Noroxin (Norfloxacin) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Single-Dose Studies

In clinical trials involving 82 healthy subjects and 228 patients with gonorrhea, treated with a single dose of norfloxacin, 6.5% reported drug-related adverse experiences. However, the following incidence figures were calculated without reference to drug relationship.

The most common adverse experiences (>1.0%) were: dizziness (2.6%), nausea (2.6%), headache (2.0%), and abdominal cramping (1.6%).

Additional reactions (0.3%-1.0%) were: anorexia, diarrhea, hyperhidrosis, asthenia, anal/rectal pain, constipation, dyspepsia, flatulence, tingling of the fingers, and vomiting.

Laboratory adverse changes considered drug-related were reported in 4.5% of patients/subjects. These laboratory changes were: increased AST (SGOT) (1.6%), decreased WBC (1.3%), decreased platelet count (1.0%), increased urine protein (1.0%), decreased hematocrit and hemoglobin (0.6%), and increased eosinophils (0.6%).

Multiple-Dose Studies

In clinical trials involving 52 healthy subjects and 1980 patients with urinary tract infections or prostatitis treated with multiple doses of norfloxacin, 3.6% reported drug-related adverse experiences. However, the incidence figures below were calculated without reference to drug relationship.

The most common adverse experiences (>1.0%) were: nausea (4.2%), headache (2.8%), dizziness (1.7%), and asthenia (1.3%).

Additional reactions (0.3%-1.0%) were: abdominal pain, back pain, constipation, diarrhea, dry mouth, dyspepsia/heartburn, fever, flatulence, hyperhidrosis, loose stools, pruritus, rash, somnolence, and vomiting.

Less frequent reactions (0.1%-0.2%) included: abdominal swelling, allergies, anorexia, anxiety, bitter taste, blurred vision, bursitis, chest pain, chills, depression, dysmenorrhea, edema, erythema, foot or hand swelling, insomnia, mouth ulcer, myocardial infarction, palpitation, pruritus ani, renal colic, sleep disturbances, and urticaria.

Abnormal laboratory values observed in these patients/subjects were: eosinophilia (1.5%), elevation of ALT (SGPT) (1.4%), decreased WBC and/or neutrophil count (1.4%), elevation of AST (SGOT) (1.4%), and increased alkaline phosphatase (1.1%). Those occurring less frequently included increased BUN, increased LDH, increased serum creatinine, decreased hematocrit, and glycosuria.

Post-Marketing

The most frequently reported adverse reaction in post-marketing experience is rash.

CNS effects characterized as generalized seizures, myoclonus and tremors have been reported with NOROXIN (see WARNINGS). Visual disturbances have been reported with drugs in this class.

The following additional adverse reactions have been reported since the drug was marketed:

Hypersensitivity Reactions

Hypersensitivity reactions have been reported including anaphylactoid reactions, angioedema, dyspnea, vasculitis, urticaria, arthritis, arthralgia and myalgia (see WARNINGS).

Skin

Toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, exfoliative dermatitis, photosensitivity/phototoxicity reactions (see PRECAUTIONS).

Gastrointestinal

Pseudomembranous colitis, hepatitis, jaundice including cholestatic jaundice and elevated liver function tests, pancreatitis (rare), stomatitis. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS).

Hepatic

Hepatic failure, including fatal cases.

Cardiovascular

On rare occasions, prolonged QTc interval and ventricular arrhythmia including torsades de pointes.

Renal

Interstitial nephritis, renal failure.

Nervous System/Psychiatric

Peripheral neuropathy, Guillain-Barré syndrome, ataxia, paresthesia, hypoesthesia, psychic disturbances including psychotic reactions and confusion.

Musculoskeletal

Tendinitis, tendon rupture; exacerbation of myasthenia gravis (see PRECAUTIONS); elevated creatine kinase (CK).

Hematologic

Neutropenia; leukopenia; agranulocytosis; hemolytic anemia, sometimes associated with glucose-6-phosphate dehydrogenase deficiency; thrombocytopenia.

Special Senses

Hearing loss, tinnitus, diplopia, dysgeusia.

Other adverse events reported with quinolones include: agranulocytosis, albuminuria, candiduria, crystalluria, cylindruria, dysphagia, elevation of blood glucose, elevation of serum cholesterol, elevation of serum potassium, elevation of serum triglycerides, hematuria, hepatic necrosis, symptomatic hypoglycemia, nystagmus, postural hypotension, prolongation of prothrombin time, and vaginal candidiasis.

REPORTS OF SUSPECTED NOROXIN SIDE EFFECTS / ADVERSE REACTIONS

Possible Noroxin side effects / adverse reactions in 60 year old female

Reported by a physician from France on 2011-10-10

Patient: 60 year old female

Reactions: Tendon Pain, Weight Decreased, Overdose, Proteinuria, Skin Disorder, Depression, Drug Dispensing Error

Adverse event resulted in: hospitalization

Suspect drug(s):
Noroxin

Other drugs received by patient: Aspirin and Caffeine and Propoxyphene Hydrochloride

Possible Noroxin side effects / adverse reactions in 38 year old female

Reported by a individual with unspecified qualification from France on 2011-10-11

Patient: 38 year old female

Reactions: Phlebitis, Photosensitivity Reaction, Chondropathy, Tendon Rupture, Liver Disorder, Arthralgia, Tendonitis, Self-Medication

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Noroxin

Other drugs received by patient: Ethinyl Estradiol (+) Norgestrel Form

Possible Noroxin side effects / adverse reactions in 32 year old male

Reported by a physician from Japan on 2011-11-04

Patient: 32 year old male

Reactions: Drug Eruption

Suspect drug(s):
Noroxin
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2009-09-11
    End date: 2009-09-13

Noroxin
    Administration route: Oral
    Start date: 2010-10-27
    End date: 2010-10-30

Noroxin
    Administration route: Oral
    Start date: 2010-10-27
    End date: 2010-10-30

Noroxin
    Administration route: Oral
    Indication: Upper Respiratory Tract Inflammation
    Start date: 2009-09-11
    End date: 2009-09-13

Other drugs received by patient: Polaramine Tablets; Loxonin; Resplen; Resplen; Berizym (Lysozyme Chloride); Mucosta; Dequalinium Chloride; Lysozyme Chloride; Resplen; Hokunalin; Primperan TAB; Polaramine Tablets; Loxonin; Lysozyme Chloride; Lysozyme Chloride; Loxonin; Zantac; Azunol (Sodium Gualenate); Lysozyme Chloride; Polaramine Tablets; Polaramine Tablets; Resplen; Loxonin; Ganaton; Marzulene-S