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Oflocet Side Effects

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Common Oflocet Side Effects


The most commonly reported Oflocet side effects (click to view or check a box to report):

Confusional State (23)
Thrombocytopenia (22)
Arthralgia (19)
Pyrexia (18)
Renal Failure Acute (17)
International Normalised Ratio Increased (15)
Eosinophilia (14)
Myoclonus (13)
Toxic Skin Eruption (13)
Convulsion (12)
Renal Failure (12)
Encephalopathy (11)
Agranulocytosis (11)
Anaemia (11)
Alanine Aminotransferase Increased (10)
Cholestasis (10)
Rash Maculo-papular (10)
Vascular Purpura (10)
Neutropenia (9)
Haematoma (9)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Oflocet Side Effects Reported to FDA



Oflocet Side Effect Report#9803401
Hypersensitivity, Rash, Pruritus, Skin Exfoliation
This is a report of a 69-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Oflocet (dosage: 200 Mg, 2 Day, start time:
Nov 24, 2013), combined with:
  • Rifadine (800mg, 2 Day)
  • Vancomycin
  • Zolpidem
  • Spironolactone
  • Inexium
  • Fenofibrate
and developed a serious reaction and side effect(s): Hypersensitivity, Rash, Pruritus, Skin Exfoliation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oflocet treatment in male patients, resulting in Hypersensitivity side effect. The patient was hospitalized.
Oflocet Side Effect Report#9526217
Oedema Peripheral, Tendonitis, Purpura
This report suggests a potential Oflocet Oedema Peripheral side effect(s) that can have serious consequences. A 81-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: sepsis and used Oflocet (dosage: NA) starting
Jun 12, 2013. After starting Oflocet the patient began experiencing various side effects, including: Oedema Peripheral, Tendonitis, PurpuraAdditional drugs used concurrently:
  • Tercian
  • Lovenox
  • Cetirizine
  • Gentamicin Sulfate
  • Diffu K
  • Movicol
  • Oxynorm
  • Orbenine (Strength: 1 G/5 Ml)
The patient was hospitalized. Although Oflocet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oedema Peripheral, may still occur.
Oflocet Side Effect Report#9526215
Oedema Peripheral, Tendonitis, Purpura
This Oedema Peripheral problem was reported by a health professional from FR. A 81-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sepsis. On
Jun 12, 2013 this consumer started treatment with Oflocet (dosage: NA). The following drugs were being taken at the same time:
  • Tercian
  • Lovenox
  • Cetirizine
  • Gentamicin Sulfate
  • Diffu K
  • Movicol
  • Oxynorm
  • Orbenine (Strength: 1 G/5 Ml)
When using Oflocet, the patient experienced the following unwanted symptoms/side effects: Oedema Peripheral, Tendonitis, PurpuraThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Oedema Peripheral, may become evident only after a product is in use by the general population.
Oflocet Side Effect Report#9440795
Neutropenia, Pyrexia, Leukopenia, Agranulocytosis, Lymphopenia, Monocyte Count Decreased
This Neutropenia side effect was reported by a health professional from FR. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: superinfection.The patient was prescribed Oflocet (drug dosage: NA), which was initiated on
May 28, 2013. Concurrently used drugs:
  • Lovenox (Lovenox (0.4 Ml Injsol))
  • Axepim (Strength: 2g, Powder For Parenteral Use)
  • Levothyrox (Strength: 75 Mcg And 25 Mcg)
  • Loxen (Prolonged Release)
  • Triatec
  • Dafalgan (Strength: 500 Mg)
  • Acupan (Frequency: 2 Times Daily If Needed)
  • Contramal (Form: Prolonged Release)
.After starting to take Oflocet the consumer reported adverse symptoms, such as: Neutropenia, Pyrexia, Leukopenia, Agranulocytosis, Lymphopenia, Monocyte Count DecreasedThese side effects may potentially be related to Oflocet. The patient was hospitalized.
Oflocet Side Effect Report#9324979
Hallucinations, Mixed
This is a report of a 23-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Oflocet (dosage: NA, start time:
Feb 27, 2012), combined with:
  • Vfend
  • Durogesic
and developed a serious reaction and side effect(s): Hallucinations, Mixed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oflocet treatment in male patients, resulting in Hallucinations, Mixed side effect. The patient was hospitalized.
Oflocet Side Effect Report#8982210
Hepatitis, Abdominal Pain, Hyperthermia, Vomiting, Weight Decreased, Ketonuria, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
This report suggests a potential Oflocet Hepatitis side effect(s) that can have serious consequences. A 21-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: urinary infection and used Oflocet (dosage: Dose:2 Unit(s)) starting
Nov 12, 2002. After starting Oflocet the patient began experiencing various side effects, including: Hepatitis, Abdominal Pain, Hyperthermia, Vomiting, Weight Decreased, Ketonuria, Aspartate Aminotransferase Increased, Alanine Aminotransferase IncreasedAdditional drugs used concurrently:
  • Stilnox
The patient was hospitalized. Although Oflocet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatitis, may still occur.
Oflocet Side Effect Report#8790124
Renal Failure, Rash Maculo-papular, Eosinophilia
This Renal Failure problem was reported by a health professional from FR. A 87-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: infected scar. On
Jun 19, 2012 this consumer started treatment with Oflocet (dosage: NA). The following drugs were being taken at the same time:
  • Lovenox
  • Vancomycine
  • Rifampicin
  • Visipaque
  • Paracetamol
When using Oflocet, the patient experienced the following unwanted symptoms/side effects: Renal Failure, Rash Maculo-papular, EosinophiliaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Failure, may become evident only after a product is in use by the general population.
Oflocet Side Effect Report#8712955
Pyrexia, Eosinophilia, Renal Failure Acute
This Pyrexia side effect was reported by a health professional from FR. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: staphylococcal bacteremia.The patient was prescribed Oflocet (drug dosage: NA), which was initiated on
Jun 11, 2012. Concurrently used drugs:
  • Targocid
  • Plavix
  • Tahor
  • Cardensiel
  • Amlor
  • Sectral
  • Lasilix
  • Atacand
.After starting to take Oflocet the consumer reported adverse symptoms, such as: Pyrexia, Eosinophilia, Renal Failure AcuteThese side effects may potentially be related to Oflocet. The patient was hospitalized.
Oflocet Side Effect Report#8483302-1
Vascular Purpura
This is a report of a 87-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: sigmoiditis, who was treated with Oflocet /00731801/ (oflocet-ofloxacin) (not Specified) (dosage: (5 Mg/ml Intravenous (not Otherwise Specified)), start time:
Apr 25, 2012), combined with:
  • Lovenox ((df Intravenous (not Otherwise Specified)))
  • Plavix ((df Oral))
  • Flagyl ((df Intravenous (not Otherwise Specified)))
  • Acupan
  • Acetaminophen
  • Venofer
and developed a serious reaction and side effect(s): Vascular Purpura after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oflocet /00731801/ (oflocet-ofloxacin) (not Specified) treatment in female patients, resulting in Vascular Purpura side effect. The patient was hospitalized.
Oflocet Side Effect Report#7457543-6
Toxic Epidermal Necrolysis
This report suggests a potential Oflocet Toxic Epidermal Necrolysis side effect(s) that can have serious consequences. A 84-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Oflocet (dosage: Dose:10 Milligram(s)/millilitre) starting
Dec 30, 2010. After starting Oflocet the patient began experiencing various side effects, including: Toxic Epidermal NecrolysisAdditional drugs used concurrently:
  • Rocephin
  • Rivotril
  • Lovenox
  • Corvasal
  • Efferalgan
  • Esomeprazole
  • Lactulose
  • Lasix
The patient was hospitalized. Although Oflocet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxic Epidermal Necrolysis, may still occur.
Oflocet Side Effect Report#7357063-3
Tenosynovitis, Tendonitis, Tendon Disorder, Arthralgia
This Tenosynovitis problem was reported by a consumer or non-health professional from France. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: ear infection. On NS this consumer started treatment with Oflocet Otic Solution (ofloxacin) (ear Drops) (ofloxacin) (dosage: Auricular (otic)). The following drugs were being taken at the same time: NA. When using Oflocet Otic Solution (ofloxacin) (ear Drops) (ofloxacin), the patient experienced the following unwanted symptoms/side effects: Tenosynovitis, Tendonitis, Tendon Disorder, ArthralgiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tenosynovitis, may become evident only after a product is in use by the general population.
Oflocet Side Effect Report#7348322-9
Aplastic Anaemia, Sclerosing Encapsulating Peritonitis
This Aplastic Anaemia side effect was reported by a health professional from France. A 32-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Oflocet (drug dosage: NA), which was initiated on
Sep 01, 2003. Concurrently used drugs:
  • Tienam
  • Folic Acid
  • Calcidia
  • Renagel
  • Tamoxifen Citrate (20 Mg, Daily)
  • Amlor
  • Atenolol
  • Triatec
.After starting to take Oflocet the consumer reported adverse symptoms, such as: Aplastic Anaemia, Sclerosing Encapsulating PeritonitisThese side effects may potentially be related to Oflocet. The patient was hospitalized.
Oflocet Side Effect Report#7346873-4
Neuropathy Peripheral, Behcet's Syndrome, Adenocarcinoma Of The Cervix
This is a report of a female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Oflocet (dosage: 400 Milligram, start time:
Jun 01, 1999), combined with:
  • Spasfon Lyoc
  • Thalidomide (50 Milligram)
  • Thalidomide
  • Thalidomide (50 Milligram)
  • Nexium (20 Milligram)
  • Colchicine (1 Tablet)
  • Oxycontin (10 Milligram)
  • Triflucan
and developed a serious reaction and side effect(s): Neuropathy Peripheral, Behcet's Syndrome, Adenocarcinoma Of The Cervix after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oflocet treatment in female patients, resulting in Neuropathy Peripheral side effect. The patient was hospitalized.
Oflocet Side Effect Report#7336336-4
Tumour Lysis Syndrome, Encephalopathy, Myoclonus
This report suggests a potential Oflocet Tumour Lysis Syndrome side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Oflocet (dosage: 200 Mg, Alternate Day) starting
Feb 11, 2009. After starting Oflocet the patient began experiencing various side effects, including: Tumour Lysis Syndrome, Encephalopathy, MyoclonusAdditional drugs used concurrently:
  • Calcidose (1000 Mg Total Daily)
  • Tazocilline (4 G, 2x/day)
  • Inipomp (20 Mg, 1x/day)
  • Dexamethasone
  • Zelitrex (500 Mg, 1x/day)
  • Lyrica (25 Mg, 2x/day)
  • Folic Acid (10 Mg Total Daily)
  • Velcade (2 Injections Of 3.5mg On 09 And 16-feb-2009)
The patient was hospitalized. Although Oflocet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tumour Lysis Syndrome, may still occur.
Oflocet Side Effect Report#7287452-7
Thrombocytopenia, Purpura, Infection
This Thrombocytopenia problem was reported by a health professional from France. A 55-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: infection,type 2 diabetes mellitus. On
Sep 01, 2010 this consumer started treatment with Oflocet (dosage: 200 Mg, 2x/day). The following drugs were being taken at the same time:
  • Novonorm (5 Mg, 1x/day)
  • Lasix
  • Xatral (10 Mg, 1x/day)
  • Januvia (1 Df, 1x/day)
  • Xanax (0.25 Mg, 2x/day)
  • Depamide (300 Mg, 3x/day)
  • Insulin Detemir
  • Augmentin '125' (1 G, 3x/day)
When using Oflocet, the patient experienced the following unwanted symptoms/side effects: Thrombocytopenia, Purpura, InfectionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thrombocytopenia, may become evident only after a product is in use by the general population.
Oflocet Side Effect Report#6920819-2
Vitamin K Deficiency
This Vitamin K Deficiency side effect was reported by a health professional from France. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Oflocet (drug dosage: NA), which was initiated on
Mar 10, 2010. Concurrently used drugs:
  • Rifadin
  • Dalacin
  • Orbenin Cap
  • Gentalline
  • Cefrom
  • Heparin
.After starting to take Oflocet the consumer reported adverse symptoms, such as: Vitamin K DeficiencyThese side effects may potentially be related to Oflocet. The patient was hospitalized.
Oflocet Side Effect Report#6918085-7
Alanine Aminotransferase Increased, Aspartate Aminotransferase, Blood Bilirubin Increased, Ear Infection, Treatment Noncompliance
This is a report of a 38-year-old male patient (weight: NA) from France, suffering from the following health symptoms/conditions: ear infection, who was treated with Oflocet (ofloxacin) (ear Drops) (ofloxacin) (dosage: Auricular (otic), start time:
Nov 23, 2009), combined with:
  • Wellvone (atovaquone) (atovaquone) (10 Ml (5 Ml, 2 In 1 D), Per Oral)
  • Bactrim (1 Dosage Forms, Per Oral)
  • Glucophage (1700 Mg, Per Oral)
  • Amoxicillin/clavulanic Acid (amoxicillin, Clavulanic Acid) (amoxicilli (Per Oral)
  • Trizivir (Per Oral)
  • Diprosone (betamethasoen Sodium Phosphate) (betamethasoen Sodium Phosp
  • Vaseline (paraffin Soft) (paraffin Soft)
  • Calcium Folinate (calcium Folinate) (calcium Folinate)
and developed a serious reaction and side effect(s): Alanine Aminotransferase Increased, Aspartate Aminotransferase, Blood Bilirubin Increased, Ear Infection, Treatment Noncompliance after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oflocet (ofloxacin) (ear Drops) (ofloxacin) treatment in male patients, resulting in Alanine Aminotransferase Increased side effect. The patient was hospitalized.
Oflocet Side Effect Report#6653286-7
Anti Factor Vii Antibody Positive, Prothrombin Time Prolonged
This report suggests a potential Oflocet Anti Factor Vii Antibody Positive side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Oflocet (dosage: NA) starting
Dec 30, 2009. After starting Oflocet the patient began experiencing various side effects, including: Anti Factor Vii Antibody Positive, Prothrombin Time ProlongedAdditional drugs used concurrently:
  • Claforan
  • Human Fibrinogen+human Thrombin
The patient was hospitalized. Although Oflocet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anti Factor Vii Antibody Positive, may still occur.
Oflocet Side Effect Report#6576960-X
Anaphylactic Shock
This Anaphylactic Shock problem was reported by a health professional from Japan. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: urinary tract infection. On NS this consumer started treatment with Oflocet (dosage: NA). The following drugs were being taken at the same time:
  • Diprivan
  • Erythromycin
  • Nexium
  • Lovenox
  • Bristopen
When using Oflocet, the patient experienced the following unwanted symptoms/side effects: Anaphylactic ShockThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaphylactic Shock, may become evident only after a product is in use by the general population.
Oflocet Side Effect Report#6576959-3
Cholestasis
This Cholestasis side effect was reported by a health professional from Japan. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Oflocet (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Flagyl
  • Tazocilline
  • Fortum
  • Cancidas
  • Neupogen (1 U)
  • Nexium
  • Perfalgan (As Needed)
  • Gluconate De Calcium (2 U)
.After starting to take Oflocet the consumer reported adverse symptoms, such as: CholestasisThese side effects may potentially be related to Oflocet.
Oflocet Side Effect Report#6576958-1
Atrial Fibrillation, Stevens-johnson Syndrome, Tendon Disorder
This is a report of a 71-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: bone marrow failure,pyrexia,myeloid leukaemia, who was treated with Oflocet (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Atrial Fibrillation, Stevens-johnson Syndrome, Tendon Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oflocet treatment in male patients, resulting in Atrial Fibrillation side effect.
Oflocet Side Effect Report#6539312-4
Agranulocytosis, Cardiac Failure, Rash, Renal Failure Acute
This report suggests a potential Oflocet Agranulocytosis side effect(s) that can have serious consequences. A 84-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: lung disorder and used Oflocet (dosage: NA) starting NS. After starting Oflocet the patient began experiencing various side effects, including: Agranulocytosis, Cardiac Failure, Rash, Renal Failure AcuteAdditional drugs used concurrently:
  • Rocephin
  • Tavanic
  • Tavanic
  • Cortancyl
The patient was hospitalized. Although Oflocet demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Agranulocytosis, may still occur.
Oflocet Side Effect Report#6381577-6
Abdominal Pain Upper
This Abdominal Pain Upper problem was reported by a health professional from France. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Aug 26, 2009 this consumer started treatment with Oflocet Auriculaire (ofloxacin) (ear Drops) (ofloxacin) (dosage: 3 Mg, Auricular (ottic)). The following drugs were being taken at the same time:
  • Inexium (esomeprazole) (tablet) (esomeprazole)
When using Oflocet Auriculaire (ofloxacin) (ear Drops) (ofloxacin), the patient experienced the following unwanted symptoms/side effects: Abdominal Pain UpperAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Pain Upper, may become evident only after a product is in use by the general population.
Oflocet Side Effect Report#6345520-8
Agitation, Hallucination, Logorrhoea, Mania
This Agitation side effect was reported by a consumer or non-health professional from . A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: pseudomembranous colitis.The patient was prescribed Oflocet /00731801/ (drug dosage: NA), which was initiated on
Mar 16, 2009. Concurrently used drugs:
  • Flagyl
.After starting to take Oflocet /00731801/ the consumer reported adverse symptoms, such as: Agitation, Hallucination, Logorrhoea, ManiaThese side effects may potentially be related to Oflocet /00731801/. The patient was hospitalized.
Oflocet Side Effect Report#6308104-3
Aphasia, Convulsion, Depressed Level Of Consciousness, Disorientation, Facial Nerve Disorder
This is a report of a 86-year-old female patient (weight: NA) from , suffering from the following health symptoms/conditions: NA, who was treated with Oflocet /00731801/ (dosage: NA, start time:
Jun 24, 2009), combined with:
  • Rifadin
  • Temerit
  • Levothyrox
  • Previscan /00789001/
  • Atacand
  • Ixprim
  • Diffu K
  • Digoxin
and developed a serious reaction and side effect(s): Aphasia, Convulsion, Depressed Level Of Consciousness, Disorientation, Facial Nerve Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Oflocet /00731801/ treatment in female patients, resulting in Aphasia side effect. The patient was hospitalized.


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The appearance of Oflocet on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

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    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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.

    Oflocet reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Side Effects reported to FDA: 284

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    Reported deaths: 37

    Reported hospitalizations: 191

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