Skip to main content

Amnesteem Side Effects

Generic name: isotretinoin

Medically reviewed by Drugs.com. Last updated on Mar 4, 2024.

Note: This document provides detailed information about Amnesteem Side Effects associated with isotretinoin. Some dosage forms listed on this page may not apply specifically to the brand name Amnesteem.

Applies to isotretinoin: oral capsule, oral capsule liquid filled.

Important warnings This medicine can cause some serious health issues

Oral route (capsule, liquid filled; capsule)

Warning: Embryo-Fetal Toxicity - Contraindicated in Pregnancy. Isotretinoin can cause life-threatening birth defects and is contraindicated in pregnancy.

There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of isotretinoin even for short periods of time.

Potentially any fetus exposed during pregnancy can be affected.

There are no accurate means of determining prenatally whether an exposed fetus has been affected.

If pregnancy occurs, discontinue isotretinoin immediately and refer the patient to an obstetrician-gynecologist experienced in reproductive toxicity for further evaluation and counseling.Because of the risk of embryo-fetal toxicity, isotretinoin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS.

Serious side effects of Amnesteem

Along with its needed effects, isotretinoin (the active ingredient contained in Amnesteem) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking isotretinoin:

More common

  • bone or joint pain
  • burning, redness, itching, or other signs of eye inflammation
  • difficulty with moving
  • nosebleeds
  • scaling, redness, burning, pain, or other signs of inflammation of the lips
  • skin infection or rash

Rare

  • attempts at suicide or thoughts of suicide (usually stops after medicine is stopped)
  • back pain
  • bleeding or inflammation of the gums
  • blurred vision or other changes in vision
  • changes in behavior
  • decreased vision after sunset or before sunrise (sudden or may continue after medicine is stopped)
  • diarrhea (severe)
  • headache (severe or continuing)
  • mental depression
  • nausea
  • pain or tenderness of the eyes
  • pain, tenderness, or stiffness in the muscles (long-term treatment)
  • rectal bleeding
  • stomach pain (severe)
  • vomiting
  • yellow eyes or skin

Incidence not known

  • black, tarry stools
  • blistering, peeling, or loosening of the skin
  • bloating
  • bloody cough
  • bloody or cloudy urine
  • bone tenderness or aching
  • burning or stinging of the skin
  • chest pain or tightness
  • confusion
  • constipation
  • continuing ringing or buzzing, or other unexplained noise in the ears
  • cough
  • dark-colored urine
  • decrease in height
  • difficulty breathing
  • difficulty speaking
  • difficulty swallowing
  • discharge from the eyes
  • dizziness
  • double vision
  • ear pain
  • excessive tearing
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever with or without chills
  • fractures or delayed healing
  • heartburn
  • high blood pressure
  • hives, itching, or skin rash
  • hoarseness
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • indigestion
  • inflamed tissue from infection
  • irregular yellow patch or lump on the skin
  • irritation
  • joint redness, stiffness, or swelling
  • lack or slowing of normal growth in children
  • loosening of the fingernails
  • loss of appetite
  • loss of bladder control
  • loss or change in hearing
  • muscle cramps, pain, spasms, or weakness
  • pain in the ribs, arms, or legs
  • pain or burning in the throat
  • pain or tenderness around the eyes and cheekbones
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • painful or difficult urination
  • pains in the chest, groin, or legs, especially calves of the legs
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • red irritated eyes
  • red skin lesions, often with a purple center
  • redness or soreness around the fingernails
  • redness, soreness, or itching skin
  • seizures
  • sensitivity of the eyes to sunlight
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • stuffy or runny nose
  • sudden loss of consciousness
  • sudden loss of coordination
  • sudden onset of severe acne on the chest and trunk
  • sudden onset of slurred speech
  • swelling of the eyelids, face, lips, hands, lower legs, or feet
  • swollen, painful or tender lymph glands in the neck, armpit, or groin
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • use of extreme physical or emotional force
  • watery or bloody diarrhea

Other side effects of Amnesteem

Some side effects of isotretinoin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • crusting of the skin
  • difficulty in wearing contact lenses (may continue after medicine is stopped)
  • dryness of the eyes (may continue after treatment is stopped)
  • dryness of the mouth or nose
  • dryness or itching of the skin
  • headache (mild)
  • increased sensitivity of the skin to sunlight
  • peeling of the skin on palms of the hands or soles of the feet
  • stomach upset
  • thinning of the hair (may continue after treatment is stopped)

Incidence not known

  • abnormal menstruation
  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
  • changes in fingernails or toenails
  • dandruff
  • darkening of the skin
  • hair abnormalities
  • hair loss
  • increased hair growth, especially on the face
  • lightening of normal skin color
  • lightening of treated areas of dark skin
  • nervousness
  • oily skin
  • redness of the face
  • severe sunburn
  • skin rash, encrusted, scaly and oozing
  • stomach burning
  • sweating
  • trouble sleeping
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • unusually warm skin of the face
  • voice changes

For healthcare professionals

Applies to isotretinoin: compounding powder, oral capsule.

General

The most commonly reported side effects include dryness of the skin and mucous membranes (e.g., cheilitis, epistaxis, conjunctivitis).[Ref]

Gastrointestinal

Hematologic

Metabolic

Respiratory

Bronchospasm occurred in patients receiving treatment, especially in those with asthma.[Ref]

Dermatologic

In some cases, acne flares occurred during the initial stages of treatment and persisted for several weeks[Ref]

Ocular

Papilledema occurred as a sign of benign intracranial hypertension.[Ref]

Musculoskeletal

Back pain occurred more frequently in children and adolescent patients.

Rhabdomyolysis, sometimes leading to hospitalization or death, has occurred, especially in patients undertaking vigorous physical activity.[Ref]

Genitourinary

Nervous system

Hepatic

Psychiatric

Depression symptoms have been reported to disappear after discontinuation of the drug and reappear when treatment is resumed.[Ref]

Hypersensitivity

Other

Cardiovascular

Renal

References

1. (2001) "Product Information. Accutane (isotretinoin)." Roche Laboratories

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

3. Cerner Multum, Inc. "Australian Product Information."

Frequently asked questions

Further information

Amnesteem side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.