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Roacutan Side Effects

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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.

Roacutan Side Effects Reported to FDA



Roacutan Side Effect Report#9495315
Pregnancy, No Adverse Event
This is a report of a 28-year-old female patient (weight: NA) from BR, suffering from the following health 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): Pregnancy, No Adverse Event 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.
Roacutan Side Effect Report#9402560
Depression, Coma, Suicidal Ideation, Weight Increased
This report suggests a potential Roacutan Depression 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. After starting Roacutan the patient began experiencing various side effects, including: Depression, Coma, Suicidal Ideation, Weight IncreasedAdditional drugs used concurrently: NA. Although Roacutan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Depression, may still occur.
Roacutan Side Effect Report#9377158
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 using Roacutan, the patient experienced the following unwanted symptoms/side effects: PregnancyAlthough 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.
Roacutan Side Effect Report#9373961
Sepsis, Large Intestine Perforation, Pancreatitis, Gallbladder Disorder, Colitis, Small Intestinal Perforation, Infection, Pulmonary Vasculitis, Pilonidal Cyst
This Sepsis side effect was reported by a physician from BR. A 22-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Roacutan (drug dosage: NA), which was initiated on 201301. Concurrently used drugs: NA..After starting to take Roacutan the consumer reported adverse symptoms, such as: Sepsis, Large Intestine Perforation, Pancreatitis, Gallbladder Disorder, Colitis, Small Intestinal Perforation, Infection, Pulmonary Vasculitis, Pilonidal CystThese side effects may potentially be related to Roacutan. The patient was hospitalized.
Roacutan Side Effect Report#9370970
Convulsion, Depression, Lip Dry, Constipation, Aphthous Stomatitis, Blood Zinc Decreased, Acne, Alopecia, Pain
This is a report of a 37-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: NA, who was treated with Roacutan (dosage: NA, start time: 201112), combined with:
  • Rivotril (5-8 Drops, As Needed)
  • Rivotril
  • Omeprazole
and developed a serious reaction and side effect(s): Convulsion, Depression, Lip Dry, Constipation, Aphthous Stomatitis, Blood Zinc Decreased, Acne, Alopecia, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roacutan treatment in female patients, resulting in Convulsion side effect.
Roacutan Side Effect Report#9357624
Pregnancy, Acne, Normal Newborn
This report suggests a potential Roacutan Pregnancy side effect(s) that can have serious consequences. A 22-year-old female patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: acne and used Roacutan (dosage: NA) starting 201103. After starting Roacutan the patient began experiencing various side effects, including: Pregnancy, Acne, Normal NewbornAdditional drugs used concurrently: NA. Although Roacutan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pregnancy, may still occur.
Roacutan Side Effect Report#9349843
Pregnancy
This Pregnancy problem was reported by a consumer or non-health professional from BR. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201206 this consumer started treatment with Roacutan (dosage: NA). The following drugs were being taken at the same time: NA. When using Roacutan, the patient experienced the following unwanted symptoms/side effects: PregnancyAlthough 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.
Roacutan Side Effect Report#9343642
Pancreatitis, Colitis Ulcerative, Pneumonia, Pilonidal Cyst, Condition Aggravated
This Pancreatitis side effect was reported by a physician from BR. A 22-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Roacutan (drug dosage: NA), which was initiated on 201211. Concurrently used drugs: NA..After starting to take Roacutan the consumer reported adverse symptoms, such as: Pancreatitis, Colitis Ulcerative, Pneumonia, Pilonidal Cyst, Condition AggravatedThese side effects may potentially be related to Roacutan. The patient was hospitalized.
Roacutan Side Effect Report#9298260
Pregnancy
This is a report of a female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: acne, who was treated with Roacutan (dosage: NA, start time: 201211), combined with: NA. and developed a serious reaction and side effect(s): Pregnancy 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.
Roacutan Side Effect Report#9289821
Pregnancy
This report suggests a potential Roacutan Pregnancy side effect(s) that can have serious consequences. A female patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: NA and used Roacutan (dosage: NA) starting NS. After starting Roacutan the patient began experiencing various side effects, including: PregnancyAdditional drugs used concurrently: NA. Although Roacutan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pregnancy, may still occur.
Roacutan Side Effect Report#9284779
Depression, Schizophrenia, Headache, Hallucination, Crying, Pain
This Depression problem was reported by a consumer or non-health professional from BR. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: acne. On
Feb 22, 2013 this consumer started treatment with Roacutan (dosage: NA). The following drugs were being taken at the same time: NA. When using Roacutan, the patient experienced the following unwanted symptoms/side effects: Depression, Schizophrenia, Headache, Hallucination, Crying, PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Depression, may become evident only after a product is in use by the general population.
Roacutan Side Effect Report#9266231
Exposure During Pregnancy, Hypersensitivity
This Exposure During Pregnancy side effect was reported by a consumer or non-health professional from BR. A female patient (weight:NA) experienced the following symptoms/conditions: acne.The patient was prescribed Roacutan (drug dosage: NA), which was initiated on 201303. Concurrently used drugs: NA..After starting to take Roacutan the consumer reported adverse symptoms, such as: Exposure During Pregnancy, HypersensitivityThese side effects may potentially be related to Roacutan.
Roacutan Side Effect Report#9264457
Meningitis
This is a report of a 18-year-old male patient (weight: NA) from BR, suffering from the following health symptoms/conditions: acne, who was treated with Roacutan (dosage: NA, start time: 201112), combined with: NA. and developed a serious reaction and side effect(s): Meningitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roacutan treatment in male patients, resulting in Meningitis side effect.
Roacutan Side Effect Report#9245796
Pregnancy, Abortion, Lip Dry, Liver Disorder
This report suggests a potential Roacutan Pregnancy side effect(s) that can have serious consequences. A 26-year-old female patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: NA and used Roacutan (dosage: NA) starting
Apr 21, 2013. After starting Roacutan the patient began experiencing various side effects, including: Pregnancy, Abortion, Lip Dry, Liver DisorderAdditional drugs used concurrently: NA. Although Roacutan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pregnancy, may still occur.
Roacutan Side Effect Report#9238789
External Ear Disorder, Gastrointestinal Disorder, Ear Canal Stenosis, Ear Disorder, Cardiac Disorder, Gastrooesophageal Reflux Disease, Feeding Disorder Neonatal
This External Ear Disorder problem was reported by a consumer or non-health professional from BR. A 0-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Roacutan (dosage: NA). The following drugs were being taken at the same time: NA. When using Roacutan, the patient experienced the following unwanted symptoms/side effects: External Ear Disorder, Gastrointestinal Disorder, Ear Canal Stenosis, Ear Disorder, Cardiac Disorder, Gastrooesophageal Reflux Disease, Feeding Disorder NeonatalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as External Ear Disorder, may become evident only after a product is in use by the general population.
Roacutan Side Effect Report#9236545
Parotitis
This Parotitis side effect was reported by a consumer or non-health professional from BR. A 43-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Roacutan (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Neozine
.After starting to take Roacutan the consumer reported adverse symptoms, such as: ParotitisThese side effects may potentially be related to Roacutan. The patient was hospitalized.
Roacutan Side Effect Report#9231030
Pregnancy, Acne
This is a report of a female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: acne, who was treated with Roacutan (dosage: NA, start time:
Jan 13, 2013), combined with: NA. and developed a serious reaction and side effect(s): Pregnancy, Acne 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.
Roacutan Side Effect Report#9210189
Heart Disease Congenital, Sepsis
This report suggests a potential Roacutan Heart Disease Congenital side effect(s) that can have serious consequences. A male patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: NA and used Roacutan (dosage: NA) starting NS. After starting Roacutan the patient began experiencing various side effects, including: Heart Disease Congenital, SepsisAdditional drugs used concurrently: NA. Although Roacutan demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Heart Disease Congenital, may still occur.
Roacutan Side Effect Report#9165650
Weight Increased
This Weight Increased problem was reported by a physician from BR. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: acne. On 200601 this consumer started treatment with Roacutan (dosage: 0.6 Mg/kg). The following drugs were being taken at the same time: NA. When using Roacutan, the patient experienced the following unwanted symptoms/side effects: Weight IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Weight Increased, may become evident only after a product is in use by the general population.
Roacutan Side Effect Report#9068739
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 (drug dosage: NA), which was initiated on 2008. Concurrently used drugs: NA..After starting to take Roacutan the consumer reported adverse symptoms, such as: Glomerulonephritis, Haematuria, Renal Disorder, Rash Macular, ErythemaThese side effects may potentially be related to Roacutan.
Roacutan Side Effect Report#9055780
Thyroid Neoplasm
This is a report of a female patient (weight: NA) from BR, suffering from the following health 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): Thyroid Neoplasm 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.
Roacutan Side Effect Report#8983798
Exposure During Pregnancy, Liver Disorder
This report suggests a potential Roacutan Exposure During Pregnancy 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. After starting Roacutan the patient began experiencing various side effects, including: Exposure During Pregnancy, Liver DisorderAdditional 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.
Roacutan Side Effect Report#8983798
Exposure During Pregnancy, Liver Disorder
This Exposure During Pregnancy 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 using Roacutan, the patient experienced the following unwanted symptoms/side effects: Exposure During Pregnancy, Liver DisorderAlthough 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.
Roacutan Side Effect Report#8983782
Pregnancy
This Pregnancy side effect was reported by a physician from BR. A 22-year-old female patient (weight:NA) experienced the following symptoms/conditions: acne.The patient was prescribed Roacutan (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Roacutan the consumer reported adverse symptoms, such as: PregnancyThese side effects may potentially be related to Roacutan.
Roacutan Side Effect Report#8983782
Exposure During Pregnancy, Abortion Spontaneous
This is a report of a 22-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: acne, who was treated with Roacutan (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Exposure During Pregnancy, Abortion Spontaneous after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roacutan treatment in female patients, resulting in Exposure During Pregnancy side effect.


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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.

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What are common 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

What are common 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

Track Your Side Effects

Note Your Observations

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.

    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.

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    Discuss Roacutan Side Effects

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