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Omnicef Safety Reports submitted to FDA
Omnicef FDA safety alerts: No.
Reported deaths: 1 Reported hospitalizations: 26.
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Reported Omnicef Side Effects: pain in extremity, clostridial infection, grand mal convulsion, arthralgia, dehydration, haematochezia, chest pain, diarrhoea, diarrhoea haemorrhagic, rash maculo-papular, joint swelling.
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Omnicef Side Effects Report #5210260-5
Consumer or non-health professional from UNITED STATES reported OMNICEF problem on Jan 12, 2007. Female patient, 57 years of age, weighting 147.0 lb, was diagnosed with sinusitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: diarrhoea. OMNICEF dosage: 300 MG, 2 X DAY X 1 THEN DAILY ORAL. During the same period patient was treated with AZITHROMYCIN, LUNESTA, AMITRIPTYLINE. Patient recovered.
Omnicef Side Effects Report #5217896-6
OMNICEF problem was reported by a Physician from UNITED STATES on Jan 15, 2007. Male patient, weighting 34.17 lb, was diagnosed with otitis media and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, confusional state, disturbance in attention, incoherent, mania, mental status changes, poor quality sleep, psychomotor hyperactivity, repetitive speech. OMNICEF dosage: 250MG/5ML. During the same period patient was treated with PARACETAMOL, PEDIATRIC COUGH AND COLD. Patient recovered.
Omnicef Side Effects Report #5220641-1
Pharmacist from UNITED STATES reported OMNICEF problem on Jan 25, 2007. Female patient, weighting 148.0 lb, was diagnosed with bronchitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: chest pain, headache. OMNICEF dosage: unknown. During the same period patient was treated with HYDROCODONE SYRUP. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5289231-9
OMNICEF problem was reported by a Health Professional from UNITED STATES on Dec 06, 2006. Female patient, 40 years of age, weighting 179.0 lb, was diagnosed with abscess and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: clostridium difficile colitis, weight decreased. OMNICEF dosage: 300 MG, 2 IN 1 D, PER ORAL. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5289232-0
Health Professional from UNITED STATES reported OMNICEF problem on Mar 02, 2006. Female patient, 57 years of age, weighting 110.0 lb, was diagnosed with sinusitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: clostridial infection. OMNICEF dosage: 300 MG, 2 IN 1 D, PER ORAL. During the same period patient was treated with LEVOTHYROXINE, CLONAZEPAM, ESTRADIOL, RISEDRONATE. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5289233-2
OMNICEF problem was reported by a Physician from UNITED STATES on July 06, 2006. Male patient, 49 years of age, weighting 209.4 lb, was diagnosed with skin infection and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: clostridial infection, colitis. OMNICEF dosage: 300 MG, 1 IN 1 DAY FOR 10 DAYS, PER ORAL. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5289235-6
Physician from UNITED STATES reported OMNICEF problem on Nov 02, 2006. Female patient, 16 years of age, weighting 120.0 lb, was diagnosed with blepharitis, hordeolum and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: back pain, clostridium difficile colitis, vomiting, weight decreased. OMNICEF dosage: 300 MG, 2 IN 1 D, PER ORAL. During the same period patient was treated with OFLOXACIN. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5289238-1
OMNICEF problem was reported by a Physician from UNITED STATES on July 10, 2006. Male patient, child 5 years of age, weighting 51.00 lb, was diagnosed with pharyngitis streptococcal and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: clostridial infection, vomiting. OMNICEF dosage: 125MG/5ML, 2 IN 1 D, PER ORAL. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5289239-3
Physician from UNITED STATES reported OMNICEF problem on Oct 06, 2006. Male patient, weighting 10.12 lb, was diagnosed with upper respiratory tract infection and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: haematochezia. OMNICEF dosage: unknown. During the same period patient was treated with ACETYLSALICYLIC ACID SRT, FUROSEMIDE, METOCLOPRAMIDE, CAPTOPRIL, DIMETICONE. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5289240-X
OMNICEF problem was reported by a Health Professional from UNITED STATES on Oct 12, 2006. Male patient, weighting 21.00 lb, was diagnosed with ear infection and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: clostridial infection, haematochezia. OMNICEF dosage: unknown. During the same period patient was treated with ORAPRED. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5234075-7
Physician from UNITED STATES reported OMNICEF problem on Jan 29, 2007. Male patient, weighting 34.17 lb, was diagnosed with otitis media, immunisation and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, confusional state, cough, disturbance in attention, excoriation, fall, incoherent, mania, mental status changes. OMNICEF dosage: 250MG/5ML. During the same period patient was treated with PARACETAMOL, PEDIATRIC COUGH AND COLD, DTAP VACCINE, POLIOVIRUS IPV BOOSTER. Patient recovered.
Omnicef Side Effects Report #5240026-1
OMNICEF problem was reported by a Physician from UNITED STATES on Feb 08, 2007. Male patient, weighting 180.2 lb, was diagnosed with skin infection and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: abdominal distension, asthenia, dehydration, gastric ulcer, helicobacter infection, hepatomegaly. OMNICEF dosage: unknown. During the same period patient was treated with PANTOPRAZOLE, METOPROLOL SUCCINATE, PHENERGAN, DIGOXIN. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5248006-7
Consumer or non-health professional from UNITED STATES reported OMNICEF problem on Feb 26, 2007. Female patient, 57 years of age, weighting 165.0 lb, was diagnosed with sinusitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: arthralgia, crying, hypoaesthesia, middle insomnia, pain, pain in extremity. OMNICEF dosage: unknown. Patient recovered.
Omnicef Side Effects Report #5255655-9
OMNICEF problem was reported by a Physician from UNITED STATES on Feb 23, 2007. Male patient, weighting 106.1 lb, was diagnosed with sinusitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: nephritis interstitial. OMNICEF dosage: unknown. Patient recovered.
Omnicef Side Effects Report #5255905-9
Physician from UNITED STATES reported OMNICEF problem on Feb 23, 2007. Female patient, weighting 126.1 lb, was diagnosed with sinusitis, contraception and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: chest pain, choking sensation, nausea, oedema peripheral, panic reaction, rash. OMNICEF dosage: unknown. During the same period patient was treated with ESOMEPRAZOLE MAGNESIUM, ORTHO EVRA, FACTIVE, RESPAIRE. Patient recovered.
Omnicef Side Effects Report #5257222-X
OMNICEF problem was reported by a Physician from UNITED STATES on Feb 26, 2007. Male patient, weighting 55.05 lb, was diagnosed with ear congestion, ear tube insertion and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: henoch-schonlein purpura, joint swelling, pain, rash maculo-papular, serum sickness. OMNICEF dosage: unknown. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5262381-9
Consumer or non-health professional from UNITED STATES reported OMNICEF problem on Mar 09, 2007. Female patient, 42 years of age, weighting 168.0 lb, was diagnosed with sinusitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: abdominal distension, abdominal pain, diarrhoea, vaginal pain. OMNICEF dosage: unknown. Patient recovered.
Omnicef Side Effects Report #5264255-6
OMNICEF problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 05, 2007. Male patient, weighting 175.2 lb, was diagnosed with pneumonia and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: pneumonia. OMNICEF dosage: unknown. During the same period patient was treated with LEVOFLOXACIN, MUCINEX DM. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5264260-X
Physician from UNITED STATES reported OMNICEF problem on Feb 24, 2007. Male patient, weighting 230.4 lb, was diagnosed with lower respiratory tract infection, cough, upper respiratory tract infection and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, arthralgia, blood pressure increased, chest pain, coordination abnormal, gait disturbance, myalgia, pain in extremity, paraesthesia. OMNICEF dosage: unknown. During the same period patient was treated with MUCINEX, BENZONATATE, ROPINIROLE, PREDNISONE. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5288367-6
OMNICEF problem was reported by a Physician from UNITED STATES on Mar 27, 2007. Male patient, weighting 35.03 lb, was diagnosed with sinusitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: body temperature decreased. OMNICEF dosage: unknown. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5295972-X
Physician from UNITED STATES reported OMNICEF problem on Apr 05, 2007. Female patient, weighting 135.1 lb, was diagnosed with skin ulcer, malaria prophylaxis, myeloproliferative disorder, polycythaemia and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: grand mal convulsion, loss of consciousness, muscle twitching. OMNICEF dosage: unknown. During the same period patient was treated with MEFLOQUINE, ANAGRELIDE. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5302865-8
OMNICEF problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 19, 2007. Male patient, child 2 years of age, weighting 27.00 lb, was diagnosed with sinusitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: anorexia, crying, diarrhoea, irritability, thirst, vomiting. OMNICEF dosage: 3.75ML 1XDAY PO. Patient recovered.
Omnicef Side Effects Report #5307858-2
Physician from UNITED STATES reported OMNICEF problem on Apr 18, 2007. Male patient, weighting 55.05 lb, was diagnosed with nasal congestion, ear tube insertion, sputum discoloured, pyrexia and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: henoch-schonlein purpura, joint swelling, pain, rash maculo-papular, serum sickness. OMNICEF dosage: unknown. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5316794-7
OMNICEF problem was reported by a Physician from UNITED STATES on May 01, 2007. Female patient, weighting 19.00 lb, was diagnosed with sinusitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: abdominal pain, diarrhoea haemorrhagic, intussusception, lethargy. OMNICEF dosage: unknown. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5357506-0
Consumer or non-health professional from UNITED STATES reported OMNICEF problem on June 04, 2007. Female patient, 47 years of age, was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: anxiety, fear, nerve injury, psychomotor skills impaired. OMNICEF dosage: unknown. Patient recovered.
Omnicef Side Effects Report #5357510-2
OMNICEF problem was reported by a Consumer or non-health professional from on June 04, 2007. Female patient, 57 years of age, was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: diarrhoea, haemorrhage, joint swelling, movement disorder, oedema peripheral, pain, rheumatoid arthritis. OMNICEF dosage: unknown. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5357766-6
Consumer or non-health professional from UNITED STATES reported OMNICEF problem on June 04, 2007. Male patient, 55 years of age, was diagnosed with sinusitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: arthritis, diabetes mellitus, infection, rash, skin lesion, vasculitis. OMNICEF dosage: unknown. Patient recovered.
Omnicef Side Effects Report #5046789-2
OMNICEF problem was reported by a Physician from UNITED STATES on July 05, 2006. Female patient, weighting 16.00 lb, was diagnosed with otitis media and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: faeces discoloured, haematochezia, unevaluable event. OMNICEF dosage: unknown. During the same period patient was treated with UNITHIST, XIRAHIST. Patient recovered.
Omnicef Side Effects Report #5088185-8
Pharmacist from UNITED STATES reported OMNICEF problem on Aug 16, 2006. Female patient, weighting 145.1 lb, was diagnosed with pharyngitis streptococcal and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: colitis, dehydration, dysphagia, infectious mononucleosis, nausea, pain, pharyngitis streptococcal. OMNICEF dosage: unknown. During the same period patient was treated with PREDNISONE, AMOXICILLIN. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5095563-X
OMNICEF problem was reported by a Physician from UNITED STATES on Aug 16, 2006. Female patient, weighting 145.1 lb, was diagnosed with pharyngitis streptococcal and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: colitis, dehydration, dysphagia, infectious mononucleosis, nausea, pain, pharyngitis streptococcal. OMNICEF dosage: unknown. During the same period patient was treated with PREDNISONE, AMOXICILLIN. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5100544-3
Consumer or non-health professional from UNITED STATES reported OMNICEF problem on Aug 31, 2006. Female patient, weighting 43.04 lb, was diagnosed with ear infection, convulsion prophylaxis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: drop attacks, grand mal convulsion. OMNICEF dosage: unknown. During the same period patient was treated with TOPIRAMATE, TRILEPTOL, CLORAZEPATE DIPOTASSIUM. Patient recovered.
Omnicef Side Effects Report #5106025-5
OMNICEF problem was reported by a Physician from UNITED STATES on Aug 31, 2006. Female patient, weighting 43.04 lb, was diagnosed with ear infection, convulsion prophylaxis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: drop attacks, grand mal convulsion. OMNICEF dosage: unknown. During the same period patient was treated with TOPIRAMATE, TRILEPTOL, CLORAZEPATE DIPOTASSIUM. Patient recovered.
Omnicef Side Effects Report #5123084-4
Consumer or non-health professional from UNITED STATES reported OMNICEF problem on Oct 04, 2006. Male patient, weighting 27.50 lb, was diagnosed with ear infection and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: haematochezia. OMNICEF dosage: 3.5 ML 1X PER DAY PO. Patient recovered.
Omnicef Side Effects Report #5123472-6
OMNICEF problem was reported by a Physician from UNITED STATES on May 16, 2006. Female patient, weighting 135.1 lb, was diagnosed with skin ulcer, malaria prophylaxis, myeloproliferative disorder and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: grand mal convulsion, loss of consciousness. OMNICEF dosage: unknown. During the same period patient was treated with MEFLOQUINE, ANAGRELIDE. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5130965-4
Physician from UNITED STATES reported OMNICEF problem on Feb 10, 2006. Male patient, weighting 230.4 lb, was diagnosed with lower respiratory tract infection, cough, upper respiratory tract infection and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, arthralgia, blood pressure increased, chest pain, coordination abnormal, gait disturbance, myalgia, pain in extremity, paraesthesia. OMNICEF dosage: unknown. During the same period patient was treated with MUCINEX, BENZONATATE, ROPINIROLE, PREDNISONE. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5131250-7
OMNICEF problem was reported by a Physician from UNITED STATES on Apr 07, 2006. Male patient, weighting 34.17 lb, was diagnosed with otitis media and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: abnormal behaviour, blood glucose increased, confusional state, disturbance in attention, eosinophil count increased, incoherent, mania, mental status changes, monocyte count increased. OMNICEF dosage: 250MG/5ML. Patient recovered.
Omnicef Side Effects Report #5136473-9
Health Professional from UNITED STATES reported OMNICEF problem on Oct 18, 2006. Female patient, child 4 years of age, weighting 37.03 lb, was diagnosed with otitis media acute and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: dyspnoea, overdose. OMNICEF dosage: unknown. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5166553-3
OMNICEF problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 30, 2006. Male patient, 57 years of age, weighting 150.0 lb, was diagnosed with abscess, cyst and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: myoglobinuria, rhabdomyolysis. OMNICEF dosage: 300 MG TWICE A DAY PO. Patient recovered.
Omnicef Side Effects Report #5166800-8
Consumer or non-health professional from UNITED STATES reported OMNICEF problem on Dec 04, 2006. Female patient, 59 years of age, weighting 230.0 lb, was diagnosed with cough and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: arthralgia, hypoaesthesia, hyporeflexia, insomnia, joint range of motion decreased, muscle atrophy, pain, polyneuropathy, rash. OMNICEF dosage: 300 MG TWICE DAILY PO. Patient was hospitalized and became disabled. Patient recovered.
Omnicef Side Effects Report #5170841-4
OMNICEF problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 06, 2006. Male patient, child 5 years of age, was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: ear infection, incorrect dose administered. OMNICEF dosage: unknown. Patient recovered.
Omnicef Side Effects Report #5187483-7
Physician from UNITED STATES reported OMNICEF problem on Dec 07, 2006. Male patient, weighting 30.53 lb, was diagnosed with otitis media, upper respiratory tract infection, tonsillitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: clostridial infection, dehydration, diarrhoea, liver function test abnormal, rash. OMNICEF dosage: unknown. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5381258-1
OMNICEF problem was reported by a Consumer or non-health professional from UNITED STATES on June 26, 2007. Female patient, weighting 150.1 lb, was diagnosed with lyme disease and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: anxiety, dyspnoea, fear, muscular weakness, neuropathy, paranoia. OMNICEF dosage: unknown. During the same period patient was treated with MESALAZINE, VALACYCLOVIR, TIZANIDINE, LEFLUNOMIDE, ZOLPIDEM TARTRATE, PANOCAPS, MEPERIDINE, CLONIDINE. Patient was hospitalized. Patient recovered.
Omnicef Side Effects Report #5392277-3
Health Professional from UNITED STATES reported OMNICEF problem on July 11, 2007. Male patient, weighting 50.04 lb, was diagnosed with sinusitis and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: pharyngeal oedema, respiratory arrest. OMNICEF dosage: unknown. Patient died on 12/24/2006.
Omnicef Side Effects Report #5412290-7
OMNICEF problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 10, 2007. Male patient, child 3 years of age, weighting 34.00 lb, was diagnosed with pneumonia and was treated with OMNICEF. After drug was administered, patient experienced the following problems/side effects: asthenia, clostridial infection, coma, diarrhoea. OMNICEF dosage: unknown. Patient was hospitalized. Patient recovered.
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