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Hydroxychlor Side Effects

Common Hydroxychlor Side Effects


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

Cardiomyopathy (47)
Dyspnoea (44)
Nausea (35)
Fatigue (30)
Rash (29)
Vomiting (28)
Myopathy (22)
Arthralgia (22)
Headache (22)
Myelodysplastic Syndrome (21)
Condition Aggravated (20)
Diarrhoea (20)
Muscular Weakness (20)
Product Substitution Issue (18)
Pain (18)
Hypotension (16)
Asthenia (16)
Cardiac Arrest (15)
Restrictive Cardiomyopathy (15)
Oedema Peripheral (15)

➢ 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.

Hydroxychlor Side Effects Reported to FDA

The following Hydroxychlor 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 Hydroxychlor 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.
Diarrhoea, Abdominal Pain, Abdominal Distension, Eyelid Oedema, Dizziness, Paraesthesia, Hypoaesthesia, Oedema Peripheral
This is a report of a female patient (weight: NA) from US, suffering from the following symptoms/conditions: undifferentiated connective tissue disease, who was treated with Hydroxychloroquine (dosage: NA, start time: Dec 01, 2012), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Diarrhoea
  • Abdominal Pain
  • Abdominal Distension
  • Eyelid Oedema
  • Dizziness
  • Paraesthesia
  • Hypoaesthesia
  • Oedema Peripheral
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hydroxychloroquine treatment in female patients, resulting in diarrhoea side effect.

Alveolitis Allergic
This report suggests a potential Hydroxychloroquine Alveolitis Allergic side effect(s) that can have serious consequences. A female patient (weight: NA) from TW was diagnosed with the following symptoms/conditions: NA and used Hydroxychloroquine (dosage: NA) starting NS. Soon after starting Hydroxychloroquine the patient began experiencing various side effects, including:
  • Alveolitis Allergic
Drugs used concurrently:
  • Sennoside
  • Sulfasalazine
  • Prednisolone
  • Folic Acid
  • Methotrexate
  • Acetaminophen/tramadol Hydrochloride (37.5/325mg)
  • Zolpidem Tartrate
  • Celecoxib
The patient was hospitalized. Although Hydroxychloroquine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as alveolitis allergic, may still occur.

Tachycardia, Dyspnoea
This Tachycardia, Dyspnoea problem was reported by a consumer or non-health professional from US. A 39-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Hydroxychloroquine (dosage: 200mg Twice Daily Po). The following drugs were being taken at the same time: NA. When commencing Hydroxychloroquine, the patient experienced the following unwanted symptoms/side effects:
  • Tachycardia
  • Dyspnoea
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as tachycardia, may become evident only after a product is in use by the general population.

Treatment Failure
This is a report of a female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Hydroxychloroquine (dosage: NA) starting 2007. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Treatment Failure
This opens a possibility that Hydroxychloroquine treatment could cause the above reactions, including treatment failure, and some female subjects may be more susceptible.


Atrial Fibrillation, Sick Sinus Syndrome, Cardiotoxicity, Muscular Weakness, Dyspnoea, Oedema Peripheral, Troponin I Increased, Diastolic Dysfunction, Differential White Blood Cell Count Abnormal
A 64-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Hydroxychloroquine treatment (dosage: NA) on NS. Soon after starting Hydroxychloroquine treatment, the subject experienced various side effects, including:
  • Atrial Fibrillation
  • Sick Sinus Syndrome
  • Cardiotoxicity
  • Muscular Weakness
  • Dyspnoea
  • Oedema Peripheral
  • Troponin I Increased
  • Diastolic Dysfunction
  • Differential White Blood Cell Count Abnormal
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Hydroxychloroquine.

Cardiomyopathy, Cardiomegaly, Biopsy Heart Abnormal, Respiratory Failure, Hypoxia, Muscular Weakness, Blood Creatine Phosphokinase Increased, Troponin I Increased
A 64-year-old female patient from US (weight: NA) experienced symptoms, such as: rheumatoid arthritis and was treated with Hydroxychloroquine Sulfate(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Cardiomyopathy
  • Cardiomegaly
  • Biopsy Heart Abnormal
  • Respiratory Failure
  • Hypoxia
  • Muscular Weakness
  • Blood Creatine Phosphokinase Increased
  • Troponin I Increased
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Hydroxychloroquine Sulfate efficacy: NA.The patient was hospitalized.

Coeliac Disease
In this report, Hydroxychloroquine Sulfate was administered for the following condition: NA.A 38-year-old female consumer from US (weight: NA) started Hydroxychloroquine Sulfate treatment (dosage: NA) on 1994.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Coeliac Disease
A possible interaction with other drugs could have contributed to this reaction:
  • Amitriptyline
  • Vitamin D
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Hydroxychloroquine Sulfate treatment could be related to the listed above side effect(s).

Toxic Epidermal Necrolysis
This is a report of the following Hydroxychloroquine (no Pref. Name) side effect(s):
  • Toxic Epidermal Necrolysis
A 15-year-old female patient from CN (weight: NA) presented with the following condition: NA and received a treatment with Hydroxychloroquine (no Pref. Name) (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Hydroxychloroquine (no Pref. Name) treatment could be associated with the listed above side effect(s).

Cardiomyopathy, Respiratory Failure, Hypoxia, Atrial Fibrillation, Sick Sinus Syndrome, Platelet Count Decreased, Blood Creatinine Increased, Aspartate Aminotransferase Increased
This Hydroxychloroquine report was submitted by a 64-year-old female consumer from US (weight: NA). The patient was diagnosed with: NA and Hydroxychloroquine was administered (dosage: 200.00-mg - 1.0days / Oral) starting: NS. The consumer developed a set of symptoms:
  • Cardiomyopathy
  • Respiratory Failure
  • Hypoxia
  • Atrial Fibrillation
  • Sick Sinus Syndrome
  • Platelet Count Decreased
  • Blood Creatinine Increased
  • Aspartate Aminotransferase Increased
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Hydroxychloroquine treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Dyspnoea
This is a report of a possible correlation between Hydroxychloroquine use and the following symptoms/side effect(s):
  • Dyspnoea
which could contribute to an assessment of Hydroxychloroquine risk profile.A 46-year-old female consumer from NL (weight: NA) was suffering from systemic lupus erythematosis and was treated with Hydroxychloroquine (dosage: NA) starting 2003.Other concurrent medications:
  • Esomeprazol
The patient was hospitalized.

Feeling Drunk, Dizziness, Abnormal Behaviour
A 46-year-old female patient from US (weight: NA) presented with the following symptoms: NA and after a treatment with Hydroxychloroquine (dosage: NA) experienced the following side effect(s):
  • Feeling Drunk
  • Dizziness
  • Abnormal Behaviour
The treatment was started on Oct 04, 2012. Hydroxychloroquine was used in combination with the following drugs: NA.This report could alert potential Hydroxychloroquine consumers.

Stevens-johnson Syndrome
In this report, a 33-year-old female patient from US (weight: NA) was affected by a possible Hydroxychloroquine side effect.The patient was diagnosed with autoimmune disorder. After a treatment with Hydroxychloroquine (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Stevens-johnson Syndrome
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Hydroxychloroquine treatment.

Palindromic Rheumatism, Condition Aggravated, Product Substitution Issue
This is a report of a female patient from US (weight: NA), who used Hydroxychloroquine Sulfate (dosage: 200 Mg, 2 Tabs Daily, Oral) for a treatment of palindromic rheumatism. After starting a treatment on 201205, the patient experienced the following side effect(s):
  • Palindromic Rheumatism
  • Condition Aggravated
  • Product Substitution Issue
The following drugs could possibly have interacted with the Hydroxychloroquine Sulfate treatment NA.Taken together, these observations suggest that a Hydroxychloroquine Sulfate treatment could be related to side effect(s), such as Palindromic Rheumatism, Condition Aggravated, Product Substitution Issue.

Hepatitis B, Alanine Aminotransferase Increased
This hepatitis b side effect was reported by a health professional from CN. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis. The patient was prescribed Hydroxychloroquine Sulfate (dosage: NA), which was started on NS. Concurrently used drugs:
  • Methotrexate
  • Prednisone
When starting to take Hydroxychloroquine Sulfate the consumer reported the following symptoms:
  • Hepatitis B
  • Alanine Aminotransferase Increased
These side effects may potentially be related to Hydroxychloroquine Sulfate.

Keratopathy
This is a Hydroxychloroquine side effect report of a 35-year-old female patient (weight:NA) from TR, suffering from the following symptoms/conditions: leukocytoclastic vasculitis, who was treated with Hydroxychloroquine (dosage:400 Mg, Qd, start time: NS), combined with: NA., and developed a serious reaction and a keratopathy side effect. The patient presented with:
  • Keratopathy
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Hydroxychloroquine treatment in female patients suffering from leukocytoclastic vasculitis, resulting in keratopathy.

Gingival Inflammation, Gingival Recession, Dry Mouth, Tooth Fracture
This report suggests a potential Hydroxychloroquine gingival inflammation side effect(s) that can have serious consequences. A 55-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): osteoarthritis and used Hydroxychloroquine (dosage: 200 Mg One Tablet Per Day Po) starting Apr 13, 2011. Soon after starting Hydroxychloroquine the patient began experiencing various side effects, including:
  • Gingival Inflammation
  • Gingival Recession
  • Dry Mouth
  • Tooth Fracture
Drugs used concurrently:NA. Although Hydroxychloroquine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as gingival inflammation, may still occur.

Progressive Multifocal Leukoencephalopathy
This progressive multifocal leukoencephalopathy problem was reported by a health professional from SE. A 29-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): dermatomyositis.On NS a consumer started treatment with Hydroxychloroquine Sulfate (watson Laboratories) (dosage: Unk Mg, Daily). The following drugs/medications were being taken at the same time: NA. When commencing Hydroxychloroquine Sulfate (watson Laboratories), the patient experienced the following unwanted symptoms /side effects:
  • Progressive Multifocal Leukoencephalopathy
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as progressive multifocal leukoencephalopathy, may become evident only after a product is in use by the general population.

Asthma, Bronchospasm, Wheezing, Dyspnoea
This is a Hydroxychloroquine side effect report of a 70-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: rheumatoid arthritis and was treated with Hydroxychloroquine (dosage: NA) starting Mar 26, 2012. Concurrently used drugs:
  • Aspirin
  • Simvastatin
  • Lansoprazole
  • Paracetamol
  • Timolol
  • Bimatoprost (Cumulative Dose: 108)
Soon after that, the consumer experienced the following of symptoms:
  • Asthma
  • Bronchospasm
  • Wheezing
  • Dyspnoea
This opens a possibility that Hydroxychloroquine could cause asthma and that some male patients may be more susceptible.

Toxic Skin Eruption, Condition Aggravated, Autoimmune Disorder, Pleural Effusion, Lymphadenopathy, Leukopenia, Anaemia, Renal Failure Acute
A 19-year-old female patient (weight: NA) from ES with the following symptoms: autoimmune disorder started Hydroxychloroquine Sulfate (watson Laboratories) treatment (dosage: Unk) on NS. Soon after starting Hydroxychloroquine Sulfate (watson Laboratories) treatment, the consumer experienced several side effects, including:
  • Toxic Skin Eruption
  • Condition Aggravated
  • Autoimmune Disorder
  • Pleural Effusion
  • Lymphadenopathy
  • Leukopenia
  • Anaemia
  • Renal Failure Acute
. Concurrently used drugs:
  • Rifampicin (Unk)
This finding indicates that some patients can be more vulnerable to developing Hydroxychloroquine Sulfate (watson Laboratories) side effects, such as toxic skin eruption.

Visual Acuity Reduced
This visual acuity reduced side effect was reported by a health professional from KOREA, REPUBLIC OF. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Hydroxychloroquine Sulfate (dosage: 400 Mg;bid;po), which was started on NS. Concurrently used drugs: NA..When starting to take Hydroxychloroquine Sulfate the consumer reported symptoms, such as:
  • Visual Acuity Reduced
These side effects may potentially be related to Hydroxychloroquine Sulfate.

Lethargy, Nausea, Visual Impairment, Asthenia, Rash, Decreased Appetite, Oral Discomfort, Lip Swelling, Mood Swings
This is a report of a 83-year-old female patient (weight: NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Hydroxychloroquine Sulfate (dosage: NA, start time: NS), combined with:
  • Colcrys
  • Crestor
and developed a serious reaction and side effect(s). The consumer presented with:
  • Lethargy
  • Nausea
  • Visual Impairment
  • Asthenia
  • Rash
  • Decreased Appetite
  • Oral Discomfort
  • Lip Swelling
  • Mood Swings
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Hydroxychloroquine Sulfate treatment in female patients, resulting in lethargy side effect.

Systemic Lupus Erythematosus, Arthralgia, Fatigue
This report suggests a potential Hydroxychloroquine Sulfate Systemic Lupus Erythematosus, Arthralgia, Fatigue side effect(s) that can have serious consequences. A 50-year-old female patient (weight: NA) from UNITED STATES was diagnosed with the following symptoms/conditions: systemic lupus erythematosus and used Hydroxychloroquine Sulfate (dosage: NA) starting Aug 01, 2010. Soon after starting Hydroxychloroquine Sulfate the patient began experiencing various side effects, including:
  • Systemic Lupus Erythematosus
  • Arthralgia
  • Fatigue
Drugs used concurrently:
  • Lexapro
  • Aspirin
Although Hydroxychloroquine Sulfate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as systemic lupus erythematosus, may still occur.

Cutaneous Lupus Erythematosus, Thyroiditis Subacute
This Cutaneous Lupus Erythematosus, Thyroiditis Subacute problem was reported by a physician from GREECE. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatoid arthritis. On NS this consumer started treatment with Hydroxychloroquine Sulfate (dosage: Unk). The following drugs were being taken at the same time:
  • Enbrel (50 Mg, Weekly)
  • Prednisolone (30 Mg/d)
  • Prednisolone (5 Mg, 1x/day)
  • Prednisolone (5 Mg/d)
When commencing Hydroxychloroquine Sulfate, the patient experienced the following unwanted symptoms/side effects:
  • Cutaneous Lupus Erythematosus
  • Thyroiditis Subacute
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 cutaneous lupus erythematosus, may become evident only after a product is in use by the general population.

Pericardial Effusion, Fatigue, Pneumonia
This is a report of a 71-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Hydroxychloroquine Sulfate (dosage: Unk) starting Jan 01, 2002. Concurrently used drugs:
  • Enbrel (25 Mg, 2 Times/wk)
  • Methotrexate (Unk)
Soon after that, the consumer experienced the following side effects:
  • Pericardial Effusion
  • Fatigue
  • Pneumonia
This opens a possibility that Hydroxychloroquine Sulfate treatment could cause the above reactions, including pericardial effusion, and some female subjects may be more susceptible.

Cellulitis
A female patient (weight: NA) from GERMANY with the following symptoms/conditions: rheumatoid arthritis started Hydroxychloroquine Sulfate treatment (dosage: NA) on Dec 18, 2009. Soon after starting Hydroxychloroquine Sulfate treatment, the subject experienced various side effects, including:
  • Cellulitis
Concurrently used drugs:
  • Prednisolone
  • Cimzia (200 Mg)
  • Omeprazole
  • Amlodipine
  • Atacand
  • Methotrexate
This finding indicates that some female patients could be more vulnerable to Hydroxychloroquine Sulfate.

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Top 10 Hydroxychlor Side Effects for Women

Women Side EffectsReports
Cardiomyopathy 43
Dyspnoea 38
Nausea 30
Fatigue 27
Rash 25
Vomiting 23
Myopathy 21
Headache 20
Arthralgia 19
Diarrhoea 19

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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    Hydroxychlor Safety Alerts, Active Ingredients, Usage Information

    NDC0143-2128
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameHydroxychloroquine Sulfate
    NameHydroxychloroquine Sulfate
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20070815
    LabelerWest-ward Pharmaceutical Corp
    Active Ingredient(s)HYDROXYCHLOROQUINE SULFATE
    Strength(s)200
    Unit(s)mg/1
    Pharma ClassAntirheumatic Agent [EPC]

    More About Hydroxychlor

    Side Effects reported to FDA: 720

    Hydroxychlor safety alerts: No

    Reported deaths: 53

    Reported hospitalizations: 168

    Latest Hydroxychlor clinical trials