Maprotiline Side Effects

For the Consumer

Applies to maprotiline: oral tablet

In addition to its needed effects, some unwanted effects may be caused by maprotiline. In the event that any of these side effects do occur, they may require medical attention.

Severity: Moderate

If any of the following side effects occur while taking maprotiline, check with your doctor or nurse as soon as possible:

• Skin rash, redness, swelling, or itching

• Constipation (severe)
• nausea or vomiting
• shakiness or trembling
• seizures (convulsions)
• unusual excitement
• weight loss

• Breast enlargement—in males and females
• confusion (especially in the elderly)
• difficulty in urinating
• fainting
• hallucinations (seeing, hearing, or feeling things that are not there)
• inappropriate secretion of milk—in females
• irregular heartbeat (pounding, racing, skipping)
• sore throat and fever
• swelling of testicles
• yellow eyes or skin

• Convulsions (seizures)
• dizziness (severe)
• drowsiness (severe)
• fast or irregular heartbeat
• fever
• muscle stiffness or weakness (severe)
• restlessness or agitation
• trouble in breathing
• vomiting

Minor Side Effects

Some of the side effects that can occur with maprotiline 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:

• Blurred vision
• decreased sexual ability
• dizziness or lightheadedness (especially in the elderly)
• drowsiness
• dryness of mouth
• headache
• increased or decreased sexual drive
• tiredness or weakness

• Constipation (mild)
• diarrhea
• heartburn
• increased appetite and weight gain
• increased sensitivity of skin to sunlight
• increased sweating
• trouble in sleeping
• weight loss

Side Effects: Post Treatment

After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

For Healthcare Professionals

Applies to maprotiline: oral tablet

General

The most commonly reported side effects include dry mouth, drowsiness, and dizziness.^[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 22%)
Common (1% to 10%): Constipation, nausea
Rare (0.01% to 0.1%): Vomiting, epigastric distress, diarrhea, bitter taste, abdominal cramps, dysphagia, increased salivation
Frequency not reported: Sublingual adenitis, black tongue, stomatitis, paralytic ileus^[Ref]

Nervous system

Very common (10% or more): Drowsiness (up to 16%)
Common (1% to 10%): Dizziness, tremor, headache
Rare (0.01% to 0.1%): Decreased memory, numbness, tingling, motor hyperactivity, akathisia, EEG alterations, extrapyramidal symptoms, ataxia, dysarthria
Frequency not reported: Stroke, peripheral neuropathy^[Ref]

Psychiatric

Common (1% to 10%): Nervousness, anxiety, insomnia, agitation
Rare (0.01% to 0.1%): Confusional states, hallucinations, disorientation, delusions, restlessness, nightmares, hypomania, mania, psychosis exacerbation, feelings of unreality, decreased libido^[Ref]

Other

Common (1% to 10%): Weakness, fatigue
Rare (0.01% to 0.1%): Tinnitus, drug fever^[Ref]

Ocular

Common (1% to 10%): Blurred vision
Rare (0.01% to 0.1%): Accommodation disorder, mydriasis^[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Hypotension, hypertension, tachycardia, palpitation, arrhythmia, heart block, syncope, edema
Frequency not reported: Myocardial infarction^[Ref]

Dermatologic

Rare (0.01% to 0.1%): Skin rash, petechia, itching, photosensitization, excessive perspiration, flushing, alopecia
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis^[Ref]

Genitourinary

Rare (0.01% to 0.1%): Urinary retention, delayed micturition, impotence, urinary frequency
Frequency not reported: Breast enlargement (in women), galactorrhea, testicular swelling^[Ref]

Hepatic

Rare (0.01% to 0.1%): Altered liver function, jaundice
Postmarketing reports: Increased liver enzymes^[Ref]

Metabolic

Rare (0.01% to 0.1%): Elevation/depression of blood sugar levels, weight loss or gain^[Ref]

Respiratory

Rare (0.01% to 0.1%): Nasal congestion
Postmarketing reports: Interstitial pneumonitis^[Ref]

Interstitial pneumonitis was occasionally associated with eosinophilia and increased liver enzymes. However, no clear causal relationship to treatment has been established.^[Ref]

Hematologic

Frequency not reported: Bone marrow depression, agranulocytosis, eosinophilia, purpura, thrombocytopenia^[Ref]

Endocrine

Frequency not reported: Gynecomastia (in men)^[Ref]

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

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