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Omnicef (Cefdinir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Omnicef (Cefdinir) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (40)
Disability (1)

Reports by Reaction Type

Rash (7)Diarrhoea (6)Clostridium Difficile Colitis (5)Sinusitis (4)Hypersensitivity (3)Drug Ineffective (3)Urticaria (3)Headache (2)Pyrexia (2)Faeces Discoloured (2)Myalgia (2)Malaise (2)

Below are a few examples of reports where side effects / adverse reactions may be related to Omnicef (Cefdinir). For a complete list or a specific selection of reports, please use the links above.

Possible Omnicef side effects in female

Reported by a physician from United States on 2012-06-05

Patient: female, weighing 69.0 kg (151.8 pounds)

Reactions: Clostridium Difficile Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded Placebo
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Blinded NO Subject Drug
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Rocephin
    Dosage: 1 mg, unk
    Start date: 2011-12-16
    End date: 2011-12-16

Omnicef
    Dosage: 300 mg, 2x/day
    Administration route: Oral
    Start date: 2011-12-16
    End date: 2011-12-25

Blinded PF-04840082
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Other drugs received by patient: Flagyl; Voltaren; Temazepam; Flagyl; Acetaminophen; Benicar; Proair HFA; Levaquin; Atenolol; Vancomycin; Lisinopril



Possible Omnicef side effects in 5 year old female

Reported by a consumer/non-health professional from United States on 2012-05-30

Patient: 5 year old female

Reactions: Head Titubation

Drug(s) suspected as cause:
Ventolin
    Dosage: 1puff twice per day
    Indication: Bronchitis
    Start date: 2011-03-18
    End date: 2011-03-31

Omnicef
    Indication: Infectious Mononucleosis



Possible Omnicef side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-22

Patient: female, weighing 81.7 kg (179.6 pounds)

Reactions: Drug Ineffective, Fungal Infection, Urinary Tract Infection, Sinusitis, Infection

Drug(s) suspected as cause:
Omnicef
    Indication: Infection

Biaxin
    Administration route: Oral
    Indication: Infection

Remicade
    Indication: Crohn's Disease
    Start date: 2002-01-01
    End date: 2011-02-26

Zithromax
    Administration route: Oral
    Indication: Infection



Possible Omnicef side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-11

Patient: male, weighing 104.3 kg (229.5 pounds)

Reactions: Abdominal Pain, Lymphadenopathy, Spinal Pain, Abnormal Faeces, Chromaturia, Urine Odour Abnormal, Myalgia, Lymph Node Pain, Neck Pain, Diarrhoea, Arthralgia, Urine Colour Abnormal

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-23

Patient: female, weighing 69.0 kg (151.8 pounds)

Reactions: Clostridium Difficile Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Placebo
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Flagyl
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Colitis
    Start date: 2011-12-16
    End date: 2011-12-22

Blinded NO Subject Drug
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Omnicef
    Dosage: 300 mg, 2x/day
    Administration route: Oral
    Start date: 2011-12-16
    End date: 2011-12-25

Blinded PF-04840082
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Rocephin
    Dosage: 1 mg, unk
    Start date: 2011-12-16
    End date: 2011-12-16

Other drugs received by patient: Levaquin; Acetaminophen; Lisinopril; Vancomycin; Flagyl; Voltaren; Proair HFA; Benicar; Temazepam; Atenolol



Possible Omnicef side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-16

Patient: female, weighing 69.0 kg (151.8 pounds)

Reactions: Clostridium Difficile Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Placebo
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Rocephin
    Dosage: 1 mg, unk
    Start date: 2011-12-16
    End date: 2011-12-16

Blinded NO Subject Drug
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Blinded PF-04840082
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Flagyl
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Colitis
    Start date: 2011-12-16
    End date: 2011-12-22

Omnicef
    Dosage: 300 mg, 2x/day
    Administration route: Oral
    Start date: 2011-12-16
    End date: 2011-12-25

Other drugs received by patient: Benicar; Proair HFA; Vancomycin; Temazepam; Levaquin; Acetaminophen; Flagyl; Atenolol; Voltaren; Lisinopril



Possible Omnicef side effects in female

Reported by a physician from United States on 2012-04-12

Patient: female, weighing 69.0 kg (151.8 pounds)

Reactions: Dehydration, Clostridium Difficile Colitis, Renal Cyst

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded NO Subject Drug
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Rocephin
    Dosage: 1 mg, unk
    Start date: 2011-12-16
    End date: 2011-12-16

Blinded PF-04840082
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Placebo
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Flagyl
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Colitis
    Start date: 2011-12-16
    End date: 2011-12-22

Omnicef
    Dosage: 300 mg, 2x/day
    Administration route: Oral
    Start date: 2011-12-16
    End date: 2011-12-25

Other drugs received by patient: Flagyl; Benicar; Proair HFA; Levaquin; Acetaminophen; Voltaren; Vancomycin; Temazepam; Lisinopril; Atenolol



Possible Omnicef side effects in 67 year old female

Reported by a consumer/non-health professional from United States on 2012-04-05

Patient: 67 year old female, weighing 61.2 kg (134.7 pounds)

Reactions: Fatigue, Emotional Disorder

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-28

Patient: female, weighing 69.0 kg (151.8 pounds)

Reactions: Clostridium Difficile Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded PF-04840082
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Flagyl
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Colitis
    Start date: 2011-12-16
    End date: 2011-12-22

Omnicef
    Dosage: 300 mg, 2x/day
    Administration route: Oral
    Start date: 2011-12-16
    End date: 2011-12-25

Rocephin
    Dosage: 1 mg, unk
    Start date: 2011-12-16
    End date: 2011-12-16

Blinded NO Subject Drug
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Placebo
    Dosage: unk
    Indication: Osteopenia
    Start date: 2011-10-10
    End date: 2011-10-10

Other drugs received by patient: Vancomycin; Lisinopril; Flagyl; Levaquin; Temazepam; Atenolol; Acetaminophen; Voltaren; Benicar; Proair HFA



Possible Omnicef side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-16

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Benzathine Penicillin G
    Dosage: unk

Omnicef
    Dosage: unk

Levaquin
    Dosage: unk

Biaxin
    Dosage: unk



Possible Omnicef side effects in 15 year old male

Reported by a consumer/non-health professional from United States on 2012-02-24

Patient: 15 year old male, weighing 86.3 kg (189.8 pounds)

Reactions: TIC, Dyskinesia, Musculoskeletal Stiffness, Muscle Tightness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Omnicef
    Indication: Bronchitis
    Start date: 2011-12-21
    End date: 2011-12-27

Omnicef
    Indication: Cough

Omnicef
    Indication: Respiratory Tract Congestion

Other drugs received by patient: Qvar 40; Albuterol



Possible Omnicef side effects in 6 month old female

Reported by a consumer/non-health professional from United States on 2012-02-23

Patient: 6 month old female, weighing 6.8 kg (15.0 pounds)

Reactions: Diarrhoea, Tongue Disorder

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-28

Patient: female, weighing 68.1 kg (149.8 pounds)

Reactions: Nasopharyngitis, Diarrhoea, Dehydration, Tonsillitis, Paranasal Sinus Hypersecretion, Nasal Congestion, Sinusitis, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omnicef
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-12-16

Humira
    Indication: Crohn's Disease
    Start date: 2010-11-01

Humira
    Start date: 2011-03-12

Augmentin '125'
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-12-01
    End date: 2010-12-16

Other drugs received by patient: Nuvaring; Multi-Vitamins; Lexapro; Supplements



Possible Omnicef side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-28

Patient: female

Reactions: Diarrhoea, Sinusitis

Drug(s) suspected as cause:
Omnicef
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2011-03-09
    End date: 2011-03-09

Humira
    Dosage: formulation unknown
    Indication: Rheumatoid Arthritis
    Start date: 2003-01-01

Other drugs received by patient: Methotrexate; Glyburide; Toprol-XL; Relafphan; Prednisone TAB; Hyzaar; Fortamet; Neurontin



Possible Omnicef side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-27

Patient: female

Reactions: Drug Ineffective, Muscular Weakness, Ovarian Cyst, Headache, Sinus Headache, Memory Impairment, Muscle Disorder, Sinusitis, Adnexa Uteri Pain

Drug(s) suspected as cause:
Omnicef
    Indication: Sinusitis
    Start date: 2010-12-01
    End date: 2010-12-01

Humira
    Indication: Psoriasis
    End date: 2010-12-01

Other drugs received by patient: Zigrid; Zantac; Zantac



Possible Omnicef side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-01-27

Patient: 54 year old female

Reactions: Upper Respiratory Tract Infection, Hypoaesthesia, Paraesthesia

Drug(s) suspected as cause:
Omnicef
    Indication: Product Used FOR Unknown Indication

Humira
    Indication: Crohn's Disease
    Start date: 2011-01-25



Possible Omnicef side effects in female

Reported by a physician from United States on 2012-01-17

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Novocain
    Dosage: unk

Ciprofloxacin
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Omnicef
    Dosage: unk

Requip
    Dosage: unk

Silvadene
    Dosage: unk

Cefdinir
    Dosage: unk

Penicillin G Procaine
    Dosage: unk

Amoxicillin
    Dosage: unk



Possible Omnicef side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-22

Patient: female, weighing 52.2 kg (114.8 pounds)

Reactions: Weight Decreased, Mood Swings, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Levaquin
    Administration route: Oral
    Indication: Multiple Allergies

Ibandronate Sodium
    Indication: Product Used FOR Unknown Indication

Asmanex Twisthaler
    Indication: Product Used FOR Unknown Indication

Levaquin
    Administration route: Oral
    Indication: Bronchial Disorder

Omnicef
    Indication: Chronic Obstructive Pulmonary Disease

Other drugs received by patient: Synthroid



Possible Omnicef side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: male, weighing 19.1 kg (41.9 pounds)

Reactions: Myalgia, Urticaria, Abdominal Distension, Pyrexia, Erythema

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in

Reported by a physician from United States on 2011-12-06

Patient:

Reactions: Faeces Discoloured

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: female

Reactions: Diarrhoea, Nausea

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in 5 year old male

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: 5 year old male

Reactions: Pyrexia, Rash

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: female

Reactions: Diarrhoea, Headache, Influenza Like Illness

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in 5 year old male

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: 5 year old male

Reactions: Oedema Peripheral

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: female, weighing 81.7 kg (179.8 pounds)

Reactions: Rash

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: female

Reactions: Rash

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in male

Reported by a physician from United States on 2011-12-06

Patient: male

Reactions: Irritability

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in 11 year old female

Reported by a physician from United States on 2011-12-06

Patient: 11 year old female, weighing 44.0 kg (96.9 pounds)

Reactions: Underdose, Oropharyngeal Pain, Streptococcal Infection

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in 6 month old male

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: 6 month old male

Reactions: Urticaria

Drug(s) suspected as cause:
Omnicef



Possible Omnicef side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-06

Patient: female, weighing 56.8 kg (124.9 pounds)

Reactions: Rash

Drug(s) suspected as cause:
Omnicef

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