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Isodine Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Vitreous Opacities, Visual Acuity Reduced (8395970-3)
on May 21, 2012 Male from JAPAN , 67 years of age, was treated with Isodine. Directly after, patient experienced the unwanted or unexpected Isodine side effects: vitreous opacities, visual acuity reduced. Isodine dosage: N/A.
Associated medications used:
  • Levobunolol Hydrochloride
  • Lucentis
  • Lucentis


Osteonecrosis (8300090-X)
Patient was taking Isodine (povidone-iodine). Patient felt the following Isodine side effects: osteonecrosis on Apr 05, 2012 from JAPAN Additional patient health information: Female , 43 years of age, weighting 114.2 lb, . Isodine (povidone-iodine) dosage: N/A.
Multiple prescriptions taken:
  • 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)


Haematemesis, Sepsis (8258366-0)
Adverse event was reported on Mar 27, 2012 by a Male taking Isodine Gargle (Dosage: N/A) . Location: JAPAN , weighting 125.7 lb, After Isodine was administered, patient encountered several Isodine side effects: haematemesis, sepsis.
Multiple concurrent drugs taken:
  • Fluconazon
  • Vidaza (100 Milligram)
  • Lasix
  • Aldactone
  • Prednisolone
  • Vidaza (100 Milligram)
  • Omeprazole
  • Prednisolone
Patient was hospitalized.

Uterine Cancer (8091744-1)
on Jan 30, 2012 Female from JAPAN , weighting 143.3 lb, was diagnosed with
  • prophylaxis
  • back pain
  • rheumatoid arthritis
and was treated with Isodine Gargle. Directly after, patient experienced the unwanted or unexpected Isodine side effects: uterine cancer. Isodine Gargle dosage: N/A.
Associated medications used:
  • Intenurse
  • Rimatil
  • Folic Acid
Patient was hospitalized.


Pyrexia, Pneumonia, Pneumothorax, Nephropathy, Pneumonia Bacterial (8051552-4)
on Jan 04, 2012 Male from JAPAN , weighting 90.39 lb, was diagnosed with
  • infection prophylaxis
  • renal hypertension
and was treated with Isodine. Patient felt the following Isodine side effects: pyrexia, pneumonia, pneumothorax, nephropathy, pneumonia bacterial. Isodine dosage: N/A.
Multiple prescriptions taken:
  • Doxazosin Mesylate
  • Certican (1mg)
  • Neoral (40mg)
  • Lansoprazole
  • Candesartan Cilexetil
  • Pravastatin Sodium
  • Spiriva
  • Urinorm
Patient was hospitalized.

Interstitial Lung Disease (7918613-9)
Patient was taking Isodine. After Isodine was administered, patient encountered several Isodine side effects: interstitial lung disease on Nov 15, 2011 from JAPAN Additional patient health information: Male , weighting 94.80 lb, . Isodine dosage: Mouthwash.
Multiple concurrent drugs taken:
  • Cefdinir
  • Dasen
  • Huscode
  • Baylotensin
  • Dickinin(caffeine, Chlorphenamine Maleate, Dihydrocodeine Phosphate
  • Marzulene S
  • Ourengedokutou


Pneumonia (7632909-X)
Adverse event was reported on Jul 15, 2011 by a Male taking Isodine Gargle (Dosage: N/A) . Location: JAPAN , 67 years of age, weighting 147.7 lb, Directly after, patient experienced the unwanted or unexpected Isodine side effects: pneumonia.
Associated medications used:
  • Symbicort (160/4.5 Ug Two Inhalation Two Times A Day)
  • Serevent
  • Albuterol Sulfate
  • Spiriva
  • Pl
  • Pl
Patient was hospitalized.

Corneal Disorder, Eye Irritation, Corneal Pigmentation (7539435-7)
on Jun 02, 2011 Male from JAPAN , 72 years of age, was diagnosed with
  • cataract operation
and was treated with Isodine. Patient felt the following Isodine side effects: corneal disorder, eye irritation, corneal pigmentation. Isodine dosage: N/A.
Multiple prescriptions taken:
  • Chlorhexidine
  • Amiodarone Hydrochloride (100 Mg, 1x/day)


Conjunctival Hyperaemia, Eye Pain, Eye Discharge, Corneal Oedema (7428537-1)
on Mar 31, 2011 Male from JAPAN , 85 years of age, was treated with Isodine (povidone-iodine). After Isodine was administered, patient encountered several Isodine side effects: conjunctival hyperaemia, eye pain, eye discharge, corneal oedema. Isodine (povidone-iodine) dosage: N/A.
Multiple concurrent drugs taken:
  • Gatifloxacin
  • Macugen (0.3 Mg, Intraocular)


Ovarian Enlargement, Mycoplasma Infection, Rash, Cystitis, Cholelithiasis, Iron Deficiency Anaemia, Urinary Tract Infection, Cytomegalovirus Infection (7412280-9)
Patient was taking Isodine. Directly after, patient experienced the unwanted or unexpected Isodine side effects: ovarian enlargement, mycoplasma infection, rash, cystitis, cholelithiasis, iron deficiency anaemia, urinary tract infection, cytomegalovirus infection on Apr 04, 2011 from JAPAN Additional patient health information: Female , weighting 145.5 lb, . Isodine dosage: N/A.
Associated medications used:
  • 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
Patient was hospitalized.

Bacterial Infection, Blood Creatinine Increased, Blood Immunoglobulin G Decreased, Dehydration, Electrolyte Imbalance, Haemodialysis, Hepatic Enzyme Increased, Nephropathy Toxic (4599664-1)
Adverse event was reported on Nov 04, 2004 by a Female taking Isodine (Dosage: N/A) . Location: , 20 years of age, weighting 97.00 lb, Patient felt the following Isodine side effects: bacterial infection, blood creatinine increased, blood immunoglobulin g decreased, dehydration, electrolyte imbalance, haemodialysis, hepatic enzyme increased, nephropathy toxic.
Multiple prescriptions taken:
  • Kn3b
  • Mucosta
  • Isoniazid
  • Pydoxal
  • Actos
  • Basen
  • Alositol
  • Nadifloxacin
Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Isodine Information

Alternative ISODINE Names:POVIDONE-

Active Ingredient: POVIDONE-

More About Isodine

Side Effects reported to FDA: 11. View Isodine Adverse Reports

Isodine safety alerts: No

Reported deaths: 1

Reported hospitalizations: 3

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