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Claravis Side Effects

Generic Name: isotretinoin

Note: This page contains information about the side effects of isotretinoin. Some of the dosage forms included on this document may not apply to the brand name Claravis.

In Summary

Common side effects of Claravis include: cheilitis, epistaxis, hypertriglyceridemia, pruritus, xerosis, decreased hdl cholesterol, increased liver enzymes, increased serum triglycerides, musculoskeletal signs and symptoms, dry nose, xeroderma, and xerostomia. Other side effects include: increased serum cholesterol. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to isotretinoin: oral capsule, oral capsule liquid filled

In addition to its needed effects, some unwanted effects may be caused by isotretinoin (the active ingredient contained in Claravis). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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
  • Abdominal or stomach pain (severe)
  • 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 and vomiting
  • pain or tenderness of the eyes
  • pain, tenderness, or stiffness in the muscles (long-term treatment)
  • rectal bleeding
  • yellow eyes or skin
Incidence not known:
  • Black, tarry stools
  • bloating
  • bloody cough
  • bloody or cloudy urine
  • bone pain, tenderness, or aching
  • burning or stinging of the skin
  • chest pain
  • confusion
  • constipation
  • convulsions
  • cough or hoarseness
  • 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 and/or delayed healing
  • heartburn
  • high blood pressure
  • hives or skin rash
  • 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 pain, 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, 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
  • redness or soreness around the fingernails
  • redness, soreness, or itching skin
  • sensitivity of the eyes to sunlight
  • sneezing
  • 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
  • tightness in the chest
  • unusual bleeding or bruising
  • unusual weight gain or loss
  • use of extreme physical or emotional force
  • watery or bloody diarrhea

Minor Side Effects

Some of the side effects that can occur with isotretinoin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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
  • continuing ringing or buzzing, or other unexplained noise in the ears
  • dandruff
  • darkening of the skin
  • flushing
  • 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

Very common (10% or more): Cheilitis/dry lips (up to 90%)
Very rare (less than 0.01%): Colitis, ileitis, gastrointestinal hemorrhage, nausea, pancreatitis/fatal pancreatitis, hemorrhagic diarrhea and inflammatory bowel disease
Frequency not reported: Esophagitis/esophageal ulceration, chapped lips, constipation, diarrhea/severe diarrhea, abdominal pain, vomiting, other nonspecific gastrointestinal symptoms, bleeding and inflammation of the gums[Ref]

Hematologic

Very common (10% or more): Increased red blood cell sedimentation rate (up to 40%)
Common (1% to 10%): Neutropenia/severe neutropenia, anemia, thrombocytopenia/decreased platelet counts, thrombocytosis
Rare (0.01% to 0.1%): Agranulocytosis
Very rare (less than 0.01%): Lymphadenopathy
Frequency not reported: Decreased red blood cell parameters, decreased red blood cell counts/hematocrit, decreased white blood cell counts, increased platelet counts[Ref]

Metabolic

Very common (10% or more): Increased blood triglycerides/hypertriglyceridemia (up to 30%)
Common (1% to 10%): Increased blood cholesterol/hyperlipidemia, increased blood glucose/alterations in blood sugar levels, decreased high density lipoprotein
Very rare (less than 0.01%): Diabetes mellitus, hyperuricemia
Frequency not reported: Weight loss/fluctuations in weight, decreased appetite, increased low density lipoprotein
Postmarketing reports: Increased fasting blood glucose levels[Ref]

Respiratory

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

Very common (10% or more): Epistaxis (Up to 30%)
Common (1% to 10%): Hoarseness, nasal dryness, nasopharyngitis
Very rare (less than 0.01%): Bronchospasm, dry throat
Frequency not reported: Respiratory infection/upper respiratory tract infection, voice alteration[Ref]

Dermatologic

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

Common (1% to 10%): Dermatitis, dry skin, localized exfoliation, pruritus, rash erythematous, skin fragility/risk of frictional trauma
Rare (0.01% to 0.1%): Allergic skin reaction, alopecia/persistent or resistant alopecia
Very rare (less than 0.01%): Mucocutaneous/gram positive bacterial infection, allergic vasculitis, acne fulminans, acne aggravated/acne flare, facial erythema, exanthema, hair disorders/persistent hair thinning, hirsutism, nail dystrophy, paronychia, photosensitivity/photoallergic reaction, pyogenic granuloma, skin hyperpigmentation, sweating/increased sweating, increased formation of granulation tissue
Frequency not reported: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eruptive xanthoma, hypopigmentation, increased sunburn susceptibility, urticaria, eczema, contact dermatitis, sunburn, peeling of the palms and soles
Postmarketing reports: Bruising, seborrhea[Ref]

Ocular

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

Common (1% to 10%): Blepharitis, conjunctivitis, dry eye, eye irritation
Very rare (less than 0.01%): Blurred vision, cataract/lenticular cataracts, color blindness/color vision deficiencies, contact lens intolerance, corneal opacity/reversible corneal opacities, decreased night vision/persistently decreased night vision, keratitis, papilledema, photophobia, visual disturbances, optic neuritis, hordeolum
Frequency not reported: Eyelid inflammation, decreased visual acuity, eye pruritus, asthenopia, ocular hyperemia, increased lacrimation[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia/severe arthralgia, back pain/severe back pain, myalgia/severe myalgia with or without elevated creatine phosphokinase (CPK) levels
Very rare (less than 0.01%): Arthritis, premature epiphyses fusion, exostosis, skeletal hyperostosis/hyperostosis, reduced bone density/decreased bone mineral density, tendonitis, rhabdomyolysis, increased blood CPK, rhabdomyolysis, other types of bone abnormalities, calcinosis/calcification of ligaments and tendons
Frequency not reported: Neck pain, musculoskeletal pain/discomfort/stiffness, extremity pain[Ref]

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

Common (1% to 10%): Proteinuria, microscopic or gross hematuria
Frequency not reported: Abnormal menses, nonspecific urogenital findings, white cells in the urine[Ref]

Nervous system

Common (1% to 10%): Headache
Very rare (less than 0.01%): Benign intracranial hypertension, convulsions, drowsiness, dizziness
Frequency not reported: Stroke, pseudotumor cerebri/increased intracranial pressure, lethargy, paresthesia, seizures, syncope[Ref]

Hepatic

Common (1% to 10%): Transient and reversible increased transaminase levels
Very rare (less than 0.01%): Hepatitis
Frequency not reported: Increased alkaline phosphatase/lactate dehydrogenase/blood bilirubin[Ref]

Psychiatric

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

Rare (0.01% to 0.1%): Depression, aggravated depression, aggression/aggressive tendencies, anxiety, mood alterations
Very rare (less than 0.01%): Abnormal behavior, psychosis/psychotic disorder, suicidal ideation/attempt, suicide
Frequency not reported: Nervousness, insomnia, violent behavior, emotional instability, irritability, panic attack, anger, euphoria, behavioral disorders
Postmarketing reports: Auditory hallucinations[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reaction, hypersensitivity/systemic hypersensitivity
Frequency not reported: Allergic reactions[Ref]

Other

Very rare (less than 0.01%): Impaired hearing/impaired hearing at certain frequencies, malaise
Frequency not reported: Fatigue, pain, tinnitus, weakness, disseminated herpes simplex, delayed wound healing, exuberant granulation tissue with crusting, local or systemic infections due to gram positive bacteria (Staphylococcus aureus)
Postmarketing reports: Infection[Ref]

Cardiovascular

Very rare (less than 0.01%): Vasculitis, Wegener's granulomatosis
Frequency not reported: Edema, palpitations, tachycardia, vascular thrombotic disease, transient chest pain, flushing[Ref]

Renal

Very rare (less than 0.01%): Glomerulonephritis[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Accutane (isotretinoin)." Roche Laboratories, Nutley, NJ.

Not all side effects for Claravis may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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