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Colace Side Effects submitted to FDA

Total Colace reports: 7.
Colace FDA safety alerts: No.
   Reported hospitalizations: 2.
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FDA Reported Colace Side Effects: blood cholesterol increased, aspartate aminotransferase increased, alanine aminotransferase increased, ischaemia, intestinal obstruction, hypotension, hiatus hernia, constipation, circulatory collapse, abdominal distension, abdominal discomfort,
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Colace Side Effects Report #5634748-8
Consumer or non-health professional from UNITED STATES reported COLACE problem on Feb 14, 2008. Female patient, 59 years of age, was diagnosed with constipation prophylaxis, antibiotic prophylaxis and was treated with COLACE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, abdominal pain lower, cold sweat, diarrhoea, diarrhoea haemorrhagic, gastrointestinal inflammation, mucous stools, nausea, paraesthesia. COLACE dosage: 50 MG, SEE TEXT. During the same period patient was treated with ZITHROMAX. Patient was hospitalized. Patient recovered.



Colace Side Effects Report #5508166-7
COLACE problem was reported by a Physician from UNITED STATES on Oct 26, 2007. Male patient, weighting 179.9 lb, was diagnosed with diarrhoea and was treated with COLACE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, dysuria, haemorrhage urinary tract, lung adenocarcinoma, pneumothorax. COLACE dosage: unknown. During the same period patient was treated with LEXAPRO, SPIRIVA, XANAX, MOBIC, PREVACID, ZESTRIL, SYNTHROID. Patient recovered.



Colace Side Effects Report #5519053-2
Consumer or non-health professional from UNITED STATES reported COLACE problem on Nov 14, 2007. Female patient was treated with COLACE. After drug was administered, patient experienced the following problems/side effects: hypotension, incorrect dose administered. COLACE dosage: unknown. During the same period patient was treated with ALTACE. Patient recovered.



Colace Side Effects Report #5503113-6
COLACE problem was reported by a Health Professional from UNITED STATES on Oct 24, 2007. Female patient was diagnosed with hepatic neoplasm malignant and was treated with COLACE. After drug was administered, patient experienced the following problems/side effects: asthenia, disease progression, dyspnoea, fatigue, mental status changes, nausea, vomiting. COLACE dosage: unknown. During the same period patient was treated with NEXIUM, COMPAZINE, ATENOLOL, OXYCODONE, CETUXIMAB, CAPECITABINE. Patient was hospitalized. Patient recovered.




Colace Side Effects Report #5456608-8
Physician from UNITED STATES reported COLACE problem on Sept 05, 2007. Female patient, 42 years of age, was diagnosed with depression, migraine and was treated with COLACE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood cholesterol increased. COLACE dosage: unknown. During the same period patient was treated with CYMBALTA, ENALAPRIL MALEATE, TRILEPTAL, SYNTHROID, PREVACID, VITAMIN B, SEROQUEL. Patient recovered.



Colace Side Effects Report #5794918-5
COLACE problem was reported by a Consumer or non-health professional from UNITED STATES on June 20, 2008. Female patient, 86 years of age, was diagnosed with constipation and was treated with COLACE. After drug was administered, patient experienced the following problems/side effects: cough, oral discomfort, pneumonia aspiration, throat irritation, vomiting. COLACE dosage: unknown. During the same period patient was treated with NORVASC, NAMENDA, KEPPRA, ASPIRIN. Patient recovered.



Colace Side Effects Report #5330205-7
Physician from UNITED STATES reported COLACE problem on May 08, 2007. Female patient, 42 years of age, was diagnosed with depression, migraine and was treated with COLACE. After drug was administered, patient experienced the following problems/side effects: hepatic enzyme increased. COLACE dosage: unknown. During the same period patient was treated with CYMBALTA, ENALAPRIL, TRILEPTAL, SYNTHROID, PREVACID, VITAMIN B, SEROQUEL. Patient recovered.




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, Colace was diagnosed with constipation prophylaxis, antibiotic prophylaxis and Colace was diagnosed with diarrhoea and