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Cracking Lips (8)
Infertility (8)
Knee (8)
Cracking Lips, Dryness Of The Eyes (5)
Dryness Of The Eyes (5)
Depression (4)
Depretion (3)
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Roacutan Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 732 

Vomiting, Headache, Nausea (7270007-8)
on Jan 27, 2011 Female from SOUTH AFRICA , 26 years of age, was treated with Roacutan. Directly after, patient experienced the unwanted or unexpected Roacutan side effects: vomiting, headache, nausea. Roacutan dosage: N/A. Patient was hospitalized.

No Adverse Event, Pregnancy (7270001-7)
Patient was taking Roacutan. Patient felt the following Roacutan side effects: no adverse event, pregnancy on Jan 25, 2011 from BRAZIL Additional patient health information: Female , weighting 149.9 lb, was diagnosed with
  • acne
  • contraception
and. Roacutan dosage: N/A.
Multiple prescriptions taken:
  • Diane


Ear Malformation (7267643-1)
Adverse event was reported on Jan 20, 2011 by a Female taking Roacutan (Dosage: Total Dose Of Isotretinoin Administered At The Time Of Pregnancy: 7200 Mg) . Location: BRAZIL , weighting 4.41 lb, After Roacutan was administered, patient encountered several Roacutan side effects: ear malformation.

No Adverse Event, Abortion Spontaneous (7247562-7)
on Jan 19, 2011 Female from SWITZERLAND , 38 years of age, was diagnosed with
  • acne
and was treated with Roacutan. Directly after, patient experienced the unwanted or unexpected Roacutan side effects: no adverse event, abortion spontaneous. Roacutan dosage: N/A.


Abortion Spontaneous, No Adverse Event (7247504-4)
on Jan 19, 2011 Female from SWITZERLAND , 38 years of age, was treated with Roacutan. Patient felt the following Roacutan side effects: abortion spontaneous, no adverse event. Roacutan dosage: N/A.

Appendicitis (7237674-6)
Patient was taking Roacutan. After Roacutan was administered, patient encountered several Roacutan side effects: appendicitis on Jan 13, 2011 from BRAZIL Additional patient health information: Female , 27 years of age, . Roacutan dosage: Stop Date: 2010. Patient was hospitalized.

Pregnancy, No Adverse Event (7235867-5)
Adverse event was reported on Jan 13, 2011 by a Female taking Roacutan (Dosage: N/A) . Location: BRAZIL , 34 years of age, weighting 125.7 lb, Directly after, patient experienced the unwanted or unexpected Roacutan side effects: pregnancy, no adverse event.

Visual Impairment, Depression, Condition Aggravated, Eye Pain, Acne, Photopsia (7213191-4)
on Jan 02, 2011 Female from BRAZIL , weighting 127.9 lb, was diagnosed with
  • acne
and was treated with Roacutan. Patient felt the following Roacutan side effects: visual impairment, depression, condition aggravated, eye pain, acne, photopsia. Roacutan dosage: 1 In The Morning And 1 In The Eveneing.
Multiple prescriptions taken:
  • Diane 35
  • Neutrofer


Mental Disorder, Hyperhidrosis, Dry Skin, Gastritis, Muscle Atrophy, Depression, Photosensitivity Reaction, Arthralgia, Myalgia (7207151-7)
on Dec 23, 2010 Male from BRAZIL , weighting 156.5 lb, was treated with Roacutan. After Roacutan was administered, patient encountered several Roacutan side effects: mental disorder, hyperhidrosis, dry skin, gastritis, muscle atrophy, depression, photosensitivity reaction, arthralgia, myalgia. Roacutan dosage: Strength: 10 And 20 Mg/ Capsule.

No Adverse Event, Pregnancy (7204339-6)
Patient was taking Roacutan. Directly after, patient experienced the unwanted or unexpected Roacutan side effects: no adverse event, pregnancy on Dec 28, 2010 from BRAZIL Additional patient health information: Female , weighting 152.1 lb, . Roacutan dosage: N/A.
Associated medications used:
  • Gracial


No Adverse Event (7201748-6)
Adverse event was reported on Dec 23, 2010 by a Female taking Roacutan (Dosage: N/A) was diagnosed with
  • acne
and. Location: SWITZERLAND , 38 years of age, Patient felt the following Roacutan side effects: no adverse event.

No Adverse Event, Pregnancy (7199867-6)
on Dec 25, 2010 Female from BRAZIL , 33 years of age, was treated with Roacutan. After Roacutan was administered, patient encountered several Roacutan side effects: no adverse event, pregnancy. Roacutan dosage: N/A.
Multiple concurrent drugs taken:
  • Gracial


No Adverse Event, Normal Newborn (7197851-X)
on Dec 23, 2010 Female from SWITZERLAND , weighting 7.72 lb, was diagnosed with
  • acne
  • contraception
and was treated with Roacutan. Directly after, patient experienced the unwanted or unexpected Roacutan side effects: no adverse event, normal newborn. Roacutan dosage: N/A.
Associated medications used:
  • Feminac 35


Depression, Suicidal Ideation, Thyroid Cancer, Vision Blurred (7191363-5)
Patient was taking Roacutan. Patient felt the following Roacutan side effects: depression, suicidal ideation, thyroid cancer, vision blurred on Dec 15, 2010 from BRAZIL Additional patient health information: Female , 35 years of age, weighting 154.3 lb, was diagnosed with
  • acne
and. Roacutan dosage: N/A.
Multiple prescriptions taken:
  • Clonazepam
  • Depakote
Patient was hospitalized.

Convulsion, Delirium, Depression, Intracranial Pressure Increased, Pain, Spinal Myelogram Abnormal (7183951-7)
Adverse event was reported on Dec 13, 2010 by a Female taking Roacutan (Dosage: Stop Date: 2010) was diagnosed with
  • neuroblastoma
and. Location: BRAZIL , weighting 59.52 lb, After Roacutan was administered, patient encountered several Roacutan side effects: convulsion, delirium, depression, intracranial pressure increased, pain, spinal myelogram abnormal. Patient was hospitalized.

No Adverse Event, Normal Newborn (7153314-9)
on Dec 06, 2010 Male from BRAZIL , weighting 7.28 lb, was diagnosed with
  • acne
and was treated with Roacutan. Directly after, patient experienced the unwanted or unexpected Roacutan side effects: no adverse event, normal newborn. Roacutan dosage: Two Capsules After Lunch And One Capsule After Dinner.

No Adverse Event, Normal Newborn (7148681-6)
on Dec 01, 2010 Male from BRAZIL , weighting 6.61 lb, was diagnosed with
  • acne
and was treated with Roacutan. Patient felt the following Roacutan side effects: no adverse event, normal newborn. Roacutan dosage: Other Indication: Oily Skin; Dose: Three Capsules A Week.

Abdominal Pain Upper, Acne, Blood Triglycerides Increased, Depression, Dry Skin, Haemolytic Anaemia, Lymphadenopathy (7142369-3)
Patient was taking Roacutan. After Roacutan was administered, patient encountered several Roacutan side effects: abdominal pain upper, acne, blood triglycerides increased, depression, dry skin, haemolytic anaemia, lymphadenopathy on Nov 23, 2010 from BRAZIL Additional patient health information: Female , 17 years of age, weighting 110.2 lb, was diagnosed with
  • acne
and. Roacutan dosage: Strength: 20 Mg, Indication: Resistant Acne..

No Adverse Event, Pregnancy (7141895-0)
Adverse event was reported on Dec 02, 2010 by a Female taking Roacutan (Dosage: 20 Mg Every Other Day For Three Months In A Year) was diagnosed with
  • acne
and. Location: BRAZIL , weighting 141.1 lb, Directly after, patient experienced the unwanted or unexpected Roacutan side effects: no adverse event, pregnancy.

Blood Cholesterol Increased, Blood Triglycerides Increased, No Adverse Event, Pregnancy (7138274-9)
on Nov 25, 2010 Female from BRAZIL , weighting 99.21 lb, was diagnosed with
  • acne
and was treated with Roacutan. Patient felt the following Roacutan side effects: blood cholesterol increased, blood triglycerides increased, no adverse event, pregnancy. Roacutan dosage: N/A.

No Adverse Event, Pregnancy (7134766-7)
on Nov 25, 2010 Female from BRAZIL , weighting 132.3 lb, was treated with Roacutan. After Roacutan was administered, patient encountered several Roacutan side effects: no adverse event, pregnancy. Roacutan dosage: N/A.

No Adverse Event, Pregnancy (7134762-X)
Patient was taking Roacutan. Directly after, patient experienced the unwanted or unexpected Roacutan side effects: no adverse event, pregnancy on Nov 24, 2010 from BRAZIL Additional patient health information: Female , 22 years of age, weighting 127.9 lb, was diagnosed with
  • acne
and. Roacutan dosage: N/A.
Associated medications used:
  • Selene


Acne, Scar, Suicidal Ideation (7130852-6)
Adverse event was reported on Nov 26, 2010 by a Male taking Roacutan (Dosage: N/A) was diagnosed with
  • acne
and. Location: BRAZIL , 18 years of age, Patient felt the following Roacutan side effects: acne, scar, suicidal ideation.

Gastrointestinal Haemorrhage, Haemoglobin Decreased (7126628-6)
on Nov 23, 2010 Female from BRAZIL , 15 years of age, weighting 99.21 lb, was treated with Roacutan. After Roacutan was administered, patient encountered several Roacutan side effects: gastrointestinal haemorrhage, haemoglobin decreased. Roacutan dosage: N/A. Patient was hospitalized.

Abdominal Pain Upper, Acne, Anxiety, Blood Triglycerides Increased, Depression, Dry Skin, Haemolytic Anaemia, Purulent Discharge (7125361-4)
on Nov 16, 2010 Female from BRAZIL , 17 years of age, weighting 110.2 lb, was diagnosed with
  • acne
and was treated with Roacutan. Directly after, patient experienced the unwanted or unexpected Roacutan side effects: abdominal pain upper, acne, anxiety, blood triglycerides increased, depression, dry skin, haemolytic anaemia, purulent discharge. Roacutan dosage: Strength: 20 Mg, Indication: Resistant Acne..

Showing 1-25 of 732 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

More About Roacutan

Side Effects reported to FDA: 732. View Roacutan Adverse Reports

Roacutan safety alerts: No

Reported deaths: 9

Reported hospitalizations: 95

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