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Lactulose Safety Reports submitted to FDA

Total Lactulose reports: 20.
Lactulose FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 13.
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Reported Lactulose Side Effects: anaemia, melaena, abdominal pain, cough, clubbing, haematemesis, encephalopathy, duodenal ulcer, hypotension, pyrexia, pulmonary embolism.
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Lactulose Side Effects Report #5212996-9
Consumer or non-health professional from UNITED KINGDOM reported LACTULOSE problem on Jan 02, 2007. Male patient, 54 years of age, was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: lower respiratory tract infection, pneumonia, toxic epidermal necrolysis. LACTULOSE dosage: 10 ML,. During the same period patient was treated with ACTRAPID, ALFENTANIL, AMOXICILLIN, AQUASEPT, BACTROBAN, CALCIUM CHLORIDE, CALCIUM GLUCONATE, CEFTRIAXONE. Patient recovered.

Lactulose Side Effects Report #5269153-X
LACTULOSE problem was reported by a Consumer or non-health professional from on Mar 12, 2007. Female patient, 62 years of age, was diagnosed with laxative abuse and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: anaemia, clubbing, cough, weight decreased. LACTULOSE dosage: unknown. During the same period patient was treated with SENNA. Patient was hospitalized. Patient recovered.

Lactulose Side Effects Report #5310970-5
Consumer or non-health professional from UNITED KINGDOM reported LACTULOSE problem on Apr 11, 2007. Female patient, 62 years of age, was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: anaemia, blood potassium decreased, clubbing, cough, diarrhoea, incorrect dose administered, melanosis coli. LACTULOSE dosage: unknown. During the same period patient was treated with SENNA ALEXANDRINA. Patient was hospitalized. Patient recovered.

Lactulose Side Effects Report #5323960-3
LACTULOSE problem was reported by a Consumer or non-health professional from UNITED STATES on May 09, 2007. Male patient, 55 years of age, weighting 186.0 lb, was diagnosed with blood bilirubin increased, encephalopathy and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: amnesia, confusional state, diarrhoea, disturbance in attention, sleep disorder. LACTULOSE dosage: unknown. Patient recovered.

Lactulose Side Effects Report #5324506-6
Consumer or non-health professional from UNITED KINGDOM reported LACTULOSE problem on Apr 26, 2007. Female patient, 62 years of age, was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: anaemia, blood potassium decreased, clubbing, cough, melanosis, renal failure chronic, urine analysis abnormal, weight decreased. LACTULOSE dosage: unknown. During the same period patient was treated with SENNA. Patient was hospitalized. Patient recovered.

Lactulose Side Effects Report #5357211-0
LACTULOSE problem was reported by a Health Professional from UNITED STATES on June 12, 2007. Female patient, 64 years of age, weighting 168.0 lb, was diagnosed with diabetes mellitus, dyspepsia and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: anaemia, chest pain, deep vein thrombosis, melaena, pulmonary embolism, pyrexia. LACTULOSE dosage: 30 ML TID PO. During the same period patient was treated with REGLAN. Patient was hospitalized. Patient recovered.

Lactulose Side Effects Report #5366303-1
Health Professional from UNITED STATES reported LACTULOSE problem on June 19, 2007. Female patient, 64 years of age, weighting 168.0 lb, was diagnosed with diabetes mellitus, dyspepsia and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: anaemia, chest pain, deep vein thrombosis, melaena, pulmonary embolism, pyrexia. LACTULOSE dosage: 30 ML TID ORAL. During the same period patient was treated with REGLAN. Patient was hospitalized. Patient recovered.

Lactulose Side Effects Report #5047151-9
LACTULOSE problem was reported by a Health Professional from UNITED KINGDOM on June 16, 2006. Female patient, 78 years of age, was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: non-hodgkin's lymphoma. LACTULOSE dosage: unknown. During the same period patient was treated with LANSOPRAZOLE, QUININE SULPHATE, SALBUTAMOL, AQUEOUS CREAM, DEXAMETHASONE, ACETAMINOPHEN, SENNA, SERETIDE. Patient died.

Lactulose Side Effects Report #5061380-X
Pharmacist from UNITED STATES reported LACTULOSE problem on July 19, 2006. Male patient, 80 years of age, was diagnosed with constipation, hypertension and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: hypotension. LACTULOSE dosage: 30 ML QD. During the same period patient was treated with FUROSEMIDE, FELODIPINE, VARDENAFIL, GLIPIZIDE, COLCHICINE. Patient was hospitalized. Patient recovered.

Lactulose Side Effects Report #5063063-9
LACTULOSE problem was reported by a Consumer or non-health professional from UNITED STATES on July 07, 2006. Female patient, 79 years of age, weighting 123.0 lb, was diagnosed with constipation and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: incorrect dose administered. LACTULOSE dosage: unknown. During the same period patient was treated with ENBREL, NAPROXEN, ACTONEL, INDERAL, HYDROCHLOROTHIAZIDE, LANOXIN, CYTOTEC. Patient recovered.

Lactulose Side Effects Report #5078535-0
Consumer or non-health professional from UNITED STATES reported LACTULOSE problem on July 24, 2006. Female patient, 82 years of age, was diagnosed with constipation and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: abdominal pain. LACTULOSE dosage: unknown. During the same period patient was treated with COZAAR, PLAVIX, LIPITOR, NORVASC, METHYLDOPA. Patient recovered.

Lactulose Side Effects Report #5129961-2
LACTULOSE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Oct 02, 2006. Female patient, 36 years of age, was diagnosed with prophylaxis of nausea and vomiting and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: food intolerance, hyperemesis gravidarum. LACTULOSE dosage: unknown. During the same period patient was treated with ONDANSETRON. Patient recovered.

Lactulose Side Effects Report #5148766-X
Physician from GERMANY reported LACTULOSE problem on Aug 11, 2006. Female patient, 85 years of age, weighting 164.2 lb, was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: gamma-glutamyltransferase increased. LACTULOSE dosage: unknown. During the same period patient was treated with PANTOZOL, SIMVASTATIN, NPH INSULIN, METOHEXAL, TRAMADOLOR, FERRLECIT, CYANOCOBALAMIN, ASCORBIC ACID. Patient was hospitalized. Patient recovered.

Lactulose Side Effects Report #5150525-9
LACTULOSE problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 17, 2006. Male patient, 40 years of age, was diagnosed with osteoporosis and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, back pain, bone density decreased, cholelithiasis, condition aggravated, haemorrhagic diathesis, spinal fracture. LACTULOSE dosage: unknown. During the same period patient was treated with ASACOL, LASIX, ALDACTONE, ENBREL, TOPROL, PROTONIX, MIACALCIN. Patient was hospitalized. Patient recovered.

Lactulose Side Effects Report #5153644-6
Consumer or non-health professional from UNITED KINGDOM reported LACTULOSE problem on Oct 30, 2006. Female patient, 31 years of age, weighting 136.7 lb, was diagnosed with hepatitis, pain and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: duodenal ulcer, encephalopathy, haematemesis, melaena. LACTULOSE dosage: 10 ML, BID, ORAL. During the same period patient was treated with PREDNISOLONE, IBUPROFEN, FOLIC ACID, SPIRONOLACTONE, THIAMINE, BENZODIAZEPINES. Patient was hospitalized. Patient recovered.

Lactulose Side Effects Report #5160880-1
LACTULOSE problem was reported by a Health Professional from UNITED KINGDOM on Nov 10, 2006. Female patient, 31 years of age, weighting 136.7 lb, was diagnosed with hepatitis, pain and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: duodenal ulcer, haematemesis, melaena. LACTULOSE dosage: 10 ML, BID, ORAL. During the same period patient was treated with PREDNISOLONE, IBUPROFEN, FOLIC ACID, SPIRONOLACTONE, THIAMINE, BENZODIAZEPINES NO INGREDIENTS. Patient was hospitalized. Patient recovered.

Lactulose Side Effects Report #5165353-8
Consumer or non-health professional from UNITED KINGDOM reported LACTULOSE problem on July 03, 2006. Female patient, 86 years of age, weighting 120.2 lb, was diagnosed with constipation, depression, hypertension, cardiovascular disorder, hypothyroidism, breast cancer and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: gout. LACTULOSE dosage: 15 ML, TID. During the same period patient was treated with TRIPTAFEN, AMLODIPINE, SIMVASTATIN, ASPIRIN, LEVOTHYROXINE, FEMARA. Patient recovered.

Lactulose Side Effects Report #5409386-2
LACTULOSE problem was reported by a Pharmacist from UNITED STATES on Aug 08, 2007. Male patient, 80 years of age, was diagnosed with liver disorder and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: bradycardia, dehydration, hypotension, renal failure acute. LACTULOSE dosage: unknown. During the same period patient was treated with METOPROLOL SUCCINATE. Patient was hospitalized. Patient recovered.

Lactulose Side Effects Report #5469967-7
Physician from UNITED STATES reported LACTULOSE problem on Sept 14, 2007. Female patient, 56 years of age, weighting 135.0 lb, was diagnosed with back pain and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: hepatic cirrhosis, hepatic failure, portal hypertension. LACTULOSE dosage: unknown. During the same period patient was treated with MIRTAZAPINE, GABAPENTIN, LORAZEPAM, METHOCARBAMOL, PROMETHAZINE, TRAMADOL, HYDROCODONE BITARTRATE, HYDROCODONE BITARTRATE. Patient was hospitalized. Patient died on 10/31/2005.

Lactulose Side Effects Report #5472289-1
LACTULOSE problem was reported by a Physician from UNITED STATES on Sept 17, 2007. Male patient, 57 years of age, was diagnosed with constipation and was treated with LACTULOSE. After drug was administered, patient experienced the following problems/side effects: abdominal distension, abdominal pain, asterixis, chronic hepatic failure, colonic atony, confusional state, constipation, encephalopathy, faecaloma. LACTULOSE dosage: 30 ML, TID, ORAL, 45 ML, QID, 60 ML, QID, ORAL, DAILY ENEMAS WERE GIVEN, RECTAL. During the same period patient was treated with DULCOLAX, NEOMYCIN. Patient was hospitalized. Patient recovered.


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lower respiratory tract infection, pneumonia, toxic epidermal necrolysis anaemia, clubbing, cough, weight decreased, was diagnosed with laxative abuse and was diagnosed with blood bilirubin increased, encephalopathy and