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Betadine Side Effects

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Common Betadine Side Effects


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

Endophthalmitis (12)
Postoperative Infection (11)
Toxic Anterior Segment Syndrome (9)
Culture Positive (6)
Burns Third Degree (4)
Caustic Injury (3)
Skin Irritation (3)
Candidiasis (2)
Burn Oesophageal (2)
Herpes Zoster (2)
Application Site Irritation (2)
Accidental Exposure To Product (2)
Post Procedural Complication (2)
Vaginal Disorder (2)
Lung Infection (2)
Urticaria (2)
Pneumonia Aspiration (2)
Nasal Discomfort (2)
Oral Discomfort (1)
Nausea (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.

Betadine Side Effects Reported to FDA



Betadine Side Effect Report#9649638
Punctate Keratitis, Corneal Opacity, Eye Pain
This is a report of a 68-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: preoperative care, who was treated with Betadine (dosage: Unk Gtt, Unk, start time: 201309), combined with: NA. and developed a serious reaction and side effect(s): Punctate Keratitis, Corneal Opacity, Eye Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betadine treatment in male patients, resulting in Punctate Keratitis side effect.
Betadine Side Effect Report#9458192
Anaphylactic Reaction, Vaginal Disorder, Pruritus, Urticaria, Rash Macular, Burning Sensation, Malaise, Hypertension, Pharyngeal Oedema
This report suggests a potential Betadine Surgical Scrub 7.5% Anaphylactic Reaction side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: surgery,supraventricular tachycardia,chronic obstructive pulmonary disease and used Betadine Surgical Scrub 7.5% (dosage: NA) starting NS. After starting Betadine Surgical Scrub 7.5% the patient began experiencing various side effects, including: Anaphylactic Reaction, Vaginal Disorder, Pruritus, Urticaria, Rash Macular, Burning Sensation, Malaise, Hypertension, Pharyngeal OedemaAdditional drugs used concurrently:
  • Diltiazem /00489702/ (300 Mg, Unk)
  • Advair
Although Betadine Surgical Scrub 7.5% demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaphylactic Reaction, may still occur.
Betadine Side Effect Report#9139548
Accidental Exposure To Product, Pneumonia Aspiration
This Accidental Exposure To Product problem was reported by a physician from US. A 34-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Betadine (dosage: NA). The following drugs were being taken at the same time:
  • Atropine
  • Meperidine /00016301/
  • Dexamethasone (4 Mg, Single)
  • Penicillin G /00000901/ (2000000 Unit, Single)
  • Thiopental Sodium
  • Halothane
  • Nitrous Oxide
  • Oxygen
When using Betadine, the patient experienced the following unwanted symptoms/side effects: Accidental Exposure To Product, Pneumonia AspirationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Accidental Exposure To Product, may become evident only after a product is in use by the general population.
Betadine Side Effect Report#9135043
Accidental Exposure To Product, Pneumonia Aspiration, Atelectasis, Acute Respiratory Distress Syndrome
This Accidental Exposure To Product side effect was reported by a consumer or non-health professional from US. A 7-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Betadine Solution Swabsticks (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Betadine Solution Swabsticks the consumer reported adverse symptoms, such as: Accidental Exposure To Product, Pneumonia Aspiration, Atelectasis, Acute Respiratory Distress SyndromeThese side effects may potentially be related to Betadine Solution Swabsticks.
Betadine Side Effect Report#9011405
Urticaria, Swelling Face, Insomnia, Flushing, Chemical Burn Of Skin, Skin Exfoliation, Wound Dehiscence
This is a report of a 22-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: wound drainage, who was treated with Betadine Solution Swabsticks (dosage: 10% Solution, start time:
Nov 16, 2012), combined with: NA. and developed a serious reaction and side effect(s): Urticaria, Swelling Face, Insomnia, Flushing, Chemical Burn Of Skin, Skin Exfoliation, Wound Dehiscence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betadine Solution Swabsticks treatment in male patients, resulting in Urticaria side effect.
Betadine Side Effect Report#8477341-4
Toxic Anterior Segment Syndrome
This report suggests a potential Betadine Toxic Anterior Segment Syndrome side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: intraocular lens implant and used Betadine (dosage: (ophthalmic)) starting
May 15, 2012. After starting Betadine the patient began experiencing various side effects, including: Toxic Anterior Segment SyndromeAdditional drugs used concurrently:
  • Bss ((intraocular))
  • Nevanac ((ophthalmic))
  • Epinephrine
  • Bss ((intraocular))
  • Vigamox ((opthalmic))
Although Betadine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxic Anterior Segment Syndrome, may still occur.
Betadine Side Effect Report#8477339-6
Toxic Anterior Segment Syndrome
This Toxic Anterior Segment Syndrome problem was reported by a health professional from United States. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: intraocular lens implant. On
May 15, 2012 this consumer started treatment with Betadine (dosage: Ophthalmic). The following drugs were being taken at the same time:
  • Nevanac (Ophthalmic)
  • Vigamox (Ophthalmic)
  • Epinephrine
  • Bss (Ophthalmic)
  • Bss (Intraocular)
When using Betadine, the patient experienced the following unwanted symptoms/side effects: Toxic Anterior Segment SyndromeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxic Anterior Segment Syndrome, may become evident only after a product is in use by the general population.
Betadine Side Effect Report#8477317-7
Toxic Anterior Segment Syndrome
This Toxic Anterior Segment Syndrome side effect was reported by a health professional from United States. A 45-year-old male patient (weight:NA) experienced the following symptoms/conditions: intraocular lens implant.The patient was prescribed Betadine (drug dosage: Ophthalmic), which was initiated on
May 15, 2012. Concurrently used drugs:
  • Nevanac ((ophthalmic))
  • Bss (Intraocular)
  • Epinephrine
  • Vigamox ((ophthalmic))
  • Bss ((intraocular))
.After starting to take Betadine the consumer reported adverse symptoms, such as: Toxic Anterior Segment SyndromeThese side effects may potentially be related to Betadine.
Betadine Side Effect Report#8399149-0
Anterior Chamber Fibrin, Corneal Oedema, Hypopyon, Vitritis, Endophthalmitis
This is a report of a 74-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Betadine (dosage: NA, start time:
Feb 22, 2012), combined with:
  • Oftalar
  • Tobradex
  • Liquifilm
  • Vancomicina
  • Ceftazidime
  • Moxifloxacin (Unk)
  • Tropicamide
  • Amikacin Sulfate
and developed a serious reaction and side effect(s): Anterior Chamber Fibrin, Corneal Oedema, Hypopyon, Vitritis, Endophthalmitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betadine treatment in female patients, resulting in Anterior Chamber Fibrin side effect.
Betadine Side Effect Report#8308075-4
Abdominal Pain, Pain, Vomiting, Device Dislocation, Nausea, Genital Haemorrhage, Presyncope, Dizziness
This report suggests a potential Betadine Abdominal Pain side effect(s) that can have serious consequences. A 19-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Betadine (dosage: NA) starting
Dec 08, 2011. After starting Betadine the patient began experiencing various side effects, including: Abdominal Pain, Pain, Vomiting, Device Dislocation, Nausea, Genital Haemorrhage, Presyncope, DizzinessAdditional drugs used concurrently:
  • Mirena (20 Mcg/24hr, Cont)
Although Betadine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain, may still occur.
Betadine Side Effect Report#8303505-6
Post Procedural Complication, Toxic Anterior Segment Syndrome
This Post Procedural Complication problem was reported by a health professional from United States. A 63-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: intraocular lens implant. On
Mar 21, 2012 this consumer started treatment with Betadine (dosage: (ophthalmic)). The following drugs were being taken at the same time:
  • Vancomycin
  • Phenylephrine Hcl
  • Alcaine ((ophthalmic))
  • Ocufen
  • Bss ((intraocular))
  • Cyclogyl ((ophthalmic))
  • Epinephrine
When using Betadine, the patient experienced the following unwanted symptoms/side effects: Post Procedural Complication, Toxic Anterior Segment SyndromeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Post Procedural Complication, may become evident only after a product is in use by the general population.
Betadine Side Effect Report#8251274-0
Iritis, Toxic Anterior Segment Syndrome
This Iritis side effect was reported by a health professional from United States. A 80-year-old male patient (weight:NA) experienced the following symptoms/conditions: intraocular lens implant.The patient was prescribed Betadine (drug dosage: Ophthalmic), which was initiated on
Feb 06, 2012. Concurrently used drugs:
  • Bss Plus (Intraocular)
  • Bss (Intraocular)
  • Zymaxid
.After starting to take Betadine the consumer reported adverse symptoms, such as: Iritis, Toxic Anterior Segment SyndromeThese side effects may potentially be related to Betadine.
Betadine Side Effect Report#8167553-1
Toxic Anterior Segment Syndrome
This is a report of a 86-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: preoperative care,intraocular lens implant, who was treated with Betadine (dosage: Ophthalmic, start time:
Feb 07, 2012), combined with:
  • Bss (Intraocular)
  • Bss Plus (Intraocular)
and developed a serious reaction and side effect(s): Toxic Anterior Segment Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betadine treatment in male patients, resulting in Toxic Anterior Segment Syndrome side effect.
Betadine Side Effect Report#8065259-0
Endophthalmitis, Post Procedural Complication, Procedural Complication
This report suggests a potential Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) Endophthalmitis side effect(s) that can have serious consequences. A 85-year-old female patient (weight: NA) from Norway was diagnosed with the following symptoms/conditions: preoperative care and used Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) (dosage: For 2 Minute Before Surgery, Ophthalmic) starting NS. After starting Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) the patient began experiencing various side effects, including: Endophthalmitis, Post Procedural Complication, Procedural ComplicationAdditional drugs used concurrently:
  • 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)
Although Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Endophthalmitis, may still occur.
Betadine Side Effect Report#8065253-X
Endophthalmitis
This Endophthalmitis problem was reported by a health professional from Norway. A 83-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: preoperative care. On NS this consumer started treatment with Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) (dosage: For 2 Minutes Before Surgery Opthalmic). The following drugs were being taken at the same time:
  • 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)
When using Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine), the patient experienced the following unwanted symptoms/side effects: EndophthalmitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Endophthalmitis, may become evident only after a product is in use by the general population.
Betadine Side Effect Report#8054028-3
Endophthalmitis, Toxic Anterior Segment Syndrome
This Endophthalmitis side effect was reported by a health professional from United States. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: cataract operation.The patient was prescribed Betadine Ophthalmic (drug dosage: Unk), which was initiated on
Oct 26, 2011. Concurrently used drugs:
  • Prednisolone Acetate (Unk)
  • Tetracaine Hydrochloride (Unk)
  • Nevanac (Unk)
  • Zymaxid (Unk)
  • Bss (Unk)
.After starting to take Betadine Ophthalmic the consumer reported adverse symptoms, such as: Endophthalmitis, Toxic Anterior Segment SyndromeThese side effects may potentially be related to Betadine Ophthalmic.
Betadine Side Effect Report#8045581-4
Hyperaesthesia, Skin Discolouration, Dermatitis
This is a report of a 61-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: therapeutic skin care topical, who was treated with Betadine (dosage: NA, start time:
Jan 01, 2011), combined with: NA. and developed a serious reaction and side effect(s): Hyperaesthesia, Skin Discolouration, Dermatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betadine treatment in female patients, resulting in Hyperaesthesia side effect.
Betadine Side Effect Report#8033826-6
Visual Acuity Reduced, Toxic Anterior Segment Syndrome
This report suggests a potential Betadine Visual Acuity Reduced side effect(s) that can have serious consequences. A 74-year-old patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Betadine (dosage: NA) starting
Nov 17, 2011. After starting Betadine the patient began experiencing various side effects, including: Visual Acuity Reduced, Toxic Anterior Segment SyndromeAdditional drugs used concurrently:
  • Bss
  • Tetracaine Hydrochloride 0.5 Opthalmic Solution (Ophthalmic)
  • Nevanac (Ophthalmic)
  • Prednisolone Acetate (Ophthalmic)
  • Bss (Intraocular)
  • Vigamox (Ophthalmic)
Although Betadine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Visual Acuity Reduced, may still occur.
Betadine Side Effect Report#8033821-7
Toxic Anterior Segment Syndrome
This Toxic Anterior Segment Syndrome problem was reported by a health professional from United States. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 03, 2011 this consumer started treatment with Betadine (dosage: NA). The following drugs were being taken at the same time:
  • Bss (Intraocular)
  • Vigamox (Ophthalmic)
  • Tetracaine Polygyl Sterile Ophthalmic Solution (Ophthalmic)
  • Nevanac (Ophthalmic)
  • Bss (Intraocular , Intraocular)
  • Prednisolone Acetate (Ophthalmic)
When using Betadine, the patient experienced the following unwanted symptoms/side effects: Toxic Anterior Segment SyndromeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxic Anterior Segment Syndrome, may become evident only after a product is in use by the general population.
Betadine Side Effect Report#7753049-5
Application Site Burn
This Application Site Burn side effect was reported by a consumer or non-health professional from United States. A 66-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Betadine (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Betadine the consumer reported adverse symptoms, such as: Application Site BurnThese side effects may potentially be related to Betadine.
Betadine Side Effect Report#7703853-4
Complication Of Device Insertion, Uterine Spasm
This is a report of a 40-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Betadine (dosage: 3 Times, start time:
Jun 07, 2010), combined with:
  • Mirena
and developed a serious reaction and side effect(s): Complication Of Device Insertion, Uterine Spasm after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betadine treatment in female patients, resulting in Complication Of Device Insertion side effect.
Betadine Side Effect Report#7509430-2
Cardiac Failure, Femur Fracture, Fall
This report suggests a potential Betadine Cardiac Failure side effect(s) that can have serious consequences. A male patient (weight: NA) from Spain was diagnosed with the following symptoms/conditions: NA and used Betadine (dosage: NA) starting
Jul 19, 2005. After starting Betadine the patient began experiencing various side effects, including: Cardiac Failure, Femur Fracture, FallAdditional drugs used concurrently:
  • Micardis Hct (Unk)
  • Eutirox (Unk)
  • Hidroaltesona (Unk)
  • Atorvastatin Calcium (40 Mg, Unk)
  • Somatropin Rdna (0.4 Mg, Qd)
The patient was hospitalized. Although Betadine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Failure, may still occur.
Betadine Side Effect Report#7294914-5
Syncope
This Syncope problem was reported by a consumer or non-health professional from United States. A 88-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: preoperative care. On
Feb 01, 2011 this consumer started treatment with Betadine Surgical Scrub 7.5% (dosage: Unk). The following drugs were being taken at the same time: NA. When using Betadine Surgical Scrub 7.5%, the patient experienced the following unwanted symptoms/side effects: SyncopeThe 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 Syncope, may become evident only after a product is in use by the general population.
Betadine Side Effect Report#6800598-X
Accidental Exposure, Hyperthyroidism
This Accidental Exposure side effect was reported by a physician from United States. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Betadine (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Betadine the consumer reported adverse symptoms, such as: Accidental Exposure, HyperthyroidismThese side effects may potentially be related to Betadine.
Betadine Side Effect Report#6766549-1
Burn Oesophageal, Candidiasis, Contusion, Dysgeusia, Dyspnoea, Gingival Recession, Herpes Zoster, Lung Infection, Nasal Discomfort
This is a report of a 59-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: intraoperative care, who was treated with Betadine (dosage: NA, start time: NS), combined with:
  • Advair Diskus 100/50
  • Spiriva
  • Flonase
  • Albuterol
  • Methotrexate
and developed a serious reaction and side effect(s): Burn Oesophageal, Candidiasis, Contusion, Dysgeusia, Dyspnoea, Gingival Recession, Herpes Zoster, Lung Infection, Nasal Discomfort after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Betadine treatment in female patients, resulting in Burn Oesophageal side effect.


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The appearance of Betadine 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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It is really important to keep track of your health 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

    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.

    Betadine 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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    Betadine Safety Alerts, Active Ingredients, Usage Information

    NDC0065-0411
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameBetadine
    Namepovidone-iodine
    Dosage FormSOLUTION
    RouteOPHTHALMIC
    On market since20000401
    LabelerAlcon Laboratories, Inc.
    Active Ingredient(s)POVIDONE-IODINE
    Strength(s)5
    Unit(s)mg/mL
    Pharma Class

    More About Betadine

    Side Effects reported to FDA: 47

    Betadine safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 3

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