"Potential drug treatments are tested on paper, in laboratories and eventually in thousands of people. But every drug that goes through this cycle â€“ every drug that FDA approves â€“ carries some risk. One of the first lines of defense against "...
(Generic versions may still be available.)
Penetrex Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Penetrex in Detail - Patient Information: Side Effects
If you experience any of the following serious side effects, stop taking enoxacin and seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- confusion or hallucinations;
- liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue); or
- muscle or joint pain.
If you experience any of the following less serious side effects, continue taking enoxacin and talk to your doctor:
- nausea, vomiting, or diarrhea;
- headache, lightheadedness, or drowsiness;
- ringing in your ears; or
- increased sensitivity of the skin to sunlight.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Read the entire detailed patient monograph for Penetrex (Enoxacin) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Penetrex FDA Prescribing Information: Side Effects
The most frequently reported events in single-dose trials, without regard to drug relationship, were nausea and vomiting (2%). Events that occurred in less than 1% of patients are listed below.
CENTRAL NERVOUS SYSTEM: headache, dizziness, somnolence; GASTROINTESTINAL: abdominal pain; GYNECOLOGIC: vaginal moniliasis; SKIN/HYPERSENSITIVITY: rash; LABORATORY ABNORMALITIES: increased AST (SGOT), decreased hemoglobin, decreased hematocrit, eosinophilia, leukocytosis, leukopenia, thrombocytosis, increased urinary protein, increased alkaline phosphatase, increased ALT (SGPT), increased bilirubin, hyperkalemia.
The incidence of adverse events reported by patients in multiple-dose clinical trials, without regard to drug relationship, was 23%. The incidence of drug-related adverse reactions in multiple-dose clinical trials was 16%. Among patients receiving multiple-dose therapy, enoxacin was discontinued because of an adverse event in 3.8% of patients.
The following events were considered likely to be drug-related in patients receiving multiple doses of enoxacin in clinical trials: nausea and/or vomiting 6%, dizziness 2%, headache 1%, abdominal pain 1%, diarrhea 1%, dyspepsia 1%.
The most frequently reported events in all multiple-dose clinical trials, without regard to drug relationship, were as follows: nausea and/or vomiting 8%, dizziness and/or vertigo 3%, headache 2%, diarrhea 2%, abdominal pain 2%, insomnia 1%, dyspepsia 1%, rash 1%, nervousness and/or anxiety 1%, unusual taste 1%, pruritus 1%.
Additional events that occurred in less than 1% of patients but >0.1% of patients are listed below.
BODY AS A WHOLE: asthenia, fatigue, fever, malaise, back pain, chest pain, edema, chills; GASTROINTESTINAL: flatulence, constipation, dry mouth/throat, stomatitis, anorexia, gastritis, bloody stools; CENTRAL NERVOUS SYSTEM: somnolence, tremor, convulsions, paresthesia, confusion, agitation, depression, syncope, myoclonus, depersonalization, hypertonia; SKIN/HYPERSENSITIVITY: photosensitivity reaction, urticaria, hyperhidrosis, mycotic infection, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome; SPECIAL SENSES: tinnitus, conjunctivitis, visual disturbances including amblyopia; MUSCULOSKELETAL: myalgia, arthralgia; CARDIOVASCULAR: palpitations, tachycardia, vasodilation; RESPIRATORY: dyspnea, cough, epistaxis; HEMIC AND LYMPHATIC: purpura; UROGENITAL: vaginal moniliasis, vaginitis, urinary incontinence, renal failure.
The following adverse events occurred in less than 0.1% of patients in multiple-dose clinical trials but were considered significant: pseudomembranous colitis, hyperkinesia, amnesia, ataxia, hypotonia, psychosis, emotional lability, hallucination, schizophrenic reaction.
LABORATORY CHANGES: The following laboratory abnormalities appeared in ≥1.0% of patients receiving multiple doses of enoxacin: elevated AST (SGOT), elevated ALT (SGPT). It is not known whether these abnormalities were caused by the drug or the underlying conditions.
Worldwide Post-Marketing Experience
The most frequent spontaneously-reported adverse events in the worldwide post-marketing experience with multiple- and single-dose enoxacin use have been rashes, seizures/convulsions, and photosensitivity reactions; however, there is no evidence that the incidences of these events were larger than those observed in the clinical trials population.
Quinolone-class adverse reactions: Although not reported in completed clinical studies with enoxacin, a variety of adverse events have been reported with other quinolones.
Clinical adverse events include: erythema nodosum, hepatic necrosis, possible exacerbation of myasthenia gravis, nystagmus, intestinal perforation, hyperpigmentation, interstitial nephritis, polyuria, urinary retention, renal calculi, cardiopulmonary arrest, cerebral thrombosis, and laryngeal or pulmonary edema.
Read the entire FDA prescribing information for Penetrex (Enoxacin) »
Additional Penetrex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.