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Roacutan Side Effects

Common Roacutan Side Effects


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

Pregnancy (269)
No Adverse Event (192)
No Adverse Effect (94)
Normal Newborn (59)
Acne (47)
Headache (40)
Depression (39)
Abortion Spontaneous (33)
Lip Dry (27)
Dry Skin (21)
Abdominal Pain Upper (21)
Suicidal Ideation (20)
Blood Cholesterol Increased (18)
Nausea (18)
Dry Mouth (17)
Abortion Induced (16)
Anxiety (15)
Insomnia (15)
Weight Decreased (14)
Caesarean Section (13)

➢ 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.

Roacutan Side Effects Reported to FDA

The following Roacutan 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 Roacutan 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.
Pregnancy, No Adverse Event
This is a report of a 28-year-old female patient (weight: NA) from BR, suffering from the following symptoms/conditions: acne, who was treated with Roacutan (dosage: NA, start time: 201307), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Pregnancy
  • No Adverse Event
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roacutan treatment in female patients, resulting in pregnancy side effect.

Depression, Coma, Suicidal Ideation, Weight Increased
This report suggests a potential Roacutan Depression, Coma, Suicidal Ideation, Weight Increased side effect(s) that can have serious consequences. A 19-year-old male patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: acne and used Roacutan (dosage: NA) starting NS. Soon after starting Roacutan the patient began experiencing various side effects, including:
  • Depression
  • Coma
  • Suicidal Ideation
  • Weight Increased
Drugs used concurrently: NA. Although Roacutan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as depression, may still occur.

Pregnancy
This Pregnancy problem was reported by a consumer or non-health professional from BR. A 35-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Jun 23, 2013 this consumer started treatment with Roacutan (dosage: NA). The following drugs were being taken at the same time:
  • Mesigyna
When commencing Roacutan, the patient experienced the following unwanted symptoms/side effects:
  • Pregnancy
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as pregnancy, may become evident only after a product is in use by the general population.

Sepsis, Large Intestine Perforation, Pancreatitis, Gallbladder Disorder, Colitis, Small Intestinal Perforation, Infection, Pulmonary Vasculitis, Pilonidal Cyst
This is a report of a 22-year-old male patient (weight: NA) from BR. The patient developed the following symptoms/conditions: NA and was treated with Roacutan (dosage: NA) starting 201301. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Sepsis
  • Large Intestine Perforation
  • Pancreatitis
  • Gallbladder Disorder
  • Colitis
  • Small Intestinal Perforation
  • Infection
  • Pulmonary Vasculitis
  • Pilonidal Cyst
The patient was hospitalized. This opens a possibility that Roacutan treatment could cause the above reactions, including sepsis, and some male subjects may be more susceptible.


Convulsion, Depression, Lip Dry, Constipation, Aphthous Stomatitis, Blood Zinc Decreased, Acne, Alopecia, Pain
A 37-year-old female patient (weight: NA) from BR with the following symptoms/conditions: NA started Roacutan treatment (dosage: NA) on 201112. Soon after starting Roacutan treatment, the subject experienced various side effects, including:
  • Convulsion
  • Depression
  • Lip Dry
  • Constipation
  • Aphthous Stomatitis
  • Blood Zinc Decreased
  • Acne
  • Alopecia
  • Pain
Concurrently used drugs:
  • Rivotril (5-8 Drops, As Needed)
  • Rivotril
  • Omeprazole
This finding indicates that some female patients could be more vulnerable to Roacutan.

Pregnancy, Acne, Normal Newborn
A 22-year-old female patient from BR (weight: NA) experienced symptoms, such as: acne and was treated with Roacutan(dosage: NA). The treatment was initiated on 201103. After that a consumer reported the following side effect(s):
  • Pregnancy
  • Acne
  • Normal Newborn
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Roacutan efficacy: NA.

Pregnancy
In this report, Roacutan was administered for the following condition: NA.A female consumer from BR (weight: NA) started Roacutan treatment (dosage: NA) on 201206.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Pregnancy
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Roacutan treatment could be related to the listed above side effect(s).

Pancreatitis, Colitis Ulcerative, Pneumonia, Pilonidal Cyst, Condition Aggravated
This is a report of the following Roacutan side effect(s):
  • Pancreatitis
  • Colitis Ulcerative
  • Pneumonia
  • Pilonidal Cyst
  • Condition Aggravated
A 22-year-old male patient from BR (weight: NA) presented with the following condition: NA and received a treatment with Roacutan (dosage: NA) starting: 201211.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Roacutan treatment could be associated with the listed above side effect(s).

Pregnancy
This Roacutan report was submitted by a female consumer from BR (weight: NA). The patient was diagnosed with: acne and Roacutan was administered (dosage: NA) starting: 201211. The consumer developed a set of symptoms:
  • Pregnancy
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Roacutan treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Pregnancy
This is a report of a possible correlation between Roacutan use and the following symptoms/side effect(s):
  • Pregnancy
which could contribute to an assessment of Roacutan risk profile.A female consumer from BR (weight: NA) was suffering from NA and was treated with Roacutan (dosage: NA) starting NS.Other concurrent medications: NA.

Depression, Schizophrenia, Headache, Hallucination, Crying, Pain
A male patient from BR (weight: NA) presented with the following symptoms: acne and after a treatment with Roacutan (dosage: NA) experienced the following side effect(s):
  • Depression
  • Schizophrenia
  • Headache
  • Hallucination
  • Crying
  • Pain
The treatment was started on Feb 22, 2013. Roacutan was used in combination with the following drugs: NA.This report could alert potential Roacutan consumers.

Exposure During Pregnancy, Hypersensitivity
In this report, a female patient from BR (weight: NA) was affected by a possible Roacutan side effect.The patient was diagnosed with acne. After a treatment with Roacutan (dosage: NA, start date: 201303), the patient experienced the following side effect(s):
  • Exposure During Pregnancy
  • Hypersensitivity
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Roacutan treatment.

Meningitis
This is a report of a 18-year-old male patient from BR (weight: NA), who used Roacutan (dosage: NA) for a treatment of acne. After starting a treatment on 201112, the patient experienced the following side effect(s):
  • Meningitis
The following drugs could possibly have interacted with the Roacutan treatment NA.Taken together, these observations suggest that a Roacutan treatment could be related to side effect(s), such as Meningitis.

Pregnancy, Abortion, Lip Dry, Liver Disorder
This pregnancy side effect was reported by a consumer or non-health professional from BR. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Roacutan (dosage: NA), which was started on Apr 21, 2013. Concurrently used drugs: NA. When starting to take Roacutan the consumer reported the following symptoms:
  • Pregnancy
  • Abortion
  • Lip Dry
  • Liver Disorder
These side effects may potentially be related to Roacutan.

External Ear Disorder, Gastrointestinal Disorder, Ear Canal Stenosis, Cardiac Disorder, Gastrooesophageal Reflux Disease, Feeding Disorder Neonatal
This is a Roacutan side effect report of a 0-year-old male patient (weight:NA) from BR, suffering from the following symptoms/conditions: NA, who was treated with Roacutan (dosage:NA, start time: NS), combined with: NA., and developed a serious reaction and a external ear disorder side effect. The patient presented with:
  • External Ear Disorder
  • Gastrointestinal Disorder
  • Ear Canal Stenosis
  • Cardiac Disorder
  • Gastrooesophageal Reflux Disease
  • Feeding Disorder Neonatal
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Roacutan treatment in male patients suffering from NA, resulting in external ear disorder.

Parotitis
This report suggests a potential Roacutan parotitis side effect(s) that can have serious consequences. A 43-year-old female patient from BR (weight:NA) was diagnosed with the following health condition(s): NA and used Roacutan (dosage: NA) starting NS. Soon after starting Roacutan the patient began experiencing various side effects, including:
  • Parotitis
Drugs used concurrently:
  • Neozine
The patient was hospitalized. Although Roacutan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as parotitis, may still occur.

Pregnancy, Acne
This pregnancy problem was reported by a consumer or non-health professional from BR. A female patient (weight: NA) was diagnosed with the following medical condition(s): acne.On Jan 13, 2013 a consumer started treatment with Roacutan (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Roacutan, the patient experienced the following unwanted symptoms /side effects:
  • Pregnancy
  • Acne
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as pregnancy, may become evident only after a product is in use by the general population.

Heart Disease Congenital, Sepsis
This is a Roacutan side effect report of a male patient (weight: NA) from BR. The patient developed the following symptoms/conditions: NA and was treated with Roacutan (dosage: NA) starting NS. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Heart Disease Congenital
  • Sepsis
This opens a possibility that Roacutan could cause heart disease congenital and that some male patients may be more susceptible.

Weight Increased
A male patient (weight: NA) from BR with the following symptoms: acne started Roacutan treatment (dosage: 0.6 Mg/kg) on 200601. Soon after starting Roacutan treatment, the consumer experienced several side effects, including:
  • Weight Increased
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Roacutan side effects, such as weight increased.

Glomerulonephritis, Haematuria, Renal Disorder, Rash Macular, Erythema
This glomerulonephritis side effect was reported by a consumer or non-health professional from BR. A male patient (weight:NA) experienced the following symptoms/conditions: acne.The patient was prescribed Roacutan (dosage: NA), which was started on 2008. Concurrently used drugs: NA..When starting to take Roacutan the consumer reported symptoms, such as:
  • Glomerulonephritis
  • Haematuria
  • Renal Disorder
  • Rash Macular
  • Erythema
These side effects may potentially be related to Roacutan.

Thyroid Neoplasm
This is a report of a female patient (weight: NA) from BR, suffering from the following symptoms/conditions: NA, who was treated with Roacutan (dosage: NA, start time: 201201), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Thyroid Neoplasm
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roacutan treatment in female patients, resulting in thyroid neoplasm side effect.

Exposure During Pregnancy, Liver Disorder
This report suggests a potential Roacutan Exposure During Pregnancy, Liver Disorder side effect(s) that can have serious consequences. A female patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: acne and used Roacutan (dosage: NA) starting 201202. Soon after starting Roacutan the patient began experiencing various side effects, including:
  • Exposure During Pregnancy
  • Liver Disorder
Drugs used concurrently: NA. Although Roacutan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as exposure during pregnancy, may still occur.

Exposure During Pregnancy, Liver Disorder
This Exposure During Pregnancy, Liver Disorder problem was reported by a consumer or non-health professional from BR. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: acne. On 201202 this consumer started treatment with Roacutan (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Roacutan, the patient experienced the following unwanted symptoms/side effects:
  • Exposure During Pregnancy
  • Liver Disorder
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as exposure during pregnancy, may become evident only after a product is in use by the general population.

Pregnancy
This is a report of a 22-year-old female patient (weight: NA) from BR. The patient developed the following symptoms/conditions: acne and was treated with Roacutan (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Pregnancy
This opens a possibility that Roacutan treatment could cause the above reactions, including pregnancy, and some female subjects may be more susceptible.

Exposure During Pregnancy, Abortion Spontaneous
A 22-year-old female patient (weight: NA) from BR with the following symptoms/conditions: acne started Roacutan treatment (dosage: NA) on NS. Soon after starting Roacutan treatment, the subject experienced various side effects, including:
  • Exposure During Pregnancy
  • Abortion Spontaneous
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Roacutan.

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Top 10 Roacutan Side Effects for Women

Women Side EffectsReports
Pregnancy 263
No Adverse Event 176
No Adverse Effect 84
Abortion Spontaneous 33
Normal Newborn 33
Headache 31
Depression 23
Acne 20
Lip Dry 18
Abortion Induced 16

Top 10 Roacutan Side Effects for Men

Men Side EffectsReports
Acne 27
Normal Newborn 23
Depression 16
No Adverse Event 14
Suicidal Ideation 12
Blood Cholesterol Increased 11
Weight Decreased 11
No Adverse Effect 10
Scar 10
Dry Skin 9

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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