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Review Modacin Safety Reports submitted to FDA

Total Modacin reports: 19.
Modacin FDA safety alerts: No.
   Reported hospitalizations: 14.
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FDA Reported Modacin Side Effects: hyperhidrosis, eosinophil count increased, wheezing, hypercapnia, pallor, prolonged expiration, painful respiration, haematemesis, cardiac failure, blood urea increased, urinary incontinence.
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Modacin Side Effects Report #5653427-4
Physician from JAPAN reported MODACIN problem on Mar 03, 2008. Male patient, child 9 years of age, weighting 30.20 lb, was diagnosed with peritonitis and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, dyskinesia, electroencephalogram abnormal, encephalopathy, feeling jittery, somnolence, tremor, unresponsive to stimuli. MODACIN dosage: .5MG THREE TIMES PER DAY. During the same period patient was treated with MEROPEN, PERITONEAL DIALYSIS. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5664487-9
MODACIN problem was reported by a Physician from JAPAN on Mar 03, 2008. Male patient, child 9 years of age, weighting 30.20 lb, was diagnosed with peritonitis and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, dyskinesia, electroencephalogram abnormal, encephalopathy, feeling jittery, somnolence, tremor, unresponsive to stimuli. MODACIN dosage: unknown. During the same period patient was treated with MEROPEN, PERITONEAL DIALYSIS. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5674675-3
Physician from JAPAN reported MODACIN problem on Mar 17, 2008. Male patient, child 9 years of age, weighting 30.20 lb, was diagnosed with peritonitis and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, dyskinesia, electroencephalogram abnormal, encephalopathy, feeling jittery, somnolence, tremor, unresponsive to stimuli. MODACIN dosage: unknown. During the same period patient was treated with MEROPEN, PERITONEAL DIALYSIS. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5684373-8
MODACIN problem was reported by a Physician from JAPAN on Mar 26, 2008. Female patient, child 1 years of age, weighting 19.84 lb, was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: renal failure. MODACIN dosage: 500MG TWICE PER DAY. During the same period patient was treated with PENTCILLIN, DECADRON. Patient recovered.

Modacin Side Effects Report #5640884-2
Physician from JAPAN reported MODACIN problem on Feb 25, 2008. Male patient, child 9 years of age, weighting 35.27 lb, was diagnosed with peritonitis and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness. MODACIN dosage: 33.3MG THREE TIMES PER DAY. During the same period patient was treated with MEROPEN, PERITONEAL DIALYSIS. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5645327-0
MODACIN problem was reported by a Physician from JAPAN on Feb 25, 2008. Female patient, 72 years of age, weighting 105.8 lb, was diagnosed with infection, cholelithiasis, gastritis, hypertension, pollakiuria, insomnia and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: abscess, body temperature increased, erythema, oliguria, rash pustular, renal failure acute, urine output decreased. MODACIN dosage: unknown. During the same period patient was treated with DALACIN, URSO, CEROCRAL, SELBEX, ATELEC, TAKEPRON, POLLAKISU, MYSLEE. Patient recovered.

Modacin Side Effects Report #5602536-4
Physician from JAPAN reported MODACIN problem on Jan 23, 2008. Male patient, child 9 years of age, weighting 35.27 lb, was diagnosed with peritonitis and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness. MODACIN dosage: 33.3MG THREE TIMES PER DAY. During the same period patient was treated with MEROPEN, PERITONEAL DIALYSIS. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5609695-8
MODACIN problem was reported by a Physician from JAPAN on Jan 24, 2008. Female patient, 72 years of age, weighting 105.8 lb, was diagnosed with infection, cholelithiasis, gastritis, hypertension, pollakiuria, insomnia and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: body temperature increased, erythema, oliguria, rash pustular, renal failure acute, urine output decreased. MODACIN dosage: unknown. During the same period patient was treated with DALACIN, URSO, CEROCRAL, SELBEX, ATELEC, TAKEPRON, POLLAKISU, MYSLEE. Patient recovered.

Modacin Side Effects Report #5564952-9
Pharmacist from JAPAN reported MODACIN problem on Dec 14, 2007. Male patient, 43 years of age, was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, aphasia, insomnia, poriomania. MODACIN dosage: unknown. During the same period patient was treated with SELOKEN, OMEPRAL, OLMETEC. Patient recovered.

Modacin Side Effects Report #5519537-7
MODACIN problem was reported by a Physician from JAPAN on Nov 13, 2007. Female patient, 32 years of age, weighting 116.8 lb, was diagnosed with otitis externa and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, dyspnoea, erythema, nausea, oedema, rash, shock. MODACIN dosage: unknown. During the same period patient was treated with MEIACT, CALONAL, EMPYNASE, MUCOSTA, TARIVID. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5480464-5
Physician from JAPAN reported MODACIN problem on Oct 05, 2007. Female patient, 32 years of age, was diagnosed with otitis externa and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: shock. MODACIN dosage: unknown. During the same period patient was treated with MEIACT, CALONAL, EMPYNASE, MUCOSTA, TARIVID. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5480580-8
MODACIN problem was reported by a Physician from JAPAN on Oct 05, 2007. Female patient, 32 years of age, was diagnosed with otitis externa and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: shock. MODACIN dosage: unknown. During the same period patient was treated with MEIACT, CALONAL, EMPYNASE, MUCOSTA, TARIVID. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5492001-X
Physician from JAPAN reported MODACIN problem on Oct 16, 2007. Female patient, 32 years of age, weighting 116.8 lb, was diagnosed with otitis externa and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, dyspnoea, erythema, nausea, oedema, rash, shock, vomiting. MODACIN dosage: unknown. During the same period patient was treated with MEIACT, CALONAL, EMPYNASE, MUCOSTA, TARIVID. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5494963-3
MODACIN problem was reported by a Pharmacist from JAPAN on Oct 18, 2007. Male patient was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: hypoxia, respiratory disorder, white blood cell count increased. MODACIN dosage: unknown. Patient recovered.

Modacin Side Effects Report #5441961-1
Physician from JAPAN reported MODACIN problem on Aug 29, 2007. Female patient, 56 years of age, was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: eosinophil count increased, hypereosinophilic syndrome, hypersensitivity, liver disorder, mucosal erosion, nausea, oral pain. MODACIN dosage: unknown. During the same period patient was treated with CLOBAZAM, DEPAKENE, PHENOBARBITAL, FAMOTIDINE, MUCOSTA, LOXONIN, LENDORMIN, DEPAS. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5384195-1
MODACIN problem was reported by a Pharmacist from JAPAN on July 06, 2007. Male patient, 67 years of age, weighting 152.1 lb, was diagnosed with spondylitis, arteriosclerosis obliterans, gastric mucosal lesion, pain, neuropathy peripheral and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: blood creatinine decreased, c-reactive protein increased, haematocrit decreased, haemoglobin decreased, leukopenia, lymphopenia, monocyte count increased, red blood cell count decreased. MODACIN dosage: unknown. During the same period patient was treated with MINOCYCLINE, ALPROSTADIL, MUCOSTA, ANPLAG, LORCAM, CEFMETAZON, TIENAM, NEOLAMIN. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5392400-0
Physician from JAPAN reported MODACIN problem on July 17, 2007. Female patient, 56 years of age, was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: eosinophil count increased, hypereosinophilic syndrome, hypersensitivity, liver disorder, mucosal erosion, nausea, oral pain. MODACIN dosage: unknown. During the same period patient was treated with CLOBAZAM, DEPAKENE, PHENOBARBITAL, FAMOTIDINE, MUCOSTA. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5384195-1
MODACIN problem was reported by a Pharmacist from JAPAN on July 06, 2007. Male patient, 67 years of age, weighting 152.1 lb, was diagnosed with spondylitis, arteriosclerosis obliterans, gastric mucosal lesion, pain, neuropathy peripheral and was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: blood creatinine decreased, c-reactive protein increased, haematocrit decreased, haemoglobin decreased, leukopenia, lymphopenia, monocyte count increased, red blood cell count decreased. MODACIN dosage: unknown. During the same period patient was treated with MINOCYCLINE, ALPROSTADIL, MUCOSTA, ANPLAG, LORCAM, CEFMETAZON, TIENAM, NEOLAMIN. Patient was hospitalized. Patient recovered.

Modacin Side Effects Report #5392400-0
Physician from JAPAN reported MODACIN problem on July 17, 2007. Female patient, 56 years of age, was treated with MODACIN. After drug was administered, patient experienced the following problems/side effects: eosinophil count increased, hypereosinophilic syndrome, hypersensitivity, liver disorder, mucosal erosion, nausea, oral pain. MODACIN dosage: unknown. During the same period patient was treated with CLOBAZAM, DEPAKENE, PHENOBARBITAL, FAMOTIDINE, MUCOSTA. Patient was hospitalized. Patient recovered.


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