Ref]

Other

Common (1% to 10%): Fatigue
Rare (0.01% to 0.1%): Fever
Frequency not reported: Asthenia, candidiasis, flu syndrome, infection (not otherwise specified), chills, malaise, pain, thirst, deafness, ear disorder, otitis media, tinnitus, increased globulins, additional isolated laboratory abnormalities[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Fracture of the hip/wrist/spine, arthralgia, myalgia
Frequency not reported: Back pain, neck pain, neck rigidity, arthritis, bone/joint disorder, leg cramps, musculoskeletal pain, myasthenia, synovitis
Postmarketing reports: Myositis[Ref]

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia, eosinophilia, leukopenia
Rare (0.01% to 0.1%): Anemia, purpura
Very rare (less than 0.01%): Agranulocytosis, pancytopenia
Frequency not reported: Neutropenia, bruising, hemolysis, lymphadenopathy, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, hemoglobin decreased, increased/decreased/abnormal platelets
Postmarketing reports: Aplastic anemia, hemolytic anemia, thrombic thrombocytopenic purpura[Ref]

Psychiatric

Uncommon (0.1% to 1%): Depression
Rare (0.01% to 0.1%): Insomnia, hallucination, confusion, restlessness
Frequency not reported: Abnormal dreams, agitation, anxiety, apathy, depersonalization, emotional lability, hostility aggravated, libido increased/decreased, nervousness, neurosis, sleep disorder, abnormal thinking[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Edema
Frequency not reported: Peripheral edema, chest pain (not otherwise specified), angina, arrhythmia, bradycardia, hypotension, hypertension, myocardial infarction, palpitations, shock/circulatory failure, syncope, tachycardia, vasodilation[Ref]

Genitourinary

Rare (0.01% to 0.1%): Impotence
Frequency not reported: Urinary tract infection, pelvic pain, abnormal menses, breast enlargement/pain/tenderness, dysmenorrhea, dysuria, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency/retention/urgency, urinary tract infection, urination impaired, vaginitis, crystal urine present, albuminuria, hematuria[Ref]

Metabolic

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

Rare (0.01% to 0.1%): Anorexia
Very rare (less than 0.01%): Increased cholesterol/triglyceride levels, hyponatremia
Frequency not reported: Hypomagnesemia, increased appetite, diabetes mellitus, avitaminosis, gout, dehydration, hyperglycemia/hypoglycemia, weight gain/loss, blood potassium increased, decreased cholesterol, increased LDH, increased/decreased electrolytes[Ref]

Ocular

Rare (0.01% to 0.1%): Visual disturbances
Frequency not reported: Ptosis, diplopia, abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, dry eyes, eye disorder/pain, glaucoma, photophobia, retinal degeneration/disorder, visual field defect[Ref]

Renal

Rare (0.01% to 0.1%): Interstitial nephritis
Frequency not reported: Renal failure, kidney calculus, kidney pain, increased creatinine, blood urea increased, glycosuria[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 glucocorticoids, increased gastrin levels[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Angioedema
Very rare (less than 0.01%): Anaphylaxis/anaphylactic shock
Frequency not reported: Allergic reaction[Ref]

Respiratory

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

Frequency not reported: Wheezing, upper respiratory tract inflammation/infection, interstitial pneumonia, asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, rhinitis, sinusitis, stridor[Ref]

Oncologic

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

References

1. "Product Information. Prevacid (lansoprazole)." TAP Pharmaceuticals Inc, Deerfield, IL.

2. Ministerio de Sanidad y Consumo. Gobierno de España "AEMPS. Agencia Española de Medicamentos y Productos Sanitarios. Available from: URL: https://sinaem4.agemed.es/consaem/fichasTecnicas.do?metodo=detalleForm."

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

It is possible that some side effects of Prevacid OTC may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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.

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