Ofloxacin Side Effects

It is possible that some side effects of ofloxacin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ofloxacin: oral tablet

As well as its needed effects, ofloxacin may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking ofloxacin, check with your doctor immediately:

Less common
  • Abdominal or stomach pain
  • anxiety
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • body aches or pain
  • chest pain
  • chills
  • cloudy urine
  • cold sweats
  • coma
  • confusion
  • congestion
  • cool, pale skin
  • cough
  • depression
  • diarrhea
  • dry mouth
  • dryness or soreness of the throat
  • eye pain
  • fast heartbeat
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of illness
  • headache
  • hoarseness
  • increased hunger
  • increased thirst
  • increased urination
  • lower back or side pain
  • nausea
  • nervousness
  • nightmares
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • pus in the urine
  • runny nose
  • seizures
  • shakiness
  • shortness of breath
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sweating
  • swollen glands
  • tender, swollen glands in the neck
  • trouble with swallowing
  • troubled breathing with exertion
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • voice changes
  • vomiting
Rare
  • Burning while urinating
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in color vision
  • continuing ringing or buzzing or other unexplained noise in the ears
  • convulsions
  • decrease in frequency of urination
  • decrease in urine volume
  • decreased hearing or any change in hearing
  • difficult or painful urination
  • difficulty in passing urine (dribbling)
  • difficulty seeing at night
  • difficulty with moving
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • false or unusual sense of well-being
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fear or nervousness
  • feeling of constant movement of self or surroundings
  • feeling of warmth or heat
  • feeling sad or empty
  • flushing or redness of the skin, especially on the face and neck
  • hearing loss
  • hives or welts
  • increased need to urinate
  • increased sensitivity of the eyes to sunlight
  • increased sweating
  • irritability
  • itching
  • joint pain
  • lack of appetite
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of bladder control
  • loss of interest or pleasure
  • muscle aching or cramping
  • muscle pains or stiffness
  • muscle spasm or jerking of all extremities
  • no blood pressure or pulse
  • no breathing
  • passing urine more often
  • pounding in the ears
  • redness, soreness, or itching skin
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • shakiness in the legs, arms, hands, or feet
  • skin rash
  • slow or fast heartbeat
  • sores, welting, or blisters
  • stopping of the heart
  • sudden loss of consciousness
  • swelling
  • swollen joints
  • trembling or shaking of the hands or feet
  • trouble concentrating
  • trouble performing routine tasks
  • trouble sleeping
  • unconsciousness
Incidence not known
  • Abdominal or stomach tenderness
  • actions that are out of control
  • back, leg, or stomach pains
  • blistering, peeling, or loosening of the skin
  • bloating
  • blue lips and fingernails
  • burning, dry, or itching eyes
  • changes in behavior
  • confusion about identity, place, and time
  • coughing that sometimes produces a pink frothy sputum
  • coughing up blood
  • cracks in the skin
  • crying
  • dark-colored urine
  • darkening of the skin
  • delusions of persecution, mistrust, suspiciousness, and/or combativeness
  • depersonalization
  • diarrhea, watery and severe, which may also be bloody
  • difficulty with breathing, chewing, or talking
  • difficulty with speaking
  • difficulty with swallowing
  • discharge or excessive tearing
  • double vision
  • drooling
  • drooping eyelids
  • dysphoria
  • euphoria
  • feeling of discomfort
  • general body swelling
  • heartburn
  • high fever
  • hyperventilation
  • increased blood pressure
  • increased menstrual flow or vaginal bleeding
  • increased sensitivity of the skin to sunlight
  • increased sweating
  • indigestion
  • inflammation of the joints
  • irregular heartbeats
  • irregular or slow heart rate
  • itching of the vagina or outside the genitals
  • loss of ability to use or understand speech or language
  • loss of appetite
  • loss of balance control
  • loss of heat from the body
  • mental depression
  • mood or mental changes
  • muscle weakness
  • noisy breathing
  • nosebleeds
  • numbness of the hands
  • pain during sexual intercourse
  • pain in the ankles or knees
  • pain, inflammation, or swelling in the calves, shoulders, or hands
  • painful, red lumps under the skin, mostly on the legs
  • paralysis
  • prolonged bleeding from cuts
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • quick to react or overreact emotionally
  • rapidly changing moods
  • rash
  • red or black, tarry stools
  • red or dark brown urine
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • red, swollen skin
  • redness or other discoloration of the skin
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • restlessness
  • scaly skin
  • severe abdominal pain, cramping, or burning
  • severe sunburn
  • severe tiredness
  • shaking
  • shuffling walk
  • stiffness of the limbs
  • stomach pain, continuing
  • swelling of the face, fingers, or lower legs
  • swollen lymph glands
  • talking, feeling, and acting with excitement
  • thick, white, curd-like vaginal discharge without odor or with mild odor
  • thoughts of killing oneself
  • twisting movements of the body
  • uncontrolled eye movements
  • uncontrolled movements, especially of the face, neck, and back
  • unexplained bleeding or bruising
  • unpleasant breath odor
  • unsteadiness or awkwardness
  • unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness, especially in children using 2% cyclopentolate
  • unusual weight loss
  • upper right abdominal pain
  • vomiting of blood or material that looks like coffee grounds
  • weakness in the arms, hands, legs, or feet
  • weight gain
  • wheezing
  • yellowing of the eyes or skin

Some ofloxacin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Sleeplessness
  • unable to sleep
Less common
  • Change in taste
  • excess air or gas in the stomach or intestines
  • full feeling
  • loss of taste
  • passing gas
  • runny nose

For Healthcare Professionals

Applies to ofloxacin: intravenous solution, oral tablet

General

Ofloxacin therapy was generally well tolerated, and side effects were mild in nature. In clinical trials, 11% of patients experienced side effects. Discontinuation of ofloxacin therapy due to side effects occurred in 4% of patients.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea (up to 10%), diarrhea (up to 4%), vomiting (up to 4%), dysgeusia (up to 3%), abdominal pain and cramps (up to 3%), dry mouth (up to 3%), flatulence (up to 3%), gastrointestinal distress (up to 3%), constipation (up to 3%)
Uncommon (0.1% to 1%): Dyspepsia (less than 1%)
Postmarketing reports: Pseudomembranous colitis, gastrointestinal hemorrhage, intestinal perforation, hiccough, pyrosis, painful oral mucosa[Ref]

Onset of pseudomembranous colitis may occur during or after therapy.[Ref]

Nervous system

Common (1% to 10%): Headache (up to 9%), dizziness (up to 5%)
Uncommon (0.1% to 1%): Seizures (less than 1%), paresthesia (less than 1%), syncope (less than 1%), vertigo (less than 1%), tremor (less than 1%), decreased hearing acuity (less than 1%), tinnitus (less than 1%)
Frequency not reported: Idiopathic intracranial hypertension
Postmarketing reports: Peripheral neuropathy (may be irreversible), ataxia, incoordination, exacerbation of myasthenia gravis, exacerbation of extrapyramidal disorders, dysphasia, lightheadedness, syncope[Ref]

Seizures are more likely to occur in elderly patients and in those with renal insufficiency.

One survey reported 6 cases of peripheral neuropathy associated with ofloxacin. In one case, a 49-year-old female developed diffuse numbness, "pins and needles" sensation, burning pain, memory loss, visual impairment, joint pain, palpitations, altered sense of smell, insomnia, tinnitus, and severe panic attacks, with some symptoms persisting after 3 years.[Ref]

Renal

Common (1% to 10%): Increased creatinine (1% or more), increased BUN (1% or more)
Frequency not reported: Nephrogenic diabetic insipidus
Postmarketing reports: Renal calculi, renal failure, interstitial nephritis[Ref]

Hepatic

Common (1% to 10%): Elevated alkaline phosphatase (1% or more), elevated AST (1% or more), elevated ALT (1% or more)
Postmarketing reports: Hepatic dysfunction (including hepatic necrosis, jaundice [cholestatic or hepatocellular], hepatitis), hepatic failure (including fatal cases), elevated liver function tests (including GGTP, LDH, bilirubin)[Ref]

Hematologic

Common (1% to 10%): Anemia (1% or more), leukopenia (1% or more), leukocytosis (1% or more), neutropenia (1% or more), neutrophilia (1% or more), increased band forms (1% or more), lymphocytopenia (1% or more), eosinophilia (1% or more), lymphocytosis (1% or more), thrombocytopenia (1% or more), thrombocytosis (1% or more), elevated ESR (1% or more)
Postmarketing reports: Anemia (including hemolytic and aplastic), hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible bone marrow depression, thrombocytopenia, thrombotic thrombocytopenic purpura, petechiae, prothrombin time prolongation, purpura, ecchymosis/bruising[Ref]

Local

IV formulation:
Common (1% to 10%): Injection site reactions (including phlebitis, swelling, erythema; about 2%)[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Arthralgia (less than 1%), myalgia (less than 1%)
Postmarketing reports: Tendonitis, tendon rupture, weakness, rhabdomyolysis[Ref]

Cardiovascular

Ofloxacin was associated with 2 cases of torsade de pointes reported to the FDA between 1996 and 2001.[Ref]

Uncommon (0.1% to 1%): Cardiac arrest (less than 1%), hypertension (less than 1%), hypotension (less than 1%), palpitations (less than 1%), vasodilation (less than 1%)
Postmarketing reports: Cerebral thrombosis, tachycardia, hypotension/shock, torsades de pointes[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Vasculitis (less than 1%)
Postmarketing reports: Anaphylactic reactions/shock, anaphylactoid reactions/shock, serum sickness[Ref]

Genitourinary

Common (1% to 10%): External genital pruritus in women (up to 6%), vaginitis (up to 5%), vaginal discharge (up to 3%), glucosuria (1% or more), proteinuria (1% or more), alkalinuria (1% or more), hyposthenuria (1% or more), hematuria (1% or more), pyuria (1% or more)
Uncommon (0.1% to 1%): Dysuria (less than 1%), urinary frequency (less than 1%), urinary retention (less than 1%), dysmenorrhea (less than 1%), menorrhagia (less than 1%), metrorrhagia (less than 1%), burning, irritation, pain, and rash of the female genitalia (less than 1%)
Postmarketing reports: Vaginal candidiasis, albuminuria, candiduria, anuria, hematuria, polyuria, crystalluria, cylindruria[Ref]

Crystalluria and cylindruria have been reported with other quinolones.[Ref]

Dermatologic

Common (1% to 10%): Rash (up to 3%), pruritus (up to 3%)
Uncommon (0.1% to 1%): Angioedema (less than 1%), diaphoresis (less than 1%), urticaria (less than 1%)
Postmarketing reports: Hyperpigmentation, erythema multiforme/Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, photosensitivity/phototoxicity reaction, vesiculobullous eruption[Ref]

A 75-year-old male developed toxic epidermal necrolysis and died of complications after receiving a total of 23.6 grams of oral ofloxacin over 51 days.[Ref]

Ocular

Common (1% to 10%): Visual disturbances (up to 3%)
Uncommon (0.1% to 1%): Photophobia (less than 1%)
Postmarketing reports: Diplopia, nystagmus, blurred vision, conjunctivitis, ophthalmologic abnormalities (including cataracts, multiple punctate lenticular opacities)[Ref]

Ophthalmologic abnormalities (including cataracts and multiple punctate lenticular opacities) have been reported with other quinolones.[Ref]

Other

Common (1% to 10%): Fatigue (up to 3%), chest pain (up to 3%), fever (up to 3%), trunk pain (up to 3%)
Uncommon (0.1% to 1%): Asthenia (less than 1%), chills (less than 1%), malaise (less than 1%), edema (less than 1%), extremity pain (less than 1%), pain (less than 1%)
Postmarketing reports: Reversible disturbances of taste, smell, hearing, and equilibrium[Ref]

Respiratory

Uncommon (0.1% to 1%): Respiratory arrest (less than 1%), cough (less than 1%), rhinorrhea (less than 1%), epistaxis (less than 1%)
Postmarketing reports: Dyspnea, bronchospasm, allergic pneumonitis, pulmonary edema, stridor[Ref]

Metabolic

Common (1% to 10%): Decreased appetite (up to 3%), hyperglycemia (1% or more), hypoglycemia (1% or more)
Uncommon (0.1% to 1%): Thirst (less than 1%), weight loss (less than 1%)
Postmarketing reports: Hypoglycemia, hyperglycemia, acidosis, elevated serum triglycerides, elevated serum cholesterol, elevated serum potassium[Ref]

Hypoglycemia and hyperglycemia have been reported, especially in diabetic patients on insulin or oral hypoglycemic agents.[Ref]

Psychiatric

In one patient, a psychotic reaction to ofloxacin presented with irritability, restlessness, insomnia, and irrational fear. The reaction was treated with haloperidol and resolved within 48 hours. One study suggests that the CNS effects of quinolones may be due to an interaction with the benzodiazepine-GABA receptor complex and may be controlled by benzodiazepine administration.[Ref]

Common (1% to 10%): Insomnia (up to 7%), nervousness (up to 3%), sleep disorders (up to 3%), somnolence (up to 3%)
Uncommon (0.1% to 1%): Anxiety (less than 1%), cognitive change (less than 1%), depression (less than 1%), dream abnormality (less than 1%), euphoria (less than 1%), hallucinations (less than 1%), confusion (less than 1%)
Postmarketing reports: Agitation, restlessness, nightmares, suicidal thought or acts, disorientation, psychotic reactions, paranoia, phobia, aggressiveness/hostility, manic reaction, emotional lability[Ref]

References

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2. Todd PA, Faulds D "Ofloxacin: a reappraisal of its antimicrobial activity, pharmacology, and therapeutic use." Drugs 42 (1991): 825-76

3. "Product Information. Floxin (ofloxacin)." Ortho Pharmaceutical Corporation, Raritan, NJ.

4. Smith JT "Ofloxacin, a bactericidal antibacterial." Chemotherapy 37 (1991): 2-13

5. Wendel GD, Cox SM, Bawdon RE, Theriot SK, Heard MC, Nobles BJ "A randomized trial of ofloxacin versus cefoxitin and doxycycline in the outpatients treatment of acute salpingitis." Am J Obstet Gynecol 164 (1991): 1390-6

6. Tack KJ, Smith JA "The safety profile of ofloxacin." Am J Med 87 (1989): s78-81

7. Basista MP "Randomized study to evaluate efficacy and safety of ofloxacin vs trimethoprim and sulfamethoxazole in treatment of uncomplicated urinary tract infection." Urology 37 (1991): 21-7

8. Dan M, Samra Z "Clostridium difficile colitis associated with ofloxacin therapy." Am J Med 87 (1989): 479

9. Fostini R, Girelli M, Dalle VP, Benedetti M, Recchia G "Safety profile of ofloxacin in elderly patients." Drugs Exp Clin Res 14 (1988): 393-5

10. Marchbanks CR, Dudley MN, Flor S, Beals B "Pharmacokinetics and safety of single rising doses of ofloxacin in healthy volunteers." Pharmacotherapy 12 (1992): 45-9

11. Giamarellou H, Tsagarakis J "Efficacy and tolerance of oral ofloxacin in treating various infections." Drugs 34 (1987): 119-23

12. Kohler RB, Arkins N, Tack KJ "Accidental overdose of intravenous ofloxacin with benign outcome." Antimicrob Agents Chemother 35 (1991): 1239-40

13. Walton GD, Hon JK, Mulpur TG "Ofloxacin-induced seizure." Ann Pharmacother 31 (1997): 1475-7

14. Traeger SM, Bonfiglio MF, Wilson JA, Martin BR, Nackes NA "Seizures associated with ofloxacin therapy." Clin Infect Dis 21 (1995): 1504-6

15. Fennig S, Mauas L "Ofloxacin-induced delirium." J Clin Psychiatry 53 (1992): 137-8

16. Cohen JS "Peripheral neuropathy associated with fluoroquinolones." Ann Pharmacother 35 (2001): 1540-7

17. Getenet JC, Croisile B, Vighetto A, et al. "Idiopathic intracranial hypertension after ofloxacin treatment." Acta Neurol Scand 87 (1993): 503-4

18. Unseld E, Ziegler G, Gemeinhardt A, Janssen U, Klotz U "Possible interaction of fluoroquinolones with benzodiazepine-GABA-receptorn complex." Br J Clin Pharmacol 30 (1990): 63-70

19. Thomas RJ, Regan DR "Association of a tourette-like syndrome with ofloxacin." Ann Pharmacother 30 (1996): 138-41

20. Carro PG, Huidobro MLL, Zabala AP, Vicente EM "Fatal subfulminant hepatic failure with ofloxacin." Am J Gastroenterol 95 (2000): 1606

21. Blum A "Ofloxacin-induced acute severe hepatitis." South Med J 84 (1991): 1158

22. Hofer T, Becker EW, Weigand K, Berg PA "Demonstration of sensititzed lymphocytes to trimethoprim/sulfamethoxazole and ofloxacin in a patient with cholestatic hepatitis." J Hepatol 15 (1992): 262-3

23. Huminer D, Cohen JD, Majadla R, Dux S "Hypersensitivity vasculitis due to ofloxacin." Br Med J 299 (1989): 303

24. Pace JL, Gatt P "Fatal vasculitis associated with ofloxacin." BMJ 299 (1989): 658

25. Khaliq Y, Zhanel GG "Fluoroquinolone-Associated Tendinopathy: A Critical Review of the Literature." Clin Infect Dis 36 (2003): 1404-1410

26. Baril L, Maisonobe T, JassonMolinier M, Haroche J, Bricaire F, Caumes E "Acute rhabdomyolysis during treatment with ofloxacin - A case report." Clin Infect Dis 29 (1999): 1598-9

27. Frothingham R "Rates of torsades de pointes associated with ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin, and moxifloxacin." Pharmacotherapy 21 (2001): 1468-72

28. Owens RC Jr, Ambrose PG "Torsades de pointes associated with fluoroquinolones." Pharmacotherapy 22 (2002): 663-8; discussion 668-72

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32. Melde SL "Ofloxacin: a probable cause of toxic epidermal necrolysis." Ann Pharmacother 35 (2001): 1388-90

33. Maunz G, Conzett T, Zimmerli W "Cutaneous vasculitis associated with fluoroquinolones." Infection 37 (2009): 466-8

34. Bharani A, Kumar H "Diabetes inspidus induced by ofloxacin." BMJ 323 (2001): 547

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