Otezla side effects and how to avoid them

Otezla side effects include weight loss, diarrhea, and sometimes depression

By Georgia C. Yalanis, MD | Dec. 16, 2021 Medically reviewed by Anne Jacobson, MD, MPH

Otezla (apremilast) is an oral, non-biologic, systemic phosphodiesterase-4 (PDE-4) inhibitor. PDE-4 inhibitors are a promising class of newer therapeutic agents used for a variety of inflammatory conditions. Otezla has been approved by the Food and Drug Administration (FDA) in the treatment of adults with active psoriatic arthritis, individuals with moderate to severe plaque psoriasis who are candidates for systemic or phototherapy, and adults with oral ulcers associated with Behcet’s disease.

Otezla is not an over-the-counter medication. It’s available by prescription only, in 14-day or 28-day convenience packs of 10-20-30 mg tablets or 30 mg tablets alone. After an initial five-day period where the dosage is slowly increased, Otezla is typically taken in 30 mg tablets once or twice per day.

All prescription drugs, including Otezla, have possible side effects. In this article, we will discuss the side effects of Otezla and how to avoid or minimize them.

Common side effects of Otezla

As with any medication, Otezla use is associated with several common side effects. If any of these side effects become bothersome, notify your healthcare provider.

Gastrointestinal problems, including:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Dyspepsia, also known as indigestion
- Increased frequency and volume of bowel movements
Feelings of malaise, including:
- Fatigue
- Insomnia
- Back pain
- Arthralgias, also known as joint pain
Tension and migraine headaches
Nasal congestion, sore throat, and upper respiratory tract infections
Decreased appetite and weight loss

Weight loss

During initial clinical trials and phase 3 studies, a weight decrease of 5% to 10% was observed in 5% to 12% of people taking Otezla. A decrease in body weight was observed in 3% to 5% of patients taking a placebo.

In more recent clinical studies, apremilast was associated with a mean weight loss of 4.85 pounds after six months of treatment. In these cases, the weight loss was considered unplanned or undesirable.

It’s possible that severe diarrhea, nausea, and vomiting contributed to this unintended weight loss. The exact mechanism is unknown and needs further investigation. Unexpected or unplanned weight loss (more than 10 pounds) should be evaluated by a healthcare professional.

Diarrhea

Otezla use is associated with severe diarrhea, nausea, and vomiting in some people. It usually resolves within the first few weeks of treatment. The exact incidence of Otezla-associated diarrhea has not been reported, but it is considered a common side effect.

While diarrhea is usually mild and self-limited, sometimes hospitalization, lowering the dose, or stopping the medication may be required.

Complications from gastrointestinal symptoms are more likely to occur in people over 65 years of age or individuals taking medications that could lead to dehydration or hypotension (low blood pressure). If any of the following signs and symptoms occur, seek medical attention right away:

Diarrhea lasting more than 48 hours
Blood or pus in the stool
Stool with a black or “tarry” appearance
Extremely foul smelling stool
Severe abdominal or rectal pain, a fever over 101 degrees Fahrenheit, or signs of dehydration

Serious side effects of Otezla

Otezla use is associated with several severe adverse reactions. If they occur, seek emergency medical treatment right away. Adverse events can also be reported directly to the FDA using MedWatch, the FDA’s safety information and adverse event reporting program.

Severe diarrhea or vomiting
Severe hypersensitivity or allergic reactions
Psychological disturbances and mood changes, including:
- Depression
- Suicidal ideation (thinking about or planning suicide)

Depression

Treatment with Otezla is associated with an increased incidence of depression. During the 16-week placebo-controlled clinical trials, 1% of patients reported depression or depressed mood.

Individuals with a history of depression and/or suicidal thoughts should talk to a healthcare provider about risks and benefits of treatment before starting Otezla.

Patients, caregivers, and family members should be aware of this side effect and contact their healthcare provider if new-onset or worsening depression occurs while taking this medication.

RELATED: Anxiety vs. depression

Can Otezla cause cancer?

Otezla is not associated with an increased risk of cancer. Otezla has been used safely for the treatment of psoriatic conditions in case reports of individuals with active malignancy.

Some autoimmune and inflammatory conditions that are treated by Otezla, such as psoriatic conditions and Bechet’s disease, are associated with an increased risk of cancer. More research is needed in this area.

How long do Otezla side effects last?

Most of the side effects (gastrointestinal problems and feelings of malaise) associated with Otezla use go away after several weeks of treatment. Immediate attention should be given to more serious side effects (severe allergic reaction, depression, and suicidal thoughts), as they may result in death.

Otezla contraindications and warnings

Otezla is not habit-forming or addictive. While there are no withdrawal symptoms associated with stopping this medication, there may be a return of the symptoms this medication was being used to treat.

In healthy adults, the maximum dosage of Otezla is 60 mg per day. For individuals with kidney disease, no more than 30 mg of Otezla should be taken per day. While it is unlikely that an overdose will result in imminent death, if too much medication is administered, seek medical care or contact the Poison Control Centers at 1-800-222-1222.

Restrictions

Otezla is contraindicated for use in individuals with a known allergy to this medication or to components of the medication. Otezla should be used with caution in the following groups of people:

Individuals with severe renal impairment

Severely decreased kidney function means that too much medication will build up in the blood. The dose should be decreased for individuals with severe renal impairment.

Pregnant women and breastfeeding mothers

There have been no adequately performed studies on the effects of Otezla on a developing fetus in pregnant women. In animal studies, Otezla showed an increase in miscarriage, fetal death, and skeletal abnormalities Women who may become pregnant should discuss these risks with a healthcare professional before starting treatment and consider using effective contraception during treatment.

There is a registry that monitors outcomes in pregnant women exposed to apremilast. Information about this registry can be obtained here or by calling 1-877-311-8972.

Apremilast was detected in the milk of lactating animals. Usually, when a drug is found in animal milk, it is also present in human breast milk. If breastfeeding, discuss the risks and benefits of treatment with a healthcare provider.

Otezla interactions

Otezla is not contraindicated for use with any medications, but there may be drug interactions if Otezla is taken with certain medications.

Taking Otezla with the following medications may result in Otezla being less effective:

Barbiturates
- Phenobarbital
- Thiopental
- Secobarbital
- Pentobarbital
- Mephobarbital
- Methohexital
- Butalbital
- Amobarbital
Carbamazepine
Phenytoin
Rifampin
St. John’s Wort

Tell your healthcare provider about all prescription and over-the-counter medications you are taking, including vitamins and supplements.

How to avoid Otezla side effects

1. It is important to follow medical advice while taking this medication.

Take only the dose prescribed by a healthcare professional. Do not take more medication and do not take less.

2. Take all of the doses how and when they are prescribed.

Otezla is often started slowly to reduce gastrointestinal side effects. It is important to follow this schedule. If there is a missed dose, take the next dose as soon as you remember. Patients should continue taking the medication as prescribed even if they feel well after the first few doses.

3. Do not stop this medication without seeking medical advice.

You should not stop taking this medication unless you and your healthcare provider have decided that is the right decision.

4. Patients should disclose a full medication list, all medical conditions, and any allergies before taking Otezla.

This includes all medications and supplements, medical conditions, and allergic reactions to medications in the past. It is important to share any previous history of depression or suicidal thoughts, as people have competed suicide while taking this medication.

5. Have a strong support system in place.

This medication is associated with an increased risk of depression and suicide. It is important to have a strong emotional support network of friends and family in place.6. Store this medication correctly and out of the reach of children.

Otezla should be stored at room temperature (68 to 77 degrees Fahrenheit). This medication should be stored away from children’s medications and out of the reach of children.

7. Swallow the tablet whole.

Do not crush, break or chew the tablet. This medication may be taken with or without food.

8. Individuals with severe renal impairment should take this medication in the morning.

Following a morning schedule allows you to watch for side effects from too much medication circulating in the blood.

9. Consider effective methods of contraception.

Use of this medication is associated with miscarriage and fetal death. Women of childbearing age should consider using appropriate contraception while taking this medication.

10. Monitor your weight.

This medication may be associated with unwanted weight loss. Check your weight regularly while taking Otezla. Your healthcare provider can adjust the dose of this medication or stop it if needed.

11. Seek medical attention for allergic reactions and severe side effects

Allergic reactions should be reported and treated right away. Any type of serious adverse effect or potential overdose should also receive medical attention immediately.