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Betadine Side Effects

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.

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.

Betadine Side Effects Reported to FDA

The following 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.


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.
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 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). The consumer presented with:
  • Punctate Keratitis
  • Corneal Opacity
  • Eye Pain
which developed 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.

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, Vaginal Disorder, Pruritus, Urticaria, Rash Macular, Burning Sensation, Malaise, Hypertension, Pharyngeal Oedema 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. Soon 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 Oedema
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.

Accidental Exposure To Product, Pneumonia Aspiration
This Accidental Exposure To Product, Pneumonia Aspiration 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 commencing Betadine, the patient experienced the following unwanted symptoms/side effects:
  • Accidental Exposure To Product
  • Pneumonia Aspiration
Although 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.

Accidental Exposure To Product, Pneumonia Aspiration, Atelectasis, Acute Respiratory Distress Syndrome
This is a report of a 7-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Betadine Solution Swabsticks (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Accidental Exposure To Product
  • Pneumonia Aspiration
  • Atelectasis
  • Acute Respiratory Distress Syndrome
This opens a possibility that Betadine Solution Swabsticks treatment could cause the above reactions, including accidental exposure to product, and some female subjects may be more susceptible.


Urticaria, Swelling Face, Insomnia, Flushing, Chemical Burn Of Skin, Skin Exfoliation, Wound Dehiscence
A 22-year-old male patient (weight: NA) from US with the following symptoms/conditions: wound drainage started Betadine Solution Swabsticks treatment (dosage: 10% Solution) on Nov 16, 2012. Soon after starting Betadine Solution Swabsticks treatment, the subject experienced various side effects, including:
  • Urticaria
  • Swelling Face
  • Insomnia
  • Flushing
  • Chemical Burn Of Skin
  • Skin Exfoliation
  • Wound Dehiscence
Concurrently used drugs: NA. This finding indicates that some male patients could be more vulnerable to Betadine Solution Swabsticks.

Toxic Anterior Segment Syndrome
A 77-year-old female patient from UNITED STATES (weight: NA) experienced symptoms, such as: intraocular lens implant and was treated with Betadine(dosage: (ophthalmic)). The treatment was initiated on May 15, 2012. After that a consumer reported the following side effect(s):
  • Toxic Anterior Segment Syndrome
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Betadine efficacy:
  • Bss ((intraocular))
  • Nevanac ((ophthalmic))
  • Epinephrine
  • Bss ((intraocular))
  • Vigamox ((opthalmic))


Toxic Anterior Segment Syndrome
In this report, Betadine was administered for the following condition: intraocular lens implant.A 71-year-old male consumer from UNITED STATES (weight: NA) started Betadine treatment (dosage: Ophthalmic) on May 15, 2012.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Toxic Anterior Segment Syndrome
A possible interaction with other drugs could have contributed to this reaction:
  • Nevanac (Ophthalmic)
  • Vigamox (Ophthalmic)
  • Epinephrine
  • Bss (Ophthalmic)
  • Bss (Intraocular)
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Betadine treatment could be related to the listed above side effect(s).

Toxic Anterior Segment Syndrome
This is a report of the following Betadine side effect(s):
  • Toxic Anterior Segment Syndrome
A 45-year-old male patient from UNITED STATES (weight: NA) presented with the following condition: intraocular lens implant and received a treatment with Betadine (dosage: Ophthalmic) starting: May 15, 2012.The following concurrently used drugs could have generated interactions:
  • Nevanac ((ophthalmic))
  • Bss (Intraocular)
  • Epinephrine
  • Vigamox ((ophthalmic))
  • Bss ((intraocular))
This report suggests that a Betadine treatment could be associated with the listed above side effect(s).

Anterior Chamber Fibrin, Corneal Oedema, Hypopyon, Vitritis, Endophthalmitis
This Betadine report was submitted by a 74-year-old female consumer from UNITED STATES (weight: NA). The patient was diagnosed with: NA and Betadine was administered (dosage: NA) starting: Feb 22, 2012. The consumer developed a set of symptoms:
  • Anterior Chamber Fibrin
  • Corneal Oedema
  • Hypopyon
  • Vitritis
  • Endophthalmitis
Other drugs used simultaneously:
  • Oftalar
  • Tobradex
  • Liquifilm
  • Vancomicina
  • Ceftazidime
  • Moxifloxacin (Unk)
  • Tropicamide
  • Amikacin Sulfate
Those unexpected symptoms could be linked to a Betadine treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Abdominal Pain, Vomiting, Device Dislocation, Nausea, Genital Haemorrhage, Presyncope, Dizziness
This is a report of a possible correlation between Betadine use and the following symptoms/side effect(s):
  • Abdominal Pain
  • Vomiting
  • Device Dislocation
  • Nausea
  • Genital Haemorrhage
  • Presyncope
  • Dizziness
which could contribute to an assessment of Betadine risk profile.A 19-year-old female consumer from UNITED STATES (weight: NA) was suffering from NA and was treated with Betadine (dosage: NA) starting Dec 08, 2011.Other concurrent medications:
  • Mirena (20 Mcg/24hr, Cont)


Post Procedural Complication, Toxic Anterior Segment Syndrome
A 63-year-old male patient from UNITED STATES (weight: NA) presented with the following symptoms: intraocular lens implant and after a treatment with Betadine (dosage: (ophthalmic)) experienced the following side effect(s):
  • Post Procedural Complication
  • Toxic Anterior Segment Syndrome
The treatment was started on Mar 21, 2012. Betadine was used in combination with the following drugs:
  • Vancomycin
  • Phenylephrine Hcl
  • Alcaine ((ophthalmic))
  • Ocufen
  • Bss ((intraocular))
  • Cyclogyl ((ophthalmic))
  • Epinephrine
This report could alert potential Betadine consumers.

Iritis, Toxic Anterior Segment Syndrome
In this report, a 80-year-old male patient from UNITED STATES (weight: NA) was affected by a possible Betadine side effect.The patient was diagnosed with intraocular lens implant. After a treatment with Betadine (dosage: Ophthalmic, start date: Feb 06, 2012), the patient experienced the following side effect(s):
  • Iritis
  • Toxic Anterior Segment Syndrome
The following simultaneously used drugs could have led to this reaction:
  • Bss Plus (Intraocular)
  • Bss (Intraocular)
  • Zymaxid
The findings here stress that side effects should be taken into consideration when evaluating a Betadine treatment.

Toxic Anterior Segment Syndrome
This is a report of a 86-year-old male patient from UNITED STATES (weight: NA), who used Betadine (dosage: Ophthalmic) for a treatment of preoperative care,intraocular lens implant. After starting a treatment on Feb 07, 2012, the patient experienced the following side effect(s):
  • Toxic Anterior Segment Syndrome
The following drugs could possibly have interacted with the Betadine treatment
  • Bss (Intraocular)
  • Bss Plus (Intraocular)
Taken together, these observations suggest that a Betadine treatment could be related to side effect(s), such as Toxic Anterior Segment Syndrome.

Endophthalmitis, Post Procedural Complication
This endophthalmitis side effect was reported by a health professional from NORWAY. A 85-year-old female patient (weight:NA) experienced the following symptoms/conditions: preoperative care. The patient was prescribed Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) (dosage: For 2 Minute Before Surgery, Ophthalmic), which was started on NS. Concurrently used drugs:
  • 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)
When starting to take Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) the consumer reported the following symptoms:
  • Endophthalmitis
  • Post Procedural Complication
These side effects may potentially be related to Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine).

Endophthalmitis
This is a Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) side effect report of a 83-year-old male patient (weight:NA) from NORWAY, suffering from the following symptoms/conditions: preoperative care, who was treated with Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) (dosage:For 2 Minutes Before Surgery Opthalmic, start time: NS), combined with:
  • 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)
, and developed a serious reaction and a endophthalmitis side effect. The patient presented with:
  • Endophthalmitis
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Betadine Ophthalmic 0.5% Ophthalmic Solution (betadine) treatment in male patients suffering from preoperative care, resulting in endophthalmitis.

Endophthalmitis, Toxic Anterior Segment Syndrome
This report suggests a potential Betadine Ophthalmic endophthalmitis side effect(s) that can have serious consequences. A 66-year-old female patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): cataract operation and used Betadine Ophthalmic (dosage: Unk) starting Oct 26, 2011. Soon after starting Betadine Ophthalmic the patient began experiencing various side effects, including:
  • Endophthalmitis
  • Toxic Anterior Segment Syndrome
Drugs used concurrently:
  • Prednisolone Acetate (Unk)
  • Tetracaine Hydrochloride (Unk)
  • Nevanac (Unk)
  • Zymaxid (Unk)
  • Bss (Unk)
Although Betadine Ophthalmic demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as endophthalmitis, may still occur.

Hyperaesthesia, Skin Discolouration, Dermatitis
This hyperaesthesia problem was reported by a consumer or non-health professional from UNITED STATES. A 61-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): therapeutic skin care topical.On Jan 01, 2011 a consumer started treatment with Betadine (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Betadine, the patient experienced the following unwanted symptoms /side effects:
  • Hyperaesthesia
  • Skin Discolouration
  • Dermatitis
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as hyperaesthesia, may become evident only after a product is in use by the general population.

Visual Acuity Reduced, Toxic Anterior Segment Syndrome
This is a Betadine side effect report of a 74-year-old patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Betadine (dosage: NA) starting Nov 17, 2011. Concurrently used drugs:
  • Bss
  • Tetracaine Hydrochloride 0.5 Opthalmic Solution (Ophthalmic)
  • Nevanac (Ophthalmic)
  • Prednisolone Acetate (Ophthalmic)
  • Bss (Intraocular)
  • Vigamox (Ophthalmic)
Soon after that, the consumer experienced the following of symptoms:
  • Visual Acuity Reduced
  • Toxic Anterior Segment Syndrome
This opens a possibility that Betadine could cause visual acuity reduced and that some patients may be more susceptible.

Toxic Anterior Segment Syndrome
A 55-year-old female patient (weight: NA) from UNITED STATES with the following symptoms: NA started Betadine treatment (dosage: NA) on Nov 03, 2011. Soon after starting Betadine treatment, the consumer experienced several side effects, including:
  • Toxic Anterior Segment Syndrome
. Concurrently used drugs:
  • Bss (Intraocular)
  • Vigamox (Ophthalmic)
  • Tetracaine Polygyl Sterile Ophthalmic Solution (Ophthalmic)
  • Nevanac (Ophthalmic)
  • Bss (Intraocular , Intraocular)
  • Prednisolone Acetate (Ophthalmic)
This finding indicates that some patients can be more vulnerable to developing Betadine side effects, such as toxic anterior segment syndrome.

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 (dosage: NA), which was started on NS. Concurrently used drugs: NA..When starting to take Betadine the consumer reported symptoms, such as:
  • Application Site Burn
These side effects may potentially be related to Betadine.

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 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). The consumer presented with:
  • Complication Of Device Insertion
  • Uterine Spasm
which developed 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.

Cardiac Failure, Femur Fracture, Fall
This report suggests a potential Betadine Cardiac Failure, Femur Fracture, Fall 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. Soon after starting Betadine the patient began experiencing various side effects, including:
  • Cardiac Failure
  • Femur Fracture
  • Fall
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.

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 commencing Betadine Surgical Scrub 7.5%, the patient experienced the following unwanted symptoms/side effects:
  • Syncope
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 syncope, may become evident only after a product is in use by the general population.

Accidental Exposure, Hyperthyroidism
This is a report of a male patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Betadine (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Accidental Exposure
  • Hyperthyroidism
This opens a possibility that Betadine treatment could cause the above reactions, including accidental exposure, and some male subjects may be more susceptible.

Burn Oesophageal, Candidiasis, Contusion, Dysgeusia, Dyspnoea, Gingival Recession, Herpes Zoster, Lung Infection, Nasal Discomfort
A 59-year-old female patient (weight: NA) from UNITED STATES with the following symptoms/conditions: intraoperative care started Betadine treatment (dosage: NA) on NS. Soon after starting Betadine treatment, the subject experienced various side effects, including:
  • Burn Oesophageal
  • Candidiasis
  • Contusion
  • Dysgeusia
  • Dyspnoea
  • Gingival Recession
  • Herpes Zoster
  • Lung Infection
  • Nasal Discomfort
Concurrently used drugs:
  • Advair Diskus 100/50
  • Spiriva
  • Flonase
  • Albuterol
  • Methotrexate
This finding indicates that some female patients could be more vulnerable to Betadine.

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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.


    Discuss Betadine Side Effects

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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

    Latest Betadine clinical trials