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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
on Mar 07, 2014 Female from IT , 72 years of age, was diagnosed with and was treated with Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: muscle strain, abdominal distension, local swelling, joint swelling. Lansoprazole dosage: N/A.
Associated medications used:
  • Aloe Vera


Osteonecrosis
Patient was taking Lansoprazole. Patient felt the following Lansoprazole side effects: osteonecrosis on Mar 10, 2014 from FR Additional patient health information: Female , 68 years of age, . Lansoprazole dosage: N/A.
Multiple prescriptions taken:
  • Coaprovel
  • Atorvastatin
  • Plavix
  • Metformin
  • Nebilox
  • Levothyrox


Dermatitis Exfoliative, Rash Erythematous, Wheezing, Eczema, Lymphocytic Infiltration, Parakeratosis, Skin Exfoliation
Adverse event was reported on Mar 24, 2014 by a Female taking Lansoprazole (Dosage: 30 Mg, Qid) . Location: GB , 72 years of age, After Lansoprazole was administered, patient encountered several Lansoprazole side effects: dermatitis exfoliative, rash erythematous, wheezing, eczema, lymphocytic infiltration, parakeratosis, skin exfoliation.
Multiple concurrent drugs taken:
  • Allopurinol (300 Mg, Qd)
  • Aranesp (100 ?g, 1/week)
  • Indapamide
  • Furosemide
  • Salbutamol
  • Ramipril
  • Acetylsalicylic Acid
  • Simvastatin
Patient was hospitalized.

Colitis Microscopic, Diarrhoea, Protein Total Decreased, Protein-losing Gastroenteropathy
on Mar 06, 2014 Female from JP , 63 years of age, weighting 134.5 lb, was diagnosed with and was treated with Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: colitis microscopic, diarrhoea, protein total decreased, protein-losing gastroenteropathy. Lansoprazole dosage: 15 Mg, Qd. Patient was hospitalized.


Dermatitis Exfoliative, Wheezing, Eczema, Lymphocytic Infiltration, Parakeratosis, Skin Exfoliation
on Mar 06, 2014 Female from GB , 72 years of age, was treated with Lansoprazole. Patient felt the following Lansoprazole side effects: dermatitis exfoliative, wheezing, eczema, lymphocytic infiltration, parakeratosis, skin exfoliation. Lansoprazole dosage: 30 Mg, Qd.
Multiple prescriptions taken:
  • 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)
Patient was hospitalized.

Duodenal Ulcer, Melaena, Presyncope, Haemoglobin Decreased
Patient was taking Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: duodenal ulcer, melaena, presyncope, haemoglobin decreased on Mar 05, 2014 from IT Additional patient health information: Female , 39 years of age, . Lansoprazole dosage: 15 Mg Daily.
Multiple concurrent drugs taken:
  • Cardioaspirin (1 Df Daily)
  • Exinef (1 Df Daily)
  • Dediol - 0.25 Mcg Capsule Molli - Leo Pharma A/s (1 Df Daily)
Patient was hospitalized.

Femoral Neck Fracture, Fall, Diabetes Mellitus, Glycosylated Haemoglobin Increased, Hypertension
Adverse event was reported on Mar 05, 2014 by a Female taking Lansoprazole (Dosage: 15 Mg, Qd) was diagnosed with and. Location: JP , 75 years of age, weighting 88.18 lb, Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: femoral neck fracture, fall, diabetes mellitus, glycosylated haemoglobin increased, hypertension.
Associated medications used:
  • 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)
Patient was hospitalized.

Duodenal Ulcer, Melaena, Circulatory Collapse
on Mar 03, 2014 Female from IT , 39 years of age, was treated with Lansoprazole. Patient felt the following Lansoprazole side effects: duodenal ulcer, melaena, circulatory collapse. Lansoprazole dosage: 15 Mg, Qd.
Multiple prescriptions taken:
  • Dediol (0.25 Ug, Qd)
  • Exinef (60 Mg, Qd)
  • Cardioaspirin (100 Mg, Qd)
Patient was hospitalized.

Aortic Aneurysm Rupture
on Mar 03, 2014 Female from JP , 95 years of age, was diagnosed with and was treated with Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: aortic aneurysm rupture. Lansoprazole dosage: 15 Mg, Qd.
Multiple concurrent drugs taken:
  • 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)


Colitis Microscopic
Patient was taking Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: colitis microscopic on Mar 28, 2014 from JP Additional patient health information: Male , 66 years of age, . Lansoprazole dosage: N/A.
Associated medications used:
  • Amlodin (Unk)
  • Famotidine
  • Cilostazol
  • Gliclazide
  • Metformin


Hypomagnesaemia, Nausea, Vomiting, Gait Disturbance, Lethargy
Adverse event was reported on Mar 03, 2014 by a Female taking Lansoprazole (Dosage: N/A) . Location: GB , 73 years of age, Patient felt the following Lansoprazole side effects: hypomagnesaemia, nausea, vomiting, gait disturbance, lethargy.
Multiple prescriptions taken:
  • Bisoprolol
  • Aspirin
  • Atorvastatin
  • Calcichew D3 (Twice Daily)
Patient was hospitalized.

Subacute Cutaneous Lupus Erythematosus
on Mar 27, 2014 Female from DK , 65 years of age, was treated with Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: subacute cutaneous lupus erythematosus. Lansoprazole dosage: N/A.
Multiple concurrent drugs taken:
  • Terbinafine


Hypocalcaemia, Hypomagnesaemia, Lethargy, Palpitations, Balance Disorder, Asthenia, Nausea, Vomiting, Supraventricular Tachycardia
on Feb 27, 2014 Female from GB , 73 years of age, was treated with Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: hypocalcaemia, hypomagnesaemia, lethargy, palpitations, balance disorder, asthenia, nausea, vomiting, supraventricular tachycardia. Lansoprazole dosage: 30 Mg, Qd.
Associated medications used:
  • Bisoprolol (5 Mg, Qd)
  • Aspirin (75 Mg, Qd)
  • Atorvastatin (20 Mg, Qd)
  • Calcichew D3
Patient was hospitalized.

Duodenal Ulcer, Melaena, Syncope
Patient was taking Lansoprazole. Patient felt the following Lansoprazole side effects: duodenal ulcer, melaena, syncope on Feb 25, 2014 from IT Additional patient health information: Female , 39 years of age, . Lansoprazole dosage: 15 Milligram Daily;.
Multiple prescriptions taken:
  • 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;)
Patient was hospitalized.

Diarrhoea, Colitis Microscopic, Weight Decreased, Hepatic Encephalopathy, Condition Aggravated
Adverse event was reported on Feb 25, 2014 by a Female taking Lansoprazole (Dosage: 30 Mg/day (1 Tablet)) was diagnosed with and. Location: JP , 75 years of age, weighting 93.70 lb, After Lansoprazole was administered, patient encountered several Lansoprazole side effects: diarrhoea, colitis microscopic, weight decreased, hepatic encephalopathy, condition aggravated. Patient was hospitalized.

Dyspnoea, Flatulence, Upper-airway Cough Syndrome, Frequent Bowel Movements
on Feb 24, 2014 Female from GB , 73 years of age, weighting 138.9 lb, was diagnosed with and was treated with Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: dyspnoea, flatulence, upper-airway cough syndrome, frequent bowel movements. Lansoprazole dosage: N/A.
Associated medications used:
  • Thyroxine


Pneumonia, Cardiac Failure
on Feb 21, 2014 Male from JP , 85 years of age, weighting 94.80 lb, was diagnosed with and was treated with Lansoprazole. Patient felt the following Lansoprazole side effects: pneumonia, cardiac failure. Lansoprazole dosage: 15 Mg, Qd.
Multiple prescriptions taken:
  • Bayaspirin (100 Mg, 1 Day)
  • Amlodin (2.5 Mg, 1 Day)
  • Mucosolate L (45 Mg, 1 Day)


Hepatic Encephalopathy, Concomitant Disease Aggravated, Diarrhoea, Weight Decreased, Hepatic Failure, Gait Disturbance, Altered State Of Consciousness, Asterixis, Hepatic Function Abnormal
Patient was taking Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: hepatic encephalopathy, concomitant disease aggravated, diarrhoea, weight decreased, hepatic failure, gait disturbance, altered state of consciousness, asterixis, hepatic function abnormal on Feb 27, 2014 from JP Additional patient health information: Female , 75 years of age, weighting 93.70 lb, was diagnosed with and. Lansoprazole dosage: 1 Df, Daily.
Multiple concurrent drugs taken:
  • 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)
Patient was hospitalized.

Erythema, Periorbital Oedema
Adverse event was reported on Feb 21, 2014 by a Male taking Lansoprazole (Dosage: N/A) was diagnosed with and. Location: IT , 56 years of age, Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: erythema, periorbital oedema.

Dyspnoea, Flatulence, Upper-airway Cough Syndrome, Frequent Bowel Movements
on Feb 20, 2014 Female from GB , 73 years of age, weighting 138.9 lb, was diagnosed with and was treated with Lansoprazole. Patient felt the following Lansoprazole side effects: dyspnoea, flatulence, upper-airway cough syndrome, frequent bowel movements. Lansoprazole dosage: 15 Milligram Daily;.
Multiple prescriptions taken:
  • Thyroxine


Hypersensitivity
on Feb 18, 2014 Female from IT , 47 years of age, was diagnosed with and was treated with Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: hypersensitivity. Lansoprazole dosage: 15 Mg Daily.
Multiple concurrent drugs taken:
  • Lyrica (1 Df Daily)
  • Supradyn /07499601/


Hypomagnesaemia, Tremor, Nausea, Balance Disorder
Patient was taking Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: hypomagnesaemia, tremor, nausea, balance disorder on Feb 18, 2014 from GB Additional patient health information: Female , 65 years of age, . Lansoprazole dosage: N/A.
Associated medications used:
  • Ramipril (Ongoing.)
  • Loperamide (Ongoing)
Patient was hospitalized.

Dyspnoea, Flatulence, Upper-airway Cough Syndrome, Frequent Bowel Movements
Adverse event was reported on Feb 18, 2014 by a Female taking Lansoprazole (Dosage: 15 Mg, Qd) was diagnosed with and. Location: GB , 73 years of age, weighting 138.9 lb, Patient felt the following Lansoprazole side effects: dyspnoea, flatulence, upper-airway cough syndrome, frequent bowel movements.
Multiple prescriptions taken:
  • Thyroxine


Pruritus, Rash
on Feb 17, 2014 Female from IT , 65 years of age, was diagnosed with and was treated with Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: pruritus, rash. Lansoprazole dosage: N/A.
Multiple concurrent drugs taken:
  • Celebrex


Erythema, Pruritus
on Feb 13, 2014 Female from IT , 65 years of age, was diagnosed with and was treated with Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: erythema, pruritus. Lansoprazole dosage: 30 Mg Daily.
Associated medications used:
  • Enoxaparin Sodium (4000 Lu Daily)
  • Alizapride Hydrochloride (100 Mg Daily)
  • Triatec /00885601/ (5 Mg)
  • Levothyroxine (75 Ug)
  • Betahistine Hydrochloride (16 Mg)
Patient was hospitalized.

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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


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  • 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?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Lansoprazole for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative LANSOPRAZOLE Names:LANSOPRAZ

    Active Ingredient: LANSOPRAZ

    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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