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Roaccutane Side Effects

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Common Roaccutane Side Effects


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

Pregnancy (163)
Depression (104)
Completed Suicide (64)
Abortion Induced (63)
No Adverse Effect (59)
No Adverse Event (46)
Suicidal Ideation (45)
Anxiety (39)
Headache (38)
Fatigue (38)
Arthralgia (29)
Suicide Attempt (29)
Dry Skin (24)
Vomiting (22)
Asthenia (18)
Dyspnoea (17)
Dry Eye (17)
Abdominal Pain (16)
Lip Dry (15)
Depressed Mood (14)

➢ 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.

Roaccutane Side Effects Reported to FDA



Roaccutane Side Effect Report#9697447
Depression, Erectile Dysfunction, Fatigue, Asthenia
This is a report of a 17-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: acne, who was treated with Roaccutane (dosage: NA, start time:
Aug 01, 2013), combined with: NA. and developed a serious reaction and side effect(s): Depression, Erectile Dysfunction, Fatigue, Asthenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roaccutane treatment in male patients, resulting in Depression side effect.
Roaccutane Side Effect Report#9504877
Pregnancy, No Adverse Event
This report suggests a potential Roaccutane Pregnancy side effect(s) that can have serious consequences. A 30-year-old female patient (weight: NA) from TW was diagnosed with the following symptoms/conditions: acne and used Roaccutane (dosage: NA) starting
Feb 22, 2013. After starting Roaccutane the patient began experiencing various side effects, including: Pregnancy, No Adverse EventAdditional drugs used concurrently: NA. Although Roaccutane demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pregnancy, may still occur.
Roaccutane Side Effect Report#9502427
Pregnancy
This Pregnancy problem was reported by a physician from IE. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: acne. On 2010 this consumer started treatment with Roaccutane (dosage: NA). The following drugs were being taken at the same time: NA. When using Roaccutane, 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.
Roaccutane Side Effect Report#9493865
Pregnancy
This Pregnancy side effect was reported by a consumer or non-health professional from AR. A 18-year-old female patient (weight:NA) experienced the following symptoms/conditions: acne.The patient was prescribed Roaccutane (drug dosage: NA), which was initiated on
Jul 14, 2013. Concurrently used drugs: NA..After starting to take Roaccutane the consumer reported adverse symptoms, such as: PregnancyThese side effects may potentially be related to Roaccutane.
Roaccutane Side Effect Report#9459208
Activities Of Daily Living Impaired, Anxiety, Depression, Dry Eye, Fear, Heart Rate Increased, Mood Swings, Panic Attack
This is a report of a 28-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: acne, who was treated with Roaccutane (dosage: NA, start time:
Jan 01, 2012), combined with: NA. and developed a serious reaction and side effect(s): Activities Of Daily Living Impaired, Anxiety, Depression, Dry Eye, Fear, Heart Rate Increased, Mood Swings, Panic Attack after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roaccutane treatment in female patients, resulting in Activities Of Daily Living Impaired side effect.
Roaccutane Side Effect Report#9458335
Thinking Abnormal, Depression, Eating Disorder, Feeling Abnormal, Mental Disorder, Negative Thoughts, Self Esteem Decreased, Suicidal Behaviour, Fatigue
This report suggests a potential Roaccutane Thinking Abnormal side effect(s) that can have serious consequences. A male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Roaccutane (dosage: NA) starting
Jan 01, 1986. After starting Roaccutane the patient began experiencing various side effects, including: Thinking Abnormal, Depression, Eating Disorder, Feeling Abnormal, Mental Disorder, Negative Thoughts, Self Esteem Decreased, Suicidal Behaviour, FatigueAdditional drugs used concurrently:
  • Amoxycillin
  • Citalopram Hydrobromide
  • Fluoxetine Hydrochloride
  • Paracetamol
  • Tetracycline
Although Roaccutane demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Thinking Abnormal, may still occur.
Roaccutane Side Effect Report#9431911
Rash Pruritic, Hypersensitivity, Polycystic Ovaries
This Rash Pruritic problem was reported by a consumer or non-health professional from RU. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 18, 2013 this consumer started treatment with Roaccutane (dosage: NA). The following drugs were being taken at the same time: NA. When using Roaccutane, the patient experienced the following unwanted symptoms/side effects: Rash Pruritic, Hypersensitivity, Polycystic OvariesAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash Pruritic, may become evident only after a product is in use by the general population.
Roaccutane Side Effect Report#9419787
Completed Suicide, Social Avoidant Behaviour, Asthenia, Rosacea, Depressed Mood, Eye Pruritus, Dry Eye, Suicidal Ideation, Depression
This Completed Suicide side effect was reported by a consumer or non-health professional from GB. A 26-year-old male patient (weight:NA) experienced the following symptoms/conditions: acne.The patient was prescribed Roaccutane (drug dosage: NA), which was initiated on 2002. Concurrently used drugs: NA..After starting to take Roaccutane the consumer reported adverse symptoms, such as: Completed Suicide, Social Avoidant Behaviour, Asthenia, Rosacea, Depressed Mood, Eye Pruritus, Dry Eye, Suicidal Ideation, DepressionThese side effects may potentially be related to Roaccutane.
Roaccutane Side Effect Report#9418593
Gout
This is a report of a 31-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: acne, who was treated with Roaccutane (dosage: NA, start time:
Jul 04, 2013), combined with: NA. and developed a serious reaction and side effect(s): Gout after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roaccutane treatment in male patients, resulting in Gout side effect.
Roaccutane Side Effect Report#9415829
Corneal Dystrophy, Dry Eye, Vision Blurred
This report suggests a potential Roaccutane Corneal Dystrophy side effect(s) that can have serious consequences. A 16-year-old male patient (weight: NA) from BE was diagnosed with the following symptoms/conditions: acne and used Roaccutane (dosage: NA) starting
Dec 01, 2011. After starting Roaccutane the patient began experiencing various side effects, including: Corneal Dystrophy, Dry Eye, Vision BlurredAdditional drugs used concurrently: NA. Although Roaccutane demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Corneal Dystrophy, may still occur.
Roaccutane Side Effect Report#9415265
Malaise, Arthralgia, Face Oedema, Eye Swelling, Rash Erythematous
This Malaise problem was reported by a consumer or non-health professional from AU. A 20-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
May 29, 2013 this consumer started treatment with Roaccutane (dosage: NA). The following drugs were being taken at the same time:
  • Doxycycline Hydrochloride
When using Roaccutane, the patient experienced the following unwanted symptoms/side effects: Malaise, Arthralgia, Face Oedema, Eye Swelling, Rash ErythematousAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Malaise, may become evident only after a product is in use by the general population.
Roaccutane Side Effect Report#9396744
Exposure During Pregnancy
This Exposure During Pregnancy side effect was reported by a physician from AR. A 21-year-old female patient (weight:NA) experienced the following symptoms/conditions: acne.The patient was prescribed Roaccutane (drug dosage: NA), which was initiated on 201304. Concurrently used drugs: NA..After starting to take Roaccutane the consumer reported adverse symptoms, such as: Exposure During PregnancyThese side effects may potentially be related to Roaccutane.
Roaccutane Side Effect Report#9392352
Completed Suicide
This is a report of a 16-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: acne, who was treated with Roaccutane (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Completed Suicide after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roaccutane treatment in male patients, resulting in Completed Suicide side effect.
Roaccutane Side Effect Report#9390339
Completed Suicide, Negative Thoughts, Mood Swings, Depressed Mood, Malaise, Social Avoidant Behaviour
This report suggests a potential Roaccutane Completed Suicide side effect(s) that can have serious consequences. A 16-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: acne and used Roaccutane (dosage: 3 Tablet) starting NS. After starting Roaccutane the patient began experiencing various side effects, including: Completed Suicide, Negative Thoughts, Mood Swings, Depressed Mood, Malaise, Social Avoidant BehaviourAdditional drugs used concurrently: NA. Although Roaccutane demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Completed Suicide, may still occur.
Roaccutane Side Effect Report#9380927
Delirium, Hallucination, Psychomotor Hyperactivity
This Delirium problem was reported by a physician from BE. A 18-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: acne,oesophagitis. On NS this consumer started treatment with Roaccutane (dosage: NA). The following drugs were being taken at the same time:
  • Omeprazole
When using Roaccutane, the patient experienced the following unwanted symptoms/side effects: Delirium, Hallucination, Psychomotor HyperactivityThe 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 Delirium, may become evident only after a product is in use by the general population.
Roaccutane Side Effect Report#9371492
Gynaecomastia
This Gynaecomastia side effect was reported by a physician from NL. A male patient (weight:NA) experienced the following symptoms/conditions: acne.The patient was prescribed Roaccutane (drug dosage: NA), which was initiated on
Feb 26, 2013. Concurrently used drugs: NA..After starting to take Roaccutane the consumer reported adverse symptoms, such as: GynaecomastiaThese side effects may potentially be related to Roaccutane.
Roaccutane Side Effect Report#9369347
Pregnancy, No Adverse Event
This is a report of a female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: acne, who was treated with Roaccutane (dosage: NA, start time: 201209), 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 Roaccutane treatment in female patients, resulting in Pregnancy side effect.
Roaccutane Side Effect Report#9368859
Dry Eye, Asthenopia, Eye Pain
This report suggests a potential Roaccutane Dry Eye side effect(s) that can have serious consequences. A 20-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Roaccutane (dosage: He Took Isotretinoin For A Duration Of 6 Months.) starting NS. After starting Roaccutane the patient began experiencing various side effects, including: Dry Eye, Asthenopia, Eye PainAdditional drugs used concurrently: NA. Although Roaccutane demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Dry Eye, may still occur.
Roaccutane Side Effect Report#9362919
Abortion, Exposure During Pregnancy, Malaise, Abdominal Pain Upper, Malaise, Abdominal Pain Upper
This Abortion problem was reported by a consumer or non-health professional from GB. A 27-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: acne. On 2011 this consumer started treatment with Roaccutane (dosage: NA). The following drugs were being taken at the same time: NA. When using Roaccutane, the patient experienced the following unwanted symptoms/side effects: Abortion, Exposure During Pregnancy, Malaise, Abdominal Pain Upper, Malaise, Abdominal Pain UpperAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abortion, may become evident only after a product is in use by the general population.
Roaccutane Side Effect Report#9356951
Intentional Self-injury, Intentional Overdose
This Intentional Self-injury side effect was reported by a physician from AU. A 14-year-old female patient (weight:NA) experienced the following symptoms/conditions: acne cystic.The patient was prescribed Roaccutane (drug dosage: NA), which was initiated on
Jun 11, 2013. Concurrently used drugs: NA..After starting to take Roaccutane the consumer reported adverse symptoms, such as: Intentional Self-injury, Intentional OverdoseThese side effects may potentially be related to Roaccutane. The patient was hospitalized.
Roaccutane Side Effect Report#9335262
Gastritis
This is a report of a 23-year-old male patient (weight: NA) from LV, suffering from the following health symptoms/conditions: acne cystic, who was treated with Roaccutane (dosage: NA, start time:
Mar 14, 2013), combined with: NA. and developed a serious reaction and side effect(s): Gastritis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roaccutane treatment in male patients, resulting in Gastritis side effect. The patient was hospitalized.
Roaccutane Side Effect Report#9332722
Epiphyses Premature Fusion, Growth Retardation, Body Height Decreased
This report suggests a potential Roaccutane Epiphyses Premature Fusion side effect(s) that can have serious consequences. A 14-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: acne and used Roaccutane (dosage: Daily Dose Of 60 Mg Or 40 Mg Alternatively) starting
Apr 19, 2011. After starting Roaccutane the patient began experiencing various side effects, including: Epiphyses Premature Fusion, Growth Retardation, Body Height DecreasedAdditional drugs used concurrently: NA. Although Roaccutane demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Epiphyses Premature Fusion, may still occur.
Roaccutane Side Effect Report#9330337
Rash Erythematous
This Rash Erythematous problem was reported by a consumer or non-health professional from ZA. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: acne. On NS this consumer started treatment with Roaccutane (dosage: 1mg/kilogram). The following drugs were being taken at the same time: NA. When using Roaccutane, the patient experienced the following unwanted symptoms/side effects: Rash ErythematousAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash Erythematous, may become evident only after a product is in use by the general population.
Roaccutane Side Effect Report#9330304
Depression, Suicidal Ideation
This Depression side effect was reported by a consumer or non-health professional from FR. A 18-year-old male patient (weight:NA) experienced the following symptoms/conditions: acne.The patient was prescribed Roaccutane (drug dosage: NA), which was initiated on 2001. Concurrently used drugs: NA..After starting to take Roaccutane the consumer reported adverse symptoms, such as: Depression, Suicidal IdeationThese side effects may potentially be related to Roaccutane.
Roaccutane Side Effect Report#9325205
Hypercalcaemia
This is a report of a 15-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: acne, who was treated with Roaccutane (dosage: NA, start time: 201303), combined with: NA. and developed a serious reaction and side effect(s): Hypercalcaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Roaccutane treatment in female patients, resulting in Hypercalcaemia side effect.


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The appearance of Roaccutane 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.

What are common Roaccutane Side Effects for Women?

Women Side EffectsReports
Pregnancy 161
Abortion Induced 63
No Adverse Effect 59
No Adverse Event 42
Depression 22
Suicidal Ideation 16
Headache 15
Abortion Spontaneous 11
Completed Suicide 10
Dyspnoea 10

What are common Roaccutane Side Effects for Men?

Men Side EffectsReports
Depression 80
Completed Suicide 51
Anxiety 29
Suicidal Ideation 29
Fatigue 27
Suicide Attempt 23
Headache 22
Arthralgia 19
Dry Skin 15
Asthenia 13

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.

    Roaccutane 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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