FDA label 442d176a-ece1-010f-e054-00144ff8d46c

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
d3417226-1f42-40cd-82ac-bc31ddf79b97
SPL ID
442d176a-ece1-010f-e054-00144ff8d46c
Version
13
Effective date
2016-12-21
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:28

Boxed warning cross-check#

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Boxed warning sections page 1 of 1 · 1 matching rows.

boxed warning

WARNING Fluoroquinolones, including ofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see WARNINGS). Fluoroquinolones, including ofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid ofloxacin in patients with known history of myasthenia gravis (see WARNINGS).

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Central Nervous System Effects: Convulsions, increased intracranial pressure, (including pseudotumor cerebri), and toxic psychosis have been reported in patients receiving quinolones, including ofloxacin. Quinolones, including ofloxacin, may also cause central nervous system stimulation which may lead to: tremors, restlessness/agitation, nervousness/anxiety, lightheadedness, confusion, hallucinations, paranoia and depression, nightmares, insomnia, and rarely suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving ofloxacin, the drug should be discontinued and appropriate measures instituted. Insomnia may be more common with ofloxacin than some other products in the quinolone class. As with all quinolones, ofloxacin should be used with caution in patients with a known or suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction) (see PRECAUTIONS , General , Information for Patients , Drug Interactions and ADVERSE REACTIONS .)

Adverse reactions cross-check#

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Adverse reactions sections page 2 of 2 · 5 matching rows.

adverse reactions table

<table border="1" width="419.000" ID="id_a5e00719-0273-4489-8660-446377ffcda7"> <col width="31.7%"/> <col width="68.3%"/> <tbody> <tr ID="id_b17f2f49-d6ba-4820-badc-d0565e401823"> <td align="left" styleCode="Toprule Botrule Lrule" valign="top">Hematopoietic:</td> <td align="left" styleCode="Botrule Rrule" valign="top">prolongation of prothrombin time</td> </tr> <tr ID="id_5b47ff40-c1f1-4026-a264-89f2b73c22d8"> <td align="left" styleCode="Lrule Botrule" valign="top">Serum Chemistry:</td> <td align="left" styleCode="Botrule Rrule" valign="top">acidosis, elevation of: serum triglycerides, serum cholesterol, serum potassium, liver function tests including: GGTP, LDH, bilirubin</td> </tr> <tr ID="id_b978d879-c516-42a4-8094-c169947239b1"> <td align="left" styleCode="Lrule Botrule" valign="top">Urinary:</td> <td align="left" styleCode="Botrule Rrule" valign="top">albuminuria, candiduria</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.