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Lansoprazole Side Effects

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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.

Lansoprazole Side Effects Reported to FDA



Lansoprazole Side Effect Report#9995105
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 health 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): Muscle Strain, Abdominal Distension, Local Swelling, Joint Swelling 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.
Lansoprazole Side Effect Report#9989227
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. After starting Lansoprazole the patient began experiencing various side effects, including: OsteonecrosisAdditional 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.
Lansoprazole Side Effect Report#9985432
Dermatitis Exfoliative, Rash Erythematous, Wheezing, Eczema, Lymphocytic Infiltration, Parakeratosis, Skin Exfoliation
This Dermatitis Exfoliative 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 using Lansoprazole, the patient experienced the following unwanted symptoms/side effects: Dermatitis Exfoliative, Rash Erythematous, Wheezing, Eczema, Lymphocytic Infiltration, Parakeratosis, Skin ExfoliationThe 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.
Lansoprazole Side Effect Report#9975913
Colitis Microscopic, Diarrhoea, Protein Total Decreased, Protein-losing Gastroenteropathy
This Colitis Microscopic side effect was reported by a health professional from JP. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: abdominal discomfort,off label use.The patient was prescribed Lansoprazole (drug dosage: 15 Mg, Qd), which was initiated on NS. Concurrently used drugs: NA..After starting to take Lansoprazole the consumer reported adverse symptoms, such as: Colitis Microscopic, Diarrhoea, Protein Total Decreased, Protein-losing GastroenteropathyThese side effects may potentially be related to Lansoprazole. The patient was hospitalized.
Lansoprazole Side Effect Report#9969697
Dermatitis Exfoliative, Wheezing, Eczema, Lymphocytic Infiltration, Parakeratosis, Skin Exfoliation
This is a report of a 72-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Lansoprazole (dosage: 30 Mg, Qd, start time:
Nov 01, 2013), combined with:
  • 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)
and developed a serious reaction and side effect(s): Dermatitis Exfoliative, Wheezing, Eczema, Lymphocytic Infiltration, Parakeratosis, Skin Exfoliation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lansoprazole treatment in female patients, resulting in Dermatitis Exfoliative side effect. The patient was hospitalized.
Lansoprazole Side Effect Report#9967651
Duodenal Ulcer, Melaena, Presyncope, Haemoglobin Decreased
This report suggests a potential Lansoprazole Duodenal Ulcer side effect(s) that can have serious consequences. A 39-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: NA and used Lansoprazole (dosage: 15 Mg Daily) starting
Jan 29, 2014. After starting Lansoprazole the patient began experiencing various side effects, including: Duodenal Ulcer, Melaena, Presyncope, Haemoglobin DecreasedAdditional drugs used concurrently:
  • 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. Although Lansoprazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Duodenal Ulcer, may still occur.
Lansoprazole Side Effect Report#9964271
Femoral Neck Fracture, Fall, Diabetes Mellitus, Glycosylated Haemoglobin Increased, Hypertension
This Femoral Neck Fracture problem was reported by a physician from JP. A 75-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: prophylaxis against gastrointestinal ulcer. On
Jul 13, 2012 this consumer started treatment with Lansoprazole (dosage: 15 Mg, Qd). The following drugs were being taken at the same time:
  • 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)
When using Lansoprazole, the patient experienced the following unwanted symptoms/side effects: Femoral Neck Fracture, Fall, Diabetes Mellitus, Glycosylated Haemoglobin Increased, HypertensionThe 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 Femoral Neck Fracture, may become evident only after a product is in use by the general population.
Lansoprazole Side Effect Report#9943331
Duodenal Ulcer, Melaena, Circulatory Collapse
This Duodenal Ulcer side effect was reported by a health professional from IT. A 39-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Lansoprazole (drug dosage: 15 Mg, Qd), which was initiated on
Mar 25, 2013. Concurrently used drugs:
  • Dediol (0.25 Ug, Qd)
  • Exinef (60 Mg, Qd)
  • Cardioaspirin (100 Mg, Qd)
.After starting to take Lansoprazole the consumer reported adverse symptoms, such as: Duodenal Ulcer, Melaena, Circulatory CollapseThese side effects may potentially be related to Lansoprazole. The patient was hospitalized.
Lansoprazole Side Effect Report#9942700
Aortic Aneurysm Rupture
This is a report of a 95-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: prophylaxis against gastrointestinal ulcer,thrombosis prophylaxis, who was treated with Lansoprazole (dosage: 15 Mg, Qd, start time:
Feb 20, 2012), combined with:
  • 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)
and developed a serious reaction and side effect(s): Aortic Aneurysm Rupture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lansoprazole treatment in female patients, resulting in Aortic Aneurysm Rupture side effect.
Lansoprazole Side Effect Report#9940661
Colitis Microscopic
This report suggests a potential Lansoprazole Colitis Microscopic side effect(s) that can have serious consequences. A 66-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: NA and used Lansoprazole (dosage: NA) starting NS. After starting Lansoprazole the patient began experiencing various side effects, including: Colitis MicroscopicAdditional drugs used concurrently:
  • Amlodin (Unk)
  • Famotidine
  • Cilostazol
  • Gliclazide
  • Metformin
Although Lansoprazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Colitis Microscopic, may still occur.
Lansoprazole Side Effect Report#9940546
Hypomagnesaemia, Nausea, Vomiting, Gait Disturbance, Lethargy
This Hypomagnesaemia problem was reported by a physician from GB. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Lansoprazole (dosage: NA). The following drugs were being taken at the same time:
  • Bisoprolol
  • Aspirin
  • Atorvastatin
  • Calcichew D3 (Twice Daily)
When using Lansoprazole, the patient experienced the following unwanted symptoms/side effects: Hypomagnesaemia, Nausea, Vomiting, Gait Disturbance, LethargyThe 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 Hypomagnesaemia, may become evident only after a product is in use by the general population.
Lansoprazole Side Effect Report#9937145
Subacute Cutaneous Lupus Erythematosus
This Subacute Cutaneous Lupus Erythematosus side effect was reported by a health professional from DK. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Lansoprazole (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Terbinafine
.After starting to take Lansoprazole the consumer reported adverse symptoms, such as: Subacute Cutaneous Lupus ErythematosusThese side effects may potentially be related to Lansoprazole.
Lansoprazole Side Effect Report#9928821
Hypocalcaemia, Hypomagnesaemia, Lethargy, Palpitations, Balance Disorder, Asthenia, Nausea, Vomiting, Supraventricular Tachycardia
This is a report of a 73-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Lansoprazole (dosage: 30 Mg, Qd, start time: NS), combined with:
  • Bisoprolol (5 Mg, Qd)
  • Aspirin (75 Mg, Qd)
  • Atorvastatin (20 Mg, Qd)
  • Calcichew D3
and developed a serious reaction and side effect(s): Hypocalcaemia, Hypomagnesaemia, Lethargy, Palpitations, Balance Disorder, Asthenia, Nausea, Vomiting, Supraventricular Tachycardia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lansoprazole treatment in female patients, resulting in Hypocalcaemia side effect. The patient was hospitalized.
Lansoprazole Side Effect Report#9922233
Duodenal Ulcer, Melaena, Syncope
This report suggests a potential Lansoprazole Duodenal Ulcer side effect(s) that can have serious consequences. A 39-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: NA and used Lansoprazole (dosage: 15 Milligram Daily;) starting
Jan 29, 2014. After starting Lansoprazole the patient began experiencing various side effects, including: Duodenal Ulcer, Melaena, SyncopeAdditional drugs used concurrently:
  • 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;)
The patient was hospitalized. Although Lansoprazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Duodenal Ulcer, may still occur.
Lansoprazole Side Effect Report#9921797
Diarrhoea, Colitis Microscopic, Weight Decreased, Hepatic Encephalopathy, Condition Aggravated
This Diarrhoea problem was reported by a health professional from JP. A 75-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: gastritis erosive,off label use. On
Jan 21, 2009 this consumer started treatment with Lansoprazole (dosage: 30 Mg/day (1 Tablet)). The following drugs were being taken at the same time: NA. When using Lansoprazole, the patient experienced the following unwanted symptoms/side effects: Diarrhoea, Colitis Microscopic, Weight Decreased, Hepatic Encephalopathy, Condition AggravatedThe 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 Diarrhoea, may become evident only after a product is in use by the general population.
Lansoprazole Side Effect Report#9920774
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 (drug dosage: NA), which was initiated on
Jun 01, 2010. Concurrently used drugs:
  • Thyroxine
.After starting to take Lansoprazole the consumer reported adverse symptoms, such as: Dyspnoea, Flatulence, Upper-airway Cough Syndrome, Frequent Bowel MovementsThese side effects may potentially be related to Lansoprazole.
Lansoprazole Side Effect Report#9916685
Pneumonia, Cardiac Failure
This is a report of a 85-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: prophylaxis against gastrointestinal ulcer,thrombosis prophylaxis, who was treated with Lansoprazole (dosage: 15 Mg, Qd, start time:
Aug 23, 2012), combined with:
  • Bayaspirin (100 Mg, 1 Day)
  • Amlodin (2.5 Mg, 1 Day)
  • Mucosolate L (45 Mg, 1 Day)
and developed a serious reaction and side effect(s): Pneumonia, Cardiac Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lansoprazole treatment in male patients, resulting in Pneumonia side effect.
Lansoprazole Side Effect Report#9916605
Hepatic Encephalopathy, Concomitant Disease Aggravated, Diarrhoea, Weight Decreased, Hepatic Failure, Gait Disturbance, Altered State Of Consciousness, Asterixis, Hepatic Function Abnormal
This report suggests a potential Lansoprazole Hepatic Encephalopathy side effect(s) that can have serious consequences. A 75-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: gastritis erosive and used Lansoprazole (dosage: 1 Df, Daily) starting NS. After starting Lansoprazole the patient began experiencing various side effects, including: Hepatic Encephalopathy, Concomitant Disease Aggravated, Diarrhoea, Weight Decreased, Hepatic Failure, Gait Disturbance, Altered State Of Consciousness, Asterixis, Hepatic Function AbnormalAdditional drugs used concurrently:
  • 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)
The patient was hospitalized. Although Lansoprazole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Encephalopathy, may still occur.
Lansoprazole Side Effect Report#9915591
Erythema, Periorbital Oedema
This Erythema problem was reported by a physician from IT. A 56-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: gastroduodenitis. On
Feb 13, 2014 this consumer started treatment with Lansoprazole (dosage: NA). The following drugs were being taken at the same time: NA. When using Lansoprazole, the patient experienced the following unwanted symptoms/side effects: Erythema, Periorbital OedemaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Erythema, may become evident only after a product is in use by the general population.
Lansoprazole Side Effect Report#9914595
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 (drug dosage: 15 Milligram Daily;), which was initiated on
Jun 01, 2010. Concurrently used drugs:
  • Thyroxine
.After starting to take Lansoprazole the consumer reported adverse symptoms, such as: Dyspnoea, Flatulence, Upper-airway Cough Syndrome, Frequent Bowel MovementsThese side effects may potentially be related to Lansoprazole.
Lansoprazole Side Effect Report#9907278
Hypersensitivity
This is a report of a 47-year-old female patient (weight: NA) from IT, suffering from the following health 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): Hypersensitivity 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.
Lansoprazole Side Effect Report#9907225
Hypomagnesaemia, Tremor, Nausea, Balance Disorder
This report suggests a potential Lansoprazole Hypomagnesaemia 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. After starting Lansoprazole the patient began experiencing various side effects, including: Hypomagnesaemia, Tremor, Nausea, Balance DisorderAdditional 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.
Lansoprazole Side Effect Report#9906286
Dyspnoea, Flatulence, Upper-airway Cough Syndrome, Frequent Bowel Movements
This Dyspnoea 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 using Lansoprazole, the patient experienced the following unwanted symptoms/side effects: Dyspnoea, Flatulence, Upper-airway Cough Syndrome, Frequent Bowel MovementsAlthough 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.
Lansoprazole Side Effect Report#9900798
Pruritus, Rash
This Pruritus side effect was reported by a physician from IT. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: prophylaxis,arthralgia.The patient was prescribed Lansoprazole (drug dosage: NA), which was initiated on
Feb 01, 2014. Concurrently used drugs:
  • Celebrex
.After starting to take Lansoprazole the consumer reported adverse symptoms, such as: Pruritus, RashThese side effects may potentially be related to Lansoprazole.
Lansoprazole Side Effect Report#9894696
Erythema, Pruritus
This is a report of a 65-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: gastrooesophageal reflux prophylaxis,thrombosis prophylaxis,prophylaxis of nausea and vomiting,hypertension,hypothyroidism,vertigo, who was treated with Lansoprazole (dosage: 30 Mg Daily, start time:
Jan 11, 2014), combined with:
  • Enoxaparin Sodium (4000 Lu Daily)
  • Alizapride Hydrochloride (100 Mg Daily)
  • Triatec /00885601/ (5 Mg)
  • Levothyroxine (75 Ug)
  • Betahistine Hydrochloride (16 Mg)
and developed a serious reaction and side effect(s): Erythema, Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lansoprazole treatment in female patients, resulting in Erythema side effect. The patient was hospitalized.


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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.

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What are common 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

What are common Lansoprazole Side Effects for Men?

Men Side EffectsReports
Hypomagnesaemia 41
Condition Aggravated 38
Cardiac Failure 33
Renal Failure Acute 33
Diarrhoea 32
Interstitial Lung Disease 32
Pneumonia 32
Atrial Fibrillation 31
Hypocalcaemia 31
Fatigue 30

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Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    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.

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    Discuss Lansoprazole Side Effects

    Did You Have a Lansoprazole Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Lansoprazole for You?

    Exceeded Expectations
    Effective
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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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