Isodine Side Effects

Common Isodine Side Effects

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

Pneumonia (2)
Uterine Cancer (1)
Urinary Tract Infection (1)
Sepsis (1)
Visual Acuity Reduced (1)
Hepatic Enzyme Increased (1)
Bacterial Infection (1)
Haematemesis (1)
Haemodialysis (1)
Rash (1)
Pneumothorax (1)
Mycoplasma Infection (1)
Iron Deficiency Anaemia (1)
Interstitial Lung Disease (1)
Nephropathy (1)
Nephropathy Toxic (1)
Pneumonia Bacterial (1)
Ovarian Enlargement (1)
Osteonecrosis (1)
Pyrexia (1)

➢ 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.

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.

Isodine Side Effects Reported to FDA

The following Isodine 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.

The appearance of Isodine 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.
Vitreous Opacities, Visual Acuity Reduced
This is a report of a 67-year-old male patient (weight: NA) from JAPAN, suffering from the following symptoms/conditions: NA, who was treated with Isodine (dosage: NA, start time: May 01, 2012), combined with:
  • Levobunolol Hydrochloride
  • Lucentis
  • Lucentis
and developed a serious reaction and side effect(s). The consumer presented with:
  • Vitreous Opacities
  • Visual Acuity Reduced
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Isodine treatment in male patients, resulting in vitreous opacities side effect.

This report suggests a potential Isodine (povidone-iodine) Osteonecrosis side effect(s) that can have serious consequences. A 43-year-old female patient (weight: NA) from JAPAN was diagnosed with the following symptoms/conditions: NA and used Isodine (povidone-iodine) (dosage: NA) starting Apr 01, 2009. Soon after starting Isodine (povidone-iodine) the patient began experiencing various side effects, including:
  • Osteonecrosis
Drugs used concurrently:
  • Epadel (ethylicosapentate)
  • Ketoprofen
  • Tacrolimus (1.5 Mg,/d, Oral; 1 Mg, /d, Oral; 2 Mg, /d, Oral)
  • Tacrolimus (1.5 Mg,/d, Oral; 1 Mg, /d, Oral; 2 Mg, /d, Oral)
  • Tacrolimus (1.5 Mg,/d, Oral; 1 Mg, /d, Oral; 2 Mg, /d, Oral)
  • Lipitor
  • Prednisolone (50 Mg, /d, Oral; 15 Mg, /d, Oral; 8 Mg, /d, Oral; 7 Mg, /d, Oral)
  • Prednisolone (50 Mg, /d, Oral; 15 Mg, /d, Oral; 8 Mg, /d, Oral; 7 Mg, /d, Oral)
Although Isodine (povidone-iodine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as osteonecrosis, may still occur.

Haematemesis, Sepsis
This Haematemesis, Sepsis problem was reported by a health professional from JAPAN. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Jan 26, 2012 this consumer started treatment with Isodine Gargle (dosage: NA). The following drugs were being taken at the same time:
  • Fluconazon
  • Vidaza (100 Milligram)
  • Lasix
  • Aldactone
  • Prednisolone
  • Vidaza (100 Milligram)
  • Omeprazole
  • Prednisolone
When commencing Isodine Gargle, the patient experienced the following unwanted symptoms/side effects:
  • Haematemesis
  • Sepsis
The 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 haematemesis, may become evident only after a product is in use by the general population.

Uterine Cancer
This is a report of a female patient (weight: NA) from JAPAN. The patient developed the following symptoms/conditions: prophylaxis,back pain,rheumatoid arthritis and was treated with Isodine Gargle (dosage: NA) starting Jan 21, 2009. Concurrently used drugs:
  • Intenurse
  • Rimatil
  • Folic Acid
Soon after that, the consumer experienced the following side effects:
  • Uterine Cancer
The patient was hospitalized. This opens a possibility that Isodine Gargle treatment could cause the above reactions, including uterine cancer, and some female subjects may be more susceptible.

Pyrexia, Pneumonia, Pneumothorax, Nephropathy, Pneumonia Bacterial
A male patient (weight: NA) from JAPAN with the following symptoms/conditions: infection prophylaxis,renal hypertension started Isodine treatment (dosage: NA) on Apr 26, 2010. Soon after starting Isodine treatment, the subject experienced various side effects, including:
  • Pyrexia
  • Pneumonia
  • Pneumothorax
  • Nephropathy
  • Pneumonia Bacterial
Concurrently used drugs:
  • Doxazosin Mesylate
  • Certican (1mg)
  • Neoral (40mg)
  • Lansoprazole
  • Candesartan Cilexetil
  • Pravastatin Sodium
  • Spiriva
  • Urinorm
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Isodine.

Interstitial Lung Disease
A male patient from JAPAN (weight: NA) experienced symptoms, such as: NA and was treated with Isodine(dosage: Mouthwash). The treatment was initiated on Oct 07, 2003. After that a consumer reported the following side effect(s):
  • Interstitial Lung Disease
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Isodine efficacy:
  • Cefdinir
  • Dasen
  • Huscode
  • Baylotensin
  • Dickinin(caffeine, Chlorphenamine Maleate, Dihydrocodeine Phosphate
  • Marzulene S
  • Ourengedokutou

In this report, Isodine Gargle was administered for the following condition: NA.A 67-year-old male consumer from JAPAN (weight: NA) started Isodine Gargle treatment (dosage: NA) on Jan 11, 2011.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Pneumonia
A possible interaction with other drugs could have contributed to this reaction:
  • Symbicort (160/4.5 Ug Two Inhalation Two Times A Day)
  • Serevent
  • Albuterol Sulfate
  • Spiriva
  • Pl
  • Pl
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Isodine Gargle treatment could be related to the listed above side effect(s).

Corneal Disorder, Eye Irritation, Corneal Pigmentation
This is a report of the following Isodine side effect(s):
  • Corneal Disorder
  • Eye Irritation
  • Corneal Pigmentation
A 72-year-old male patient from JAPAN (weight: NA) presented with the following condition: cataract operation and received a treatment with Isodine (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
  • Chlorhexidine
  • Amiodarone Hydrochloride (100 Mg, 1x/day)
This report suggests that a Isodine treatment could be associated with the listed above side effect(s).

Conjunctival Hyperaemia, Eye Pain, Eye Discharge, Corneal Oedema
This Isodine (povidone-iodine) report was submitted by a 85-year-old male consumer from JAPAN (weight: NA). The patient was diagnosed with: NA and Isodine (povidone-iodine) was administered (dosage: NA) starting: Mar 01, 2011. The consumer developed a set of symptoms:
  • Conjunctival Hyperaemia
  • Eye Pain
  • Eye Discharge
  • Corneal Oedema
Other drugs used simultaneously:
  • Gatifloxacin
  • Macugen (0.3 Mg, Intraocular)
Those unexpected symptoms could be linked to a Isodine (povidone-iodine) treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Ovarian Enlargement, Mycoplasma Infection, Rash, Cystitis, Cholelithiasis, Iron Deficiency Anaemia, Urinary Tract Infection, Cytomegalovirus Infection
This is a report of a possible correlation between Isodine use and the following symptoms/side effect(s):
  • Ovarian Enlargement
  • Mycoplasma Infection
  • Rash
  • Cystitis
  • Cholelithiasis
  • Iron Deficiency Anaemia
  • Urinary Tract Infection
  • Cytomegalovirus Infection
which could contribute to an assessment of Isodine risk profile.A female consumer from JAPAN (weight: NA) was suffering from NA and was treated with Isodine (dosage: NA) starting Apr 09, 2009.Other concurrent medications:
  • Diovan
  • Simulect
  • Senna Leaf (Single Use (one Sac Once))
  • Alosenn (Single Use (one Sac Once))
  • Mycophenolate Mofetil
  • Daio-kanzo-to (Single Use (one Sac Once))
  • Pantosin (Dosage Is Uncertain.)
  • Neoral
The patient was hospitalized.

Bacterial Infection, Blood Creatinine Increased, Blood Immunoglobulin G Decreased, Dehydration, Electrolyte Imbalance, Haemodialysis, Hepatic Enzyme Increased, Nephropathy Toxic
A 20-year-old female patient from (weight: NA) presented with the following symptoms: NA and after a treatment with Isodine (dosage: NA) experienced the following side effect(s):
  • Bacterial Infection
  • Blood Creatinine Increased
  • Blood Immunoglobulin G Decreased
  • Dehydration
  • Electrolyte Imbalance
  • Haemodialysis
  • Hepatic Enzyme Increased
  • Nephropathy Toxic
The treatment was started on Nov 11, 2004. Isodine was used in combination with the following drugs:
  • Kn3b
  • Mucosta
  • Isoniazid
  • Pydoxal
  • Actos
  • Basen
  • Alositol
  • Nadifloxacin
The patient was hospitalized.This report could alert potential Isodine consumers.

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

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

    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.

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    Isodine Safety Alerts, Active Ingredients, Usage Information

    More About Isodine

    Side Effects reported to FDA: 11

    Isodine safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 3

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