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Lansoprazole Side Effects

Common Lansoprazole Side Effects


The most commonly reported Lansoprazole side effects (click to view or check a box to report):

Diarrhoea (114)
Condition Aggravated (78)
Nausea (74)
Dizziness (70)
Product Substitution Issue (68)
Vomiting (68)
Malaise (66)
Hypomagnesaemia (62)
Dyspnoea (59)
Renal Failure Acute (57)
Fatigue (57)
Rash (55)
Decreased Appetite (49)
Colitis Collagenous (47)
Pyrexia (44)
Pneumonia (44)
Abdominal Pain (44)
Haemoglobin Decreased (43)
Interstitial Lung Disease (41)
Hypocalcaemia (40)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Lansoprazole Side Effects Reported to FDA

The following Lansoprazole reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Lansoprazole on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Muscle Strain, Abdominal Distension, Local Swelling, Joint Swelling
This is a report of a 72-year-old female patient (weight: NA) from IT, suffering from the following symptoms/conditions: gastritis, who was treated with Lansoprazole (dosage: NA, start time: Jul 08, 2012), combined with:
  • Aloe Vera
and developed a serious reaction and side effect(s). The consumer presented with:
  • Muscle Strain
  • Abdominal Distension
  • Local Swelling
  • Joint Swelling
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lansoprazole treatment in female patients, resulting in muscle strain side effect.

Osteonecrosis
This report suggests a potential Lansoprazole Osteonecrosis side effect(s) that can have serious consequences. A 68-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Lansoprazole (dosage: NA) starting 2004. Soon after starting Lansoprazole the patient began experiencing various side effects, including:
  • Osteonecrosis
Drugs used concurrently:
  • Coaprovel
  • Atorvastatin
  • Plavix
  • Metformin
  • Nebilox
  • Levothyrox
Although Lansoprazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as osteonecrosis, may still occur.

Dermatitis Exfoliative, Rash Erythematous, Wheezing, Eczema, Lymphocytic Infiltration, Parakeratosis, Skin Exfoliation
This Dermatitis Exfoliative, Rash Erythematous, Wheezing, Eczema, Lymphocytic Infiltration, Parakeratosis, Skin Exfoliation problem was reported by a pharmacist from GB. A 72-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Oct 14, 2013 this consumer started treatment with Lansoprazole (dosage: 30 Mg, Qid). The following drugs were being taken at the same time:
  • Allopurinol (300 Mg, Qd)
  • Aranesp (100 ?g, 1/week)
  • Indapamide
  • Furosemide
  • Salbutamol
  • Ramipril
  • Acetylsalicylic Acid
  • Simvastatin
When commencing Lansoprazole, the patient experienced the following unwanted symptoms/side effects:
  • Dermatitis Exfoliative
  • Rash Erythematous
  • Wheezing
  • Eczema
  • Lymphocytic Infiltration
  • Parakeratosis
  • Skin Exfoliation
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as dermatitis exfoliative, may become evident only after a product is in use by the general population.

Colitis Microscopic, Diarrhoea, Protein Total Decreased, Protein-losing Gastroenteropathy
This is a report of a 63-year-old female patient (weight: NA) from JP. The patient developed the following symptoms/conditions: abdominal discomfort,off label use and was treated with Lansoprazole (dosage: 15 Mg, Qd) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Colitis Microscopic
  • Diarrhoea
  • Protein Total Decreased
  • Protein-losing Gastroenteropathy
The patient was hospitalized. This opens a possibility that Lansoprazole treatment could cause the above reactions, including colitis microscopic, and some female subjects may be more susceptible.


Dermatitis Exfoliative, Wheezing, Eczema, Lymphocytic Infiltration, Parakeratosis, Skin Exfoliation
A 72-year-old female patient (weight: NA) from GB with the following symptoms/conditions: NA started Lansoprazole treatment (dosage: 30 Mg, Qd) on Nov 01, 2013. Soon after starting Lansoprazole treatment, the subject experienced various side effects, including:
  • Dermatitis Exfoliative
  • Wheezing
  • Eczema
  • Lymphocytic Infiltration
  • Parakeratosis
  • Skin Exfoliation
Concurrently used drugs:
  • Salbutamol/salbutamol Sulfate (100 Mg, As Necessary)
  • Ramipril (10 Mg, Qd)
  • Novomix (30 Unk, Bid)
  • Aranesp (100 Mug, Qwk)
  • Furosemide (80 Mg, Qmo)
  • Tiotropium/tiotropium Bromide (18 Mg, Qd)
  • Acetylsalicylic Acid (75 Mg, Qd)
  • Simvastatin (40 Mg, Unk)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Lansoprazole.

Duodenal Ulcer, Melaena, Presyncope, Haemoglobin Decreased
A 39-year-old female patient from IT (weight: NA) experienced symptoms, such as: NA and was treated with Lansoprazole(dosage: 15 Mg Daily). The treatment was initiated on Jan 29, 2014. After that a consumer reported the following side effect(s):
  • Duodenal Ulcer
  • Melaena
  • Presyncope
  • Haemoglobin Decreased
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Lansoprazole efficacy:
  • Cardioaspirin (1 Df Daily)
  • Exinef (1 Df Daily)
  • Dediol - 0.25 Mcg Capsule Molli - Leo Pharma A/s (1 Df Daily)
The patient was hospitalized.

Femoral Neck Fracture, Fall, Diabetes Mellitus, Glycosylated Haemoglobin Increased, Hypertension
In this report, Lansoprazole was administered for the following condition: prophylaxis against gastrointestinal ulcer.A 75-year-old female consumer from JP (weight: NA) started Lansoprazole treatment (dosage: 15 Mg, Qd) on Jul 13, 2012.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Femoral Neck Fracture
  • Fall
  • Diabetes Mellitus
  • Glycosylated Haemoglobin Increased
  • Hypertension
A possible interaction with other drugs could have contributed to this reaction:
  • Actos (7.5 Mg, 1 Days)
  • Benet Tablets 17.5mg (17.5 Mg, 1/week)
  • Bayaspirin (100 Mg, 1 Days)
  • Amaryl (5 Mg, 1 Days)
  • Seibule (150 Mg, 1 Days)
  • Panaldine (200 Mg, 1 Days)
  • Lipitor (10 Mg, 1 Days)
  • Exforge (1 Df, 1 Days)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Lansoprazole treatment could be related to the listed above side effect(s).

Duodenal Ulcer, Melaena, Circulatory Collapse
This is a report of the following Lansoprazole side effect(s):
  • Duodenal Ulcer
  • Melaena
  • Circulatory Collapse
A 39-year-old female patient from IT (weight: NA) presented with the following condition: NA and received a treatment with Lansoprazole (dosage: 15 Mg, Qd) starting: Mar 25, 2013.The following concurrently used drugs could have generated interactions:
  • Dediol (0.25 Ug, Qd)
  • Exinef (60 Mg, Qd)
  • Cardioaspirin (100 Mg, Qd)
The patient was hospitalized.This report suggests that a Lansoprazole treatment could be associated with the listed above side effect(s).

Aortic Aneurysm Rupture
This Lansoprazole report was submitted by a 95-year-old female consumer from JP (weight: NA). The patient was diagnosed with: prophylaxis against gastrointestinal ulcer,thrombosis prophylaxis and Lansoprazole was administered (dosage: 15 Mg, Qd) starting: Feb 20, 2012. The consumer developed a set of symptoms:
  • Aortic Aneurysm Rupture
Other drugs used simultaneously:
  • Bayaspirin (100 Mg, 1 Days)
  • Amlodin (5 Mg, 1 Days)
  • Racol Nf (1000 Ml, 1 Days)
  • Selenica-r (0.5 G, 1 Days)
  • Sodium Chloride (2 G, 1 Days)
  • Lac B (1 G,1 Days)
  • Lac B
  • Gasmotin (10 Mg,1 Days)
Those unexpected symptoms could be linked to a Lansoprazole treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Colitis Microscopic
This is a report of a possible correlation between Lansoprazole use and the following symptoms/side effect(s):
  • Colitis Microscopic
which could contribute to an assessment of Lansoprazole risk profile.A 66-year-old male consumer from JP (weight: NA) was suffering from NA and was treated with Lansoprazole (dosage: NA) starting NS.Other concurrent medications:
  • Amlodin (Unk)
  • Famotidine
  • Cilostazol
  • Gliclazide
  • Metformin


Hypomagnesaemia, Nausea, Vomiting, Gait Disturbance, Lethargy
A 73-year-old female patient from GB (weight: NA) presented with the following symptoms: NA and after a treatment with Lansoprazole (dosage: NA) experienced the following side effect(s):
  • Hypomagnesaemia
  • Nausea
  • Vomiting
  • Gait Disturbance
  • Lethargy
The treatment was started on NS. Lansoprazole was used in combination with the following drugs:
  • Bisoprolol
  • Aspirin
  • Atorvastatin
  • Calcichew D3 (Twice Daily)
The patient was hospitalized.This report could alert potential Lansoprazole consumers.

Subacute Cutaneous Lupus Erythematosus
In this report, a 65-year-old female patient from DK (weight: NA) was affected by a possible Lansoprazole side effect.The patient was diagnosed with NA. After a treatment with Lansoprazole (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Subacute Cutaneous Lupus Erythematosus
The following simultaneously used drugs could have led to this reaction:
  • Terbinafine
The findings here stress that side effects should be taken into consideration when evaluating a Lansoprazole treatment.

Hypocalcaemia, Hypomagnesaemia, Lethargy, Palpitations, Balance Disorder, Asthenia, Nausea, Vomiting, Supraventricular Tachycardia
This is a report of a 73-year-old female patient from GB (weight: NA), who used Lansoprazole (dosage: 30 Mg, Qd) for a treatment of NA. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Hypocalcaemia
  • Hypomagnesaemia
  • Lethargy
  • Palpitations
  • Balance Disorder
  • Asthenia
  • Nausea
  • Vomiting
  • Supraventricular Tachycardia
The following drugs could possibly have interacted with the Lansoprazole treatment
  • Bisoprolol (5 Mg, Qd)
  • Aspirin (75 Mg, Qd)
  • Atorvastatin (20 Mg, Qd)
  • Calcichew D3
The patient was hospitalized.Taken together, these observations suggest that a Lansoprazole treatment could be related to side effect(s), such as Hypocalcaemia, Hypomagnesaemia, Lethargy, Palpitations, Balance Disorder, Asthenia, Nausea, Vomiting, Supraventricular Tachycardia.

Duodenal Ulcer, Melaena, Syncope
This duodenal ulcer side effect was reported by a physician from IT. A 39-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Lansoprazole (dosage: 15 Milligram Daily;), which was started on Jan 29, 2014. Concurrently used drugs:
  • Cardioaspirin - 100 Mg Compresse Gastroresistenti - 4pharma S.r.l. (1 Dosage Forms Daily;)
  • Exinef - 60 Mg Compresse Rivestite Con Film - Abiogen Pharma S.p.a . (1 Dosage Forms Daily;)
  • Dediol - 0.25 Mcg Capsule Molli - Leo Pharma A/s (1 Dosage Forms Daily;)
When starting to take Lansoprazole the consumer reported the following symptoms:
  • Duodenal Ulcer
  • Melaena
  • Syncope
The patient was hospitalized. These side effects may potentially be related to Lansoprazole.

Diarrhoea, Colitis Microscopic, Weight Decreased, Hepatic Encephalopathy, Condition Aggravated
This is a Lansoprazole side effect report of a 75-year-old female patient (weight:NA) from JP, suffering from the following symptoms/conditions: gastritis erosive,off label use, who was treated with Lansoprazole (dosage:30 Mg/day (1 Tablet), start time: Jan 21, 2009), combined with: NA., and developed a serious reaction and a diarrhoea side effect. The patient presented with:
  • Diarrhoea
  • Colitis Microscopic
  • Weight Decreased
  • Hepatic Encephalopathy
  • Condition Aggravated
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Lansoprazole treatment in female patients suffering from gastritis erosive,off label use, resulting in diarrhoea.

Dyspnoea, Flatulence, Upper-airway Cough Syndrome, Frequent Bowel Movements
This report suggests a potential Lansoprazole dyspnoea side effect(s) that can have serious consequences. A 73-year-old female patient from GB (weight:NA) was diagnosed with the following health condition(s): hiatus hernia and used Lansoprazole (dosage: NA) starting Jun 01, 2010. Soon after starting Lansoprazole the patient began experiencing various side effects, including:
  • Dyspnoea
  • Flatulence
  • Upper-airway Cough Syndrome
  • Frequent Bowel Movements
Drugs used concurrently:
  • Thyroxine
Although Lansoprazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as dyspnoea, may still occur.

Pneumonia, Cardiac Failure
This pneumonia problem was reported by a physician from JP. A 85-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): prophylaxis against gastrointestinal ulcer,thrombosis prophylaxis.On Aug 23, 2012 a consumer started treatment with Lansoprazole (dosage: 15 Mg, Qd). The following drugs/medications were being taken at the same time:
  • Bayaspirin (100 Mg, 1 Day)
  • Amlodin (2.5 Mg, 1 Day)
  • Mucosolate L (45 Mg, 1 Day)
When commencing Lansoprazole, the patient experienced the following unwanted symptoms /side effects:
  • Pneumonia
  • Cardiac Failure
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as pneumonia, may become evident only after a product is in use by the general population.

Hepatic Encephalopathy, Concomitant Disease Aggravated, Diarrhoea, Weight Decreased, Hepatic Failure, Gait Disturbance, Altered State Of Consciousness, Asterixis, Hepatic Function Abnormal
This is a Lansoprazole side effect report of a 75-year-old female patient (weight: NA) from JP. The patient developed the following symptoms/conditions: gastritis erosive and was treated with Lansoprazole (dosage: 1 Df, Daily) starting NS. Concurrently used drugs:
  • Losartan Potassium+hydrochlorothiazide (1 Df, Daily)
  • Ursodeoxycholic Acid (6 Df, Tid)
  • Azelnidipine (1 Df, Unk)
  • Valsartan (1 Df, Unk)
  • Alfacalcidol (2 Df, Unk)
  • Raloxifene (1 Df, Unk)
  • Acetaminophen (3 Df, Tid)
Soon after that, the consumer experienced the following of symptoms:
  • Hepatic Encephalopathy
  • Concomitant Disease Aggravated
  • Diarrhoea
  • Weight Decreased
  • Hepatic Failure
  • Gait Disturbance
  • Altered State Of Consciousness
  • Asterixis
  • Hepatic Function Abnormal
The patient was hospitalized. This opens a possibility that Lansoprazole could cause hepatic encephalopathy and that some female patients may be more susceptible.

Erythema, Periorbital Oedema
A 56-year-old male patient (weight: NA) from IT with the following symptoms: gastroduodenitis started Lansoprazole treatment (dosage: NA) on Feb 13, 2014. Soon after starting Lansoprazole treatment, the consumer experienced several side effects, including:
  • Erythema
  • Periorbital Oedema
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Lansoprazole side effects, such as erythema.

Dyspnoea, Flatulence, Upper-airway Cough Syndrome, Frequent Bowel Movements
This dyspnoea side effect was reported by a consumer or non-health professional from GB. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: hiatus hernia.The patient was prescribed Lansoprazole (dosage: 15 Milligram Daily;), which was started on Jun 01, 2010. Concurrently used drugs:
  • Thyroxine
.When starting to take Lansoprazole the consumer reported symptoms, such as:
  • Dyspnoea
  • Flatulence
  • Upper-airway Cough Syndrome
  • Frequent Bowel Movements
These side effects may potentially be related to Lansoprazole.

Hypersensitivity
This is a report of a 47-year-old female patient (weight: NA) from IT, suffering from the following symptoms/conditions: abdominal pain upper,postoperative analgesia,vitamin supplementation, who was treated with Lansoprazole (dosage: 15 Mg Daily, start time: Nov 19, 2013), combined with:
  • Lyrica (1 Df Daily)
  • Supradyn /07499601/
and developed a serious reaction and side effect(s). The consumer presented with:
  • Hypersensitivity
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lansoprazole treatment in female patients, resulting in hypersensitivity side effect.

Hypomagnesaemia, Tremor, Nausea, Balance Disorder
This report suggests a potential Lansoprazole Hypomagnesaemia, Tremor, Nausea, Balance Disorder side effect(s) that can have serious consequences. A 65-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Lansoprazole (dosage: NA) starting Dec 10, 2013. Soon after starting Lansoprazole the patient began experiencing various side effects, including:
  • Hypomagnesaemia
  • Tremor
  • Nausea
  • Balance Disorder
Drugs used concurrently:
  • Ramipril (Ongoing.)
  • Loperamide (Ongoing)
The patient was hospitalized. Although Lansoprazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as hypomagnesaemia, may still occur.

Dyspnoea, Flatulence, Upper-airway Cough Syndrome, Frequent Bowel Movements
This Dyspnoea, Flatulence, Upper-airway Cough Syndrome, Frequent Bowel Movements problem was reported by a health professional from GB. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hiatus hernia. On Jun 01, 2010 this consumer started treatment with Lansoprazole (dosage: 15 Mg, Qd). The following drugs were being taken at the same time:
  • Thyroxine
When commencing Lansoprazole, the patient experienced the following unwanted symptoms/side effects:
  • Dyspnoea
  • Flatulence
  • Upper-airway Cough Syndrome
  • Frequent Bowel Movements
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as dyspnoea, may become evident only after a product is in use by the general population.

Pruritus, Rash
This is a report of a 65-year-old female patient (weight: NA) from IT. The patient developed the following symptoms/conditions: prophylaxis,arthralgia and was treated with Lansoprazole (dosage: NA) starting Feb 01, 2014. Concurrently used drugs:
  • Celebrex
Soon after that, the consumer experienced the following side effects:
  • Pruritus
  • Rash
This opens a possibility that Lansoprazole treatment could cause the above reactions, including pruritus, and some female subjects may be more susceptible.

Erythema, Pruritus
A 65-year-old female patient (weight: NA) from IT with the following symptoms/conditions: gastrooesophageal reflux prophylaxis,thrombosis prophylaxis,prophylaxis of nausea and vomiting,hypertension,hypothyroidism,vertigo started Lansoprazole treatment (dosage: 30 Mg Daily) on Jan 11, 2014. Soon after starting Lansoprazole treatment, the subject experienced various side effects, including:
  • Erythema
  • Pruritus
Concurrently used drugs:
  • Enoxaparin Sodium (4000 Lu Daily)
  • Alizapride Hydrochloride (100 Mg Daily)
  • Triatec /00885601/ (5 Mg)
  • Levothyroxine (75 Ug)
  • Betahistine Hydrochloride (16 Mg)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Lansoprazole.

1 of 82 



Top 10 Lansoprazole Side Effects for Women

Women Side EffectsReports
Diarrhoea 81
Vomiting 48
Nausea 47
Product Substitution Issue 45
Dizziness 43
Colitis Collagenous 39
Condition Aggravated 39
Malaise 39
Melaena 34
Haemoglobin Decreased 32

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


    Discuss Lansoprazole Side Effects

    Did You Have a Lansoprazole Side Effect?

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    Yes, Moderate
    Yes, Minor
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    How Effective is Lansoprazole for You?

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    Lansoprazole Safety Alerts, Active Ingredients, Usage Information

    NDC0093-7350
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameLansoprazole
    NameLansoprazole
    Dosage FormCAPSULE, DELAYED RELEASE
    RouteORAL
    On market since20091111
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)LANSOPRAZOLE
    Strength(s)15
    Unit(s)mg/1
    Pharma ClassProton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]

    More About Lansoprazole

    Side Effects reported to FDA: 2036

    Lansoprazole safety alerts: 2011

    Reported deaths: 272

    Reported hospitalizations: 1021

    Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral Syringes and Feeding Tubes

    [Posted 04/15/2011]

    AUDIENCE: Risk Manager, Pharmacy, Home Care

    ISSUE: The FDA has received reports that Teva’s lansoprazole delayed-release orally disintegrating tablet has clogged and blocked oral syringes and feeding tubes, including both gastric and jejunostomy types, when the drug is administered as a suspension through these devices. The tablets may not fully disintegrate when water is added to them and/or they may disintegrate but later form clumps. These clumps can adhere to the inside walls of oral syringes and feeding tubes. In some cases, patients have had to seek emergency medical assistance and their feeding tubes have had to be unclogged or removed and replaced.

    BACKGROUND: Lansoprazole is a proton pump inhibitor (PPI) medication. It is approved for the treatment of gastric and duodenal ulcers, gastroesophageal reflux disease (GERD), erosive esophagitis (EE), and Zollinger-Ellison Syndrome (a condition involving overproduction of stomach acid).

    Teva Pharmaceuticals has voluntarily withdrawn its lansoprazole delayed-release ODT product from distribution at this time. However, some product may remain in stock in pharmacies and other facilities, and some patients may still have the product in their possession. The product may also be sold under the following labels: Sharp Corporation, Cardinal Health, and Quality Packaging Specialist, Inc.

    RECOMMENDATIONS:

    • FDA recommends that healthcare professionals evaluate their medication stock and not dispense the Teva lansoprazole delayed-release ODT product to patients for whom the product will be administered through an oral syringe or feeding tube.
    • Patients and caregivers should be instructed not to administer the Teva lansoprazole delayed-release ODT product through oral syringes and/or feeding tubes due to the potential for clogging and blockage of the oral syringe or tube.
    • Read the Healthcare Professional Letter for other specific recommendations and for National Drug Code (NDC) numbers for the affected Teva products.

     

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [04/15/2011 - Letter to Healthcare Professionals - FDA]
     

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