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Review Zelmac Safety Reports submitted to FDA

Total Zelmac reports: 46.
Zelmac FDA safety alerts: No.
Reported deaths: 7    Reported hospitalizations: 20.
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FDA Reported Zelmac Side Effects: abdominal pain upper, abdominal pain, dizziness, diarrhoea, diarrhoea haemorrhagic, surgery, asthenia, headache, dyspnoea exertional, abdominal distension, cerebrovascular accident.
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Zelmac Side Effects Report #5650634-1
Consumer or non-health professional from BRAZIL reported ZELMAC problem on Feb 21, 2008. Female patient, 68 years of age, weighting 152.1 lb, was diagnosed with constipation, abdominal pain, diabetes mellitus and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: abdominal pain, diarrhoea. ZELMAC dosage: unknown. During the same period patient was treated with BROMAZEPAM, METFORMIN. Patient recovered.

Zelmac Side Effects Report #5669527-9
ZELMAC problem was reported by a Consumer or non-health professional from on Mar 08, 2008. Male patient, 45 years of age, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: hernia repair. ZELMAC dosage: unknown. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5669621-2
Consumer or non-health professional from reported ZELMAC problem on Mar 08, 2008. Male patient, 45 years of age, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: hernia repair. ZELMAC dosage: unknown. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5669717-5
ZELMAC problem was reported by a Physician from UNITED STATES on Mar 03, 2008. Female patient was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: cardiac disorder, cardiac failure congestive, cardiac pacemaker insertion, hepatic steatosis, pulmonary embolism, sleep apnoea syndrome. ZELMAC dosage: 3 MG, QD. During the same period patient was treated with ZELMAC HTF, ZELMAC HTF. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5670546-7
Consumer or non-health professional from BRAZIL reported ZELMAC problem on Mar 04, 2008. Female patient, 69 years of age, weighting 103.6 lb, was diagnosed with constipation, parkinson's disease, hypertension, gastric disorder, depression, osteoporosis and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: asthenia, blood pressure fluctuation, decreased activity, diarrhoea, dyspepsia, dysstasia, electrocardiogram abnormal, eyelid disorder. ZELMAC dosage: unknown. During the same period patient was treated with SIFROL, LOSARTAN POTASSIUM, OMEPRAZOLE, REMILEV VALERIANA, ALENDRONATE, CALCIUM CARBONATE. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5614219-5
ZELMAC problem was reported by a Physician from UNITED STATES on Jan 25, 2008. Female patient was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: cardiac disorder, cardiac failure congestive, cardiac pacemaker insertion, pulmonary embolism, sleep apnoea syndrome. ZELMAC dosage: 3 MG, QD. During the same period patient was treated with ZELMAC HTF, ZELMAC HTF. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5616677-9
Consumer or non-health professional from BRAZIL reported ZELMAC problem on Jan 30, 2008. Female patient, 47 years of age, weighting 105.8 lb, was diagnosed with constipation, diabetes mellitus and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: cold sweat, diarrhoea, dizziness, dyspnoea, fatigue, heart rate decreased, heart rate increased, hysterectomy, malaise. ZELMAC dosage: unknown. During the same period patient was treated with GLUCOFORMIN. Patient recovered.

Zelmac Side Effects Report #5630526-4
ZELMAC problem was reported by a Consumer or non-health professional from on Feb 08, 2008. Male patient, 75 years of age, was diagnosed with constipation, diabetes mellitus, hypertension and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: carotid artery aneurysm, cerebrovascular accident, coma, stent placement. ZELMAC dosage: unknown. During the same period patient was treated with DAONIL, ADALAT SL. Patient was hospitalized. Patient died on 02/04/2008.

Zelmac Side Effects Report #5642337-4
Consumer or non-health professional from BRAZIL reported ZELMAC problem on Feb 18, 2008. Female patient, weighting 110.2 lb, was diagnosed with constipation, nervous system disorder, blood cholesterol, peripheral vascular disorder, chest pain and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: abdominal distension, agitation, blood pressure increased, diarrhoea, flatulence, hepatic steatosis. ZELMAC dosage: 6 MG, QD. During the same period patient was treated with OLCADIL, VYTORIN, VENORUTON, ANGIPRESS. Patient recovered.

Zelmac Side Effects Report #5597218-1
ZELMAC problem was reported by a Consumer or non-health professional from on Jan 08, 2008. Male patient, 69 years of age, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: prostatectomy. ZELMAC dosage: 2 TABLETS ,6 MG PER DAY. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5542039-9
Physician from SINGAPORE reported ZELMAC problem on Dec 03, 2007. Female patient, 22 years of age, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. ZELMAC dosage: 6 MG, BID. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5545264-6
ZELMAC problem was reported by a Consumer or non-health professional from SWITZERLAND on Nov 30, 2007. Female patient, 44 years of age, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, placenta accreta. ZELMAC dosage: unknown. Patient recovered.

Zelmac Side Effects Report #5553608-4
Consumer or non-health professional from reported ZELMAC problem on Dec 05, 2007. Female patient, 47 years of age, weighting 105.8 lb, was diagnosed with constipation, diabetes mellitus and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: dyspnoea, fatigue, heart rate decreased, heart rate increased, hysterectomy, pallor, palpitations, somnolence. ZELMAC dosage: unknown. During the same period patient was treated with GLUCOFORMIN. Patient recovered.

Zelmac Side Effects Report #5566616-4
ZELMAC problem was reported by a Consumer or non-health professional from on Dec 13, 2007. Female patient, 39 years of age, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: feeling hot, pain, renal cyst, ultrasound scan. ZELMAC dosage: 6 MG/DAY. Patient recovered.

Zelmac Side Effects Report #5572794-3
Physician from BRAZIL reported ZELMAC problem on Dec 14, 2007. Female patient, 52 years of age, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: bronchospasm, urticaria. ZELMAC dosage: unknown. During the same period patient was treated with MACROGOL. Patient recovered.

Zelmac Side Effects Report #5575444-5
ZELMAC problem was reported by a Consumer or non-health professional from BRAZIL on Dec 21, 2007. Female patient, 47 years of age, weighting 105.8 lb, was diagnosed with constipation, diabetes mellitus and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: cold sweat, diarrhoea, dizziness, dyspnoea, fatigue, heart rate decreased, heart rate increased, hysterectomy, malaise. ZELMAC dosage: unknown. During the same period patient was treated with GLUCOFORMIN. Patient recovered.

Zelmac Side Effects Report #5575774-7
Consumer or non-health professional from BRAZIL reported ZELMAC problem on Dec 21, 2007. Female patient, 47 years of age, weighting 105.8 lb, was diagnosed with constipation, diabetes mellitus and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: cold sweat, diarrhoea, dizziness, dyspnoea, fatigue, heart rate decreased, heart rate increased, hysterectomy, malaise. ZELMAC dosage: unknown. During the same period patient was treated with GLUCOFORMIN. Patient recovered.

Zelmac Side Effects Report #5521682-7
ZELMAC problem was reported by a Consumer or non-health professional from on Nov 09, 2007. Female patient, 71 years of age, was diagnosed with gastrointestinal disorder, thyroid disorder, diabetes mellitus, hypertension, sleep disorder and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, crying, depression, diarrhoea, dizziness, headache, hyperglycaemia, hyperhidrosis, vision blurred. ZELMAC dosage: unknown. During the same period patient was treated with SYNTHROID, GLIMEPIRIDE, NIFEDIPINE, LORAX. Patient recovered.

Zelmac Side Effects Report #5523000-7
Consumer or non-health professional from MEXICO reported ZELMAC problem on Nov 10, 2007. Female patient, 55 years of age, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: gallbladder operation, upper limb fracture, wrist fracture. ZELMAC dosage: unknown. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5492739-4
ZELMAC problem was reported by a Consumer or non-health professional from COLOMBIA on Oct 10, 2007. Male patient, 65 years of age, weighting 143.3 lb, was diagnosed with irritable bowel syndrome, platelet aggregation, hypertension, type 2 diabetes mellitus and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: angina pectoris, cardiac failure congestive, chest pain, hyperhidrosis, nausea. ZELMAC dosage: unknown. During the same period patient was treated with PLAVIX, DILATREND, LANITOP, LASIX, GLYBURIDE, GLUCOPHAGE, INSULIN. Patient recovered.

Zelmac Side Effects Report #5301820-1
Consumer or non-health professional from KOREA, REPUBLIC OF reported ZELMAC problem on Apr 10, 2007. Female patient, 67 years of age, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: abasia, myocardial ischaemia. ZELMAC dosage: unknown. Patient recovered.

Zelmac Side Effects Report #5304177-5
ZELMAC problem was reported by a Consumer or non-health professional from AUSTRALIA on Apr 09, 2007. Female patient, 55 years of age, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, myocarditis, myopathy, troponin increased, ventricular dysfunction. ZELMAC dosage: unknown. During the same period patient was treated with CONTRACEPTIVES UNS. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5307063-X
Consumer or non-health professional from reported ZELMAC problem on Apr 16, 2007. Female patient, 65 years of age, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: dyspnoea exertional, electrocardiogram abnormal, palpitations. ZELMAC dosage: 6 MG, UNK. Patient recovered.

Zelmac Side Effects Report #5307192-0
ZELMAC problem was reported by a Consumer or non-health professional from on Apr 16, 2007. Female patient, 65 years of age, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: dyspnoea exertional, electrocardiogram abnormal, palpitations. ZELMAC dosage: 6 MG, UNK. Patient recovered.

Zelmac Side Effects Report #5308106-X
Consumer or non-health professional from AUSTRALIA reported ZELMAC problem on Apr 17, 2007. Female patient, 55 years of age, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: angina pectoris, blood creatine phosphokinase increased, bundle branch block left, dyspnoea, myocardial infarction, myocarditis, myopathy, troponin increased, ventricular dysfunction. ZELMAC dosage: unknown. During the same period patient was treated with CONTRACEPTIVES UNS. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5375832-6
ZELMAC problem was reported by a Consumer or non-health professional from on June 25, 2007. Female patient, 65 years of age, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus, hepatitis. ZELMAC dosage: unknown. Patient was hospitalized. Patient died on 08/29/2006.

Zelmac Side Effects Report #5375863-6
Physician from BRAZIL reported ZELMAC problem on June 20, 2007. Female patient, 67 years of age, weighting 143.3 lb, was diagnosed with irritable bowel syndrome, hypertension and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, diarrhoea, dysentery, headache, hypotension, malaise. ZELMAC dosage: 6 MG, ONCE/SINGLE. During the same period patient was treated with RENITEC. Patient recovered.

Zelmac Side Effects Report #5378122-0
ZELMAC problem was reported by a Consumer or non-health professional from CHILE on June 22, 2007. Female patient was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: rectal haemorrhage. ZELMAC dosage: unknown. Patient recovered.

Zelmac Side Effects Report #5379650-4
Consumer or non-health professional from BRAZIL reported ZELMAC problem on June 25, 2007. Female patient, 52 years of age, weighting 169.8 lb, was diagnosed with gastrointestinal disorder and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: arrhythmia, blood pressure decreased, blood pressure increased, dizziness, headache, heart rate increased. ZELMAC dosage: 6 MG, BID. During the same period patient was treated with LEXAPRO. Patient recovered.

Zelmac Side Effects Report #5381746-8
ZELMAC problem was reported by a Consumer or non-health professional from VENEZUELA on July 02, 2007. Male patient, 88 years of age, was diagnosed with hypertension and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident, gastric disorder, pneumonia, respiratory arrest. ZELMAC dosage: 6 MG, BID. During the same period patient was treated with DIOVAN HCT, AMLODIPINE, OMEPRAZOLE, HIDROSMIN, ASPIRIN, ATIVAN. Patient was hospitalized. Patient died on 03/06/2007.

Zelmac Side Effects Report #5382582-9
Consumer or non-health professional from BRAZIL reported ZELMAC problem on June 29, 2007. Male patient, 65 years of age, was diagnosed with colitis, hypertension and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: abdominal distension, gastric lavage, malignant neoplasm of spinal cord. ZELMAC dosage: 6 MG, ONCE/SINGLE. During the same period patient was treated with METHYLDOPA. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5387233-5
ZELMAC problem was reported by a Consumer or non-health professional from BRAZIL on July 04, 2007. Male patient, 38 years of age, weighting 110.2 lb, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, diarrhoea, dizziness, feeling abnormal, feeling cold, gastrointestinal motility disorder, hyperhidrosis, lip swelling, paraesthesia. ZELMAC dosage: unknown. Patient recovered.

Zelmac Side Effects Report #5389844-X
Consumer or non-health professional from UNITED STATES reported ZELMAC problem on July 09, 2007. Female patient, 69 years of age, weighting 178.0 lb, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: angina pectoris, cardiac stress test normal, chest pain, mitral valve incompetence, mitral valve prolapse. ZELMAC dosage: unknown. Patient recovered.

Zelmac Side Effects Report #5301820-1
ZELMAC problem was reported by a Consumer or non-health professional from KOREA, REPUBLIC OF on Apr 10, 2007. Female patient, 67 years of age, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: abasia, myocardial ischaemia. ZELMAC dosage: unknown. Patient recovered.

Zelmac Side Effects Report #5304177-5
Consumer or non-health professional from AUSTRALIA reported ZELMAC problem on Apr 09, 2007. Female patient, 55 years of age, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: myocardial infarction, myocarditis, myopathy, troponin increased, ventricular dysfunction. ZELMAC dosage: unknown. During the same period patient was treated with CONTRACEPTIVES UNS. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5307063-X
ZELMAC problem was reported by a Consumer or non-health professional from on Apr 16, 2007. Female patient, 65 years of age, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: dyspnoea exertional, electrocardiogram abnormal, palpitations. ZELMAC dosage: 6 MG, UNK. Patient recovered.

Zelmac Side Effects Report #5307192-0
Consumer or non-health professional from reported ZELMAC problem on Apr 16, 2007. Female patient, 65 years of age, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: dyspnoea exertional, electrocardiogram abnormal, palpitations. ZELMAC dosage: 6 MG, UNK. Patient recovered.

Zelmac Side Effects Report #5308106-X
ZELMAC problem was reported by a Consumer or non-health professional from AUSTRALIA on Apr 17, 2007. Female patient, 55 years of age, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: angina pectoris, blood creatine phosphokinase increased, bundle branch block left, dyspnoea, myocardial infarction, myocarditis, myopathy, troponin increased, ventricular dysfunction. ZELMAC dosage: unknown. During the same period patient was treated with CONTRACEPTIVES UNS. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5375832-6
Consumer or non-health professional from reported ZELMAC problem on June 25, 2007. Female patient, 65 years of age, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus, hepatitis. ZELMAC dosage: unknown. Patient was hospitalized. Patient died on 08/29/2006.

Zelmac Side Effects Report #5375863-6
ZELMAC problem was reported by a Physician from BRAZIL on June 20, 2007. Female patient, 67 years of age, weighting 143.3 lb, was diagnosed with irritable bowel syndrome, hypertension and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, diarrhoea, dysentery, headache, hypotension, malaise. ZELMAC dosage: 6 MG, ONCE/SINGLE. During the same period patient was treated with RENITEC. Patient recovered.

Zelmac Side Effects Report #5378122-0
Consumer or non-health professional from CHILE reported ZELMAC problem on June 22, 2007. Female patient was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: rectal haemorrhage. ZELMAC dosage: unknown. Patient recovered.

Zelmac Side Effects Report #5379650-4
ZELMAC problem was reported by a Consumer or non-health professional from BRAZIL on June 25, 2007. Female patient, 52 years of age, weighting 169.8 lb, was diagnosed with gastrointestinal disorder and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: arrhythmia, blood pressure decreased, blood pressure increased, dizziness, headache, heart rate increased. ZELMAC dosage: 6 MG, BID. During the same period patient was treated with LEXAPRO. Patient recovered.

Zelmac Side Effects Report #5381746-8
Consumer or non-health professional from VENEZUELA reported ZELMAC problem on July 02, 2007. Male patient, 88 years of age, was diagnosed with hypertension and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident, gastric disorder, pneumonia, respiratory arrest. ZELMAC dosage: 6 MG, BID. During the same period patient was treated with DIOVAN HCT, AMLODIPINE, OMEPRAZOLE, HIDROSMIN, ASPIRIN, ATIVAN. Patient was hospitalized. Patient died on 03/06/2007.

Zelmac Side Effects Report #5382582-9
ZELMAC problem was reported by a Consumer or non-health professional from BRAZIL on June 29, 2007. Male patient, 65 years of age, was diagnosed with colitis, hypertension and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: abdominal distension, gastric lavage, malignant neoplasm of spinal cord. ZELMAC dosage: 6 MG, ONCE/SINGLE. During the same period patient was treated with METHYLDOPA. Patient was hospitalized. Patient recovered.

Zelmac Side Effects Report #5387233-5
Consumer or non-health professional from BRAZIL reported ZELMAC problem on July 04, 2007. Male patient, 38 years of age, weighting 110.2 lb, was diagnosed with irritable bowel syndrome and was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, diarrhoea, dizziness, feeling abnormal, feeling cold, gastrointestinal motility disorder, hyperhidrosis, lip swelling, paraesthesia. ZELMAC dosage: unknown. Patient recovered.

Zelmac Side Effects Report #5389844-X
ZELMAC problem was reported by a Consumer or non-health professional from UNITED STATES on July 09, 2007. Female patient, 69 years of age, weighting 178.0 lb, was treated with ZELMAC. After drug was administered, patient experienced the following problems/side effects: angina pectoris, cardiac stress test normal, chest pain, mitral valve incompetence, mitral valve prolapse. ZELMAC dosage: unknown. Patient recovered.


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abdominal pain, diarrhoea, hernia repair, hernia repair, cardiac disorder, cardiac failure congestive, cardiac pacemaker insertion, hepatic steatosis, pulmonary embolism, sleep apnoea syndrome, , was diagnosed with constipation, abdominal pain, diabetes mellitus and was diagnosed with irritable bowel syndrome and