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Showing 1-25 of 1547 

Decreased Appetite, Blood Lactate Dehydrogenase Increased, Hepatic Function Abnormal, Alanine Aminotransferase Increased, Gamma-glutamyltransferase Increased, Nausea, Jaundice, Abdominal Pain, Aspartate Aminotransferase Increased (8448117-9)
on Jun 15, 2012 Male from JAPAN , 40 years of age, weighting 161.4 lb, was treated with Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: decreased appetite, blood lactate dehydrogenase increased, hepatic function abnormal, alanine aminotransferase increased, gamma-glutamyltransferase increased, nausea, jaundice, abdominal pain, aspartate aminotransferase increased. Lansoprazole dosage: 15 Mg, 1x/day.
Associated medications used:
  • Irribow (5 Ug, 1x/day)
  • Gastrom (1.0 G, 3x/day)
  • Famotidine (20 Mg, 2x/day)
  • Tsukushi Am (1.3 G, 3x/day)
Patient was hospitalized.

Enterocolitis (8447397-3)
Patient was taking Lansoprazole. Patient felt the following Lansoprazole side effects: enterocolitis on Jun 12, 2012 from JAPAN Additional patient health information: Male , 62 years of age, weighting 189.6 lb, . Lansoprazole dosage: 30 Mg, 1x/day.
Multiple prescriptions taken:
  • Temsirolimus (25 Mg, Weekly)
  • Mucosolvan (45 Mg, 1x/day)
  • Betamethasone (2 Mg, 1x/day)
  • Adenosine (100 Mg, 3x/day)
  • Mucodyne (500 Mg, 3x/day)
  • Chlor-trimeton (10 Mg, Weekly (single))
  • Vitamedin Capsule (Unk)
  • Norvasc (10 Mg, 1x/day)
Patient was hospitalized.

Bronchopulmonary Aspergillosis, Acute Graft Versus Host Disease, Febrile Neutropenia (8443887-8)
Adverse event was reported on Jun 12, 2012 by a Female taking Lansoprazole (Dosage: Unk) was diagnosed with
  • prophylaxis against gastrointestinal ulcer
and. Location: JAPAN , weighting 110.2 lb, After Lansoprazole was administered, patient encountered several Lansoprazole side effects: bronchopulmonary aspergillosis, acute graft versus host disease, febrile neutropenia.
Multiple concurrent drugs taken:
  • Platelets (Unk)
  • Sulfamethoprim (Unk)
  • Tacrolimus (Unk)
  • Methotrexate (Unk)
  • Fludara (50 Mg, Qd, 5 Times)
  • Sulfamethoprim (Unk)
  • Acyclovir (Unk)
  • Thymoglobulin (60 Mg, Qd)
Patient was hospitalized.

Oedema Peripheral, Heparin-induced Thrombocytopenia, Pulmonary Embolism, Disseminated Intravascular Coagulation, Deep Vein Thrombosis (8439649-8)
on Jun 06, 2012 Female from JAPAN , 79 years of age, weighting 132.3 lb, was treated with Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: oedema peripheral, heparin-induced thrombocytopenia, pulmonary embolism, disseminated intravascular coagulation, deep vein thrombosis. Lansoprazole dosage: N/A.
Associated medications used:
  • Enoxaparin Sodium (Every 12 Hours)
  • Loxonin
  • Mucosta
Patient was hospitalized.


Inappropriate Antidiuretic Hormone Secretion, Hyponatraemia, Urinary Tract Infection, Cardiac Failure Congestive, Loss Of Consciousness, Renal Failure, Decreased Appetite (8439562-6)
on Jun 05, 2012 Male from DENMARK , weighting 105.8 lb, was diagnosed with
  • gastric ulcer
  • still's disease adult onset
  • depression
  • abdominal pain
and was treated with Lansoprazole. Patient felt the following Lansoprazole side effects: inappropriate antidiuretic hormone secretion, hyponatraemia, urinary tract infection, cardiac failure congestive, loss of consciousness, renal failure, decreased appetite. Lansoprazole dosage: 15 Mg.
Multiple prescriptions taken:
  • Prednisolone (10 Mg)
  • Lexapro (10 Mg)
  • Gascon (120 Mg)
  • Dogmatyl (100 Mg)
  • Zoloft (50 Mg)


Nausea, Vomiting, Rash, Dizziness, Abdominal Pain Upper, Headache, Treatment Failure, Eructation, Paraesthesia (8438740-X)
Patient was taking Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: nausea, vomiting, rash, dizziness, abdominal pain upper, headache, treatment failure, eructation, paraesthesia on Jun 11, 2012 from UNITED STATES Additional patient health information: Female , 61 years of age, weighting 103.0 lb, was diagnosed with
  • gastrooesophageal reflux disease
and. Lansoprazole dosage: 30 Mg 2 Daily.

Pain In Jaw, Abdominal Pain Upper, Rash, Paraesthesia, Diarrhoea, Chest Pain, Dyspnoea, Pharyngeal Oedema, Dyspepsia (8436853-X)
Adverse event was reported on Jun 08, 2012 by a Female taking Lansoprazole (Dosage: 30 Mg 2daily) . Location: UNITED STATES , 61 years of age, weighting 103.0 lb, Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: pain in jaw, abdominal pain upper, rash, paraesthesia, diarrhoea, chest pain, dyspnoea, pharyngeal oedema, dyspepsia.

Interstitial Lung Disease (8436710-9)
on Jun 06, 2012 Female from JAPAN , 76 years of age, was treated with Lansoprazole. Patient felt the following Lansoprazole side effects: interstitial lung disease. Lansoprazole dosage: N/A.
Multiple prescriptions taken:
  • Loxonin
  • Sulfasalazine
  • Orencia (Infu Dts 27may11,10jun11,8jul11,5aug11 Stopped Rest On 6jan12)
  • Alendronate Sodium
  • Methotrexate
  • Prednisolone
  • Ferrous Citrate
Patient was hospitalized.

Wound Complication, Purpura, Purpura Non-thrombocytopenic, Skin Disorder, Skin Ulcer, Petechiae (8434985-3)
on May 23, 2012 Female from FRANCE , 89 years of age, was diagnosed with
  • gastric disorder
and was treated with Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: wound complication, purpura, purpura non-thrombocytopenic, skin disorder, skin ulcer, petechiae. Lansoprazole dosage: 15 Mg (15 Mg, 1 In 1 D) Sublingual.
Multiple concurrent drugs taken:
  • Perindopril Erbumine
  • Digoxin
Patient was hospitalized.

Muscular Weakness, Pulmonary Embolism (8433426-X)
Patient was taking Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: muscular weakness, pulmonary embolism on Jun 01, 2012 from UNITED KINGDOM Additional patient health information: Male , 65 years of age, weighting 134.5 lb, . Lansoprazole dosage: N/A.
Associated medications used:
  • Enoxaparin Sodium
  • Fortisip (1 Df : 2 Carton)
  • Loperamide
  • Zimovane
  • Carboplatin (Recent Dose:2mar2012)
  • Metformin Hcl
  • Acetaminophen
  • Acetaminophen And Codeine Phosphate (30mg/500 Mg X 4-8)
Patient was hospitalized.

Spinal Column Stenosis, Alopecia (8431712-0)
Adverse event was reported on Jun 05, 2012 by a Female taking Lansoprazole (Dosage: N/A) . Location: JAPAN , 60 years of age, Patient felt the following Lansoprazole side effects: spinal column stenosis, alopecia.
Multiple prescriptions taken:
  • Lyrica
  • Tramadol Hydrochloride And Acetaminophen (1 Df X 4 Per 1 Day)
  • Opalmon
  • Prochlorperazine
  • Tramadol Hydrochloride And Acetaminophen (1 Df X 2 Per 1 Day)


Headache, Eye Pain (8431415-2)
on May 16, 2012 Male from FRANCE , 65 years of age, was treated with Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: headache, eye pain. Lansoprazole dosage: 30 Mg (30 Mg, 1 In 1 D), Sublingual.

Psychomotor Hyperactivity, Rhabdomyolysis, Abdominal Pain Upper, Renal Failure Acute (8429373-X)
on Jun 04, 2012 Female from UNITED STATES , 85 years of age, was treated with Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: psychomotor hyperactivity, rhabdomyolysis, abdominal pain upper, renal failure acute. Lansoprazole dosage: N/A.
Associated medications used:
  • Gabapentin
  • Haloperidol


Vaginal Haemorrhage, Blood Blister, Red Blood Cell Count Decreased, Purpura, Haematocrit Decreased, Rectal Haemorrhage, Neutrophil Count Increased, Melaena (8426413-9)
Patient was taking Lansoprazole. Patient felt the following Lansoprazole side effects: vaginal haemorrhage, blood blister, red blood cell count decreased, purpura, haematocrit decreased, rectal haemorrhage, neutrophil count increased, melaena on May 03, 2012 from UNITED KINGDOM Additional patient health information: Female , 34 years of age, weighting 220.0 lb, was diagnosed with
  • gastrooesophageal reflux disease
  • haematology test abnormal
  • idiopathic thrombocytopenic purpura
and. Lansoprazole dosage: 30 Mg;qd;po.
Multiple prescriptions taken:
  • Rituximab (rituximab) (375 Mg/m**2;biw;iv)
  • Immune Globulin Intravenous (human) (1000 Mg/kg;qd;iv)
  • Romiplastim (no Pref. Name) (1 Ug/kg;sc)
  • Tranexamic Acid (Qid;po)
  • Dexamethasone (Po)
  • Vincristine Sulfate
  • Norethindrone (Po)
  • Anti-d Immunoglobulin
Patient was hospitalized.

Purpura, Rash Maculo-papular, Haemoglobin Decreased, Vaginal Haemorrhage, Melaena, Rectal Haemorrhage, Rash Erythematous, Arthralgia (8422818-0)
Adverse event was reported on May 03, 2012 by a Female taking Lansoprazole (Dosage: 30 Mg Qd, Oral) was diagnosed with
  • gastrooesophageal reflux prophylaxis
and. Location: UNITED KINGDOM , 33 years of age, After Lansoprazole was administered, patient encountered several Lansoprazole side effects: purpura, rash maculo-papular, haemoglobin decreased, vaginal haemorrhage, melaena, rectal haemorrhage, rash erythematous, arthralgia.
Multiple concurrent drugs taken:
  • Tranexamic Acid (Oral)
  • Immune Globulin Intravenous (human)
  • Dexamethasone (Oral)
  • Norethindrone (5 Mg Tid, Oral)
  • Rituximab (rituximab) (375 Mg/m2 2x/week, Intravenous (not Otherwise Specified))
  • Nplate (1 Mg/kg Qd, Subcutaneous)
Patient was hospitalized.

Pulmonary Embolism, Dyspnoea (8421741-5)
on May 30, 2012 Male from GERMANY , 66 years of age, weighting 218.3 lb, was treated with Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: pulmonary embolism, dyspnoea. Lansoprazole dosage: N/A.
Associated medications used:
  • Doxycycline
  • Temazepam
  • Ondansetron
  • Sucralfate
  • Cetuximab (Recent Dose 16jan2012 Cetuximab Iv Infusion)
  • Cisplatin (Recent Dose 04jan2012)
  • Levothyroxine Sodium
  • Dexamethasone


Agranulocytosis, Sepsis (8420827-9)
on May 14, 2012 Male from JAPAN , 71 years of age, was treated with Lansoprazole. Patient felt the following Lansoprazole side effects: agranulocytosis, sepsis. Lansoprazole dosage: N/A.

Femur Fracture, Low Turnover Osteopathy (8420404-X)
Patient was taking Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: femur fracture, low turnover osteopathy on Jun 01, 2012 from JAPAN Additional patient health information: Female , 74 years of age, was diagnosed with
  • gastric ulcer
  • osteoporosis
  • hyperlipidaemia
and. Lansoprazole dosage: N/A.
Multiple concurrent drugs taken:
  • Fosamax
  • Crestor
Patient was hospitalized.

Blood Creatine Phosphokinase Increased, Nausea, Gait Disturbance, Disorientation (8415924-8)
Adverse event was reported on May 30, 2012 by a Male taking Lansoprazole (Dosage: Daily Dose: 15mg) was diagnosed with
  • gastritis prophylaxis
  • paronychia
  • convulsion prophylaxis
  • non-small cell lung cancer
and. Location: JAPAN , 65 years of age, weighting 110.2 lb, Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: blood creatine phosphokinase increased, nausea, gait disturbance, disorientation.
Associated medications used:
  • Gentamicin Sulfate
  • Depakene
  • Erlotinib Hydrochloride
  • Minocycline Hcl (Daily Dose: 100mg)
  • Clobetasol Propionate
  • Hirudoid
  • Biolactis
  • Depakene
Patient was hospitalized.

Oedema Peripheral, Lip Swelling, Angioedema, Eyelid Oedema (8414244-5)
on May 31, 2012 Female from UNITED KINGDOM , 66 years of age, weighting 176.4 lb, was treated with Lansoprazole. Patient felt the following Lansoprazole side effects: oedema peripheral, lip swelling, angioedema, eyelid oedema. Lansoprazole dosage: N/A.
Multiple prescriptions taken:
  • Metformin
  • Varenicline Tartrate (1 Mg, Unk)
  • Ramipril
  • Atorvastatin
  • Glimepiride
  • Clopidogrel


Erythema Multiforme (8413360-1)
on May 28, 2012 Female from JAPAN , weighting 134.5 lb, was diagnosed with
  • helicobacter infection
and was treated with Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: erythema multiforme. Lansoprazole dosage: N/A.
Multiple concurrent drugs taken:
  • Clarithromycin
  • Amoxicillin
Patient was hospitalized.

Erythema Multiforme, Hepatic Function Abnormal, Disseminated Intravascular Coagulation, Renal Impairment, Blood Potassium Increased, Hypoproteinaemia, Pleural Effusion (8413265-6)
Patient was taking Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: erythema multiforme, hepatic function abnormal, disseminated intravascular coagulation, renal impairment, blood potassium increased, hypoproteinaemia, pleural effusion on Jun 01, 2012 from JAPAN Additional patient health information: Female , 77 years of age, weighting 108.0 lb, was diagnosed with
  • gastric ulcer
  • renal failure chronic
  • rhinitis allergic
and. Lansoprazole dosage: 15 Mg, 1x/day.
Associated medications used:
  • Furosemide (20 Mg, 1x/day)
  • Onon (250 Mg, 2x/day)
  • Spironolactone (25 Mg, 1x/day)
  • Allopurinol (100 Mg, 1x/day)
  • Levofloxacin (500 Mg, 2x/day)
  • Diclofenac Sodium (25 Mg Once As Needed)
  • Celebrex (100 Mg Once Daily As Needed)
Patient was hospitalized.

Melaena, Sepsis, Anaemia, Rectal Haemorrhage, Neoplasm Malignant (8412016-9)
Adverse event was reported on May 31, 2012 by a Female taking Lansoprazole (Dosage: 30 Mg, 2x/day) . Location: UNITED KINGDOM , 71 years of age, Patient felt the following Lansoprazole side effects: melaena, sepsis, anaemia, rectal haemorrhage, neoplasm malignant.
Multiple prescriptions taken:
  • Theophylline (200 Mg, 2x/day)
  • Aspirin (1 G, 4x/day)
  • Metformin Hcl (500 Mg, 1x/day)
  • Capecitabine (Unk)
  • Ethamsylate (500 Mg, 4x/day)
  • Tranexamic Acid (1 G, 3x/day)
  • Acetaminophen (1 G, 4x/day)
Patient was hospitalized.

Dyspnoea, Dysphagia, Flatulence, Chest Pain, Fatigue, Dizziness, Rash, Pruritus (8408094-3)
on Jun 01, 2012 Female from UNITED STATES , weighting 194.0 lb, was diagnosed with
  • gastric ph decreased
and was treated with Lansoprazole. After Lansoprazole was administered, patient encountered several Lansoprazole side effects: dyspnoea, dysphagia, flatulence, chest pain, fatigue, dizziness, rash, pruritus. Lansoprazole dosage: 1 Capsule 1 Daily.

Cytomegalovirus Infection (8407501-X)
on May 22, 2012 Male from JAPAN , 64 years of age, was treated with Lansoprazole. Directly after, patient experienced the unwanted or unexpected Lansoprazole side effects: cytomegalovirus infection. Lansoprazole dosage: 30 Mg, 1x/day.
Associated medications used:
  • Doripenem Monohydrate (Unk)
  • Neo-minophagen C (40 Ml, Unk)
  • Ganciclovir (500 Mg, Unk)
  • Levofloxacin (500 Mg, 1x/day)
  • Cyclophosphamide (510 Mg, Unk)
  • Funguard (100 Mg, Unk)
  • Doxorubicin Hydrochloride (45 Mg, Unk)
  • Oncovin (1.5 Mg, Unk)
Patient was hospitalized.

Showing 1-25 of 1547 

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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

Alternative LANSOPRAZOLE Names:LANSOPRAZ

Active Ingredient: LANSOPRAZ

More About Lansoprazole

Side Effects reported to FDA: 1547. View Lansoprazole Adverse Reports

Lansoprazole safety alerts: 2011

Reported deaths: 209

Reported hospitalizations: 790

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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