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Rashes (24)
Burning (21)
Extreme Swelling (15)
Skin Blisters (15)
Lesions (10)
Extreme Swelling, Skin Blisters, Lesions (8)
Burning Eyes (7)
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Betadine Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 42 

Toxic Anterior Segment Syndrome (8477341-4)
on Jun 07, 2012 Female from UNITED STATES , 77 years of age, weighting 111.0 lb, was diagnosed with
  • intraocular lens implant
and was treated with Betadine. Directly after, patient experienced the unwanted or unexpected Betadine side effects: toxic anterior segment syndrome. Betadine dosage: (ophthalmic).
Associated medications used:
  • Bss ((intraocular))
  • Nevanac ((ophthalmic))
  • Epinephrine
  • Bss ((intraocular))
  • Vigamox ((opthalmic))


Toxic Anterior Segment Syndrome (8477339-6)
Patient was taking Betadine. Patient felt the following Betadine side effects: toxic anterior segment syndrome on Jun 07, 2012 from UNITED STATES Additional patient health information: Male , 71 years of age, weighting 181.0 lb, was diagnosed with
  • intraocular lens implant
and. Betadine dosage: Ophthalmic.
Multiple prescriptions taken:
  • Nevanac (Ophthalmic)
  • Vigamox (Ophthalmic)
  • Epinephrine
  • Bss (Ophthalmic)
  • Bss (Intraocular)


Toxic Anterior Segment Syndrome (8477317-7)
Adverse event was reported on Jun 07, 2012 by a Male taking Betadine (Dosage: Ophthalmic) was diagnosed with
  • intraocular lens implant
and. Location: UNITED STATES , 45 years of age, weighting 154.0 lb, After Betadine was administered, patient encountered several Betadine side effects: toxic anterior segment syndrome.
Multiple concurrent drugs taken:
  • Nevanac ((ophthalmic))
  • Bss (Intraocular)
  • Epinephrine
  • Vigamox ((ophthalmic))
  • Bss ((intraocular))


Anterior Chamber Fibrin, Corneal Oedema, Hypopyon, Vitritis, Endophthalmitis (8399149-0)
on Apr 02, 2012 Female from UNITED STATES , 74 years of age, was treated with Betadine. Directly after, patient experienced the unwanted or unexpected Betadine side effects: anterior chamber fibrin, corneal oedema, hypopyon, vitritis, endophthalmitis. Betadine dosage: N/A.
Associated medications used:
  • Oftalar
  • Tobradex
  • Liquifilm
  • Vancomicina
  • Ceftazidime
  • Moxifloxacin (Unk)
  • Tropicamide
  • Amikacin Sulfate



Abdominal Pain, Vomiting, Device Dislocation, Nausea, Genital Haemorrhage, Presyncope, Dizziness (8308075-4)
on Apr 16, 2012 Female from UNITED STATES , 19 years of age, weighting 139.0 lb, was treated with Betadine. Patient felt the following Betadine side effects: abdominal pain, vomiting, device dislocation, nausea, genital haemorrhage, presyncope, dizziness. Betadine dosage: N/A.
Multiple prescriptions taken:
  • Mirena (20 Mcg/24hr, Cont)


Post Procedural Complication, Toxic Anterior Segment Syndrome (8303505-6)
Patient was taking Betadine. After Betadine was administered, patient encountered several Betadine side effects: post procedural complication, toxic anterior segment syndrome on Apr 03, 2012 from UNITED STATES Additional patient health information: Male , 63 years of age, weighting 155.0 lb, was diagnosed with
  • intraocular lens implant
and. Betadine dosage: (ophthalmic).
Multiple concurrent drugs taken:
  • Vancomycin
  • Phenylephrine Hcl
  • Alcaine ((ophthalmic))
  • Ocufen
  • Bss ((intraocular))
  • Cyclogyl ((ophthalmic))
  • Epinephrine


Iritis, Toxic Anterior Segment Syndrome (8251274-0)
Adverse event was reported on Mar 19, 2012 by a Male taking Betadine (Dosage: Ophthalmic) was diagnosed with
  • intraocular lens implant
and. Location: UNITED STATES , 80 years of age, weighting 215.0 lb, Directly after, patient experienced the unwanted or unexpected Betadine side effects: iritis, toxic anterior segment syndrome.
Associated medications used:
  • Bss Plus (Intraocular)
  • Bss (Intraocular)
  • Zymaxid


Toxic Anterior Segment Syndrome (8167553-1)
on Feb 08, 2012 Male from UNITED STATES , 86 years of age, was diagnosed with
  • preoperative care
  • intraocular lens implant
and was treated with Betadine. Patient felt the following Betadine side effects: toxic anterior segment syndrome. Betadine dosage: Ophthalmic.
Multiple prescriptions taken:
  • Bss (Intraocular)
  • Bss Plus (Intraocular)


Endophthalmitis, Post Procedural Complication (8065259-0)
on Dec 30, 2011 Female from NORWAY , 85 years of age, was diagnosed with
  • preoperative care
and was treated with Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine). After Betadine was administered, patient encountered several Betadine side effects: endophthalmitis, post procedural complication. Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) dosage: For 2 Minute Before Surgery, Ophthalmic.
Multiple concurrent drugs taken:
  • Phenylephrine 1.5% (phenylephrine) (0.15-0.30 Ml Mixture With Lidocaine 10 Mg/ml, Intraocular)
  • Cefuroxime (1 Mg, Intraocular)
  • Phenylephrine Eye Drops (phenylephrine) (Topical)
  • Maxidex Ophthalmic 0.1% Ophthalmic Solution (dexamethasone) (0.1% Tid, 0.1% Bid, Topical)
  • Lidocaine 1% (0.15-0.30 Ml Mixture With Phenlephrine 15 Mg.ml, Intraocular)
  • Cyclopentolate Eye Drops (cyclopentolate) (Topical)


Endophthalmitis (8065253-X)
Patient was taking Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine). Directly after, patient experienced the unwanted or unexpected Betadine side effects: endophthalmitis on Dec 30, 2011 from NORWAY Additional patient health information: Male , 83 years of age, was diagnosed with
  • preoperative care
and. Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) dosage: For 2 Minutes Before Surgery Opthalmic.
Associated medications used:
  • Phenylephrine Eye Drops (phenylephrine) (Topical)
  • Phenylephrine 1.5% (phenylephrine) (0.15-0.30 Ml Mixture With Lidocaine 10 Mg/ml, Intraocular)
  • Cefuroxime (1 Mg, Intraocular)
  • Cyclopentolate Eye Drops (cyclopentolate) (Topical)
  • Maxidex Ophthalmic 0.1% Ophthalmic Suspension (dexamethasone) (0.1% Tid; 0.1% Bid, Topical)
  • Lidocaine 1% (0.15-0.30 Ml Mixture With Phenylephrine 15 Mg/ml, Intraocular)


Endophthalmitis, Toxic Anterior Segment Syndrome (8054028-3)
Adverse event was reported on Jan 09, 2012 by a Female taking Betadine Ophthalmic (Dosage: Unk) was diagnosed with
  • cataract operation
and. Location: UNITED STATES , 66 years of age, Patient felt the following Betadine side effects: endophthalmitis, toxic anterior segment syndrome.
Multiple prescriptions taken:
  • Prednisolone Acetate (Unk)
  • Tetracaine Hydrochloride (Unk)
  • Nevanac (Unk)
  • Zymaxid (Unk)
  • Bss (Unk)


Hyperaesthesia, Skin Discolouration, Dermatitis (8045581-4)
on Jan 12, 2012 Female from UNITED STATES , 61 years of age, weighting 185.0 lb, was diagnosed with
  • therapeutic skin care topical
and was treated with Betadine. After Betadine was administered, patient encountered several Betadine side effects: hyperaesthesia, skin discolouration, dermatitis. Betadine dosage: N/A.

Visual Acuity Reduced, Toxic Anterior Segment Syndrome (8033826-6)
on Dec 19, 2011 Patient from UNITED STATES , 74 years of age, weighting 175.0 lb, was treated with Betadine. Directly after, patient experienced the unwanted or unexpected Betadine side effects: visual acuity reduced, toxic anterior segment syndrome. Betadine dosage: N/A.
Associated medications used:
  • Bss
  • Tetracaine Hydrochloride 0.5 Opthalmic Solution (Ophthalmic)
  • Nevanac (Ophthalmic)
  • Prednisolone Acetate (Ophthalmic)
  • Bss (Intraocular)
  • Vigamox (Ophthalmic)


Toxic Anterior Segment Syndrome (8033821-7)
Patient was taking Betadine. Patient felt the following Betadine side effects: toxic anterior segment syndrome on Dec 19, 2011 from UNITED STATES Additional patient health information: Female , 55 years of age, weighting 150.0 lb, . Betadine dosage: N/A.
Multiple prescriptions taken:
  • Bss (Intraocular)
  • Vigamox (Ophthalmic)
  • Tetracaine Polygyl Sterile Ophthalmic Solution (Ophthalmic)
  • Nevanac (Ophthalmic)
  • Bss (Intraocular , Intraocular)
  • Prednisolone Acetate (Ophthalmic)


Application Site Burn (7753049-5)
Adverse event was reported on Sep 13, 2011 by a Female taking Betadine (Dosage: N/A) . Location: UNITED STATES , 66 years of age, After Betadine was administered, patient encountered several Betadine side effects: application site burn.

Complication Of Device Insertion, Uterine Spasm (7703853-4)
on Sep 17, 2010 Female from UNITED STATES , 40 years of age, was treated with Betadine. Directly after, patient experienced the unwanted or unexpected Betadine side effects: complication of device insertion, uterine spasm. Betadine dosage: 3 Times.
Associated medications used:
  • Mirena


Cardiac Failure, Femur Fracture, Fall (7509430-2)
on May 20, 2011 Male from SPAIN , weighting 198.2 lb, was treated with Betadine. Patient felt the following Betadine side effects: cardiac failure, femur fracture, fall. Betadine dosage: N/A.
Multiple prescriptions taken:
  • Micardis Hct (Unk)
  • Eutirox (Unk)
  • Hidroaltesona (Unk)
  • Atorvastatin Calcium (40 Mg, Unk)
  • Somatropin Rdna (0.4 Mg, Qd)
Patient was hospitalized.

Syncope (7294914-5)
Patient was taking Betadine Surgical Scrub 7.5%. After Betadine was administered, patient encountered several Betadine side effects: syncope on Feb 07, 2011 from UNITED STATES Additional patient health information: Male , 88 years of age, was diagnosed with
  • preoperative care
and. Betadine Surgical Scrub 7.5% dosage: Unk. Patient was hospitalized.

Accidental Exposure, Hyperthyroidism (6800598-X)
Adverse event was reported on Jun 25, 2010 by a Male taking Betadine (Dosage: N/A) . Location: UNITED STATES , weighting 160.0 lb, Directly after, patient experienced the unwanted or unexpected Betadine side effects: accidental exposure, hyperthyroidism.

Burn Oesophageal, Candidiasis, Contusion, Dysgeusia, Dyspnoea, Gingival Recession, Herpes Zoster, Lung Infection, Nasal Discomfort (6766549-1)
on Jun 03, 2010 Female from UNITED STATES , 59 years of age, weighting 170.0 lb, was diagnosed with
  • intraoperative care
and was treated with Betadine. Patient felt the following Betadine side effects: burn oesophageal, candidiasis, contusion, dysgeusia, dyspnoea, gingival recession, herpes zoster, lung infection, nasal discomfort. Betadine dosage: N/A.
Multiple prescriptions taken:
  • Advair Diskus 100/50
  • Spiriva
  • Flonase
  • Albuterol
  • Methotrexate


Chemical Poisoning, Hypersensitivity, Lung Disorder, Post Procedural Drainage (6727712-9)
on May 14, 2010 Female from UNITED STATES , weighting 183.0 lb, was diagnosed with
  • cataract operation
and was treated with Betadine. After Betadine was administered, patient encountered several Betadine side effects: chemical poisoning, hypersensitivity, lung disorder, post procedural drainage. Betadine dosage: N/A.

Burn Oesophageal, Candidiasis, Herpes Zoster, Lung Infection, Nasal Discomfort, Oral Discomfort, Productive Cough, Rhinorrhoea, Sputum Abnormal (6724479-5)
Patient was taking Betadine. Directly after, patient experienced the unwanted or unexpected Betadine side effects: burn oesophageal, candidiasis, herpes zoster, lung infection, nasal discomfort, oral discomfort, productive cough, rhinorrhoea, sputum abnormal on Apr 26, 2010 from UNITED STATES Additional patient health information: Female , 59 years of age, . Betadine dosage: N/A.

Consciousness Fluctuating (6523886-3)
Adverse event was reported on Dec 24, 2009 by a Male taking Betadine (Dosage: N/A) was diagnosed with
  • wound treatment
and. Location: UNITED STATES , 62 years of age, Patient felt the following Betadine side effects: consciousness fluctuating.

Application Site Irritation, Burns Third Degree, Caustic Injury, Skin Irritation (6393989-5)
on Oct 06, 2009 Female from UNITED STATES , weighting 122.4 lb, was diagnosed with
  • preoperative care
  • arrhythmia
  • hypertension
and was treated with Betadine. After Betadine was administered, patient encountered several Betadine side effects: application site irritation, burns third degree, caustic injury, skin irritation. Betadine dosage: 3 Spray, See Text.
Multiple concurrent drugs taken:
  • Coumadin
  • Antihypertensives


Application Site Irritation, Burns Third Degree, Caustic Injury, Skin Irritation, Vaginal Disorder (6231228-6)
on Jun 09, 2009 Female from UNITED STATES , weighting 122.4 lb, was diagnosed with
  • preoperative care
  • arrhythmia
  • hypertension
and was treated with Betadine. Directly after, patient experienced the unwanted or unexpected Betadine side effects: application site irritation, burns third degree, caustic injury, skin irritation, vaginal disorder. Betadine dosage: 3 Spray, See Text.
Associated medications used:
  • Coumadin
  • Antihypertensives


Showing 1-25 of 42 

Betadine Health Episodes

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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.

Betadine Information

Alternative BETADINE Names:POVIDONE-

Active Ingredient: POVIDONE-

More About Betadine

Side Effects reported to FDA: 42. View Betadine Adverse Reports

Betadine safety alerts: No

Reported deaths: 1

Reported hospitalizations: 3

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